Advanced medical post for 300 patients, of which 50% severe

• To manage medical, surgical, gynaecological/obstetrical and paediatric cases
• Severe patients must be stabilised and referred by ambulance to the hospital (2 hours drive)
• Exceptionally the patient can stay overnight
• No power
• Full treatment course for “green” ones
• 300 patients:
• 15% red = 45
• 25 % yellow = 75
• 10% black = 30
• 50% green = 150
• The presence of a medical doctor is required

It is composed of 3 parts

• Medical equipment
• Medicines and renewable medical supplies
• Complementary part if electricity available

The support activities Sterilisation and Pharmacy are mandatory in one of the 6 main activity focal points.

Boats and outboard motors selected by MSF are intended for emergency situations: as lightweight as possible, and simple to assemble and operate.

If you use water transport regularly in your mission, the appropriate choice of boat and engine is more complicated.

Ask your technical department for advice.

BUY OR RENT

The choice between purchase or rental is usually based on 3 criteria: availability, quality and price.

Availability

Compare the lead time to the requirement.

Quality

The technical standards used by those who sell or hire boats are not reliable measures of quality.

In case of rental, check that the boat is in good condition (engine, safety devices, fuel quality etc.) and that there is no repair required that could subsequently be attributed to lack of maintenance by MSF. Think about establishing a system of quality checks and carry out regular assessments (once a year).

In case of purchase, try to follow the general specifications given below.

In either case, ask your technical department for advice, and if possible ask other organizations about their experiences.

Cost

In case of rental, the decisive point is not the price, but the quality! Choose a company that offers good quality over one that offers the lowest price.

In case of purchase, costs are important, especially the initial investment. Make a proposal to the financial coordinator. The higher the initial investment, the longer it will take to recover the cost.

EFFICIENCY

Water transport by slow vessel is the most energy-efficient. "Slow" corresponds to the hull's displacement speed (also known as "hull speed"), expressed as follows:

S = 4.5 x the square root of L

S = displacement speed in km/h

L = waterline length of the boat in m

If a higher speed is required, the fuel consumption will increase drastically. At a certain point, the bottom of the boat – if it is designed for this purpose – will rise to the surface of the water as a result of its speed: this is known as planing. Once the boat is planing, the fuel consumption will drop, but it will stay far above the consumption of a slow vessel.

Planing starts at about 25 km/h, depending on hull design and total weight.

For each boat design, the manufacturer or supplier produces a graph showing estimated speeds and a curve plotting weight against required engine horsepower. These graphs also indicate the planing speeds.

CHOICE OF BOAT

Before choosing a boat, it is essential to assess the requirements and conditions of use.

The type of propulsion, the shape, the size and the weight of the boat will be determined by:

• the environment: river with clear or turbid water, or with floating or submerged objects (tree trunks etc.); fresh or brackish water, or coastal salt water; shallow or deep water etc.
• the required payload
• the required speed
• the required range
• the engine selected (see "choice of engine" below)

A long wooden canoe (± 15 metre) equipped with a small 25 HP outboard motor is a good example. It has good energy efficiency, good payload and reasonably good speed (close to 20 km/h).

Such a canoe can easily carry 500 kg of cargo, 200 litre of fuel and 8 people for about US $0.20/km.

STANDARDIZATION AND LOCAL MARKET

Choice of engine

Most MSF boats have outboard engines.

Two-stroke outboard engines have the advantage of being simple, lightweight, reliable and efficient. They are also easy to maintain and can be repaired almost everywhere. However, it is likely that two-stroke engines will gradually disappear from the market and be replaced by four-stroke engines. Two strokes engines are more and more difficult to find, report to your supply center for availability.

Four-stroke outboards are less noisy and have a greater range and longer lifespan. They are more demanding to maintain, slightly heavier and more expensive, but they are the most economic engines in the short and medium term.

Four-stroke outboards are therefore preferable if they are available locally. However, you should be aware that introducing them often leads to difficulties and negative feedback from local people and boat drivers, hence the importance of proper training.

If you opt for an inboard engine, choose a diesel model rather than a petrol one. Inboards are the most economic engines in the long term.

Choice of propeller

Due to the wide variety of types and sizes available, it is very important to make the correct choice. There is a wide variety of types and sizes available. The standard propeller delivered with any outboard engine is a three blade aluminium propeller with a pitch intended to be used on a fast (light) boat. Aluminium propellers are cheaper compared to stainless steel ones that last longer. If you want to use the outboard engine on a slow boat, ask for advice from the supplier or your support department. An incorrect match of propeller, engine and boat will result in high costs and reduced lifespan.

"Water jet" propulsion is another option; it should be limited to inboard engines and to boats operating in shallow water. Water jet propulsion provides better manoeuvrability, but is less efficient.

Choice of hull

For slow boats, the weight is not very important. Hulls are often made of wood or steel.

For fast boats, weight is an important factor in fuel consumption and costs. Ranked according to increasing weight, the options for fast boats are:

• welded aluminium
• glass reinforced plastic (GRP)
• welded steel

Provided that the boat is suitable for the context and that all materials meet our requirements, the choice will be determined by the local availability of repair facilities.

When you buy a boat

Enquire about the local boatyard's quality and reliability. Test a boat which is equivalent to the one you intend to buy, with the same engine and same power.

Order the boat with an engine, sold and fitted by the boatyard. If this is not possible, or if you decide to order the engine from a different supplier, follow the boatyard's recommendations and make it responsible for the final functioning of the boat/engine combination.

Do not forget to specify the propeller you have chosen in the order or quotation request, and to include a fuel tank, buoyancy chambers etc.

The central masterdata system, UniData is implemented with some new codification rules.

The diverse code or “Z-code”, created by the OC’s (Operational Centers) and ESC’s (European Supply Centers) disappeared and are replaced by the code structure of a standard article. It will still be possible to make the difference between a standard, a non-standard code and a non-standard local code with another attribute directly linked to the code.

• STD = standard article ( = validated by the 5 OC’s)
• NST = non-standard article ( = not validated by the 5 OC’s but used by one or few operational centres)
• NSL = non-standard local article ( = validated by one or few operational centres and purchased locally due to country constraints)

A DIVERSE CODE (Z-code) was used in the past for the creation of LOCAL codes. It has a similar structure as the standard codes that allow classifying the referred article according to GROUP and FAMILY (as for a standard article), while clearly indicating who created it:

Places of issue for diverse codes:

• KE MSF in Nairobi
• SL MSF in Sierra Leone...

There are no LOCAL CODES in the catalogues, but they may appear in order tools.

The local codes are nowadays integrated in UniData following the same codification rules as the standard and non-standard codes (regular codes). The diverse codes (Z-codes) are progressively disappearing.

For some groups of articles MSF chooses to work with a manufacturer (supplier) code instead of setting up an MSF code when it fits the following criteria

• technical complexity of the assortment
• clear codification of maximum 16 characters set up by the manufacturer with a good documentation reference, that can easily be consulted (catalogue or online)
• many articles concerning the same purpose or main article

On logistical side this is the case for articles such as Toyota spare parts.

On medical side this it the case for articles used for internal fixation: Stryker system and Nail of Sign.

These specific codes, called free codes, are built up with an MSF group and family followed by the manufacturer’s code which could be up to 16 characters long.

Example:

CORTICAL SCREW, self tapping, full thread, Ø4.5 x 24 mm (STRY340624);

V-BELT fan and alternator, PZ-HZJ78/79, pair (YTOY90916-02452).

A code allows ordering an article without any ambiguity on what is requested and helps to streamline the supply chain. MSF has created an international codification based on the article’s English label, and is significant so that codes itself “tells” what is being ordered.

With the central masterdata system, UniData, both types of articles, standard and non-standard are codified with the following set of codification rules. An MSF code is composed of min 11 and max 13 alphanumerical characters and structured in 4 subdivisions.

In the order tools, the code of the article is followed by the attribute indicating the standardization level.

• STD = standard article ( = validated by the 5 operational centres = OC’s)
• NST = non-standard article (= not validated by the 5 OC’s but used by one or few operational centres)
• NSL = non-standard local article ( = validated by one or few OC’s and purchased locally due to country constraints).

The MSF catalogues include only STD articles.

1. THE GROUP SUBDIVISION

The GROUP is defined by 1 character which identifies a functional category. Some groups are exclusively medical and others exclusively logistic, while group K (kits) contains both categories.

9 groups have been defined:

2. THE FAMILY SUBDIVISION

The FAMILY is defined by 3 characters which identify a speciality within a group. A family is either exclusively medical, exclusively logistical or exclusively library, except the leaflets family (LEAF) which is both: medical and logistical.

Medical families

Logistical families

Field Library families

3. THE ROOT SUBDIVISION

The ROOT is defined by 4 characters and is built from the article’s English label or description.

E.g.: CLOXACILLIN, 250 mg, caps => CLOX

A same root can belong to several families:

E.g.: CLOXACILLIN, 250 mg, caps => DORA CLOX

CLOXACILLIN, 500 mg, powder, vial => DINJ CLOX

NB: When an article’s label starts with the letter “Z”, the first character of its root will be “Y” to prevent any confusion with the “local code”.

Electro-mechanical equipment and their accessories, consumables and spare-parts are identified with a root of 3 letters followed by a letter E for equipment, A for accessory, C for consumable, S for spare-part and T for test/control.

See introduction on Electro mechanical medical devices in Medical Catalogue Volume 3

4. THE SPECIFICATION SUBDIVISION

The SPECIFICATION is defined by 3 to 5 characters and allows the differentiation of two similar articles. These specifications are often significant and follow the rules set-up for that specific root.

The Delivery part of the hospital kit is a complementary part to the ward.

• Material to perform about 50 deliveries
• Material for the care of 5 neonates
• All furniture is optional (delivery table, examination table, Mayo table, stretcher, stool, infant warmer)

It is composed of two main parts:

• Medical equipment
• Medicines and renewable medical supplies

1. VISION

SPINCO is the driver for effective collaboration across the movement to deliver a central source of trusted product information that enables continuous process improvements.

SPINCO is the unit of MSF that was proposed and developed by the logistics and medical departments with the name ITC. The International Technical Coordination was officially recognised at International level in 1994 to maintain consistency in the choice of medical and non-medical articles between MSF sections in order to improve MSF interventions, while taking into account field realities. In 2006 ITC was integrated into MSF International.

The core role is coordinating the expression of the demand of articles (medical and non medical) and ensure it is properly translated for supply whose role is to fulfil that demand. For the last 25 years, SPINCO (former ITC) has been coordinating, producing and dispatching MSF catalogues within the movement which have been developed over all these years to be aligned with the operational needs in the field.

In 2016 UniData has been implemented, which is the unique central article database of MSF that contains all the products created in MSF, avoiding duplication, improving the articles description. Therefore, it provides visibility on the expression of the demand and helps streamlining supply chain processes. UniData details standard, non-standard and non-standard local products, with their descriptions, available for the field and shares article changes with the MSF movement.

SPINCO has been continuously implementing new tools and projects according to operational field priorities. Whilst the focus remains on making the product information available, by integrating UniData with systems and tools across MSF, UniData brings us up to date with the today’s way of working.

2. MISSION

The mission of SPINCO is fourfold:

Social Mission Focus

To contribute towards MSF’s social mission by enabling improvements to field operations through the provision of product information to all layers in the organisation. This enables product quality and visibility for better quality of care, enables assortment management, improves supply chain performance and increases overall interoperability whilst reducing duplications of effort.

Governance

To continuously improve the quality of product information by developing and enforcing information governance rules, definitions and processes. This is done in close cooperation with multiple stakeholders in the domains of Operations, Medical, Logistics and Supply.

Information management

To provide a single source of truth for the product information and ensure that it is available in real time throughout the MSF movement and is accessible together with supporting information via a centralised point.

Co-ordination & Expertise

To provide expertise through product knowledge, services and tools that enable technical integration between the SPINCO systems & tools that manage the information and the MSF systems & tools used in assortment management, supply chain management and other processes for which information managed in SPINCO systems is needed.

INTRODUCTION

Cytotoxic drugs are toxic compounds and are known to be carcinogenic, mutagenic and/or teratogenic. On direct contact, they may cause skin, eyes, and mucous membranes irritation, as well as tissue ulceration and necrosis. The toxicity of cytotoxic drugs makes it necessary to minimise the exposure of health-care workers to these drugs. The handling and administration of cytotoxic drugs should not be carried out by pregnant staff. At the same time, aseptic conditions should be maintained.

In order to highlight the danger of cytotoxic materials, the following signs are used:

• In some countries, it is mandatory that cytotoxic drugs and their waste are properly identified with the capital “C” symbol and, under it, the words “CYTOTOXIC /CYTOTOXIQUE “ in capital letters, and the both words and the symbol should appear on a dark grey rectangle.
• This sign will be added to the cytotoxic drugs in the MSF catalogue.

• Cytotoxic materials can also be identified by a purple symbol representing a cell in the late phase of division know as telophase. The labels are dark purple and bear the telophase symbol.

CYTOTOXIC DRUGS IN THE MSF STANDARD LIST (ACCORDING WHO CLASSIFICATION)

http://www.whocc.no/atc_ddd_index/?code=L01D&showdescription=no

GENERAL RULES

• Provide safety measures (equipment, protocols, instructions) in all areas where cytotoxic drugs are stored, handled, prepared, administered and disposed of.
• Handling and movement should be kept to a minimum from reception to preparation.
• Medicines should be kept in their original secondary or tertiary packaging (sealed plastic bag and/or carton), as the outside of many commercial medicine vials may be contaminated and present an exposure risk to anyone handling the vials.
• Cytotoxic vials are usually well packed by pharmaceutical companies and therefore no specific PPE (Personal Protective Equipment) is required for staff transporting cytotoxic agents as long as they are still packaged in their original packaging and show no signs of damage or leakage.
• When transporting vials that have not yet been opened, but are no longer in their original packaging, use protective gloves (nitrile, powder-free).
• As damage or leakage can only be detected by picking up the product, it may be advisable to use gloves when handling cytotoxic agents.
• Centralise the preparation of cytotoxic agents
• One single person should transport all cytotoxic drugs needed for the next 24 hours from the pharmacy to preparation area at one time.
• Prepare the drugs in one place.
• Provide safety equipment (see below) in all areas where cytotoxic drugs are stored, handled, prepared or administered.
• Easily visible posters with protocols/instructions describing how to manage cytotoxic drug spills should be available on the wards and are part of nursing care.
• The following materials should be present (or readily available):
• Cytotoxic Spill Kit containing all PPE and materials needed to clean up spills.
• Running water supply + soft soap.
• Device for eye wash (EMEQEYEW7++) (or alternatively 1l of 0.9% NaCl + 60ml syringe Luer (SINSSYDL60-) or infusion set (SINSSETI2-).
• Movement of cytotoxic drugs should be limited and rationalised. All transports should be coordinated from departure up to the arrival. The TREM card (transport emergency card) and MSDS (material safety data sheet) sheet should be prepared and given to the driver to facilitate transport through customs or by air.

RECEPTION AND STORAGE OF CYTOTOXIC DRUGS

• Ensure that the cytotoxic drugs are stored under the correct storage conditions, according to the manufacturer's requirements. Be aware that storage conditions for the same product may vary from manufacturer to manufacturer.
• Centralise the storage of cytotoxic drugs in the main pharmacy, avoid storage in the preparation room.
• Cytotoxic drugs should NOT be stored near or on top of other medicines or medical equipment, but in a secure manner, limiting the risk of breakage and allowing spillage to be contained, with clear visible labelling.
• The best storage option is a closed cupboard, lower shelves can be an alternative.
• Add arrows on the outside of the boxes to indicate how the box should be stored (to avoid it turning upside down), add a "hazardous" sticker to the box and make sure that the labels are understood by all staff involved in handling of these products.
• Reception: visually check that there has been no damage or leakage during transport. In case of damage or leakage, appropriate PPE should be worn and appropriate actions taken.

CYTOTOXIC SPILL KIT

All areas where cytotoxic substances are being used shall have a Cytotoxic Spill Kit available at all times. All staff involved in handling cytotoxic drugs and waste should be trained in spill management and decontamination. A ready-to-use cytotoxic spill kit can be ordered (SDDCCYTTS2-).

• PPE
• 1 surgical cap (ELINCADS1S-)
• 1 pair of shoe cove (ELINSHOC001)
• 4 pairs of of long-sleeved nitrile examination gloves (SMSUGLEN1+++): inner and outer pair, for 2 persons
• 2 respirators FFP2 (ELINMASP+++)
• 2 protective glasses (SPPEGOGPR++)
• 1 non-woven surgical gown (ELINGOWS+++)
• Pean forceps (ESURFOAP14S) or standard dressing forceps (ESURFODR14-) for collecting glass from broken ampoules or vials.
• Single use plastic sharps container (SINSCONT2P-).
• Disposable absorbent material : cotton roll, compresses, toilet paper, kitchen paper. Enough to absorb 1 litre.
• Absorbent towel with waterproof layer (ELINDRAW6D-)
• Disposable cleaning cloths (towels).
• Liquid soap (for cleaning the floor).
• 3 plastic bags:
• one for contaminated absorbent material and cleaning materials
• one for disposable protective clothing
• one for protective goggles which should be washed after use.
• 1 biohazardous waste bag (ELABBAGR001) to place the first two bagsç.
• Instruction card for safety mopping up spills on surfaces.
• Instruction card for wearing / removing PPE.

Remark on gloves

All gloves have some degree of permeability to cytotoxic drugs. This permeability increases over time. Vinyl and latex surgical gloves should not be used as they do not provide the required level of protection.

Gloves should be:

• Made of materials that minimise drug permeability e.g. nitrile, polyurethane or neoprene
• Powder-free: powder can absorb contaminants, leading to aerosolisation and an increased risk of contact contamination
• Long enough to cover the gowns when the wearer's arm is fully extended

SPILL MANAGEMENT

A system should be in place to report spills or contamination of staff as soon as possible. The following information should be included in an incident report:

• the type of incident
• the actions taken to manage the spill
• the actions taken to prevent recurrence

PROCEDURE FOR LARGE SPILLS

• Alert to notify people in the immediate vicinity that a hazardous spill has occurred and direct them to stay clear. Call for assistance of an additional person to give material, read the instruction cards, handle the waste bag.
• Cordon off the area. If possible, close windows and doors.
• Turn off any fans which may spread the spill or aerosols.
• Open the Cytotoxic Spill Kit.
• Display hazard sign(s) around perimeter of spills.
• Don PPE in the following order:
• respiratory protection
• goggles
• cap
• 1^st pair of gloves
• gown
• overshoes
• 2^nd pair of glove
• the assistant should also wear two pairs of gloves + goggles + respiratory protection
• Contain the spill:
• For a liquid spill: cover the spill with absorbent waterproof plastic-lined towel.
• For a powder spill: cover the spill with absorbent towel ensuring minimal dust production. Carefully wet the the towel with water (without flooding so that the powder dissolves and is absorbed by the towel).
• Using the scoop and scraper, gather the absorbed material and collect any broken glass.
• Discard collected cleaning materials into the 1^st plastic bag held by the assistant.
• Do NOT handle sharps/glass with your hands! Use forceps or tweezers to carefully dispose of needles and glass into the sharps container.
• Wash several times the area with water and detergent and rinse thoroughly several time with water. Always work from the outside of the spill towards the centre.
• Remove PPE in the following order:
• outer gloves
• overshoes
• gown
• goggles
• cap
• respiratory protection
• inner gloves
• place used disposable items into the 2^nd plastic bag.
• place the protective glasses into the 3^rd bag (for cleaning).
• The assistant (still wearing PPE) closes the first two plastic bags and places them into the "biohazard" bag.
• The assistant removes his PPE and adds the single-use PPE in the "biohazard" bag.
• Wash hands with soap and water.
• Goggles should be washed in hot soapy water while wearing non-sterile gloves, then dried with paper towels (discard paper towels into the "biohazard" bag).
• Place the "biohazard" bag into the appropriate hazardous waste bin.
• Contact the waste or Watsan manager responsible for transport and disposal.
• Replace Cytotoxic Spill Kit.

PROCEDURE FOR SMALL SPILLS:
DROPS OR SPLASHES ON EQUIPMENT / FURNITURE / FLOOR

• If not already done, don PPE (see above).
• Cover the area immediately with absorbent material.
• If the spill involves a powder, cover gently with an absorbent towel ensuring minimal dust production, then, wet the towel so that the powder dissolves and is absorbed by the towel.
• Collect absorbed material, being careful to pick up any broken glass with a forceps.
• Discard collected waste into appropriate waste bin (solid container dedicated to cytotoxic waste: vials, needles etc.).
• Wash the area with water and detergent and rinse thoroughly several times with water.
• Dry the area with absorbent towels or cloths.
• Discard the waste into the cytotoxic waste bin.
• Change gloves.

MANAGEMENT OF ACCIDENTAL EXPOSURE TO CYTOTOXIC SUBSTANCES

• Inhalation of drug aerosols, dust, powder or droplets. When opening the vial or handling the drug, inhalation of large quantities is unlikely (small vial size). In case of respiratory symptoms, move the victim away from source into fresh air
• Skin exposure: splashes, drops or contaminated surface on healthy skin or wound may cause irritation, allergic reaction, itching and burning, skin lesions (more with vincristine). Remove any contaminated clothing / shoes immediately. Flush the skin of the affected area with a large volume of water for 10-20 minutes, then thoroughly wash with soap and rinse with running water. If skin is damaged, apply a clean dressing.
• Eyes contact: flush the eyes with a large volume of water or normal saline eye drops for at least 15-20 minutes. Seek immediate medical attention. If gloves are worn, remove them before flushing the eyes as they may be contaminated. If contact lenses are worn, remove them immediately before flushing.
• Ingestion of splashes, contaminated food or drink or hand-to-mouth contact (unlikely). Do not induce vomiting.
• All contaminated clothing should be removed and discarded in the "biohazard" waste bag if it is to be disposed of. For clothing that is not to be discarded, wash separately in hot water, and repeat washing.

See also: Hazardous waste management of health structures within low-income Countries, MSF, 2013, 3rd edition.

Contact your section pharmacist for more details.

Definition

The EEMD (Electro mechanical medical devices) family includes medical equipment and their accessories, consumables and spare-parts that operate on electrical energy and/or through some integrated physical mechanism or machinery (mechanical).

MSF guide

See the MSF guide that each mission should have and read!

• Medical equipment management guideline, MSF, 2021

MSF codification

Each type of equipment is identified with a specific root of 3 letters

• +E for the equipment = Medical devices requiring calibration, maintenance, repair, user training and decommissioning (the machine, the apparatus, also called parent device)
• +A for the accessories = Supplementary reusable parts or devices, used in combination with an item of medical equipment, to provide specific or additional functionality (e.g. ultrasound probes, barcode scanner, transport bag, warming sleeve).
• +C for the related consumables = Items requiring periodic replacement. Replacement can be required in order to reduce cross-infection risks (e.g. cannula, mask, anti-bacterial filter, syringe, tubing, etc.) or to ensure continued performance of the device (e.g. air (dust) filters, gaskets, etc.)
• +S for the different spare-parts = Integral components which are replaced in order to restore functioning, safety or physical integrity of the equipment. Spare parts can either be purchased new or, when within manufacturers tolerances and local legislation, be removed and retained for future use during decommissioning of equipment.

Further specification of the code: qualifier per brand, by sequential counting/numbering.

The person defining the needs of the accessories, consumables and spare-parts is

• for accessories => medical staff
• for consumables => logistical or medical staff, depending on the type of consumable: for use (medical) or for technical maintenance (logistical)
• for spare-parts => logistical staff

MSF articles

The different roots for the standard equipment are

Other families do also contain electro mechanical medical devices: EANE, EDIM, ELAE, ESTE.

Components of equipment

When ordering medical equipment EEMD***E, certain accessories and consumables are delivered with the equipment: they are listed in the technical sheet under “components” and/or “supplied with the article”. These additions are supplied by the manufacturer and/or compiled by the MSF Supply Centres (ESC's) to go with the equipment. This ensures that the equipment can be used correctly upon arrival in the MSF project.

Norms

General standard

IEC = International Electrotechnical Commission

IEC 60601-1 Edition 3.1 (or IEC 60601-1:2005+AMD1:2012 +AMD2:2020) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

• IEC 60601-1 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission
• It concerns any type of medical electrical equipment without distinction
• It is presented in ten sections
• General: Scope and purpose of the standard. Terminology and definitions, general characteristics of devices.
• Environmental conditions
• Protection against electric shock
• Protection against mechanical shock
• Protection against risks due to unwanted or excessive radiation
• Protection against ignition hazards of flammable anesthetic mixtures
• Protection against excessive temperatures and other risks.
• Accuracy of operating characteristics and protection against hazardous output characteristics.
• Abnormal operation and fault conditions, environmental testing.
• Construction rules

The European EN version of the standard is identical to the IEC standard.

The equipment and all accessories selected by MSF are tested according the primary standard governing medical device design.

Collateral standards

Collateral standards (numbered 60601-1-X) define the requirements for certain aspects of safety and performance, or protection for diagnostic use of X-rays.

• IEC 60601-1-2: Electromagnetic disturbances - Requirements and tests
• IEC 60601-1-3: Radiation protection in diagnostic X-ray equipment
• IEC 60601-1-6: Usability
• IEC 60601-1-8: General requirements, tests and guidance for alarm systems
• IEC 60601-1-9: Requirements for environmentally conscious design
• IEC 60601-1-10: Requirements for the development of physiologic closed-loop controllers
• IEC 60601-1-12: Requirements for medical electrical equipment/systems intended for use in the emergency medical services environment

Particular standards

Particular standards for the medical electrical equipment, numbered 60601-2-X / 80601-2-X define the requirements for specific products or specific measurements built into products. These quality standards are listed in the technical sheets per equipment under the “norms”.

• EN 60601-2-2 : Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
• EN 60601-2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
• EN 60601-2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
• EN 60601-2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
• EN 80601-2-12: Particular requirements for basic safety and essential performance of critical care ventilators
• EN 80601-2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
• EN 60601-2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
• EN 60601-2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
• EN 60601-2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
• EN 60601-2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
• EN 60601-2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
• EN 80601-2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
• EN 60601-2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
• EN 80601-2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
• EN 60601-2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
• EN 60601-2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis
• EN 60601-2-43 : Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
• EN 60601-2-46: Particular requirements for the basic safety and essential performance of operating tables
• EN 80601-2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
• EN 60601-2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
• EN 60601-2-52: Particular requirements for basic safety and essential performance of medical beds
• EN 60601-2-54 : Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy electrocardiographs
• EN 80601-2-55 : Particular requirements for the basic safety and essential performance of respiratory gas monitors
• EN 80601-2-56 : Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
• EN 60601-2-57 : Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
• EN 80601-2-61 : Particular requirements for basic safety and essential performance of pulse oximeter equipment
• EN 80601-2-67 : Particular requirements for basic safety and essential performance of oxygen-conserving equipment
• EN 80601-2-69 : Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
• EN 80601-2-74 : Particular requirements for basic safety and essential performance of respiratory humidifying equipment
• EN 80601-2-79 : Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
• EN 80601-2-80 : Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
• EN 80601-2-84: Medical electrical equipment — Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment

Protection against electric shocks‌

The IEC 60601-1 standard has a significant impact on the product development process, going beyond performance test and verification. This is because product complexity generally yields innumerable potential test cases, permutations, and combinations in both normal and abnormal operating modes, and these cannot be assessed in the final design alone.

While power supplies by themselves are not medical devices and, are therefore, not directly covered by the IEC 60606-1 standard, they are nevertheless integral to the design and operation of medical equipment.

Protection method

All electrical equipment is categorised into classes according to the method of protection against electric shock that is used.This decribes the way the electric equipment is protected agains electric shocks: by being connected to the ground, by double casing ….

For mains powered electrical equipment there are usually two levels of protection used, called "basic" and "supplementary" protection. The supplementary protection is intended to come into action in the event of failure of the basic protection.

• Class I equipment: insulation between live parts and exposed conductive parts with supplementary protection: 3^rd protective earth reference point. Symbols seen on earthed equipment
• Class II equipment: Reinforced insulation or double insulation
• Class III equipment: internal power supply or SELV, Very Low Voltage Safety:
• Max 25 V AC (alternating current)
• Max 60 V DC (direct current)

Degree of protection

The degree of protection for medical electrical equipment is defined by the type designation. The reason for the existence of type designations is that different pieces of medical electrical equipment have different areas of application and therefore different electrical safety requirements.

B, BF or CF are classifications of applied parts = parts of the medical device which come in physical contact with the patient.

Types are assigned according to the level of protection to leakage currents

• Type B
• B = "Body"
• equipment operates within a 2 meter radius from the patient but without patient contact
• medical device with non-floating inputs
• average level of electrical protection of the patient
• Type BF
• BF = "Body Floating"
• equipment makes physical contact with the patient
• medical device with floating inputs
• average level of electrical protection of the patient
• CF type
• CF = "Cardiac Floating"
• makes physical contact with the heart
• medical device with floating inputs
• high level of electrical protection of the patient

Degrees of protection provided by enclosures (IP Code)

IEC 60529:1989+AMD1:1999+AMD2:2013

The different degrees of protection described in the standard are

• protection of persons against access to hazardous parts inside the enclosure
• protection of the equipment inside the enclosure against ingress of solid foreign objects
• protection of the equipment inside the enclosure against harmful effects due to the ingress of water

The protection index (IP) indicates the degree of protection of a material against the ingress of solids and liquids.

The format of the index, given by the IEC 60529 standard, is IPyy where the characters y are two numbers and/or a letter. The numbers indicate compliance with the conditions summarised in the tables below. Where no criteria are met, the number may be replaced by the letter X.

Protection against ingress of solid foreign bodies

Protection against ingress of liquids

Protection against access to hazardous parts

Waste of electrical and electronic equipment (WEEE)

WEEE is a complex mixture of materials and components that because of their hazardous content, and if not properly managed, can cause major environmental and health problems. Moreover, the production of modern electronics requires the use of scarce and expensive resources. To improve the environmental management of WEEE and to contribute to a circular economy and enhance resource efficiency the improvement of collection, treatment and recycling of electronics at the end of their life is essential.

To address these problems pieces of EU legislation have been put in place:

• The Directive on waste electrical and electronic equipment (Directive 2012/19/EU = WEEE Directive) which sets collection, recycling and recovery targets for electrical goods.
• The Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS Directive) which specifies maximum levels for 10 substances (heavy metals and phthalates)

Substances subject to limitations as referred to in Article 4 (1) and maximum concentration values by weight in homogeneous materials

• Lead (0.1%)
• Mercury (0.1%)
• Cadmium (0.01%)
• Hexavalent chromium (0.1%)
• Polybrominated biphenyls (PBB) (0.1%)
• Polybrominated diphenyl ethers (PBDEs) (0.1%)

Regarding the disposal of the equipment / apparatus: it must be dismantled and all pieces must be segregated based on matter used: plastic, metallic (iron, aluminium, ...), electronic

• WARNING: All electronic parts are classified as WEEE, sub-category of Hazardous waste.
• Most of consumables can be burnt in a normal incinerator.

Contact your WatSan and Biomedical advisors to receive the detailled procedure about management of each waste parts.

Quality standards related to batteries

• IEC 62133, 2017: Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 1: Nickel systems, Part2: Lithium systems​ (AMD1:2021)

The use of batteries in medical equipment

Types of batteries

Transport of batteries

US Regulations for batteries: all batteries, regardless of chemistry (e.g., alkaline, lithium, lead, nickel metal hydride, carbon zinc, etc., or battery powered products) are subject to 49 CFR 173.21(c) in the U.S. hazardous materials regulations.

Lithium ion and lithium metal cells and batteries

Lithium ion and lithium metal cells and batteries are subject to specific packaging, marking, labeling, and shipping paper requirements.

The regulations that govern the transport of lithium ion and lithium metal cells and batteries are very complex.

Classification (DGR 3.9.2.6): Lithium batteries are classified in Class 9 – Miscellaneous dangerous goods as:

• UN 3090, Lithium metal batteries; and
• UN 3480, Lithium ion batteries

or, if inside a piece of equipment or packed separately with a piece of equipment to power that equipment as:

• UN 3091, Lithium metal batteries contained in or packed with equipment; and
• UN 3481, Lithium ion batteries contained in or packed with equipment.

Since 2016, all lithium ion cells and batteries (UN 3480) and lithium metal cells and batteries (UN 3090) shipped by themselves are forbidden for transport as cargo on passenger planes. Transporting the batteries is organized by Packaging Instructions (PI) numbers. All packages must bear a «Cargo Aircraft Only» label, in addition to existing marks and/or labels.

Lead acid batteries

Lead acid batteries are listed as Class 8 Corrosive hazardous materials in the U.S. and international hazardous materials (dangerous goods) regulations (IATA) and also are subject to specific packaging, marking, labeling, and shipping paper requirements. “Nonspillable” lead acid batteries are provided an “exception” to the regulations if certain testing and marking requirements are met.

“Dry cell” batteries

“Dry cell” batteries, such as alkaline, nickel cadmium, and carbon zinc are not listed as hazardous materials or dangerous goods in the U.S. and international regulations. However, the batteries must be packed in a manner that prevents the generation of a dangerous quantity of heat and short circuits and packaged in strong outer packaging.

Nickel metal hydride batteries

Nickel metal hydride batteries are listed as Class 9 hazardous materials/dangerous goods (UN3496). When shipped by vessel in quantities over 100 kg they must be shipped as fully-regulated Class 9 hazardous materials/dangerous goods. In all other cases (when shipped via road, rail and air), they may be offered as dry cell batteries in accordance with the applicable Special Provisions.

Handling used batteries

The Batteries Directive 2006/66/EC (consolidated version in 2018): it intends to contribute to the protection, preservation and improvement of the quality of the environment by minimising the negative impact of batteries and accumulators and waste batteries and accumulators.

Properly use and dispose of batteries or they may leak or explode

Lithium batteries may present a fire or chemical burn hazard if mistreated. Do not disassemble, heat above 100°C (212°F) or incinerate. Dispose of used cells promptly.

Emergency room for 300 patients and 4 beds/boxes:

• General emergencies: medical, surgical, gynaecological/obstetric, paediatric
• The patient receives only the first dose of treatment (it is not an OPD = outpatient department)
• The patient is referred rapidly to one of the hospital wards
• A medical doctor trained in the management of complicated emergencies must be present.

It is composed of 2 parts

• Medical equipment
• Medicines and renewable medical supplies

The support activities Sterilisation and Pharmacy are mandatory in one of the 6 main activity focal points.

The deterioration of medicines varies according to the product, the manufacturing technique, the quality of the raw material, the excipients, etc. But, it is also linked to storage conditions. The shelf-life of a product is based on an average rate of deterioration under standard conditions of temperature, humidity and light corresponding to the International Conference on Harmonisation (ICH) limits for the climatic zone where the medicine is to be marketed. The expiry date is set such that under those conditions, the therapeutic effectiveness remains unchanged (at least 90% of the active ingredients must be present) and there is no substantial increase in toxicity.

Quality is defined as “the suitability of a pharmaceutical product for its intended use”. Each medicine intended for a patient must be of acceptable quality: conform to its specifications (identity, purity and other characteristics), safe, and effective.

If a medicine does not meet the established quality standards, the possible consequences are:

• lack of therapeutic effect leading to prolonged illness or death,
• toxic and adverse reactions,
• waste of financial resources, and
• loss of patients confidence

The quality of pharmaceutical products is affected by raw materials, the manufacturing process, packaging, transport and storage conditions; these influences may be cumulative.

Stability is defined as “the extent to which a product retains, within specified limits, and throughout its period of storage and use (i.e., its shelf-life), the same properties and characteristics as it possessed at the time of its manufacture” (USP 37).

EXPIRY DATE

Even when stored under appropriate conditions, medicines gradually deteriorate through various processes.

In most countries, manufacturers are required by law to study the stability of their products under standardised and exaggerated environmental conditions. These studies allow the manufacturer to select the optimal formulation and packaging and to assign recommended storage conditions and an expiry date for each dosage form in its packaging.

The manufacturer’s expiry date is the expiry date of the unopened container.

The International Conference on Harmonisation (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use guidance document defines shelf-life as: “The period of time during which a pharmaceutical product is expected to remain within the approved shelf-life specification, provided it is stored under the conditions defined on the container label.”

Most pharmaceutical products have a shelf-life of 3 to 5 years. Those containing less stable substances are only guaranteed for 1 or 2 years.

Practical definition of shelf-life: time between the date of manufacture and the expiry date.

For products sent to the field, the remaining shelf-life should be at least 1/3 of the total shelf-life. (Note that this means 1/3 at the time the product is released from stock. Transport and handling may also take some time). Medical kits only have 6 months of remaining shelf-life, therefore they should only be ordered for an emergency situation (not for EPREP stock).

The expiry date is clearly indicated on the primary (immediate) packaging as well as the secondary packaging:

The UK MHRA’s advice to pharmaceutical manufacturers is: the term ‘expiry date’ should be taken to mean that the product should not be used after the end of the month stated. Therefore, an expiry date of 12/2025 means that the product should not be used after 31 December 2025.

However, according to the UK Royal Pharmaceutical Society (RPS), where a product states ‘Use by’ or ‘Use before’, this means that the product should be used before the end of the previous month. For example, ‘Use by 06/2025’ means that the product should not be used after 31 May 2025.

Caution

Be careful not to confuse date of manufacture with expiry date (“Exp. Date”).

SHELF-LIFE - IN-USE SHELF-LIFE

After opening a multi-dose drug container, the drug will be exposed to the environment and the shelf-life might be shorter due to repeated opening and closing which may pose a risk of microbiological contamination and/or physico-chemical degradation. This risk is especially high in the case of bulk packaging and for certain categories of medicines such as anti-tuberculosis medicines which are particularly sensitive to the effects of temperature and humidity.

Additionally, some oral or injectable multi-dose products are formulated as powders that must be reconstituted before use. Reconstituted powders may undergo significant hydrolysis after reconstitution and therefore have a limited shelf-life. Some will need to be refrigerated. For non-sterile medicines, always check the manufacturer's leaflet for information on the in-use shelf-life and if present, use the manufacturer’s information. If not, use the table below. Write the date the product was opened and the new expiry date on the medicine label (or on the outer packaging if there is not enough space).

Notes:

• For sterile products: any remaining content should be discarded immediately after the first use.
• Ointments are semi-solid, greasy preparations for application to the skin or mucous membranes.
• Creams are similar to ointments, but contain an aqueous phase (and are therefore more prone to microbiological contamination).
• Use of jars: a 100 g jar is for individual use, but a 500 g jar can be used between several patients in an hospital ward, but with an increased risk of contamination.

BASIC STORAGE GUIDELINES

Proper storage is important, medications react to the environment around them. Factors that negatively affect drugs: light (especially sunlight), oxygen, moisture, extreme temperatures.

MSF follows manufacturer storage recommendations for the specific product/ family according to WHO GDP Guidelines and MSF transport policy

• Keep all medication in the original container and in their original outer packaging, to protect from sunlight.
• Keep the container tightly closed.
• Avoid opening containers before use.
• Never remove capsules/ sachets of desiccant.
• Be vigilant with product expiry dates, do not obscure expiry dates with labels or writings.
• Store as recommended by manufacturer.
• Always store all products in a manner that facilitates FEFO policy for stock management.
• Arrange cartons so arrows point up and identification labels, expiry dates, and manufacturing dates are visible.

To protect products from sunlight:

• Cover windows or use curtains, if they are exposed to direct sunlight.
• Keep products in their original packaging and in cartons.
• Do not store or package products in direct sunlight.
• Use opaque plastic or dark glass bottles for products that require them.
• Keep trees on site around the facility to help provide shade, but check regularly to ensure that there are no branches that could damage the facility.

The following terms relate to temperature and medical consumables:

• Store frozen: some products, such as certain vaccines, need to be transported in a cold chain and stored at –20°C. Frozen storage is normally intended for longer-term storage at higher-level facilities.
• Store refrigerated: between 2°C and 8°C. Some products are very heat sensitive but should not be frozen. This temperature is appropriate for the storage of vaccines. (For further information see Vaccines family).
• Keep cool: store between 8°C and 15°C.
• Store at room temperature: between 15°C and 25°C.
• Store at ambient temperature: this term is not widely used because of the wide variations in ambient temperatures. It means “room temperature” or normal storage conditions, i.e. storage in a dry, clean, well-ventilated area at room temperatures between 15°C and 25°C or up to 30°C, depending on climatic conditions.

To reduce effects of humidity:

• Ventilation: open windows (with screens and bars) or air vents, use of pallets, space between pallets and walls.
• Secure lids of containers.
• Air circulation: use of a fan.
• Air conditioning.

Measuring temperature and humidity in the medical storage area

Twice a day (including manual checking). There are many electronic instruments for monitoring temperature and humidity, with the possibility of checking the minimum and maximum obtained during a certain period. Remote monitoring of temperature conditions does not replace the need for daily manual monitoring (including weekends)

DETERIORATION

It is possible that theoretically valid drugs may deteriorate even if their expiry date has not yet been reached, in particular because their storage conditions (temperature, humidity and light) are very different from those under which their stability was tested. Excessive/ accelerated deterioration can also occur if the initial quality of the product is defective (e.g. due to a manufacturing problem). For this reason, it is important to know the normal characteristics of each medicine (colour, odour, solubility, consistency) in order to be able to detect any changes in appearance that might indicate alteration, although some forms of deterioration do not cause external changes.

Observe products for physical changes and discard any product that looks as if it may be unfit for use, regardless of the expiry date. If there is any doubt, contact the pharmacist for advice.

• All products: broken or ripped packages, missing, incomplete or illegible label.
• Liquids: discoloration, cloudiness (turbidity), sediment, unsuspended agglomerate of a powder or suspension, broken seal on bottle, cracks in an ampoule, bottle or vial, moisture in packaging.
• Light-sensitive products: torn or ripped packaging
• Tablets: discoloration, crumbled tablets, tablets missing from the blister pack, sticky tablets (especially coated tablets), unusual smell..
• Capsules: discoloration, sticky, crushed capsules
• Injectables: liquid that does not return to suspension after shaking.
• Tubes: sticky tubes, leaking contents, perforations or holes in the tube.
• Sterile products: torn or ripped packing; missing parts; broken or bent parts, moisture inside packaging; stained packaging.
• Foil packaging: perforation(s) in packaging.
• Suppositories, pessaries, creams and ointments: melting, separation of phases.

Using expired or deteriorated drugs

MSF does NOT recommend the use of expired or damaged medicines due to the significant risk for patient safety.

DESTRUCTION OF EXPIRED AND/OR DETERIORATED DRUGS

Check with local authorities for laws on medical waste management and environmental protection before implementing a disposal technique.

It is very important to dispose of pharmaceuticals properly, as improper disposal can have very negative consequences. Improper disposal can result in:

• contaminated water
• diversion and resale of expired or inactive medicines
• improperly incinerated products, which can release toxic pollutants into the air.

Special attention must be given to the disposal of the following categories of pharmaceuticals: controlled substances such as narcotics and psychotropic drugs, anti-infective drugs, cytotoxic anti-cancer drugs, toxic drugs, aerosols, antiseptics and disinfectants.

Normally, MSF should obtain a permit for destruction from the relevant local authorities and advocate for a safe method of destruction that complies with WHO and MSF guidelines, as these may not necessarily be reflected in local guidelines (if they exist). In some cases, such as recall situations, MSF must obtain a certificate of destruction.

Frequently, for stability or other reasons such as taste or solubility, the base form of a drug is administered in an altered form such as an ester or salt. This modified cform of the drug usually has a different molecular weight.

Example of caffeine citrate:

There are therefore two ways of expressing the active ingredient content of a medicine: either in terms of the salts contained in the medicine (20 mg of caffeine citrate in our example), or in terms of the base equivalent constituting the pharmacological activity of the medicine (10 mg caffeine base in our example).

In English-speaking countries, the content is more often expressed as salt, while in French-speaking countries, it is usually expressed as base. Unfortunately, there is no international rule on this matter and confusion between the two methods of expression is frequent. Thus it is not unusual that drugs labelled as bases are used with protocols expressed as salts, and vice versa.

For salts where the non-active part is relatively small compared to the active part, these confusions lead to negligible errors. But for small active molecules coupled with heavy salts (phosphates, sulphates, carbonates, citrates, fumarates, etc.), the non-active part can constitute more than half of the molecular weight, and confusions can lead to under dosages (ineffective treatment or risk of resistance) or over dosages (risk of adverse effects). Examples of such products are caffeine citrate solution for injection and chloroquine phosphate tablets.

The nail systemis composed of the intra-medullary nails with sliding screw system needed to insert the nail.

It contains the nailing instruments set, the spare parts, the different sizes of reamers, screws and nails (=implants).

When making an initial order for the Gamma nail, one of each set should be ordered which corresponds to the management of 40 patients. Established trauma centers may need to order more implants depending on the consumption.

Used for intertrochanteric and subtrochanteric fractures of the femur.

Only orthopedic surgeons are allowed to use this set.

There has to be a certain number of intertrochanteric and subtrochanteric fractures being admitted and treated in the trauma center to justify its order since not all trauma centers admit and treat these type of fractures.

See introduction KSUI

Definition

SUTURE

• Surgical suture (commonly called stitches) is a medical device used to hold body tissues together after an injury or surgery. Application generally involves using a needle with an attached length of thread. Sutures are used to repair tissue and facilitate healing
• Single-armed suture: the classic combination consists of a thread and a single needle.
• A double-armed suture consists of a thread with a needle at each end.

LIGATURE

• A strand of material used to identify or differentiate anatomical structures and to clamp blood vessels or ducts.

Characteristics of threads used for sutures

Thread memory is the capacity of the suture thread to return to its former, packaged shape. Thread memory has little effect on the quality of the suture, however it does affect manageability, as threads with memory tend to form knots spontaneously during use.

Tensile strength is defined as the force required to break a suture. The knot tensile strength is usually 30 to 50% less than the linear tensile strength of a suture. The suture material and diameter are key factors where tensile strength is concerned.

The capillarity of a suture describes the ease with which fluids can be wicked along the suture thread. This property is inherent to multifilament sutures as a result of the loose interstices of their fibers.

Surgical suture material can be classified on the basis of the characteristics, absorbability, origin of material and thread structure.

Absorbability

Absorption = resorption = loss of mass.

The rate of absorption of absorbable sutures depends on what they are made of and their thickness. Disappearance of the suture occurs through inflammatory reaction, hydrolysis or enzymatic degradation.

Absorbable sutures may be used to hold wound edges in approximation temporarily, until they have healed sufficiently to withstand normal stress. Some are absorbed rapidly, while others are treated or chemically structured to lengthen absorption time.

Non-absorbable sutures are those which are not digested by body enzymes or hydrolyzed in body tissue. They are made from a variety of non-biodegradable materials and are ultimately encapsulated or walled off by the body’s fibroblasts. When used for skin closure, they must be removed postoperatively.

Origin of material :

• Natural absorbable sutures: CATGUT: thread of animal origin.
• Natural non-absorbable sutures
• Silk fibers, often coated with wax or silicone. Tensile strength decreases as moisture is absorbed and is completely lost within 1 year.
• Cotton or linen fibers, or coated natural fibers where the coating contributes to suture thickness without adding strength.
• Metal wire of monofilament or multifilament construction.
• Synthetic origin: produced from synthetic polymers as polyamide, polyolefines and polyesters.

Number of strands:

Sutures are classified according to the number of strands of which they are comprised

Synthetic absorbable sutures

Absorbable sutures are medical devices class III according to rule 8 (surgically invasive long term use, mainly absorbed)

characteristics

Low tissue reaction.

Absorption occurs by enzymatic process. This process can become altered in patients with a fever, infection or protein deficiency, resulting in an accelerated decline of tensile strength. Furthermore, the absorption process can begin prematurely if the sutures are placed in a moist or fluid filled part of the body, or if the material becomes wet or moist during handling or any other time prior to implantation.

composition

Most of synthetic absorbable sutures are made of absorbable polyesters and contain one or more of the five basic building blocks: Glycolide, L-lactide, p-dioxanone, ε-caprolactone and trimethylene carbonate

Table 1: Synthetic absorbable sutures

PGA and PGLA sutures rapid

Absorption rate is higher for the sutures “Rapid” “Fast” or “Quick”: treating absorbable braided sutures with gamma radiation reduces their resistance. Tensile strength 50% @ 5 days, absorption complete by 42 days (PGA rapid is sometimes indicated as PGAP).

Synthetic non-absorbable sutures

Low tissue reaction, uniform and resistant.

Non absorbable sutures are in general medical devices class IIb according to rule 8 (surgically invasive, long term use)

If the suture is intended to be used in direct contact with the heart or central circulatory or nervous system, the medical device class becomes III)

Table 2: Synthetic non-absorbable sutures

Gauge of suture threads

Two parallel systems are used for measuring the gauge of thread (size of the thread):

• EP (European Pharmacopoeia) measurement: decimal size, representing a tenth of the thread diameter, expressed as a Metric size number (Metric 2 = DEC2 = 0.20 mm diameter). It ranges from 0.1 to 7.
• USP (United States Pharmacopoeia) measurement: ranges from 11/0 to 5 (the more zeros in the number, the finer the thread)

Length of the sutures: there is no standard length for the sutures. Manufacturers offer different lengths for each suture, habits change per country, very thin threads are often shorter.

Other features

Colour

The suture threads are available dyed (violet, green, blue, black, etc.) or undyed. The colour acts as an indicator, which can be particularly useful in certain cases (e.g. vascular surgery) for distinguishing the different anatomical structures. The colour enhances their visibility, even if they are steeped in blood. In contrast, undyed threads have the advantage of being less visible and more discreet, and thus better for use in eye surgery or skin suturing, to avoid a tattoo effect.

Coating

Coating is a surface treatment that can be used for the needle as well as for braided sutures and has the purpose of modifying the surface.

Coating the needles improves precision and penetration. Coating the thread optimizes its passage through the tissue and at the same time makes it less traumatic while still maintaining good knot security. However, this surface coating is thin and friction during manipulation can rub off the protective coating.

Antimicrobial suture

They contain / are coated with an agent to locally inhibit bacterial growth: triclosan or chlorhexidine.

• prevent bacterial adhesion and biofilms formation and avoid long-term systemic antibiotics.
• be biocompatible with medical products
• do not impair healing processes and be well tolerated in wounds with no toxicity or systemic absorption.

Barbed suture

The knotless barbed suture is widely used in both skin and deeper structures. It is a specifically designed monofilament suture (absorbable or non absorbable) with barbs orientated in the opposite direction to the needle. While suturing tissue, these barbs penetrate inside the tissue and lock them into place, eliminating the need for knots to tie the suture. Initial fixation of the suture is with a fixation tab or a loop.

Three types according to the direction of the barbs: bidirectional, unidirectional or spiral

PTFE Pledgets

Reinforcement of a suture: PTFE pledgets are used as a suture buttress

• Protect tissue from thread tension
• Distribute tension evenly across the pledget
• Enable better tightening

Various materials and sizes available, packed separately or preloaded on the suture

Control release needle

To save time, the needle-thread combination has been constructed with a removable needle. After the suture has been placed, the needle can be removed from the suture with a slight pull.

​

The suture needle

In addition to the thread, the needle is an essential component of sutures.

Atraumatic sutures are defined as needle-suture combinations, where the (eyeless) needle is firmly attached (swaged) to the suture in order to reduce tissue trauma.

General characteristics

Most of surgical needles are fabricated from heat treated steel. There is no formal definition on what constitutes a "surgical stainless steel", so product manufacturers and distributors apply the term to refer to any grade of corrosion resistant steel.

The most common "surgical steels" are austenitic 316 stainless and martensitic 440 and 420 stainless steels.

The surgical needle has a basic design composed of three parts

• The point is the sharpest portion and is used to penetrate the tissue. The point runs from the tip to the maximum cross-sectional area of the body.
• The body represents the mid portion of the needle, made of solid steel. It is the strongest and widest portion of the needle and is also referred to as the grasping area.
• The swage is the portion to which the suture material is attached. Instrumentation here will break or weaken the suture. This part permits the suture and needle to act as a single unit to decrease trauma

Shape of the needle

Needle Body

Needles with round bodies pierce and spread the tissues with minimal cutting. They are used in easily penetrated tissues like the peritoneum and abdominal viscera.

Needles with triangular shaped bodies are referred to as “cutting” needles. Each of the three edges is a cutting edge, and they are used to penetrate tough tissues and are ideal for suturing skin.

Needle curvature (longitudinal shape)

In practice, the deeper the layer, the more curved the needle should be.

• 1/4 circle: shallow curvature, used on easily accessible convex surfaces: for ophthalmic and microsurgical procedures
• 3/8 circle: most commonly used needle. The curvature makes it easy to manipulate in large and superficial wounds, however it is impossible to use in deep cavities due to the large arc of manipulation needed.
• 4/8 = ½ circle: to be used in confined locations, but requires more pronation and supination of wrists
• 5/8 circle: ideal for deep, confined holes (nasal cavity), and can be used by rotating the wrist with little to no lateral movement.

Needle Point

• Taper point: needle body is round and tapers smoothly to a point. Penetrates the tissue by separating rather than by cutting.
• Conventional cutting: has a triangular cross section with the apex of the triangle on the inside of the needle curvature. The effective cutting edges are restricted to the front section of the needle and merge into a triangulated body which continues for half the length of the needle.
• Reverse cutting needle: is triangular in cross section, having the apex cutting edge on the outside of the needle curvature. This improves the strength of the needle and particularly increases its resistance to bending.
• Protection point: designed to minimize the risk of needle stick injury. The needle point is sharp enough to penetrate fascia and muscle but not skin.
• Blunt point: designed to suture extremely friable tissue such as liver.
• Tapercut needle: combines the initial penetration of a cutting point with the minimized trauma of a round bodied needle. The cutting is limited to the point of the needle, which then tapers out to merge into a round cross section.
• Side cutting or spatula points: flat on top and bottom with a cutting edge along the front to one side, for eye surgery

Sutures selected by MSF

The list of sutures has been drawn up by a group of surgeons who wished limiting their number while keeping a sufficient range to cover the surgical needs in the MSF missions.

Norms

The sutures must meet the characteristics and tests described in the pharmacopoeia. They must also meet the essential requirements of medical devices.

Characteristics

• Material: the selected sutures are all synthetic. The use of catgut is forbidden within MSF because it has unstable characteristics and involves a risk of contamination (bovine spongiform encephalopathy, scrapie...)
• Absorbable sutures braided (SSUTSABB+++) and the absorbable sutures braided rapid (SSUTSABR+++): coated polyyglycolid (PGA) or polygalactin 910 (PGLA), both materials are considered equivalent.
• Absorbable sutures monofilament (SSUTSAMD+++): polydioxanone = different type of material that has different characteristics.
• Non absorbable sutures, monofilament (SSUTSNAM+++): nylon (PA) and polypropylene (PP) are considered equivalent for most applications, unless specified otherwise.
• Length: sutures are 70 to 75 cm long (ligatures = 250 cm), variations occur according to the manufacturer.
• Surface: the absorbable braided sutures are coated, the monofilament sutures are not. All sutures have a smooth surface without barbs or pledgets and without antibacterial coating.
• Colour of the suture: the absorbable sutures are most often violet, the rapid ones are undyed. The specification coloured or undyed will only be added when necessary (important for plastic surgery, for intradermal continuous suture)

Codes and labels

The MSF labels are generic and mention the main characteristics of the selected sutures

• absorbable or non absorbable
• braided or monofilament
• gauge in USP measurement
• type of needle (curvature, length, type of point)
• double needle in case the suture is double armed
• all sutures are sterile and for single use, this is not specified in the label because lack of space

The codes of the sutures

• Family: SSUT
• Root: identifies the material
• SSUTSABB = absorbable braided
• SSUTSABR = absorbable braided rapid
• SSUTSAMD = absorbable monofilament PDA
• SSUTSNAM = non absorbable monofilament
• Qualifier:
• The gauge of the thread: 1 for gauge 1, 20 for gauge 2/0, 30 for gauge 3/0…
• The next letter identifies the tip of the needle
• T (trocar)
• R (reverse cutting
• C (conventional cutting
• B (blunt / protection point)
• The following digit is a sequential numbering for all other specifications (mainly linked to the needle: length, curve..)

Table 1: Synthetic absorbable sutures

Table 2: Synthetic non-absorbable sutures

*in common usage, the prefix 'PA' (polyamide) or the name 'Nylon' are used interchangeably and are equivalent in meaning

d'usage courant, le préfixe «PA» (polyamide) ou le nom «Nylon» sont interchangeables et ont un sens équivalent

• Indication of type

A nationally recognized type

H harmonized type

• Nominal voltages U0 / U

1 100/100 Volt

3 300/300 Volt

5 300/500 Volt

7 450/750 Volt

• Conductor insulation materials

B EPR (ethylene propylene rubber)

E PE (polyethylene)

G EVA (ethylene-vinyl acetate copolymer)

N2 chloroprene rubber for welding cable

R natural rubber

S silicone rubber

V PVC (polyvinyl chloride)

V2 PVC + 90 ° C

V3 Flexible cold PVC

V4 Cross-linked PVC

X crosslinked PE (polyethylene), XLPE

Z halogen-free

• Insulation materials for inner and outer sheaths / braid

B EPR (ethylene propylene rubber)

J Glass fiber braid

N Chloroprene rubber

N2 Chloroprene rubber for welding cable

N4 Chloroprene rubber resistant to high temperatures

Q Polyurethane

R Rubber

T Textile Braid

V PVC (polyvinyl chloride)

V2 PVC + 90 ° C

V3 Flexible cold PVC

V4 Cross-linked PVC

V5 PVC with improved resistance to oils

Z halogen-free

• Construction features

C4 braid copper braid

D central support member

H flat cable with separable conductors

H2 flat cable with non-separable conductors

H6 flat cable for lifts with non-separable conductors

H8 stretch cord

• Core Construction

D flexible core for welding cable

E extra flexible core for welding cable

F flexible core class 5 (flexible)

H flexible core of class 6 (ultra flexible)

K flexible core class 5 (fixed installation)

R wired core class 2

U massive core class 1

Y braid in fine ribbons

• Number of Conductors
• Earth conductor

G with green / yellow earth conductor

X without green / yellow earth conductor

• Section in mm²

E.G.

H07RN-F 3G2.5

H means that this is a harmonized cable at European level.

07 means a resistance of 700 volts max.

R specifies the insulating material of the conductor

N specifies the insulating material of the sheath

F specifies the flexibility of the cable

3 indicates the number of wires

G indicates that it is equipped with a green / yellow earth wire.

2.5 specifies the section in mm² of each wire.

Non-contact infrared thermometers (NCITs) can be used to measure temperature rapidly and non-invasively

These NCITs were introduced into the MSF lists solely as a means of rapidly screening people during the Ebola outbreak in West Africa. There are not intended to replace the standard clinical thermometer. According to the literature, and MSF experience, reliability of these devices is an issue, an accuracy can easily be reduced by environmental conditions and the way the measurement is taken. They cannot be used to check the vital signs of a patients, but they are a practical screening tool.

There are no consumables (except the batteries) and no accessories (maybe a case / pouch for storage of the device

GMDN

• Code : 17888
• Name : Infrared patient thermometer, skin
• Definition: A hand-held, battery-powered, electronic instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

NCITs are non standard articles, currently 3 models are used in MSF projects

EEMDTISE3— INFRARED THERMOMETER, skin (Thermoflash LX26)

• Manufacturer: Visiomed technology, Shenzhen, China
• Issues noticed by MSF users: problem with the accuracy of the measurement, requires to wait 1 min between each measurement
• Range: 32.0 to 42.9°C
• Accuracy = 0.2°C
• Resolution: 0.1°C
• Distance measure = 2-5 cm
• Automatic shutdown, 5 sec
• CE marked (NB0197)

EEMDTISE4— INFRARED THERMOMETER, skin no contact (EX-IR200)

• Manufacturer : Extech
• Range: 32.0 to 42.5°C
• Accuracy = 0.3°C
• Resolution: 0.1°C
• fast response (0.5 seconds)
• measurement distance: 5 - 15 cm
• memory = 32 readings
• 2AA batteries + pouch

EEMDTISE5— INFRARED THERMOMETER, skin (Masimo TIR-1)

• Range: 34.4 to 42.2°C
• Accuracy = 0.2°C (36-39 °C), 0.3°C above and below that.
• Resolution: 0.1°C
• fast response (1 second)
• measurement distance: 1.2 - 5 cm
• memory = 30 readings
• Bluetooth connectivity
• 2AA batteries

CHECKLIST

• Legal manufacturer
• Name + Address clearly visible on package
• Website available (check)
• Known manufacturer?
• Availability of QA docs
• CE marking:
• check if CE marking is correct
• NB identification (MD Class IIa): If no NB identified: article not registered as MD
• Registered in other HRC
• check GUDID if the device is listed (use manufacturer + brand/model as terms)
• Availability of a technical sheet, reference to a national / international standard?
• Battery powered, 2AA batteries is most common, but they sometime use the rectangular 9V battery (PP3), or AAA batteries (much shorter autonomy)
• Specifications: check IFU
• Range: 32 – 43 °C
• Temp in °F or °C possible
• Accuracy: 0.2 – 0.3 °C
• Distance for measuring: 3 – 5 cm most common, some 5 – 15 cm
• Response in 0.5 – 3 seconds
• Presence of alarms are practical but not essential, alarms can be audible or visible (often a traffic light system)
• Bluetooth connectivity: limited added value (often limited to a specific range of devices)
• Practical use of the device
• Screen of practical size, letters / numbers can be read easily, also with poor light or in bright sunlight
• Change of temperature reading from °F to °C is possible
• Time needed to get the reading of temperature
• Check distance of measuring: minimum and maximum as stated in IFU
• Waiting time between two readings?
• Automatic shutdown after 1-15 minutes, to save the batteries, > 20 minutes = batteries may not last long.
• If alarms present, settings can be adjusted
• Device is not heavy (can be operated by one person during a relatively long period)
• Can be operated using (examination) gloves
• Compare readings with results obtained with other thermometers (limited value, intended use = screening)

Benefits of NCITs

• Non-contact approach may reduce the risk of spreading disease between people being evaluated
• Easy to use
• Easy to clean and disinfect
• Measures temperature and displays a reading rapidly
• Provides ability to retake a temperature quickly

Limitations of NCITs

• How and where the NCIT is used may affect the measurement (for example, head covers, environment, positioning on forehead).
• The close distance required to properly take a person’s temperature represents a risk of spreading disease between the person using the device and the person being evaluated.

Proper Use of NCITs

• The person using the device should strictly follow the manufacturer’s guidelines and instructions for use for the specific NCIT being used.
• Use in a draft-free space and out of direct sun or near radiant heat sources.
• Typically, the environmental temperature should be between 16-40 ºC and relative humidity below 85 percent.
• Place the NCIT in the testing environment or room for 10-30 minutes prior to use to allow the NCIT to adjust to the environment.
• The test area of the forehead is clean, dry and not blocked during measurement.
• The person’s body temperature or temperature at the forehead test area has not been increased or decreased by wearing excessive clothing or head covers (for example headbands, bandanas), or by using facial cleansing products (for example cosmetic wipes).
• Hold the NCIT sensing area perpendicular to the forehead and instruct the person to remain stationary during measurement(s).
• The distance between the NCIT and forehead is specific to each NCIT. Consult the manufacturer’s instructions for correct measurement distances.
• Do not touch the sensing area of the NCIT and keep the sensor clean and dry.

More info online:

• https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/non-contact-infrared-thermometers
• https://www.cebm.net/2020/08/screening-for-covid-19-with-infrared-thermometers-more-marketing-than-medical-evidence/
• https://www.businesswire.com/news/home/20200803005329/en/Non-Contact-Infrared-Thermometers-Market-2020-2030-COVID-19-Implications
• https://pubmed.ncbi.nlm.nih.gov/21651612/#:~:text=The%20sensitivity%20and%20specificity%20for,avoid%20unnecessary%20laboratory%20work%2Dup.
• https://www.community.healthcare.mic.nihr.ac.uk/reports-and-resources/horizon-scanning-reports/hs-report-0025

Galenic formulations presented as co-formulations (mix of several molecules in the same pharmaceutical form, called "FDC" = fixed dose combination) are labelled with a "/" separating the different molecules.

Example: ATOVAQUONE 250mg / PROGUANIL HCl 100mg, tab., >40 kg

Galenical forms presented as co-blisters (molecules in separate dosage forms but combined in the same blister pack) are labelled with a "+" separating the different molecules. The co-blister form is always mentioned in the labelling.

Example: SP 1 x 500/25mg + AQ 3 x eq.150-153mg base, coblister disp.tab, 9-17kg

Some excipients are prohibited in paediatric medicines, e.g. benzyl alcohol in injectable formulations, ethanol in the oral formulation (unless no other source is available). Oral paediatric medicines containing sucrose should also be avoided as much as possible in children.

The Intensive Care Kit (ICU kit) is intended to be used as part of the hospital kit for various types of critical care services (HDU, ICU ..).

The ICU part can only be ordered together with:

• the OPD part
• the ward part (minimum 1 ward)
• the operating theatre part (minimum 1 operating room)
• the 4 mandatory support activities modules:
• laboratory
• sterilization
• pharmacy
• divers modules

The kit contains equipment necessary for a mixed critical care unit (4 beds).

The ICU part can not be ordered if you are not located in a fully equipped hospital with skilled ICU staff, that can ensure a presence 24 hours a day.

It is composed of 2 parts

• Medical equipment for 4 beds
• Medicines and renewable medical supplies

Diagnostic equipment and supplies are included in the two parts

Stationary materials and other miscellaneous parts are included in the renewable supplies.

The kit is organised in different modules with a basic configuration (only mandatory modules) and an advanced configuration (some or all optional modules). This is intended to give flexibility and to be better adapted to each and every field.

Optional modules that can be added as needed depending on the type, level of care, skills and structure in which they are used.

Remarks

Although specialised activities were taken into account, purely specialised services such as burn ICUs, paediatric ICUs and neonatal ICUs should use an order with a medical standard list as some items and quantities might not be suitable.

The kit contains internationally controlled substances (= psychotropic and narcotic drugs). It might be necessary to get an Import Licence from receiving National Authorities for these drugs.

Choice : it is mandatory to order one the two proposed choices

In part medical equipment it is mandatory to order either the English version, either the French version for the syringe pump “Agilia SP MC” and the defibrillator "AED Pro", both presented as choice.

All options, indicated as "OPTION" (column "Tot Qty"), must be ordered in addition.

A protocol for starting an orthopaedic programme with internal fixation exists for the MSF missions.

The authorization to practise internal fixations in an MSF mission must meet all the criteria listed in the reference document. They are absolute minimum criteria checked and signed by a referent before implementing such a programme.

The articles can only be used in projects where the prerequisites for internal fixation are already in place and internal fixation is ongoing with good follow up of surgical complications and surgical infections.

Only orthopedic surgeons are allowed to use these sets.

A protocol for starting an orthopaedic programme with internal fixation exists for the MSF missions.

The authorization to practise internal fixations in an MSF mission must meet all the criteria listed in the reference document. They are absolute minimum criteria checked and signed by a referent before implementing such a programme.

The articles can only be used in projects where the prerequisites for internal fixation are already in place and internal fixation is ongoing with good follow up of surgical complications and surgical infections.

Only orthopedic surgeons are allowed to use these sets.

For information follows a non-exhaustive and non-detailed list about the means which must be present.

Material means

• Operation suite: electricity, air, water, electric cautery, tourniquet, single use gowns, surgical gloves, alcohol hand rub, iodineskin preparations...
• Sterilization: existing sterilization circuit (clean/dirty), autoclave with cycle at 134°C, MSF protocols for sterilization, tracability and sterilization indicators ...
• Radiology: must be present...
• Laboratory: blood transfusion, bacteriology examinations...
• In Patient Department: clear separation infected and not...

Human Resources

• OT nurse
• Ward nurse
• Surgeons: qualified "MSF" orthopedics
• Physiotherapist
• Prothesist
• Anesthetist...

Protocols

• Antibiotics
• Thromboembolic prevention
• Pain

Data collection

• Data collection according existing forms

Organization

• Implementing evaluation systems in the different parts: sterilization, data collection, complications, anesthaesia quality, mortality...

All articles for internal fixation are closed: manufacturer is STRYKER or SIGN.

Codification of the articles: manufacturer (STRY or SIGN) followed by the reference of the manufacturer.

The content of these lists may change for several reasons. MSF is always looking for the best products in terms of quality/price ratio and the manufacturer can also update his product list.

Definitions

• In a chronic wound the usual orderly process of healing is disrupted at one or more points, resulting in delayed healing or failure to heal (more than 6 weeks). A wound becomes chronic because of an underlying pathology (e.g. arterial/venous insufficiency, diabetes, etc.) or an external factor (e.g. infection).
• An acute wound follows the orderly process of healing (hemostasis or coagulation, inflammation, cell proliferation, epithelialization and remodeling). Examples of acute wounds are: burns, frostbite, bites, grafts and graft donor areas, deep derm-abrasions, surgical wounds.
• Primary wound dressings are applied directly to a wound and may be active or passive. Passive dressings don’t have an active effect on the wound healing. They are used because of their covering, non-adherent and/or absorbent characteristics. Active dressings have an active influence on the wound healing: they promote and maintain a moist wound environment. They may contain medication.
• Secondary wound dressings are put on top of a primary dressing in order to strengthen it, to make it more occlusive, or to create more absorption capacity.
• Fixation dressing: used to secure the primary and secondary dressing in place, and to support and protect the wound site.
• Compress: Piece of material(s), in any shape, form or size that is used for one or more following purposes: cleansing skin or wound, absorbing body exudate during surgical procedures, use with agents commonly used in wound management, support organs, tissue, etc. during surgical procedure. (according to EN 1644-1).
• Bandage: is wrapping material placed over a dressing or closed skin to hold the dressing , to immobilize a joint or for compression therapy.
• The FDA defines a medical adhesive as “a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing...The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.”

Dressing materials

The most suitable dressing for wound management depends not only on the characteristics of wound but also on the stage of the healing process. The ideal dressing respects moist wound healing principle, removes excess of exudate, adapted to the healing phase, impermeable to micro- organisms, thermal insulation, allows gaseous exchange, conforms to wound surface, non-toxic; induces no allergic reactions, offers mechanical protection, relieves pain, avoids trauma and pain at dressing removal.

Gauze dressings

Gauze wound dressings were made from woven (cotton) or non-woven (cellulose fibers) gauze. Gauze is highly permeable and relatively non-occlusive, they may dry out and stick in the wound bed in wounds with minimal exudate unless used in combination with another dressing or topical agent. Gauze applied directly to the wound has many disadvantages, shedding of fibers (quality of compress) and the leakage of exudate (‘strike through’) with an associated risk of infection.

Gauze may be used as a primary or secondary wound dressing. Woven and non-woven gauze dressings can be used as secondary layers in the management of heavily exuding wounds. According to the absorbent capacity the compresses can be divided in different groups: normal absorbent capacity, the simple woven and non-woven compresses, and the more absorbent capacity: absorbent compresses and the superabsorbent compresses, they contain - next to gauze - also other types of material.

Cotton gauze fabric can be used for swabbing and cleaning skin. Ribbon gauze can be used to pack wound cavities, but adherence to the wound bed may cause bleeding and tissue damage on removal of the dressing (moistening the dressing with saline may help). An advanced wound dressing is often more suitable. Gauze dressings are inexpensive for one-time or short-term use. Gauze dressings come in many forms: squares, sheets, rolls, or ribbons (packing rope).

Paraffin gauze dressing

Tulle dressings are manufactured from cotton or viscose fibers which are impregnated with white or yellow soft paraffin to prevent the fibers from sticking, This is only partly successful and it may be necessary to change the dressings frequently. The wound exudate can be absorbed in the secondary dressing through the holes in the paraffin gauze (this is impeded if more than one layer is applied). Dressings with a reduced content (light loading) of soft paraffin are less liable to interfere with absorption. Paraffin gauze may be impregnated with antiseptic or antibiotic.

Vapour permeable films

They allow the passage of water vapour and oxygen but are impermeable to water and micro-organisms from outside. The sterile dressing can be used as a primary dressing to create/ maintain a moist wound environment in flat, shallow wounds with low to medium exudate. They are highly conformable, provide protection, and a moist healing environment; Transparent film dressings permit constant observation of the wound.

Water vapour loss can occur at a slower rate than exudate is generated, so that fluid accumulates under the dressing, which can lead to tissue maceration and to wrinkling at the adhesive contact site (with risk of bacterial entry). Vapour-permeable films are unsuitable for infected, heavily exuding wounds.

Most commonly, they are used as a secondary dressing over other types of dressing and as a fixation dressing.

Types of bandages

A bandage is a piece of material used either to secure a medical device such as a dressing or splint, or on its own to provide support to or to restrict the movement of a part of the body. Other bandages are used without dressings, such as elastic bandages that are used to reduce swelling or provide support to a sprained ankle. Tight bandages can be used to slow blood flow to an extremity, such as when a leg or arm is bleeding heavily or as compression therapy (e.g. in case of venous leg ulcers).

Bandages are available in a wide range of types, from generic cloth strips to specialised shaped bandages designed for a specific limb or part of the body. Bandages can often be improvised as the situation demands, using clothing, blankets or other material. In American English, the word bandage is often used to indicate a small gauze dressing attached to an adhesive bandage.

Gauze bandage

The most common type of bandage is the gauze bandage, a simple woven strip of material, or a woven strip of material with an absorbent barrier to prevent adhering to wounds. A gauze bandage can come in any number of widths and lengths, and can be used for almost any bandage application, including holding a dressing in place.

Long-stretch or elastic bandages

Long-stretch bandages (LSBs) = bandages for which the extensibility is high: greater than 100% to 120. They contain elastic fibers and may be dry or cohesive (self-adhering bandage or cohesive bandage is a type of bandage that coheres to itself, but does not adhere well to other surfaces).

The elastic behaviour provides constant pressure, which is almost the same at rest and at work, therefore leading to a low static stiffness index (SSI), with little or no massage effect.

This type of action is particularly recommended for immobile or not very mobile patients, incapable of sufficiently activating their calf-muscle pump.

Elastic systems have to be taken off at night since the pressure that they exert is difficult to tolerate when sleeping. The need for re-application every day can sometimes be a significant obstacle in terms of a patient’s compliance with treatment.

Short-stretch or low-elasticity bandages

These bandages are defined as having low elasticity (or non-elastic) if they have an extensibility of less than 100%.

Short-stretch bandages deliver a low resting pressure and a high working pressure (high SSI), producing a significant massage effect on the calf-muscle when the patient is active. This massage effect reactivates the efficacy of the muscle pump by propelling the venous blood flow from the superficial network to the deep network. Short-stretch systems are therefore very effective in the treatment of severe stages of chronic venous disease (CVD), especially in the treatment of venous leg ulcers and severe oedema, since they significantly improve venous return and lymphatic drainage.

They are effective in patients with sufficient mobility and are particularly recommended in the event of severe oedema. They can usually be kept on day and night, due to their low resting pressures.

Tube bandage

A tube bandage is applied using an applicator, and is woven in a continuous circle. It is used to hold dressings or splints on to limbs.

Adhesive bandage

An adhesive bandage, also called a sticking plaster (or simply plaster) in British English, is a medical dressing used for small injuries. An adhesive bandage is a small, flexible sheet of material which is sticky on one side, with a smaller, non-sticky, absorbent pad stuck to the sticky side.

Medical tape

Properties of medical tapes

• The tape needs to adhere to a surface (skin) being shed, a surface that is highly lipid, a surface that is very irregular.
• It has elastic properties.
• Tapes are called pressure sensitive adhesives (PSA): they adhere to the surface best with application of light pressure on the backing.
• Tapes need to be able to handle moisture vapour that normally leaves the skin = MVTR (moisture vapour transmission rate): it depends on the chemical composition of the adhesive, the tape thickness and the permeability of the backing.
• Tape must be non-toxic, hypoallergenic.
• The base of the tape is made of fabric, non-woven, hypoallergenic material or porous plastic.

The ideal tape must be compatible with skin, adhere strongly, be permeable to air and moisture, and remove gently without skin trauma.

Zinc Oxide Tape

Zinc Oxide tape is also known as Strapping Tape or Sports Tape because it is widely used to prevent sports injuries and soft tissue damage. It can also support muscles to stabilise injured ligaments. Zinc Oxide will remain intact when worn for a long period of time, and tolerates moisture, even in humid environments. It is usually made from non-stretch cotton or rayon (woven) with a Zinc Oxide adhesive.

Do and Don’t when using tape

• Consider using a barrier film to protect skin, but avoid alcohol or solvents on neonates
• Avoid substances that are tacky and increase adhesion such as tincture of benzoin
• Do not put tape strips on bed rails, IV trays or any other surface; do not carry rolls in pockets or on stethoscopes to keep tape clean
• Make sure skin is clean and dry before applying tape
• Avoid stretching tape; apply without tension or pulling on underlying skin

Classification of dressings according to European classification rules

Wound dressings may be any class of medical device, depending upon the intended purpose of the dressing, the constituents, how long it will be applied and where on (or where in) the body it is intended to be used.

The majority of wound dressings are non-invasive devices which come in to contact with injured skin:

• Class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates (e.g. gauze dressings, absorbent pads, cotton wool)
• Class IIb if they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent (e.g. dressings for chronic ulcerated wounds and severe burns)
• Class IIa in all other cases, including devices principally intended to manage the micro-environment of a wound (film, hydrogel, non-medicated impregnated gauze dressings). These dressings have specific properties to assist the healing process by controlling the level of moisture at the wound and to generally regulate the environment in terms of humidity and temperature, levels of oxygen and other gases, pH values, or by influencing the process by other physical means.

Classification is highly dependent upon the manufacturer’s intended use. Example: a polymeric film dressing would be a class IIa if the intended use is to manage micro-environment of the wound and class I if its intended use is limited to retaining an invasive cannula at the wound site.

A claim that a device is interactive or active with respect to the wound healing process usually implies that the device is a class IIb.

Dressings incorporating an antimicrobial agent, where the purposes of such agent are to provide additional action to the wound, are classified as Class III devices.

Antiseptics are used to kill or eliminate microorganisms and/or inactivate viruses on living tissues, including intact or broken skin and mucous membranes.

The following table provides an overview of the standard antiseptics mentioned in the MSF catalogue.

Medicon reference

Almost all labels or surgical instruments give the Medicon reference at the end of the label. The reference has the following structure: 3 x 2 numbers separated by a dash e.g. 11-22-33.

The Medicon reference gives clear specifications for the article, but it remains an open article. Several sources (other than Medicon) are possible if the same quality level is met.

The reference of Medicon can also be used to view the article in their online catalogue (replace the dash by a dot to search in the Medicon catalogue).

Norms for surgical instruments

The technical commission 170 from ISO is responsible for the standardization in the field of surgical instruments

• ISO 7151:1988 (3rd edition is under development): Surgical instruments -- Non-cutting, articulated instruments -- General requirements and test methods
• specification of basic requirements for as well physical characteristics as workmanship, of the steel grades used and heat treatment of component parts, excluding rivets, screws and parts manufactured of material grade M.
• ISO 7153-1:2016: Surgical instruments -- Materials -- Part 1: Metals
• specifies metals commonly used to manufacture various types of standard surgical instruments, including but not limited to those used in general surgery, orthopaedics and dentistry.
• is not intended for surgical instruments used in special applications, such as implantology and minimally invasive surgery, parts of it might be applicable to those instruments.
• ISO 7740:1985 (reviewed and confirmed in 2021): Instruments for surgery -- Scalpels with detachable blades -- Fitting dimensions
• lays down the dimensions of two sizes of fitting features for detachable scalpel blades and the handles with which they are used. It secures a good fitting and interchangeability of detachable blades for scalpels
• ISO 7741: 1986 (reviewed and confirmed in 2017): Instruments for surgery -- Scissors and shears -- General requirements and test methods
• deals with materials, heat treatment and hardness of component parts, corrosion resistance, workmanship and cutting ability of scissors and shears used in the surgery and defines the test methods.
• ISO 13402:1995 (reviewed and confirmed in 2021): Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure

Metals used to manufacture surgical instruments

Since there are different requirements to various surgical instruments, there also have to be different requirements to the materials from which the instruments are manufactured. Not all of the materials are suited to use in every type of instrument.

For most types of surgical instruments materials which are known from experience to be suitable for those instruments are given in the tables of ISO 7153.

Surgical stainless steel

Surgical stainless steel is a grade of stainless steel used in biomedical applications. There is no formal definition on what constitutes a "surgical stainless steel", product manufacturers and distributors apply the term to refer to any grade of corrosion resistant steel.Table 4 of ISO 7153 lists the grades of stainless steels used in surgical instruments using the material number and short term according to EN 10088-1:2014.

The most common "surgical steels" are austenitic 316 stainless steels and martensitic 440 and 420 stainless steels.

440 and 420 stainless steels, known also by the name "Cutlery Stainless Steel", are high carbon steels alloyed with chromium. They have very good corrosion resistance compared to other cutlery steels, but their corrosion resistance is inferior to 316 stainless. Biomedical cutting instruments are often made from 440 or 420 stainless steel due to its high hardness coupled with acceptable corrosion resistance. This type of stainless steel may be slightly magnetic.

316 stainless steel, also referred to as marine grade stainless steel, is a chromium, nickel, molybdenum alloy of steel that exhibits relatively good strength and corrosion resistance.

Chemical composition of the stainless steels

Stainless steel is a steel alloy with a minimum of 10.5% chromium content by mass and a maximum of 1.2% carbon by mass.

Alloy steel is steel that is alloyed with a variety of elements in total amounts between 1.0% and 50% by weight to improve its mechanical properties.

The simplest steels are iron (Fe) alloyed with carbon (C): about 0.1% to 1%, depending on type. As the carbon percentage content rises, steel has the ability to become harder and stronger through heat treating; however, it becomes less ductile. Regardless of the heat treatment, a higher carbon content reduces weldability.

The term "alloy steel" is the standard term referring to steels with other alloying elements added deliberately in addition to the carbon.

• Si = silicium: increases the hardness and wear resistance
• Mn = manganese: can increase the tensile strength, could remove or improve the bad influence of Sulfur, could improve the hardening capacity of heat treatment. High content of Mn will cause worse welding capability and reduce the heat conductivity of steel = easier to cause cracks.
• Ni = nickel: could improve the tensile strength and toughness of cast steel, improve the hardening capacity of heat treatment. High content of Ni could improve the corrosion resistance and the properties of other alloys.
• P = phosphorus: reduces the plasticity and toughness of cast steel, especially at low temperature: better to keep it at less than 0.04%.
• S = sulfur: is the harmful impurity of cast steel, it causes fragility, especially after quenching heat treatment, and during machining at high temperature. A lower Sulfur is better (less than 0.04%).
• Mo = molybdenum: could improve the hardening capacity, and heat-resisting strength of heat treatment, = reducing the brittleness of quenching treatment. It can also improve the surface abrasive resistance.
• V = vanadium: promotes fine grain size, increases hardenability and improves wear resistance. Small amount of Vanadium increases the strength of steels significantly

Surgical stainless steels for families of products

Pressure force instruments and springs (haemostatic forceps, dissecting forceps, gripping forceps, surgical towel clamps, needle holding forceps, threading forceps, clamping forceps) ► martensitic steel

• The steel used must be springy and highly impact resistant.
• Carbon gives them hardness, while chromium gives them corrosion resistance.
• The steel have to undergo a complex, rigorous heat treatment which allows the steel to be hardened; otherwise they will bend the first time they are used.
• The steel must be carefully polished; the quality of the polishing determines the corrosion resistance.

Instruments that cut by shearing (scissors curettes, raspatories, gouge shears, cutting forceps) ► martensitic steel

• The steel used has a higher percentage of carbon than for the pressure force instruments in order to increase hardness.
• The percentage of chromium is the same to give corrosion resistance, while incorporation of molybdenum makes up the balance and improves the cutting qualities.

Instruments that cut by percussion (chisel shears, osteotomes, gouges) ⇒ martensitic steel

• For the cutting part, the heat treatment and polishing are the same as for instruments that cut by shearing.
• For the non cutting part, the heat treatment and polishing are the same as for pressure force instruments.

Static function instruments: self-retaining retractors, long-handles retractors, valves, specula, dilators) ► martensitic or austenitic steel

Miscellaneous instruments (instrument boxes, obstetrical hook, manual drill) ► austenitic steel

Hard metals used in surgical instruments

Alloy type used for instruments with wear protection (inserts or coating):

• cobalt-chrome-tungsten: for scissors
• tungsten carbide cobalt-binder: for forceps and needle holders
• tungsten carbide nickel-binder: for forceps, scissors and needle holders

Tungsten carbide is a chemical compound containing equal parts of tungsten and carbon atoms. It is approximately twice as stiff as steel and is double the density of steel—nearly midway between that of lead and gold.

Tungsten Carbide materials have a unique combination of properties, high compressive strength, hardness and resistance to wear, as well as an ability to withstand shock and impact.

The binder in most grades of Tungsten Carbide is cobalt. The other binder used is nickel. The binder is added as a percentage by weight varying from 3% to 30%. The amount of binder used is a very important factor in determining the properties of each grade. As a rule of thumb the lower the cobalt content the harder the material will become. However variation in grain size and additives can upset this rule.

Titanium used in surgical instruments

Different grades of pure titanium and titanium alloy are used in surgical instruments. Information about the quality can be found in ISO 5832 Implants for surgery -- Metallic materials

Retractors and probes: pure titanium = Unalloyed Commercially Pure (CP) Titanium, ISO implant quality 5832-2 grade 1, 2, 3 and 4. Grade 1 has the highest corrosion resistance, formability and lowest strength, grade 4 offers the highest strength and moderate formability.

A titanium alloy (ISO 5832-3) can be used for: forceps, scissors, retractors, probes, needle holders, springs, screws, rivets, guide pins.

Titanium is naturally a grey metal, but by anodizing the surgical instruments, manufacturers change the surface properties of the metal. Titanium surgical instruments are typically blue. The anodizing also makes the surgical instruments non-reflective so that there is no glare.

Titanium surgical instruments offer several advantages over stainless steel instruments:

• lightweight: reduces hand fatigue especially during long surgical procedures
• high tensile strength.
• durable, even after repeated autoclaving without damaging the surfaces or cutting edges
• corrosion resistant, non-ferrous (it will not rust), non-magnetic (=MRI compatible) and bio-compatible.

PRECONDITIONS

Prior to implementing X-ray services or installing new equipment, it is essential to:

• Inquire about national radiation regulations as this may impact; equipment selection, X-ray room design, radiation safety requirements, licensing, HR staffing requirements etc
• Contact the Diagnostic Imaging Working Group (diagnostic-network@msf.org) for support and to:
• select the most appropriate x-ray equipment or assess the functioning of existing equipment
• organize the installation, implementation, maintenance and technical support
• assess the x-ray room and the need for general and personal protective equipment
• arrange training and implementation of MSF policies and procedures
• assess and/or provide training on appropriate clincal indications (use of X-ray) & X-ray interpretation for the medical team

GENERAL RADIOPROTECTION MEASURES

Staff and patients’ attendants protection

• Time, distance and shielding are the fundamentals of radioprotection measures
• Time
• Where appropriate reduce the time near the X-ray source. Limit access to the x-ray room to only those people absolutely necessary.
• Distance
• One of the most simple and effective measures. Increase your distance from the X-ray machine and patient when taking radiographs - in particular when using a mobile X-ray to decrease your dose (inverse square law).
• Shielding
• Fixed X-ray rooms are designed to protect the operators by providing a protective barrier (e.g. lead lined walls and lead glass window).
• Operators using a mobile X-ray wear radioprotective clothing (lead or lead equivalent material apron & thyroid protection).
• Extra
• Any person staying beside patient when taking a radiograph must:
• stand as far as away from the radiation beam
• wear individual radioprotective clothing (lead or lead equivalent material apron & thyroid protection).

Protection of patients

• Justification: only x-ray a patient when it is clinically indicated. See MSF X-ray indications.
• Optimization - ALARA, use the lowest reasonable dose for the specfic patient / examination that produces a quality image. See MSF X-ray exposure chart (requires trained radiographers).
• Ensure appropriate radiographic technique is used for each examination, including restricting the X-ray beam to the area of interest (collimation), correct X-ray equipment use, patient communication and positioning supports are available.
• Ensure an appropriate policy is in place for screening potentially pregnant patients prior to performing X-ray imaging.

MEASUREMENT OF RADIATION DOSES

Before starting an x-ray program, it is essential to:

• Inquire about national regulations concerning radioprotection
• Check if there is a national organisation in charge to monitor x-ray doses by dosimetry and try to install a similar monitoring system

For more information, contact the Diagnostic Imaging Working Group (diagnostic-network@msf.org).

SELECTING AN X-RAY MACHINE

The most appropriate X-ray equipment will depend on the specific project requirements. The WHIS-RAD or MULTI-RAD x-ray unit is generally preferred as the primary option for MSF hospital based projects, but may not be suitable in all scenarios. Before ordering an x-ray unit, please contact the Diagnostic Imaging Working Group (diagnostic-network@msf.org) for advice, and to discuss radiation safety requirements, human resources requirements, servicing and necessary accessory equipment.

Manufacture

• 5.1.1 : Manufacturer (+ name and address)
• 5.1.2 : Authorized representative in the European Community / European Union (+ name and address)
• 5.1.8: Importer (+ name and address)
• 5.1.9: Distributor (+ name and address)
• 5.1.11: Country of manufacture (the CC in the symbol shall be replaced 2 or 3-letter country code)

Identification of product

• 5.1.5: Batch code = lot code = batch number
• 5.1.6: Catalogue number = reference number = reorder number = commercial product code
• 5.1.7: Serial number
• 5.1.10: Model number

User information

• 5.1.3: Date of manufacture
• 5.1.4 : Use-by date : the date after which the device is not to be used (after the end of the year, month or day shown)
• 5.2.8: Do not use if package is damaged and consult instructions for use
• 5.4.3: Consult instructions for use
• 5.4.4: Caution

Safe use

• 5.4.1: Biological risk
• 5.4.5: Contains or presence of natural rubber latex as material of construction within the medical device or the packaging of it.
• 5.4.10: Contains hazardous substance(s)
• 5.4.2: Do not re-use = medical device is intended for single use only = use only once
• 5.4.12: single patient multiple use: the medical device may be used multiple times on a single patient

Sterility

• 5.2.1: Sterile: indicates that a medical device has been subjected to a sterilization process.
• 5.2.2: Sterilized using aseptic processing techniques
• 5.2.3: Sterilized using ethylene oxide
• 5.2.4: Sterilized using irradiation
• 5.2.5: Sterilized using steam or dry heat
• 5.2.6: Do not resterilize (only to be used when there is also the sterile symbol)
• 5.2.7: Non-sterile (to be used only to distinguish between identical or similar medical devices sold in both sterile and non-sterile conditions)
• 5.2.12: double sterile barrier system

Storage conditions

• 5.3.1: Fragile, handle with care
• 5.3.2: Keep away from sunlight = keep away from heat
• 5.3.3: Protect from heat and radiation sources
• 5.3.4: Keep dry = keep away from rain
• 5.3.5: Lower temperature limit (+ temp limit adjacent to lower horizontal line)
• 5.3.6: Upper temperature limit (+ temp limit adjacent to upper horizontal line)
• 5.3.7: Temperature limit (+ temp limits adjacent to both horizontal lines)
• 5.3.8: Humidity limitation (+ limits adjacent to both horizontal lines)
• 5.3.9: Atmospheric pressure limitation + limits adjacent to both horizontal lines)

IVD-specific

• 5.5.1: In vitro diagnostic medical device
• 5.5.2: Control material intended to verify the performance of another medical device
• 5.5.3: Negative control
• 5.5.4: Positive control
• 5.5.5: Contains sufficient for “n” tests

Transfusion / infusion

5.6.2: Fluid path present (liquid or gas)

5.6.3: Non-pyrogenic

5.6.4: Drops per milliliter: the number of drops to be specified in the symbol

5.6.5: Liquid filter with pore size: the infusion or transfusion system of the medical device contains a filter of a particular nominal pore size (size indicated in the symbol)

5.6.6: One-way valve: the flow is only possible in one direction and cannot be reversed

General / other

• 5.7.7: Medical Device
• 5.7.9: Repackaging (+ name + address of unit responsible for repacking, if not by manufacturer)
• 5.7.10: Unique Device Identifier

In case the order of an article has to be justified, one or more justification codes (P, M, E, F, A, S) appear on the top of the technical sheet in the catalogue, and in a separate column on the order list. These codes give the reasons why the order of that article has to be justified. A more detailed explanation can be found in the catalogue, under the heading “Article to be justified”.

The request for justification aims at ensuring the programs’ quality, preventing medical risks, and highlighting the existence of programs that the medical or logistics department needs to be aware of.

P PROGRAM

Article reserved for a specific program (e.g.: drugs used in TB programs) or for specific applications (e.g.: HIV testing equipment used for pre-transfusion screening in surgical programs).

M MEDICAL RISK

Article involving a potential medical risk if misused. Its use is reserved for duly trained staff having sufficient knowledge of the medical context which is concerned (e.g.: drugs used in the treatment of angina pectoris).

■ Particular case:

Drug implying a potential risk of abuse and which must be used and/or prescribed by duly trained staff, and safely managed. It may be subject to particular national or international controls (e.g.: narcotic and psychotropic drugs).

E EXPENSIVE

Expensive article of which the choice has to be justified in comparison with cheaper alternatives, considering the cost-effectiveness, the sustainability of the program and the severity of the situation (e.g.: surgical sets for external fixators).

F FOLLOW-UP OR MONITOR

Article newly introduced in the MSF list, for which additional information is necessary in terms of criteria for use, evaluation, consumption, ease of use, follow up of side effects, etc.

A ACKNOWLEDGE

Article that needs to be adapted to each situation after a technical evaluation (e.g.: bungalow containers of which the configuration is specific to each installation).

S SECOND CHOICE

Article must only be used if the first choice is not available or cannot be used in a specific context

Once the order of an article has been justified and agreed by the medical or logistics department for one project, there is no need to justify the following orders of the same article for the same project.

CAUTION: All orders of non-standard medical articles have to be justified

The hospital kit is modular. You don’t order the hospital kit as a whole, but you order the part according the context and the activities you are carrying out.

6 main activity focal points

• OPD = out patient department: 10 000 persons/3 months
• Advanced medical post = AMP: 300 patients (50% severe)
• Emergency room: 300 severe patients
• Hospital ward: 20 to 40 beds / 300 patients
• and complementary module to the ward : delivery room: 50 deliveries
• Operating suite: 100 interventions
• Intensive care unit: 4 beds

4 support activities

These activities are mostly presented as an option

• Central sterilisation part: choose between the 90 or 39 litres autoclave
• Laboratory part: rapid diagnostic tests, equipment, reagents, …
• Central pharmacy part containing cold chain equipment
• Divers modules

The 6 main activities are composed of 2 or 3 parts each:

• Medical equipment (sometimes split into 2 parts like in the operating suite activities)
• Medicines and medical renewable supplies
• Complementary part (for OPD, advanced medical post, and ward)

In these parts, some modules are mandatory and other modules are optional.

Sometimes two articles/modules are indicated as Choice : it is mandatory to order one the two proposed choices according to the context.

The modules that are common to the different parts are called hospital modules:

The modules that are specific to a main activity are indicated by a letter in the code:

• C: OPD/consultations: 10 000 persons/3 months
• A: advanced medical post: 300 patients (50% severe)
• E: emergency room: 300 severe patients
• W: Ward: 20 to 40 beds / 300 patients
• O: Operating room: 100 interventions
• I: intensive care unit: 4 beds

4 support activities

These activities are mostly presented as options, but the sterilization and the pharmacy must be ordered with one of the main activities.

• Central sterilization part: choose the 90 litres or 39 litres autoclave
• Laboratory part: modules rapid diagnostic tests, sampling, transport, reagents, equipment, transfusion, blood bank, clinical chemistry blood analyser
• Central pharmacy part including cold chain equipment, refrigerator or deep freezer, library, stationary, and blood bank refrigerator.
• Divers modules:
• TB and ARV medicines
• Emergency box KMEDKFAI5--
• Module PEP
• Gynecology-obstetrical material
• VHF investigation module
• Module with medicines for the team
• Basic book kit
• Stationary module
• Some optional modules (injectable and oral antimalarial drugs, rape management)

Examples of use:

• Displaced camp
• OPD + Sterilisation 39l + Pharmacy
• OPD + Sterilisation 39l + Pharmacy + Observation beds
• Conflict with hospital intervention
• ER +/‐ OPD, +/‐ AMP
• Ward 30 beds/400 patients
• OT suite + 1 OT room + 100 procedures
• Sterilisation 90l
• Pharmacy
• Earthquakes
• OPD
• ER + Ward 30 beds/400 patients
• OT suite + 2 OT room + 200 procedures
• Sterilisation 90l
• Pharmacy
• Complementary delivery
• Physiotherapy module

The primary purpose of labelling is to identify the medical device and its manufacturer, and communicate safety and performance related information to the user, professional or lay, or other person, as appropriate. Such information may appear on the device itself, on packaging or as instructions for use.

• Label: written, printed, or graphic information either appearing on the medical device itself, or on the packaging of each unit, or on the packaging of multiple devices.
• Labelling: the label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents.
• Primary Packaging: contains and protects the article so it is normally in contact with it. Can be sterile or no sterile EX: sachet, plastic box, peel-open pack
• Secondary Packaging: A pack component with no product contact but may add protection to that provided by the immediate pack. EX: cardboard box, rigid wrapping.

Guideline

IMDRF (International Medical Device Regulators Forum): IMDRF/GRRP WG/N52 FINAL:2019: Principles of Labeling for Medical Devices and IVD Medical Devices

​https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-190321-pl-md-ivd.pdf

UNIQUE DEVICE IDENTIFICATION – UDI

Definition of UDI

A series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market.
UDI is a unique numeric or alphanumeric code, displayed in both human readable (plain text) and machine readable AIDC (Automatic identification and data capture) form, that consists of two parts: the device identifier (DI) and the production identifier(s) (PI)

• DI = Device Identifier: Mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device. It is also the identifier used to access the UDI Database.
• PI = Production Identifiers: a variable code related to production data of the device, such as lot/batch number, expiry date, manufacturing date, etc.

Objective of UDI

• Establish a system to adequately identify devices through distribution and use
• Facilitate the rapid and accurate identification of a device
• Enable access to important information concerning the device
• Allow more accurate reporting, reviewing, and analyzing of adverse event reports.
• Provide a standard and clear way to document device use in electronic health records, clinical information systems, claims, data sources and registers.
• Enable more efficiently managed device recalls

Example

UDI barcode combines the Device Identifier (DI) which would be a static portion to the barcode and then the Production Identifier (PI), which would be a dynamic portion to the barcode, including Application Identifiers such as Manufacturing date (AI-11), Serial (AI-21), Lot Number (AI-10) and Expiration Dates (AI-17).

Data delimiter means a defined character or set of characters that identifies specific data elements within an encoded data string. The data delimiters are key to UDI comprehensibility and utility. The data delimiters indicate the DI value or the PI values that follow each data delimiter within the UDI.

The final human readable string for this example: (01)51022222233336(11)141231(17)150707(10)A213B1(21)1234

UDI regulation

UDI’s are issued by an accredited UDI issuing agency (FDA or EU)
Conform to each of the following international standards:
ISO/IEC 15459: Information technology -- Automatic identification and data capture techniques -- Unique identification. the different parts are confirmed in 2020.

• Part 2: 2015: Registration procedures
• Part 4: 2014: Individual products and product packages
• Part 6: 2014: Groupings

Use only characters and numbers from the invariant character set of ISO/IEC 646 (information technology: 7-bit coded character set for information interchange)

UDI issuing entities

The Official Journal of the European Union (OJEU) of 7 June 2019, has announced the four UDI issuing agencies applicable for Medical Devices under the MDR and In-Vitro Diagnostic Medical Devices IVDR. These agencies will issue the unique codes necessary for UDI. This assignment will be valid for five years, after which designations will be reviewed by the European Commission and possibly renewed.

• IFA GmbH: Informationsstelle für Arzneispezialitäten (IFA GmbH is an information service provider for the pharmaceutical market, providing information services including economic, legal and logistic data for goods sold in pharmacies in Germany)

The other identified agencies are already active for US FDA UDI. They are:

• GS1: a not-for-profit organization that develops and maintains global standards for business communication. The best known of these standards is the barcode, a symbol printed on products that can be scanned electronically.
• Health Industry Business Communications Council (HIBCC): was established in 1983 as an industry-sponsored nonprofit council by major health care associations to develop a standard for data transfer using uniform bar code labelling. Over time, it has expanded its focus to include additional electronic data interchange standards.
• International Council for Commonality in Blood Banking Automation (ICCBBA): is an international not-for-profit non-governmental standards organization in official relations with the World Health Organization (WHO) and is responsible for management and development of the ISBT 128 Standard (a global standard for the identification, labelling, and information transfer of medical products of human origin, including blood).

GUDID

The Global Unique Device Identification Database (GUDID) is administered by the FDA and serves as a reference catalog for every device marketed in the US with an identifier. Under the UDI rule, the labeler of each medical device labeled with a unique device identifier (UDI) must submit information concerning that device to the GUDID, unless subject to an exception or alternative. The GUDID contains ONLY the device identifier (DI), which serves as the primary key to obtain device information in the database. The database is free access.

Guideline

IMDRF (International Medical Device Regulators Forum): UDI Guidance, December 2013

MEDICAL DEVICE NOMENCLATURE

A global Medical Devices nomenclature is required, to support faster regulatory process, easier selection, improved procurement and supply, increased trade and better asset management, in order to increase patient safety, better allocation of resources, post market surveillance and impact the access and availability of medical devices to support better health care delivery.
The European Medical Device Nomenclature (EMDN) will be the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database.
Founded on pre-established criteria and requirements and based on orientations provided by the Medical Device Coordination Group (MDCG), the European Commission decided in favour of the use of the ‘Classificazione Nazionale Dispositivi medici (CND)’ as the basis for the EMDN. To the extent possible, the Commission will map the EMDN to the Global Medical Device Nomenclature (GMDN).

EMDN / CND nomenclature

This nomenclature is characterized by its alphanumeric structure that is established in a multi-level hierarchical tree. It clusters medical devices in three main levels:
1 = Category
2 = Group
3 = Type (which if necessary, expands into several levels of detail)
Each MD is classified by an alphanumeric code consisting of a letter referring to the Category, a couple of numbers referring to the Group and a series of other couples of numbers referring to the Type (whose amount depends on the level of detail) up to a maximum of 7 levels.

GMDN: Global Medical Device Nomenclature

GMDN is a system of internationally agreed descriptors used to identify medical device products.
GMDN is managed by the GMDN Agency, a non-profit organization which reports to its Board of Trustees, that represents medical device regulators and industry.
Medical device experts from around the world (manufacturers, healthcare authorities and regulators) compiled the GMDN, based on the international standard ISO 15225. The work was mandated by the European Commission in order to provide the necessary tool to carry out the implementation of the Medical Devices Directive, including the European databank for medical devices (Eudamed)
The GMDN term is in the form of a 5-digit numeric GMDN Code cross-referenced to a specific Term Name and Definition, with which all specific medical devices having substantially similar generic features, can be identified. They are mentioned at the bottom of the definition in the technical sheet of the MD.

UMDNS: Universal Medical Device Nomenclature System

UMDNS is owned and copyrighted by ECRI Institute (an independent international nonprofit organization that researches approaches to improving patient care). Codes are free to be used by any stakeholder but do not contain the granularity required.
UMDNS contains 10,056 unique medical device concepts and definitions (preferred terms), along with an additional 23,004 entry terms to facilitate classifying of biomedical information. UMDNS contains explicit relationships among the 33,000+ terms, including hierarchical relationships and synonymous relations, as well as relationships among related devices.

UNSPSC: United Nations Standard Products and Services Code

UNSPSC a four-level hierarchy coded as an eight-digit number, with an optional fifth level adding two more digits. The UNSPSC was jointly developed by UNDP and is currently managed by GS1 US.

HS (Harmonized System)

The Harmonized Commodity Description and Coding System is an internationally standardized system of names and numbers to classify traded products. It came into effect in 1988 and has since been developed and maintained by the World Customs Organization (WCO), an independent intergovernmental organization based in Brussels, with over 200 member countries.

GRAPHICAL SYMBOLS FOR USE IN THE LABELLING OF MD AND IVD

Definition

According to ISO 14971: graphical representation appearing on the label and/or associated documentation of a medical device that communicates characteristic information without the need for the supplier or receiver of the information to have knowledge of the language of a particular nation or people. The symbol can be an abstract pictorial or a graphical representation, or one that uses familiar objects, including alphanumeric character. These symbols may be used on the medical device itself, on its packaging or in the associated documentation.

Standards

• ISO 15223-1: 2021: Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
• identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices.
• It also lists symbols that satisfy the requirements of ISO 15223-1.
• is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.
• EN 15986:2011: Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
• ISO 7000:2019: Graphical symbols for use on equipment -- Registered symbols
• ISO 780:2015 (confirmed in 2021): Packaging — Distribution packaging — Graphical symbols for handling and storage of packages
• IEC TR 60878:2015: Graphical symbols for electrical equipment in medical practice

QUALITY OF REAGENTS

A same product comes in many different forms and quantities depending on the manufacturer. Quality standards, corresponding to various degrees of purity, and therefore to different purposes, allow to differentiate them:

• No specification
• Pure, ultra pure, very pure
• For analysis or PA
• According to pharmacopoeia
• For synthesis, chromatography, etc.

According to their use on the field (See Updated laboratory procedures, MSF, 2022), MSF selected products which are meeting the following criteria:

• Quality ensuring a very good result
• Best price
• Available in small packaging

3 quality standards have been selected:

• No specification (general use)
• Pure, ultra pure, very pure (specific pharmacopoeia use)
• For analysis (organic analyses and syntheses)

Concerning staining products, the quality standards "for bacteriology" or "for microscopy" correspond exactly to the specifications of solutions and reagents prepared in laboratories equipped by MSF.

Quality standards "for synthesis" or "for chromatography" are indicating a very high degree of purity, with the level of residues following analysis on the label. They are more expensive and should not be ordered.

USE OF POWDERS

The decision to use powders for the preparation of reagents should only be taken until a careful study of the laboratory to be equipped has been made.

It is recommended to use ready to use reagents in liquid form if available, because the preparation of reagents or staining products from powder requires additional equipment (test tubes, flasks, scales etc.), complementary reagents (alcohol, phenol, etc.)and well-trained laboratory personnel.

PACKAGING OF REAGENTS

Powders

It is recommended to always select the smallest possible packaging, since powders are used only in very small quantities (especially staining products).

A 100 g bottle can last for several years.

Liquids

In 500 ml or 1 l bottle, but there are exceptions.

Bottles are designed to preserve the product as best as possible (e. g.: Lugol in brown glass bottle for protecting it from light).

Always screw the bottle caps tightly.

EXPIRATION OF REAGENTS

• Reagents should not be used beyond the expiry date indicated on the package.
• Reagents with no expiry date should be regularly controlled for their quality, e.g. by staining a known sample.
• If no expiry date is indicated, the reagents can be used until empty but a quality check is required for these reagents. Indicators for expiration can be (but don't have to be):
• Change of colour
• Precipitation in a liquid reagent

STORAGE CONDITIONS

• Follow the manufacturer's instructions
• Always protect reagents from heat, light and humidity
• For safety reasons, bottles should be stored in the lower shelves
• If possible, store toxic reagents in a laboratory cabinet with a lock.

TRANSPORT OF REAGENTS

International transport

Chemical dangerous products must be labelled, wrapped, packaged and labelled in accordance with the IATA (International Air Transport Association) standards.

The technical sheets of the concerned products mention the air freight code (UNxxxx) as well as the hazard symbol(s).

This information should appear on the packaging, necessarily in English and in well defined dimensions.

National transport

For any transport, the reagents must be packaged and labelled in accordance with the instructions given on their technical sheet. It is recommended to keep them in their original packaging until final destination.

Follow IATA regulations for any shipment by air.

HAZARD IDENTIFICATION

New CLP classification (Classification - Packaging - Labelling) according the EC Regulation N°1272/2008 (GHS/SGH):

• Classification categories
• Hazard pictograms
• Signal word
• Hazard and precautionary statements

HAZARD PICTOGRAMMES

MANAGEMENT OF LABORATORY WASTE

Management of laboratory waste should be planned on a case-by-case basis according to the specific activities of the laboratory. Treatment and/or final disposal of (hazardous) laboratory waste will depend on local conditions, availability of treatment options and the waste’s characteristics, packaging, volume and recurrence. Safety, environmental and cost factors also need to be considered.

Existing applicable national, regional or local regulations for treatment and disposal of hazardous waste should always be adhered to. It is recommended to investigate if there are specialized institutions for waste elimination and/or recycling facilities available. If facilities are substandard, the MSF alternatives can be proposed and/or lobbying by WHO or MSF can be done to improve the elimination procedures within the legislation. When legislation is non-existent, the MSF strategy will most probably have to be implemented.

Please contact your laboratory and/or WatSan advisor for support on the management of waste in your laboratory.

MEDICAL GRADE MATERIAL

For the designing of a medical device, each composing material should have certain characteristics, which should be in a harmony with the final properties of the medical device as well the target application.
The manufacturing companies take into consideration the following criteria:

• availability of the material in sufficient quantities and material cost, (including the costs of production, transportation, and amounts required for each device)
• matching between the material properties and the required specifications of the designed device.
• biocompatibility of the finally designed device, as well as its components. This can be considered one of the most important factors for selecting material, where the formation of any harmful products following the usage of the device will lead to its failure.
• required sterilization technique which can preserve the structure and properties of the constituting materials as well.
• sustainability of the medical device: choice of material, the manufacturing method and its related economic issues, and finally the disposal of the device.

ISO standard for medical grade materials

Because they come in contact with the human body, materials are tested for biocompatibility and safety in order to receive the “medical grade” designation
ISO 10993: biological evaluation of medical devices. The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices.

• Part 1: Evaluation and testing within a risk management process (2018)
• Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (2014)
• Part 4: Selection of tests for interactions with blood (2017)
• Part 5: Tests for in vitro cytotoxicity (2009)
• Part 6: Tests for local effects after implantation (2016)
• Part 7: Ethylene oxide sterilization residuals (2008)
• Part 9: Framework for identification and quantification of potential degradation products (2019)
• Part 10: Tests for irritation and skin sensitization (2021)
• Part 11: Tests for systemic toxicity (2017)
• Part 12: Sample preparation and reference material (2021)
• Part 13: Identification and quantification of degradation products from polymeric medical devices (2010)
• Part 14: Identification and quantification of degradation products from ceramics (2009)
• Part 15: Identification and quantification of degradation products from metals and alloys (2009)
• Part 16: Toxicokinetic study design for degradation products and leachables (2018)
• Part 17: Establishment of allowable limits for leachable substances (2002)
• Part 18: Chemical characterization of medical device materials within a risk management process (2020)
• Part 23: Tests for irritation (2021)

PLASTICS AND ELASTOMERS

Definition

Plastic is material consisting of any of a wide range of synthetic or semi-synthetic organic compounds that are malleable and so can be molded into solid objects. Most plastics contain organic polymers. The vast majority of these polymers are formed from chains of carbon atoms, ‘pure’ or with the addition of: oxygen, nitrogen, or sulfur. The chains comprise many repeat units, formed from monomers. Each polymer chain will have several thousand repeating units.

An elastomer is a polymer with viscoelasticity (i.e., both viscosity and elasticity) and very weak intermolecular forces compared with other materials. The term of elastic polymer, is often used interchangeably with rubber. Each of the monomers which link to form the polymer is usually a compound of several elements among carbon, hydrogen, oxygen and silicon.

Characteristics

They are generally lightweight, can have excellent flexibility, and are generally inexpensive. Approximately 75 percent of polymers used in medical device manufacturing are thermoplastics (plastics that, when heated, do not undergo chemical change in their composition and so can be molded again and again), allowing them to be molded to precise shapes. Unlike metals, polymers do not interfere with medical scanning devices such as MRIs.

Polymers used in medical device manufacturing must be sterilizable, resistant to contamination, and have acceptable low levels of toxicity.

Many of the properties of plastics are determined by intenational standards.

Plastic number code

The plastic symbols are the Resin Identification Coding System (RICS). They advise what type of plastic the item is. Recyclers use these plastic codes: they can visually identify plastics to sort if for recycling, but the symbol doesn’t tell you if it will be recycled or not.

Properties of some plastics

Polyvinyl chloride (PVC / V)

• inert, chemically stable and flexible polymer that is used in a wide array of products
• the material has a smooth surface and is firm enough for easy insertion, yet soft enough to be slightly pliable. It tends to warm to body heat which can also aid in overall pliability.
• it is often used for medical devices which are sterilized by the manufacturer, it is the most popular material used for intermittent catheters. It is clear, you can view the output.
• unplasticized PVC is hard and brittle at room temperature. A plasticizer (=phthalate) is typically added to increase the flexibility of the polymer. DEHP (= Di-ethylhexyl phthalate) is the plasticizer for most PVC medical devices.
• platelet affinity is significantly higher for PVC = more thrombogenic.
• incineration generates dioxins (carcinogenic) which escape in the atmosphere via the fumes of the incinerator, may also contain some lead (Pb).

In 2002, the US FDA issued a Public Health Notification concerning PVC. The agency expressed concerns regarding exposure to the PVC plasticizer DEHP that is used in numerous medical devices. In view of the available animal data, the agency advised, “precautions should be taken to limit the exposure of the developing male to DEHP.” In the wake of public health concerns regarding phthalate plasticizers, PVC is becoming an outdated legacy material overtaken by others “better suited to the demands of healthcare applications.

For MD used by MSF: For new products: the potential benefits of products containing phthalates will be evaluated against their risks. Enteral nutrition for neonates seems to be the highest risk procedure at present time. For the existing articles: No phthalate eviction policy.

Polypropylene (PP)

Rugged material which resists very well against chemical solvents, bases and acids, as well as bacterial growth. It is therefore often used in the manufacture of medical devices and laboratory equipment.
Incineration of PP is less polluting than the one of PVC. Moreover, its components are elements that give off a lot of calorific value when incinerated. This allows helping incineration of other medical waste that doesn’t burn that well without having to add (too much) additional fuel. Polypropylene (PP) and polypropylene copolymer (PPCO) containers can be autoclaved many times.

Polycarbonate (PC)

• group of thermoplastic polymers containing carbonate groups in their chemical structures
• has high impact-resistance but also a low scratch-resistance
• can undergo large plastic deformations without cracking or breaking
• products made from polycarbonate can contain trace quantities of the precursor monomer bisphenol A
• polycarbonate (PC) products can be autoclaved with caution, as they should not be exposed to alkaline detergents or steam additives, and they may withstand only up to 30 – 50 autoclaving cycles. Sterlizing PC reduces the mechanical strength of the material.
• commonly used in eye protection

Polyester (PES)

• polyester is a synthetic polymer made of purified terephthalic acid (PTA) or its dimethyl ester dimethyl terephthalate (DMT) and monoethylene glycol (MEG)
• it most commonly refers to a type called polyethylene terephthalate (PET)
• polyester fabrics are highly stain-resistant, they have high water, wind and environmental resistance compared to plant-derived fibers but they are less fire resistant and can melt when ignited
• polyester fibers are sometimes spun together with natural fibers to produce a cloth with blended properties

Polystyrene (PS)

• a synthetic aromatic hydrocarbon polymer made from the monomer styrene
• can be solid or foamed (Styrofoam): “open cell” form, in which the foam bubbles are interconnected, as in an absorbent sponge or “closed cell”, in which all the bubbles are distinct
• general-purpose polystyrene is clear, hard, and rather brittle, is a poor barrier to oxygen and water vapor and has a relatively low melting point
• widely used in packaging, petri dishes, test tubes and microplates
• generally non-biodegradable, burns to give carbon dioxide and water vapor, it typically combusts incompletely as indicated by the sooty flame.

Polytetrafluorethylene (PFTE)

• synthetic fluoropolymer of tetrafluoroethylene, thermoplastic polymer
• best known brand name of PTFE-based formulas is Teflon
• commonly used as a graft material in surgical interventions.
• frequently employed as coating on catheters; this interferes with the ability of bacteria and other infectious agents to adhere to catheters. (catheters using PTFE cannot be sterilized by irradiation because the irradiation process degrades PTFE)

Polyurethane (PUR)

• polymer composed of organic units joined by carbamate. there are many types of thermoplastic polyurethanes available: polyester or polyether or polycarbonate based polyurethanes
• thermoplastic polyurethanes do not use plasticizers to obtain softness, the additives used are biocompatible
• they are key polymers in the vascular catheter market: Polycarbonate-based polyurethanes are first choices for long-term central venous catheter applications. Polyether-based polyurethanes soften considerably within minutes of insertion in the body: this promotes patient comfort and reduces risk of vascular trauma.
• larger internal diameter compared with same CH silicone catheter = increased flow. PUR requires less wall thickness for strength compared to silicone. PUR is easily coated with a variety of specialized coatings

Silicone (SI)

• inherent chemical and thermal stability, low surface tension and hydrophobicity, does not contain proteins and are non-allergenic, can be autoclaved ➔ intrinsic biocompatibility and biodurability.
• super-smooth material, softness may reduce vein trauma
• its flexibility as an intermittent catheter lies somewhere between vinyl and rubber latex. It is firmer than latex, which helps with an easy insertion, but it can feel slightly more flexible than vinyl materials.
• kink resistant
• greater wall diameter compared to PUR
• it is clear, so you can view your output.
• extensive application in catheters and other medical products: short- and long-dwelling catheters, drains, and shunts
• compared to PVC: does not contain phthalates or another organic plasticizer which might leach out. Show significantly less sepsis, prolonged service life and fewer catheter insertions per patient.
• mineral incrustation with urinary catheters: the all-silicone and silicone-coated catheters remained patent the longest (compared to latex and latex-coated catheters)

Polyamide (PA)

• macromolecule with repeating units linked by amide bonds, occur both naturally (proteins) and artificially
• synthetic polyamides are classified according to the composition of their main chain: Aliphatic polyamides, Polyphthalamides and Aramids = aromatic polyamides.
• nylon is a generic designation for the synthetic polymers, based on aliphatic polyamides. In common usage, the prefix ‘PA’ (polyamide) or the name ‘Nylon’ are used interchangeably and are equivalent in meaning
• nylon is a thermoplastic silky material that can be melt-processed into fibers films or shapes.
• nomenclature used for nylon polymers uses numbers to describe the number of carbons in each monomer unit

Natural Rubber (NR)

• Rubber and latex are not the same, but many people use the words as if they both referred only to natural rubber
• a latex is a dispersion of extremely small particles of an insoluble liquid or solid material in a liquid (the particles are almost always polymeric, and the liquid is usually water, most latexes also contain a surfactant)
• natural Rubber Latex refers to the white sap that comes from the hevea brasiliensis tree. The latex then is refined into rubber, also called India rubber or caoutchouc, ready for commercial processing.
• thermos-sensitive: warms up to the surrounding temperatures and becomes easily pliable.
• very soft, has a large stretch ratio and high resilience, and is extremely waterproof.
• is almost always given a tint with special dyes while it is still in a liquid state.
• Latex allergy: prevalence among medical professionals is estimated at 8 – 17%, in the general population: 1 – 6%. Latex allergies usually present as a type I (IgE-mediated) immediate allergic reaction to proteins contained in the natural rubber. Several of the additives used during manufacture have also been implicated as causal agents. Latex allergies are regarded as a major healthcare issue.

Synthetic rubber

Synthetic rubber is a man-made rubber which is produced in manufacturing plants by synthesizing it from petroleum and other minerals. It has the property of undergoing elastic stretch or deformation under stress but can also return to its previous size without permanent deformation. Depending on the chemicals added and the properties associated with it, the synthetic rubber can be as hard as a bowling ball or as resilient as a rubber band or as soft as a sponge. Approximately 70% of all rubber used today are one from many synthetic rubber varieties. Some of the popular synthetic rubber types include the following:

• Isoprene Rubber (IR)
• Nitrile Rubber (NBR)
• Polychloroprene (CR)/ Neoprene
• Silicone Rubber (SiR)
• Styrene Butadiene Rubber (SBR)

Ethylene-vinyl acetate (EVA)

• also known as poly (ethylene-vinyl acetate) (PEVA) = copolymer of ethylene and vinyl acetate
• elastomeric polymer that produces materials which are “rubber-like” in softness and flexibility. The material has good clarity and gloss, low-temperature toughness, stress-crack resistance, hot-melt adhesive waterproof properties, and resistance to UV radiation. EVA is competitive with rubber and vinyl polymer products in many electrical applications.
• used in: Hot melt adhesives, in biomedical engineering applications as a drug-delivery device, EVA foam is used as padding or as a shock absorber in physiotherapy equipment.

TEXTILES USED IN LINEN AND CLOTHING

Surgical drapes and materials are a key element when preventing postoperative wound infections. Surgical fabrics have to fulfill the following requirements:

• Maximum protection for patients, users and third parties
• High microbiological and hygiene standards to prevent the risk of infection
• Good wearing comfort of the clothing to maintain the high performance
• Liquid-absorbing
• Easy handling of the drapes

​Types of fabrics

• Woven fabrics have an over/under structure of machine direction (MD) and cross machine direction (XD) threads-produced on a loom that feeds thread in only two directions and are generally inelastic.
• Knit fabrics are constructed through series’ of interlocked loops, which make a knit fabric more flexible in multiple directions.
• Non-woven fabric is a fabric-like material made from staple fiber (short) and long fibers (continuous long), bonded together by chemical, mechanical, heat or solvent treatment.

Non-woven textiles

Non-woven fabrics are structures of textile materials, such as fibres, continuous filaments, or chopped yarns of any nature or origin, that have been formed into webs by any means, and bonded together by any means, excluding the interlacing of yarns as in woven fabric, knitted fabric, laces, braided fabric or tufted fabric (Film and paper structures are not considered as non-wovens)
Non-woven fabrics are engineered fabrics that may be single-use, have a limited life, or be very durable.
Different manufacturing processes classify non-woven fabrics: Staple non-wovens, Melt-blown non-wovens, Spunlaid (also called spunbond) non-wovens, Flashspun fabrics

• SMS non-woven fabric = fabric consisting of 3 layers (polypropylene is mostly used): 1 layer of meltblown non-woven in sandwich between 2 layers of spunbond non-woven.
• SMMS non-woven contains 4 layers: spunbond non-woven fabric + meltblown non-woven fabric + meltblown non-woven fabric + spunbond non-woven fabric

With special treatments during the production process, different specifications can be obtained: hydrophilic, antibacterial, anti-mite, anti-static, alcohol and blood repellent, oil repellenty, hydrostatic pressure resistance.

Medical use:

• medical packaging: porosity allows gas sterilization
• isolation gowns, surgical gowns, surgical drapes and covers, surgical masks, surgical scrub suits, caps, gloves, shoe covers, wound dressings, plasters,..

Regulations for non-woven fabrics:

• ISO 9092: 2019: Textiles — Nonwovens — Definition
• ISO 9073: Textiles -- Test methods for nonwovens – different parts

Woven fabrics

Woven fabric is any textile formed by weaving. Woven fabrics are often created on a loom, and made of many threads woven on a warp and a weft. Technically, a woven fabric is any fabric made by interlacing two or more threads at right angles to one another.

• Polyester/cotton: 50% polyester-50% cotton fabric
• Cotton: 100 % cotton cretonne fabric

Comparative results of the tests made on reusable woven textiles

• Dusting rates: Polyester/cotton gives off 50% less particles than cotton and is therefore particularly recommended for surgical linen.
• Physical properties : Polyester/cotton shows the best physical properties. However, its resistance decreases in proportion to use and to the number of sterilization cycles.
• Barrier properties (bacteriological and physical resistance to liquids): New cotton can absorb the equivalent of its weight: high permeability, immediate bacterial passage. After the 1st sterilization cycle, polyester/cotton shows a high level of absorption, but the permeability is limited thanks to waterproofing treatments, performed by the manufacturer.

Tychem® used in SARS or VHF contexts

Tyvek is a non-woven product consisting of spunbond olefin fiber. It is a brand of flashspun high-density polyethylene fibers, a synthetic material; the name is a registered trademark of DuPont. The material is very strong; it is difficult to tear but can easily be cut with scissors or a knife. Water vapor can pass through Tyvek, but liquid water cannot.
Tychem® fabric is a Tyvek® brand fabric with additional coating to increase chemical protection.

• Barrier against infectious agents
• Impervious to many inorganic chemicals and particles < 1 μm
• Impervious to liquids and aerosols
• Resistant to splashes up to 2 bars
• Permeable to air and steam
• Antistatic treated
• Stitched and covered seams for better strength and protective barrier

Selection of textiles within MSF

• The single-use non-woven textile is used for single use surgical masks and for the single use surgical linen module → intended for emergencies or kept in “reserve” in surgical programmes.
• Tychem® is used for items intended for the personal protection of medical/non-medical staff and patients’ attendants in contact with suspected or known cases of SARS or viral hemorrhagic fever (Ebola, Marburg, Lassa, etc.).
• Polyester/cotton fabric is used for surgical gowns and drapes (comfort of cotton and long life of polyester)
• 100 % cotton fabric is used for all other articles (easy local supply).

METALS USED IN MD MANUFACTURING

Metals are solid, non-organic materials. They have long been the most common material in medical device manufacturing and are currently used in some way shape or form in 80 percent of all medical devices. The combination of metals with other materials allows the properties of the material to be modified through the creation of alloys. Because most metals oxidize easily, stainless steel—comprising iron, carbon, and chromium—is often the metal of choice for medical device manufacturers. The use of titanium alloys is increasing, in part due to its modulus of elasticity which is closer to that of bone than that of steel.
Steels used in the manufacture of surgical instruments: see introduction ESUR family.

Types of stainless steel

In metallurgy, stainless steel, also known as inox, is a steel alloy with a minimum of 10.5% chromium content by mass and a maximum of 1.2% carbon by mass. Stainless steel is divided into different families depending on its metallurgical structure.

Austenitic steel

These steels are the most common. Their microstructure is derived from the addition of Nickel, Manganese and Nitrogen. It is the same structure as occurs in ordinary steels at much higher temperatures. Corrosion resistance can be enhanced by adding Chromium, Molybdenum and Nitrogen. They cannot be hardened by heat treatment but have the useful property of being able to be work hardened to high strength levels whilst retaining a useful level of ductility and toughness. Higher nickel austenitic steels have increased resistance to stress corrosion cracking. They are nominally non-magnetic but usually exhibit some magnetic response depending on the composition and the work hardening of the steel.

• Grade 302 and 304 =18/8: containing a minimum of 18% chromium and 8% nickel, combined with a maximum of 0.08% carbon
• Grade 316: the carbon content is held to 0.08% maximum, while the nickel content is increased slightly with addition of molybdenum up to a maximum of 3% (it increases the corrosion resistance)

Martensitic steel

These steels are similar to ferritic steels in being based on Chromium but have higher Carbon levels up as high as 1%. This allows them to be hardened and tempered much like carbon and low-alloy steels. They are used where high strength and moderate corrosion resistance is required. They are more common in long products than in sheet and plate form. They have generally low weldability and formability. They are magnetic.

• Grade 410 is the basic martensitic type: 11.5 – 13.5 % chromium, carbon max 0.15%, Manganese max 1%, Silicon max 1%, Nickel 0.75%
• Grade 416 is a modification of type 410: sulfur or selenium have been added

Ferritic steel

These steels are based on Chromium with small amounts of Carbon usually less than 0.10%. These steels have a similar microstructure to carbon and low alloy steels. They are usually limited in use to relatively thin sections due to lack of toughness in welds. However, where welding is not required they offer a wide range of applications. They cannot be hardened by heat treatment. Ferritic steels are also chosen for their resistance to stress corrosion cracking. They are not as formable as austenitic stainless steels. They are magnetic. (Steel grade 430 is the basic type)

Designation of steel types

Steel grades to classify various steels by their composition and physical properties have been developed by a number of standards organizations.

• SAE steel grades: a standard alloy numbering systems for steel grades maintained by SAE International (Society of Automotive Engineers (a U.S.-based professional association and standards developing organization for engineering professionals in various industries)
• British Standards
• International Organization for Standardization ISO/TS 4949:2016
• European standards - EN 10027: designation system for steels:

• Part 1 (2016): Steel names: specifies rules for designating steels by means of symbolic letters and numbers to express application and principal characteristics, e.g. mechanical, physical, chemical, so as to provide an abbreviated identification of steels.

• Part 2 (2015): Numerical system: sets out a numbering system, referred to as steel numbers, for the designation of steel grades. It deals with the structure of steel numbers and the organization for their registration, allocation and dissemination. Such steel numbers are complementary to steel names set out in EN 10027-1.

• Japanese steel grades : Japanese Industrial Standards (JIS) standard
• Germany steel grades : DIN standard
• China steel grades : GB standard

CERAMICS USED IN MD MANUFACTURING

Ceramics play an increasing role in medical devices manufacturing. In materials sciences, the term ceramics applies to solid materials that are neither metallic nor organic. The category includes glass, clay, and concrete. They are usually oxides but can also be carbides, silicides, or nitrides. They are ideal for implantable medical devices as they are chemically nonreactive, good insulators, can be molded at small sizes and do not degrade within the body.

Disposable gloves

Disposable gloves fall into two categories:

• Primary concern = protecting patient: Medical Device Regulation (EU) 2017/745. Applicable standard is EN455 for Single Use Medical Gloves.
• Primary concern = protecting wearer: Regulation (EU) 2016/425 on personal protective equipment.

Definition of "Medical gloves for single use " according to EN 455: gloves intended for use in the medical field to protect patient and user from cross-contamination, intended to be used on one individual during a single procedure.

For MSF:

• medical gloves = SMSU / SPPE family
• PPE gloves = PSAF family.

The two main types of disposable medical gloves are examination and surgical (including gynecological gloves) – each with a specific function.

Medical gloves are further designated by their material – nitrile, latex or other.

If the wearer is to be protected from chemical and physical risks as well as biological agents (e.g., during work in a microbiological laboratory or care of patients harboring highly pathogenic microorganisms), gloves declared as PPE must be used. Dual labeling of products for dual purposes as MD and PPE is possible.

Examination Gloves versus Surgical Gloves

General purpose examination gloves are most commonly used by caregivers and healthcare workers to protect themselves from contamination between caregiver and patient during an examination or procedure. These gloves are used during procedures that do not require sterile conditions when a risk of contact with biologic fluids exists (either from patient = most common or from caregiver = breach in hand skin), for example drawing blood for a blood test. Some of these gloves can also protect the wearer from harm caused by dangerous chemicals or pharmaceuticals

The primary purpose of surgical gloves is to act as a protective barrier to prevent possible transmission of micro-organisms between healthcare professionals and patients during surgical procedures.

Differences between surgical gloves and medical examination gloves (the type of gloves found in bulk containers in clinical examination rooms) are:

• Manufacturers of surgical gloves are required to meet a higher level of quality standards.
• Surgical gloves are sterile and individually packaged in pairs (or double pairs) with clear identification of right and left hand.
• They are anatomically shaped medical gloves with the thumb positioned towards the palmar surface of the index finger.
• Surgical gloves have a more precise range of sizing than medical examination gloves (sizes 5 ½ up to 9, per ½ size).
• Donning surgical gloves is according to a strict procedure.

Materials

Common surgical glove material: latex, neoprene, polyisoprene or nitrile. Material selected by MSF: standard surgical gloves are latex (latex allergies are rare in MSF projects for the moment), alternatives are gloves made of neoprene (polychloroprene) .

Common examination glove material: latex, vinyl or nitrile. Material selected by MSF: standard examination gloves are latex or nitrile.

LATEX gloves

The natural rubber latex is derived from physical and chemical processing of the sap of certain species of trees, mainly the Hevea braziliensis.

GMDN: glove made of Hevea natural rubber latex (NRL)

• Hevea-latex surgical glove, non-powdered (47178
• Hevea-latex examination/treatment glove, non-powdered, non-sterile (47172)

Properties

• Level of barrier protection: Excellent: long standing benchmark for barrier protection.
• Allergen content: Varies: latex contains protein and chemical allergens.
• Strength and durability: Excellent: very strong and durable, tensile strength typically 3000 psi or better. Is a heat sensitive item (storage)
• Elasticity: Excellent: superior to the other gloves. Memory is very high allowing the film always to return to its original shape. Elongation limit +/- 750%.
• Puncture resistance: Very good: very resistant to punctures but can be pierced by very sharp objects.
• Fit and comfort: Excellent due to its high elasticity and memory, preferred by surgeons.
• Chemical resistance: Good: provides good protection from most caustics and detergents. May be used for handling cytotoxic drugs.
• Economy: Very good
• Environmental impact: Excellent: easily decomposes in landfills (natural product), incineration produces mostly water and carbon dioxide

NITRILE gloves

The nitrile is a synthetic rubber latex, derived from Acrylonitrile Butadiene copolymer (NBR).

GMDN: glove made of nitrile

• Nitrile surgical glove, non-powdered (56291)
• Nitrile examination/treatment glove, non-powdered, non-sterile (56286)

Properties

• Level of barrier protection: Excellent: nitrile is highly resistant to punctures and tears.
• Allergen content: Very good: contains no latex proteins but contains some curing agents.
• Strength and durability: nitrile film is extremely strong with puncture resistance superior to all glove films. Tensile strength is well above 3000 psi.
• Elasticity: Very good: elongation typically 500% or better. Nitrile exhibits some memory effect allowing the film to adapt to the wearer’s hand.
• Puncture resistance: Excellent. Superior to all medical glove films currently available.
• Fit and comfort: Very good: due to the high elasticity and memory effect. Has a slightly tighter fit (choose a larger size)
• Chemical resistance: Excellent: resistance to most chemicals. May be used for handling cytotoxic drugs.
• Economy: price of nitrile is +/- similar to latex
• Environmental impact: Varies: does not decompose in landfills, incineration produces mostly water and carbon dioxide.

NEOPRENE gloves

GMDN: glove made of polychloroprene (neoprene)

• Polychloroprene surgical glove, non-powdered (57970)
• Polychloroprene examination/treatment glove, non-powdered (56288)

Properties

• Level of barrier protection: Very good, similar to latex
• Allergen content: Excellent: contains no latex proteins but a low level of chemical allergens
• Strength and durability: Very good: unbroken neoprene is very strong. Once punctured however the film tends to tear rapidly. Tensile strength typically 3000 psi or better.
• Elasticity: Excellent: close to that of latex, memory is very high allowing the film to retains its original shape. Elongation limit +/- 750%
• Puncture resistance: Good: neoprene is somewhat puncture resistant.
• Fit and comfort: Excellent: provides excellent comfort and fit due to its high elasticity and memory.
• Chemical resistance: Excellent: good resistance to most chemicals
• Economy: more expensive than latex
• Environmental impact: Varied: does not decompose in landfills. Incineration produces significant amounts of hydrochloric acid.

POLYISOPRENE gloves

GMDN: glove made of polyisoprene

• Polyisoprene surgical glove, non-powdered (56293)
• Polyisoprene examination/treatment glove, non-powdered (60624)

Properties

• Level of barrier protection: Fair: good barrier protection but more permeable than latex.
• Allergen content: Very good: contains no latex proteins but contains some curing agents.
• Strength and durability: Very good: polyisoprene is durable. Tensile strength typically 2500 psi or better.
• Elasticity: Excellent: similar to natural rubber.
• Puncture resistance: Good: is somewhat puncture resistant.
• Fit and comfort: Very good: similar to natural rubber but slightly stiffer
• Chemical resistance: fair protection against alcohol and other water based solutions.
• Economy: more expensive than latex
• Environmental impact: Varies: does not decompose in landfills, incineration produces mostly water and carbon dioxide.

VINYL gloves

Vinyl gloves are made ​​from polyvinyl chloride (PVC), plus a number of plasticizers to confer specific properties.

GMDN: Vinyl examination/treatment glove, non-powdered (47176)

Properties

• Level of barrier protection: Poor: breaks and punctures easily during use, fit around the wrist is baggy making it a poor barrier.
• Allergen content: Very good: contains no natural rubber proteins and no chemical curing agents.
• Strength and durability: vinyl is the weakest of the glove films. Tensile strength is typically below 2000 psi.
• Elasticity: Fair to poor: vinyl elasticity is limited and varies from brand to brand. Typical elongation limit is less than 500%. The film has limited memory.
• Puncture resistance: Poor: vinyl is punctured by sharp objects easily.
• Fit and comfort: Fair: low elasticity limits fit and comfort. The wrist diameter is usually very large making the glove baggy around the cuff.
• Chemical resistance: Fair, often less protection than the other polymer materials.
• Economy: Very good: similar to latex.
• Environmental impact: Poor: does not decompose in landfills, plasticisers may leach out. Incineration produces significant amount of hydrochloric acid.

Latex allergy and other skin reactions from surgical gloves

Healthcare workers and anyone with frequent exposure to latex are at the greatest risk for developing latex sensitivity and allergies. Symptoms range from minor skin irritation or redness to respiratory problems. Shock has been reported in rare cases.

• Irritant contact dermatitis – The gloves, chemicals used in glove manufacture, glove powder or sweat may have a direct irritant action on hands as a result of mechanical disruption of the skin due to the rubbing of gloves; it is not due to an allergic reaction.
• Allergic contact dermatitis – Often due to an allergy to rubber accelerators (chemicals used in the manufacturing of rubber). Can also be due to other glove chemicals such as preservatives, colorants, and other additives.
• Latex allergy – Due to allergy to natural rubber latex protein.

There is a big push by the healthcare industry to become latex-free to prevent further development of latex allergies. However, hand hygiene remains important: hands have to be washed thoroughly after glove removal.

Powdered versus unpowered Gloves

Powder is used to lubricate the gloves, making them easier to put on your hands. Cornstarch is most often used.

On December 19, 2016, the FDA published a final rule banning powdered gloves based on the unreasonable and substantial risk of illness or injury to individuals exposed to the powdered gloves. The risks to both patients and health care providers when internal body tissue is exposed to the powder include severe airway inflammation and hypersensitivity reactions. Powder particles may also trigger the body's immune response, causing tissue to form around the particles (granulomas) or scar tissue formation (adhesions) which can lead to surgical complications.

Special inner coatings on gloves have now replaced powder in many gloves, thus eliminating powder-related complications.

MSF standard = non-powdered gloves.

European norms for single use medical gloves

• EN 455-1 : 2020: Medical gloves for single use - Part 1: Requirements and testing for freedom from holes. Routine testing is done by the watertightness test where the gloves are filled with 1 liter of water in a specific time. A minimum sample size equivalent to sample size code letter L ensures that an adequate assessment of the quality of the lot is obtained when the lot size is small or unknown. AQL (Acceptance Quality Limit = max % of the gloves presenting a defect) = 1.5 for examination gloves and 0.65 for surgical gloves. It is important that the minimum level of pinholes is kept, as the risk of getting an infection through the glove will be increased with a higher AQL level

• EN 455-2 : 2015: Medical gloves for single use - Part 2: Requirements and testing for physical properties.
• Dimensions: length and width (2 tables: one for surgical gloves, one for examination / procedure gloves)
• Strength: force at break in Newton (median values):
• ≥ 9.0 N for all surgical gloves
• ≥ 6.0 N for examination / procedure gloves not made from thermoplastics
• ≥ 3.6 N for examination / procedure gloves made from thermoplastic material: e.g. polyvinylchloride, polyethylene
• EN 455-3 : 2015: Medical gloves for single use - Part 3: Requirements and testing for biological evaluation, it specifies requirements for the evaluation of biological safety for medical gloves for single use.
• Chemicals: Gloves shall not be dressed with talcum powder (magnesium silicate). The manufacturer shall disclose, upon request, a list of chemical ingredients either added during manufacturing or already known to be present in the product.
• Medical gloves containing natural rubber latex shall be labelled on the packaging of at least the smallest packaging unit with symbol for latex. The labelling shall include the following or equivalent warning statement together with the symbol: “contains natural rubber latex which may cause allergic reactions, including anaphylactic responses”.
• The manufacturer shall monitor the endotoxin contamination of sterile gloves.
• For powder-free gloves the total quantity of powder shall not exceed 2 mg per glove, the labelling shall include a prominent indication of whether the glove is powdered or powder-free.
• The manufacturer shall strive to minimize the leachable protein level.
• EN 455-4 : 2009: Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
• Whenever there is any significant change to the product the manufacturer shall re-determine shelf life.
• Attention is drawn to the maintenance of the sterility for the given shelf life of the product.
• Manufacturers shall provide storage instructions to the end user.
• Test methods: real time shelf life determination and accelerated shelf life determination (gloves must keep all the performance after 7 days in a stove at 70°C)

ISO standards

• ISO 11193-1:2020: Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution (edition 3)
• ISO 10282:2014: Single-use sterile rubber surgical gloves - Specification

ASTM standards

• ​D3577: Standard Specification for Rubber Surgical Gloves: covers certain requirements for packaged sterile rubber surgical gloves of the natural rubber latex type (Type 1) and of the synthetic rubber latex type (Type 2).
• Thickness (single wall): fingers, palm & cuff: min. 0.1 mm
• Elongation at break: before aging = min 750%, after aging = min 560%
• Tensile strength: before aging = min 24 MPa, after aging = min 18 MPa

• D3578: Standard Specification for Rubber Examination Gloves

• D5151: Test Method for Detection of Holes in Medical Gloves

• D412: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension

• D6124: Test Method for Residual Powder on Medical Gloves

​Practical medical glove use in MSF

• Gloves must always be worn if there is a risk of contact with human body fluids or the patient’s mucous membranes or non-intact skin, especially during high risk procedures (blood cultures, blood sampling, placement and removal of venous lines, wound dressing, etc.).
• They must also be worn when handling laboratory sample tubes and soiled linens and equipment.
• They are always used when the care provider has a lesion on his or her hand (cut, injury, abrasion or skin condition).
• Wearing gloves is not recommended for contact with intact skin (for example, during physical therapy for rehabilitation, outpatient consultation, etc.).
• Single-use gloves are never washed; they are changed between patients and procedures (even on the same patient). They are donned just prior to contact, care procedure or treatment. They are removed as soon as the care procedure is over, and discarded in the medical waste bin.
• After removing gloves, hands should be washed (with soap and water) or disinfected (with an alcohol-based product).

Practical medical glove use (WHO)

• Gloves are effective in preventing contamination of health-care workers’ hands and helping reduce transmission of pathogens dependent upon two critical factors:
• They are used appropriately
• Timely hand hygiene is performed using the method of hand rubbing or hand washing.
• Safe glove use involves:
• Using the correct technique for donning gloves that prevents their contamination
• Using the correct technique for removing gloves that prevents health-care workers’ hands becoming contaminated
• The unnecessary and inappropriate use of gloves results in a waste of resource and may increase the risk of germ transmission.
• Health-care workers should be trained in how to plan and perform procedures according to a rational sequence of events and to use non-touch techniques as much as possible in order to minimize the need for glove use and change.
• If the integrity of a glove is compromised (e.g., punctured), it should be changed as soon as possible and complemented with hand hygiene.
• Double gloving in countries with a high prevalence of HBV, HCV and HIV for long surgical procedures (>30 minutes), for procedures with contact with large amounts of blood or body fluids, for some high-risk orthopaedic procedures, is considered an appropriate practice.
• Use of petroleum-based hand lotions or creams may adversely affect the integrity of latex gloves and some alcohol-based handrubs may interact with residual powder on health-care workers’ hands.
• The reuse of gloves after reprocessing or decontamination is not recommended.

INTERNATIONAL NARCOTICS CONTROL BOARD (INCB)

The International Narcotics Control Board (INCB) is an independent, quasi-judicial expert body established by the Single Convention on Narcotic Drugs of 1961 through the merging two bodies:

• the Permanent Central Narcotics Board, established by the 1925 International Opium Convention and;
• the Drug Supervisory Body, established by the 1931 Convention for Limiting the Manufacture and Regulating the Distribution of Narcotic Drugs.

The INCB has 13 members elected by the Economic and Social Council for a period of five years. These members are eligible for re-election. Ten of these members are elected from a list of persons nominated by governments. The remaining three members are elected from a list of persons nominated by the World Health Organisation (WHO) for their medical, pharmacological or pharmaceutical experience. The members of the INCB serve in an impartial personal capacity and are independent of their governments.

The production and distribution of controlled substances must be licensed and supervised. Governments must provide the INCB with estimates and statistical reports on the quantities of drugs required, manufactured and used, as well as on the quantities seized by police and customs. Each year, the INCB publishes information on the illicit movement of drugs under international control.

INTERNATIONAL CLASSIFICATION OF NARCOTIC AND PSYCHOTROPIC DRUGS

Approximatively 250 substances are listed in the schedules annexed to the Single Convention on Narcotic Drugs (New York, 1961, amended in 1972), the Convention on Psychotropic Substances (Vienna, 1971) and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (including precursor control) (Vienna, 1988). The purpose of this list is to control and limit the use of these drugs according to a classification of their therapeutic value, risk of abuse and health hazards, and to minimise the diversion of precursor chemicals to illegal drug manufacturers.

Narcotic drugs

Narcotic drugs are classified and placed under international control by the United Nations Single Convention on Narcotic Drugs of 1961, as amended in 1972. The Single Convention limits 'exclusively to medical and scientific purposes the production, manufacture, export, import, distribution of, trade in, use and possession of drugs' (art. 4c).

The Yellow List contains the complete list of narcotic drugs under international control under the 1961 Convention.

The Yellow List is available at: https://www.incb.org/incb/en/narcotic-drugs/Yellowlist/yellow-list.html

Narcotic drugs are classified in four schedules:

To identify the narcotic drugs schedule and their MSF attribute (Narcotic 1, 2, 3, 4), consult your European Supply Centre website (see below).

Psychotropic drugs

Psychotropic substances are placed under international control by the 1971 United Nations Convention on Psychotropic Substances. The objectives of this Convention are again to limit the use of these substances to medical and scientific purposes (arts. 5 and 7).

The Green list contains the list of psychotropic substances under international control under the 1971 Convention.

The Green List is available at: https://www.incb.org/incb/en/psychotropics/green-list.html

Psychotropic drugs are classified in four schedules:

To identify the schedule of psychotropics drugs and their MSF attribute (Psychotropic 1, 2, 3, 4), consult the website of your European Supply Centre (see below).

Precursors

Precursors are chemicals frequently used in the illicit manufacture of narcotic drugs and psychotropic substances and are under international control in accordance with the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988.

The Red List contains the list of precursors of the 1988 Convention.

The Red List is available at: https://www.incb.org/incb/en/precursors/Red_Forms/red-list.html

Precursors are classified in two tables with the MSF attribute "DP" (Drug Precursor).

To identify the table of precursors and their MSF attribute (Drug Precursor 1, 2), consult the website of your European Supply Centre (see below).

INTERNATIONAL ORDER OF NARCOTIC AND PSYCHOTROPIC DRUGS

For each export or import of narcotic or psychotropic drugs, the legislation of all countries concerned must be taken into consideration.

The exporter can usually only obtain an export permit for these substances upon presentation of an import permit from the country of destination.

In case of import for re-export (ImpEx) via a third country (e.g. via Kenya for Somalia), the regulations of the third country must also be considered OR the transit regime only selected.

In some countries, these products may be subject to additional controls (beyond those applied by the National Drug Regulatory Authority) if they are also considered to fall under the category of chemical weapons (Office of National Security).

Importing country

Check the regulations in place and the procedure for customs clearance at the Ministry of Health, National Medicines Regulatory Authorities (NMRA), etc.

Import of narcotics by humanitarian agencies is banned in some countries where MSF is working or may only be possible in case of rupture of National Programme supply (exceptional import request)

Import permit for narcotic and psychotropic drugs

An import permit, usually issued by the Department of Narcotics of the Ministry of Health or NMRA, must include at least the following:

• Permit number
• Date of issue
• Expiry date of this permit: should be at least 3 or 4 months, date by which importation must take place. NB: in some countries it is possible to apply for an extension of import permit validity.
• Name and address of the importer: only mention the name of MSF (instead of the medical coordinator), otherwise the MSF procurement centre has to apply for a new address to the concerned European MoH in case the coordinator changes, which may delay the supply process
• Name and address of the exporter: to be checked with your procurement centre or medical department.
• Number of units (ampoules/ vials/ capsules/ tablets/ oral drops/ oral solution/ patches or rectal tubes): in letters and numbers, with precise details of volume and dose. Total content of active ingredient (in mg or g) should be correctly calculated. Example: one hundred (100) ampoules of fentanyl, 0.05 mg/ml, 2 ml. Total content of active ingredient of 100 ampoules of fentanyl 0.05mg/ml 2 ml is equivalent to 10 mg. Some countries request the base content of the drugs. So, if your product is a salt (e.g. morphine HCl), you have to convert the salt to base. Example: 40 vials of morphine hydrochloride 10 mg/ml, 1 ml contain 400 mg of morphine hydrochloride, but only 40 x 7.6 mg = 304 mg of morphine base
• Name and signature of the authority issuing the permit: on headed paper if possible

Remarks

• Import permits must be free of errors as changes are not possible after issue. Check them carefully before sending!
• Check the quantity per package: you have to order per full pack. You can import less than what is specified on the permits but not more.
• For some countries, the name and address of the manufacturer is also required. The specific additional document requirements to obtain the import permit should also be clarified (Certificate of Analysis, cGMP, Proforma INV etc.) as this is important for procurement centre re-order process (if stock (picking) reservation is required for example).
• In some countries, it is required to obtain first the general import permit prior to applying for the Special Import Permit (regulated items) (e.g. Ethiopia and Nigeria)
• Normally scanned copy of the import permit can be sent to the procurement centre to initiate export permit application process and followed later by the hard copy. Some countries require return of the hard copy permit after the export permit is obtained (e.g. Uganda)
• The MSF procurement centre requests an export permit to their concerned MoH. The import permit can be used only ONE time by the procurement centre to apply for the export permit.
• Please check the website of your procurement centre where this information is available: list of drugs that require an export licence, which drugs can be grouped on a single import permit, number of orders per mission (usually one order for the whole mission instead of one per project and preferably annual due to the time to obtain the import/export permits), how to send the import permit.
• The import permit must be sent direct to your procurement centre (and not the NMRA)

Exporting country (where the order will be placed)

Check the instructions on the website of your procurement centre:

MSF Supply: https://msfsupply.atlassian.net/wiki/spaces/SC/pages/1549598721/Narcotics+and+psychotropic+drugs

MSF Logistique: https://msfintl.sharepoint.com/sites/SP-BDX-msflog-op-general-info/products-information/chemical-precursors

https://msfintl.sharepoint.com/sites/SP-BDX-msflog-op-general-info/products-information/psychotropic-narcotic-classified-products

Exceptional cases

In situations where the competent authority is no longer operational (civil war, guerrilla-controlled areas etc.) or the competent authority is not INCB member (e.g. South Sudan) or KMCA (Kurdistan Medical Control Agency) competent authority for Iraq is under Baghadi authorities and is therefore unable to issue import permits, responsible pharmacist/person of each European Supply Centre can negotiate with its ministry (and with the International Narcotic Control Board in Vienna) and often obtain a permit to export small quantities of controlled narcotic or psychotropic drugs via WHO Emergency Authorisation Procedure. This procedure is also possible in emergency situations (natural disasters...). Normally a written request should be signed by the medical director of the MSF section and sent to the pharmacist responsible for controlled drugs at the concerned MSF procurement centre. Upon reception, Medical coordinator needs to send back promptly the acknowledgement of receipt (accusé de réception) which is then used to make the reconciliation with the NMRA linked to the supply centre.

Transportation of narcotic and psychotropic drugs to missions

Transport will be mainly by air, as the import permit is normally valid for three months (fortunately, it is usually longer). The drugs have to arrive in the country before the permit expires.

CONTROLLED SUBSTANCES IN THE KITS

A specific module is created per kit for the regulated drugs (code ending with C). This module is NOT supplied systematically when ordering the kit. These products will not be delivered as a kit or module: you have to order each medicine separately and an import permit for each of these drugs has to be sent to the procurement centre.

NB: this only considers medical article codes regulated at supply centre level (requiring an export permit in EU). If the item is regulated (narcotic, psychotropic or precursor) only in the destination country then these items are NOT automatically separated by module in the kit and the mission is responsible to screen the kit contents using the Medical Kit List detailed (available via MSF Catalogues website).

STORAGE AND HANDLING OF REGULATED PRODUCTS IN THE FIELD

Check the list of regulated drugs and legal requirements in the country: these must be applied in MSF pharmacies, as we are not above the law, we work with national staff and our pharmacy may be subject to inspection by the health authorities for evaluation.

In general

• Check what is considered a “regulated drug” by the national authorities, as the list may change from country to country.
• Identify the person responsible for the movement of products and their tracking (maximum 2 or 3 people).
• All pharmacies have a written list of regulated drugs.
• Store regulated drugs (according to the country list) under lock and key (under the responsibility of the designated person). Drugs that are part of a kit are identified by the name of the kit to which they belong.
• Double check for the different steps (reception, packing, authorisation, dispatch, etc.).
• The "first expired first of (FEFO) principles also apply to regulated drugs. Check the expiry dates of drugs in the kits.
• Record the movement of drugs in a separate register. National health authorities often require a regular written report of movements and consumption. If national health authorities requires an official written record of stock movements, this should be done.

Norms for enteral devices

• EN 1615: 2001: Enteral feeding catheters and enteral giving sets for single use and their connectors, edition: 2
• ISO 80369-1: 2010: Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements
• ISO 80369-3: 2016 ​(A 1:2019): Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications
• ISO 80369-20: 2015: Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods

ISO 80369 standards were created to reduce the frequency of misconnections and at the same time harmonize delivery systems across one therapeutic area.

ENFit

There were numerous reports detailing the risks of compatible tubing systems and the risk to patients. Cases of misconnections are under-reported and many may show as medication errors. Several people did die from misconnections and many more were put at serious risk.

The ISO 80369 series of standards were designed to prevent misconnections of medical devices and ensure patient safety. ISO 80369-3 specifically addresses enteral and gastric medical device applications by defining the geometry, material characteristics and performance of a new standard connector pair.

ENFit is a global change to make all enteral (tube feeding) devices specific to tube feeding. Every administration set, enteral syringe, nasoenteral tube, and nasogastric tube will be designed with a specific ENFit end so that you can only use products designed for enteral/tube feeding access.

Preventing misconnection errors

• Regularly inspect tubing for proper connections.
• Use the correct fittings and connect them according to the manufacturer's instructions.
• Reconnect tubing only under good lighting. Trace tubing back to the source prior to reconnecting.
• Do not modify or try to adapt connections to enteral devices.
• Do not use IV pumps to administer enteral feedings.
• Use enteral syringes (that cannot connect with an IV line) to deliver medications enterally.

Confirm the correct position of nasogastric tubes

using pH test strip (ELABPAPEPH2G)

Check the tube position:

• Following initial insertion
• Before any liquid (feed or medication) is introduced into the tube. At the change of feed if the child is receiving continuous tube feeding (four-hourly for expressed breast milk and six-hourly for all other feeds)
• Following episodes of vomiting, retching or coughing
• Following evidence of tube displacement (e.g. when the visible tube length has increased)

Recommended procedure:

• Check whether the patient is on medication that may increase the pH level of gastric contents (antacids, H2 antagonists)
• Obtain sufficient aspirate (0.5 – 1 ml) to cover an adequate area on the pH test strip
• Aspirate is pH 5.5 or below: OK
• Aspirate is pH 6 or above: DO NOT FEED: leave up to one hour and try again: possible bronchial secretion or dilution of the gastric acid by enteral feed.

The system is composed of a lag screw, a side plate, cortical screws and accessories to insert the screw into the site of the fracture of the proximal femur.

The Omega 3 System is indicated for closed fractures of the proximal femur which include

• simple and complicated pertrochanteric and intertrochanteric fractures
• fractures of the femoral neck and certain subtrochanteric fractures

Only orthopedic surgeons are allowed to use this set.

There has to be a certain number of of femoral neck fractures, pertrochanteric and subtrochanteric fractures being admitted and treated in the trauma center to justify its order since not all trauma centers admit and treat this type of fractures.

See introduction to KSUI

The operating suite part can be ordered only if hospital beds are already present.

The operating suite part contains general medical equipment for a maximum of 2 operating rooms.

Each operating room includes its own equipment, plus the equipment for the recovery room.

One or two operating theatres can be ordered according to the planned activities.

The supplies are calculated for 100 interventions.

The operating suite part cannot be sent if there is no skilled surgeon with anaesthetist and an OT nurse present on the spot.

It is composed of 3 main parts

1. General medical equipment for the whole operating suite and the modules of the support activities (laboratory, sterilization, divers modules, pharmacy)

2. Medical equipment part for 1 operating room (OT 1 room) + 1 recovery room. This part needs to be ordered the number of times according the number of OR.

3. Medicines and renewable medical supplies for 100 interventions

The support activities Sterilisation and Pharmacy are mandatory in one of the 6 main activity focal point.

Choice : it is mandatory to order one the two proposed choices

• In part 1 (equipment for the whole operating suite) an autoclave must be ordered: either the 39 litres autoclave (if small number of small interventions planned), either the 90 litres autoclave (that enables to sterilize all type/size of instrument sets), both presented as choices
• In part 2 (medical equipment for 1 operating room) it is mandatory to order either the manual anaesthesia circuit (Diamedica DPA 02), either the anaesthesia ventilor “Glostavent Helix”, both presented as choices.

The OPD kit is aimed for a general OPD: 10 000 people / 3 months

• Includes the full treatment course for the patient
• The severe cases must be referred: there is no Oxygen, no transfusion
• Contains small size sterilization equipment: 39 litres autoclave and few injectable medicines

It is composed of 3 parts

• Medical equipment
• Medicines and renewable medical supplies
• Optional complementary part with observation beds

The support activities Sterilisation and Pharmacy are mandatory in one of the 6 main activity focal points.

ROLE OF PACKAGING

Packaging plays significant roles in maintaining product quality and promoting safe and effective use of a medical device, namely:

• It protects the product from the environment and vice versa: effective barrier to light, moisture, oxygen, bacteria; etc., protection from damage, maintain product integrity until its in-use phase is completed (or the expiry date has passed)
• It provides all necessary information for: identification of the article, safe use of the product (clearly worded instructions, pictograms) including precautions, storage and shelf life of in-use product, appropriate disposal of the unused product and the packaging itself.
• It enables accurate dosing and compliance: additional spoons or syringes for oral dose measurement and delivery, dropper tubes, applicators, dispensing devices, dose counters and calendar devices.
• It ensures supply-chain integrity of the product: “Track-and-Trace” systems, anti-counterfeiting measures.

A well-designed and correctly used sterilization pack provides effective sterilization, safe handling and storage of all items until the moment they are used. A pack must remain sealed against bacteria and facilitate aseptic presentation of the packaged product. The sterile state of a medical device is maintained with the help of an appropriate packaging. The design, materials and manufacture of the packaging materials have to be compatible with the medical device to be packed, the handling processes of the medical device, the sterilization method to be used, the labelling systems, and the distribution and storage conditions as well.

STANDARDS APPLICABLE TO PACKAGING

Directive (EU) 2018/852 on packaging and packaging waste must ensure that the packaging placed on the EU market meets the essential requirements:

• limit the weight and volume of packaging to a minimum to meet the required level of safety, hygiene and acceptability for consumers
• reduce the content of hazardous substances and materials in the packaging material and its components
• design reusable or recoverable packaging

Medical device packaging is highly regulated. Often medical devices are sterilized in the package (=terminal sterilization). A series of special packaging tests documents and ensures that packages meet regulations and end-use requirements. Manufacturing processes must be controlled and validated to ensure consistent performance.
ISO 11607-1:2018 – is the principal guidance document

• Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems. Details the elemental attributes demanded of materials and pre-formed systems intended for use in packaging systems. It takes into consideration the vast array of potential materials, packaging system designs and sterilisation methods. Specifies the requirements and test methods until the point of use.
• Part 2: Validation requirements for Forming, Sealing and Assembly Processes. The development and validation of the packaging processes are crucial to ensure that sterile barrier system integrity is maintained until opened by the users.

TERMINOLOGY

The following definitions can be found in EN868 or EN ISO 11607:

• Packaging material: any material used in the fabrication or sealing of the packaging system or a primary pack.
• Primary pack: sealed or closed packaging system which forms a microbial barrier, enclosing a medical device.
• Seal: result of joining of surfaces together (e.g. by use of adhesive, thermal fusion or gaskets).
• Seal integrity: characteristics of the seal which ensures that it presents a microbial barrier.
• Secondary pack: pack containing one or more medical devices, each in its primary pack.
• Sterile: condition of a medical device which is free from viable micro-organisms (EN 556 standard on sterility of medical devices)
• Terminally sterilized: term for medical devices which are sterilized after being completely sealed or enclosed in at least the primary pack.
• Transport pack (or tertiary pack): pack containing one or more primary and/or secondary packs intended to provide the necessary protection during the transport and storage.
• Sterile barrier system is defined as “the minimum packaging configuration that provides a microbial barrier and allows aseptic presentation of the product unit at the point of use”.
• A preformed sterile barrier system is a “partially assembled sterile barrier system prior to filling and final closure and sealing”.
• Protective packaging is the “packaging configuration designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use”.
• Packaging system is the “combination of the sterile barrier system and protective packaging” and could include the transit packaging.

PACKAGING SEALING SYSTEM

Pouches are typically fabricated from two or more different materials with plastic, Tyvek, film, paper, and/or laminates of these materials sealed to form a peel-open or tear-open package. In general, peel pouches should be used for small, lightweight, low-profile items. For larger and heavier items, thermoformed trays provide a stronger, more protective package.
The regular pouches are manufactured of medical grade paper (allows penetration for sterilization process) and clear plastic film (allows the content to be seen) and are suitable for sterilization in steam and EO processes.
Dimensioning of pouches: outside dimensions are given: first the opening or width, secondly the length of the pouch.

Characteristics of packages closed by “heat sealing”:

• The MD may occupy at most 75 % of the pouch in order to allow the package to conform to air evacuation processing during sterilization
• The space between the MD upper end and the seal seam on the peeling side must be at least 3 cm with an excess of up to 3 cm above the seal seam to allow for un-impeded peeling as well as aseptic withdrawal
• A protective must be fitted to any pointed or sharp instruments before they are placed in pouches or reels.
• The opening of MDs with a cavity (e.g. kidney dish) will face the paper side.
• End of the article to be grasped is presented first when the package is opened.
• Each seal must extend along the total width and length of the seal lines with no channels, kinks, folds, air pockets or notches and no signs of burning or melting.
• Protective packaging in the form of an outer see through wrap: The pouch size must permit unimpeded introduction of the inner wrap. The inner see through foil must not be kinked or folded, the inner wrap is not sealed into the seal seam of the outer wrap and the paper side of inner pouches face the paper side of the outer pouches
• Labels should be affixed to the foil side. If the label is to be affixed to the paper side, the size of the label must not exceed 20% of the paper surface. Label only outside the seal seam and outside the area surrounding the sterile MD.

USE OF DESICCANTS

Desiccants are used to control the exposure of products to ingress of moisture. They vary in their capacity and the rate that they can adsorb/absorb moisture.
Silica gel is an amorphous and porous form of silicon dioxide (silica), consisting of an irregular tridimensional framework of alternating silicon and oxygen atoms with nanometer-scale voids and pores. The voids may contain water or some other liquids, or may be filled by gas or vacuum. Silica gel is usually commercialized as coarse granules or beads, a few millimeters in diameter. Some grains may contain small amounts of a substance that changes color when they have absorbed some water. Small paper envelopes containing silica gel pellets, usually with a “do not eat” warning, are often included in dry food packages to absorb any humidity that might cause spoilage of the food.
When a visible indication of the moisture content of the silica gel is required, ammonium tetrachlorocobaltate or cobalt chloride is added. This will cause the gel to be blue when dry and pink when hydrated. An alternative indicator is methyl violet which is orange when dry and green when hydrated. Due to the connection with cancer, cobalt chloride has been forbidden on silica gel in Europe.

KEY MESSAGES

• The packaging protects the medical device from the environment and maintains sterility
• Medical devices must be transported and stored in their original packaging
• Sterile medical devices must be stored at least in their secondary packaging
• Sterile medical devices must be packaged in easy handling pouches that can be opened while maintaining product sterility before use
• Nest paper to paper and plastic to plastic for steam penetration
• Basic control of the packaging before use of sterile medical devices :
• Expiry date
• Seal strength (sufficient peeling force)
• Packaging integrity (no holes)
• Validity of the desiccant when applicable

INTRODUCTION

WHO defines packaging as the collection of different components (e.g. bottle, vial, closure, cap, ampoule, blister) which surround the pharmaceutical product from the time of production until its use¹. US FDA defines container closure system (CCS) as the sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product².

Every proposed packaging system should be shown to be suitable for its intended use: it should adequately protect the dosage form (as appropriate against light, moisture, oxygen, contaminants, etc.); it should be compatible with the dosage form (no adsorption of the API, etc.); it should be composed of materials that are considered safe for use with the dosage form and the route of administration (no migration of potential toxic substances); and it should function in the manner for which it was designed (performance features).

Child-resistant closures make it difficult for drug packaging to be opened by young children, while allowing adults easy access. The use of child-resistant packaging has proved effective in reducing child mortality from intoxication by oral prescription drugs. The three most common reclosable child-resistant types of closure are the “press–turn”, the “squeeze–turn” and a combination lock (WHO TRS 902).

Tamper-evident packaging is a packaging system that may not be accessed without obvious destruction of the seal or some portion of the packaging system (USP 659) or which “provides visible evidence to consumers that tampering has occurred” (WHO 902). Examples of packaging technologies capable of meeting the TRP requirements are given in “FDA Compliance Policy Guide, 7132a. 17, CPG Sec. 450.500 Tamper-Resistant Packaging Requirements for Certain Over-the-Counter Human Drug Products”.

¹ WHO, TRS 902 Annex 9

² USFDA, Container Closure Systems for Packaging Human Drugs and Biologics

CONTAINER CLOSURE SYSTEMS FOR SPECIFIC PHARMACEUTICAL FORMS

CONTAINER CLOSURE SYSTEMS FOR PARENTERAL PREPARATIONS (DINJ and DINF)

Parenteral drug products are sterile preparations, and may be liquids in the form of solutions, emulsions, suspensions, or dry solids that need to be combined with an appropriate vehicle to obtain a solution or suspension. They are classified as small-volume parenterals (SVPs), if they volume of the solution is 100 mL or less, or as large-volume parenterals (LVPs), if the volume of the solution exceeds 100 ml.

SVPs (DINJ family) may be packaged in a disposable cartridge, disposable syringe, vial, ampoule, flexible bag or semi-rigid bottle. Only single-ended ampoules are accepted by MSF.

• Cartridges, syringes, vials, and ampoules are usually made of Type I or II glass or polypropylene. Details on the type of glass to be used according to the pharmaceutical form can be found in the EP (European Pharmacopoeia) /BP (British Pharmacopoeia) or the USP (United States Pharmacopoeia).
• Stoppers and septa in cartridges, syringes, and vials are typically made of elastomeric materials. Closures for use with injectable preparations must comply with the Type I (for aqueous preparations) or Type II (for non-aqueous preparations) test limits defined in the EP or USP.
• Caps or over seals are used to secure the rubber closure to the container in order to maintain the integrity of the seal under normal conditions of transport, handling and storage during the intended shelf-life of the product. Such caps are usually made of aluminium and can be equipped with a plastic top to facilitate opening. Caps also provide evidence of tampering.

LVPs (DINF family) may be packaged in a flexible bag (with or without PVC), a semi-rigid bottle or a glass bottle. At MSF the first choice is the PVC-free flexible bag or semi-rigid bottle. Flexible bags or semi-rigid bottles containing PVC are no longer accepted by MSF. The containers must have a site suitable for the attachment of an infusion set and a site that allows admixture of drugs.

Flexible bags are usually made of multi-layer plastic.

• Cyclo-olefins are an alternative to PVC or glass. They are flexible and have a low permeability.
• The input (medication) and output (administration) ports of flexible bags can be made of plastic and/or elastomeric materials. The bags usually have a hanging part that must withstand the tension occurring during use.
• Depending on the type of plastic used, IV fluids bags can be presented with a plastic over pouch/overwrap that protects the product from solvent loss (which can lead to increased concentration), oxygen ingress and dust. The over pouch is made of a material less permeable to water vapour/gas.

Semi-rigid plastic bottles are usually manufactured through Blow-Fill-Seal (BFS) technology and have a sealed top that can be fitted with different types of closures. Note that some manufacturers also propose open-neck bottles fitted with a rubber stopper and a flip-off capsule.

• BFS bottles with a nipple head are not appropriate, as the base of the nipple head is particularly fragile and the small cap does not offer adequate protection, hence fatigue points and micro-holes can develop during transport. Additionally, they do not have an administration or injection site: the top of the nipple must be pierced with the IV set or the needle. If no other alternative can be found to nipple head, experts recommended the use of larger caps that offer better head protection.
• Euro head caps are acceptable, but also have disadvantages: there is a risk of contamination of the top before the cap is welded if this is not done in an aseptic environment and, a risk that the space between the top of the bottle and the cap will not be sterilised because water vapour does not penetrate inside.
• Newer generation caps have two access ports for the IV set and admixture of drugs – protected by an aluminium seal or a plastic cover (Twincap^®, Duocap^®).

CONTAINER CLOSURE SYSTEMS FOR OPHTHALMIC PRODUCTS (DEXO)

Ophthalmic preparations are sterile liquid, semi-solid or solid preparations intended to be administered to the eye. Ophthalmic preparations can be divided into several categories: eye drops, eye lotions, semi-solid eye preparations, and ophthalmic inserts.

Liquid preparations for ophthalmologic use can be supplied in sterilised single-dose (often preservative-free) or multi-dose containers. The most common type of packaging used for multi-dose preparations is a PE or PP bottle with an integrated dropper on the neck (sometimes referred to as droptainer). Some eye drops use a glass container when product stability or compatibility issues exclude the use of flexible plastic. The container should be tamper evident and contain a maximum of 15 ml of the preparation. Single-dose containers are usually made of PP manufactured with BFS technique. Some preparations may be indicated for ophthalmic or otic use (e.g. DEXTCIPR1D- : preparation for eye and/or ear)

Semi-solid eye preparations are packed in small collapsible sterilised tubes with or without an ophthalmic cannula/ tip. The tubes are usually made of metal but, ophthalmic ointments that are reactive to metal may be packaged in a tube lined with an epoxy or vinyl plastic coating. The packaging must be tamper evident and contain no more than 5 g of the preparation³.

³ USFDA, Container Closure Systems for Packaging Human Drugs and Biologics.

CONTAINERS FOR TOPICAL PHARMACEUTICAL PRODUCTS⁴ (DEXT)

Topical dosage forms include aerosols, creams, emulsions, gels, lotions, ointments, pastes, powders, solutions, and suspensions. These dosage forms are generally intended for local (non-systemic) effect and are usually applied to the skin or oral mucosa. Topical products also include some nasal and ear preparations. Vaginal and rectal pharmaceuticals are also considered as topical products.

Semi-solid or liquid preparations are most often packed in multi-dose containers (e.g. a jar or a collapsible tube).

• Flexible (collapsible) tubes are usually made of metal (or metal-lined), LDPE or laminated material. The tubes are identified as closed-ended or open-ended. In the former case, the product does not come into contact with the cap during storage.
• Jars are usually made of polypropylene with a screw cap. The same cap liners and inner seals are sometimes used for solid oral dosage forms.
• Nasal, otic, vaginal or rectal preparations should be supplied in containers adapted for the appropriate administration of the product at the site of application, or should be supplied with an appropriate applicator.

The closures of these containers should be designed to minimise microbial contamination and be tamper evident.

Liquid ear preparations⁵ are supplied in multi-dose containers made of glass or suitable plastic. The containers have an integral dropper or a screw cap of suitable material incorporating a rubber dropper or plastic teat, sometimes supplied separately.

Vaginal and rectal products are usually supplied in aluminium/aluminium strips or blisters (or sometimes in tubes e.g. vaginal gel).

⁴ WHO, TRS 902 Annex 9 ; Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products, Sarfaraz K Niazi, CRC Press, 2009
⁵ Ph Eur monograph 0652, Ear Preparations

CONTAINERS FOR ORAL MEDICINES (DORA)

Liquid oral pharmaceutical products⁶ are solutions, syrups, or suspensions. A oral medicine in liquid form generally needs to be protected from solvent loss, microbial contamination, and sometimes from exposure to light or reactive gases (e.g. oxygen). These dosage forms may be supplied in multiple-dose (bottles) or single-dose (sachets) containers .

• A bottle is usually made of glass or plastic (PET, HDPE, etc.), often with a screw cap (Alu or PP) with a liner, and possibly with a tamper-resistant seal or an overcap welded to the bottle.
• Each dose of a multi-dose container is administered by means of a device suitable for measuring the prescribed volume. For this purpose, a measuring cup, a dosing spoon (for volumes of 5ml or more), an oral syringe (for other volumes), or a dropper may be added to the packaging.
• Many of the associated components are graduated for dose administration. Graduations should be legible and indelible.
• Pouches may be made of a single-layer plastic or laminated material.

Solid Oral dosage forms (e.g. tablets and capsules) and powders for reconstitution should generally be protected from the potential adverse effects of water vapour (moisture). Typical container closure systems are bulk containers, strips, blister packs and sachets.

Bulk containers are plastic or glass bottles with a screw or snap closure.

• Glass containers are made of type III glass. Plastic containers are most often made of HDPE, PP or PET. The primary packaging may be a LDPE bag, which is then placed in HDPE/PP bottles and provides additional protection.
• A typical closure consists of a cap (often made of PP), often with a sealed part. The seal is a piece of material that sits between the cap and the bottle. Different liner materials can be used to provide a moisture barriers, chemical resistance, or preventing leakage. Another benefit is tamper evidence; once the sealed part has been removed, it cannot be reapplied to the container.
• A filler material can be added to the container to fill the empty spaces and prevent the tablets from breaking during transport. Fillers can be made of cotton, rayon or polyester.
• Desiccant is used to reduce the amount of moisture in the head space of the bottle, and to protect gelatin capsules or moisture sensitive products/substances. The shape and size of the desiccant should be clearly distinguishable from the shape of the medicine to prevent accidental consumption. The desiccant is usually packed in a small HDPE canister or sachet which should be placed on top of the tablets.
• A bulk container should not contain more than 1000 tablets.

Strips are multi-dose containers consisting of two layers of aluminium, usually provided with perforations, suitable for containing single doses of solid or semi-solid preparations⁷.

Blisters are multi-dose containers consisting of a moulded film insert that contains the product and a cover, which is the material that seals the blister.

For the film blister, different types of materials and many combinations - offering different degrees of protection from water vapour, gas and light - are available on the market ⁸. However, due to the lack of barrier properties of PVC film, multi-layer PVC-based films are often used when better moisture protection is required, e.g. PVC coated with PVDC (polyvinylidene chloride), PVC laminated with PCTFE (polychlorotrifluoroethylene, or Aclar®), triplex laminates made of PVC/PE/PCTFE, etc.

The lid stock is sealed to the moulded blister. Its material is usually a laminate that includes a barrier layer (e.g., aluminium foil).

Sachets are adequate packaging for oral powders in single-dose preparations. Each dose is enclosed in an individual sachet preferably made of laminated aluminium foil, the edges of which are sealed by heat or adhesive.

⁶ USFDA, Container Closure Systems for Packaging Human Drugs and Biologics; USP <659> Packaging and storage requirements

⁷ WHO, TRS 902 Annex 9

⁸ USP <1146> Packaging practice—repackaging a single solid oral drug product into a unit-dose container

PHARMACEUTICAL PRODUCTS FOR INHALATION (DORA)

Preparations for inhalation are intended to be administered as vapours or aerosols into the lung to obtain a local or systemic effect. They may be supplied in multi-dose or single-dose containers ⁹.

Inhalation pharmaceuticals include:

• Aerosols in pressurised metered-dose devices (the preparation is released from the container as an aerosol, after actuation of an appropriate valve);
• Liquid preparations for inhalation (administered by nebulizers). They are usually packaged in a PP single-dose container.
• Inhalation powders (delivered by dry powder inhalers loaded with pre-dispensed powders in capsules or other suitable dosage forms or with a powder reservoir and a metering mechanism); and nasal sprays.

⁹ Ph Eur monograph 0671: Preparations for inhalation; USFDA, Container Closure Systems for Packaging Human Drugs and Biologics.

Practical checking instructions and report form for rapid control at delivery

This checking procedure is meant to point out any major failure which might occur with the material. It is not meant to be an exact check up of all the physical characteristics given in the technical description. Two people are required, but it is really easier with three. It takes about 2 hours for one sample and up to six hours for six samples.

Equipment needed

Physical check of the product

• a measuring tape, 10 metre long
• a scale which measures up to 100 kg, in increments of 100 g, to weigh rolls and/or a scale which measure up to 10 kg, in increments of 10 g, to weigh tarpaulins
• a cutter knife
• a note book, a pen and as many copies of the report form as per number of samples
• a calculator
• a pair of scissors
• a 20 cm ruler
• a pocket knife
• a permanent marker

Mechanical tests

• two clamps with minimum 40 mm wide jaws
• one hook made of 8 mm diameter steel rod
• one "adjustable weight" in order to weigh 10 kg when combined with one of the clamps (i.e. a strong canvas bag filled with iron pieces)
• one weight of 70 kg (i.e. a tarpaulin bale plus the canvas bag)
• two wooden bars of 1 m in length and 4 x 4 cm² in diameter or equivalent
• one punch of 8 mm in diameter
• one hammer and some nails
• one crow bar with nail extractor

Checking procedure

Physical check

NB. Before starting the procedure, write a reference on each roll or tarpaulin to be tested, mentioning the name of the customer, the date of the test and the number of the sample (i.e. MSFKenya-23/03/2019 nr 1, 2, 3,…). This reference has to be reported in the heading of the respective report form.

• weigh the roll or the tarpaulin, without any packaging, and note the result for further calculation
• unroll, or unfold the tarpaulin and check the colour of the sheet: it should be a strong white, without significant colour fluctuation
• compare the presence of the 6 bands to the position given in the drawing (see figure 1), one can accept up to 5 cm fluctuation from the given position
• the bands must be blue
• check that there is a length indicator mark every meter, ensure that the distance between two marks is really 1 m, and check at 3 places
• check for the presence of the manufacturer name and the manufacturing date and month in letters 2.5 cm high, at least one every 6 meter on a roll and twice on a tarpaulin
• measure the width of the tarpaulin or the roll at 3 different places. Measurements must be minimum 3.96 m up to 4.04 metre.
• measure the length on the two edges and in the middle between the two central blue bands: it should be 6 metre for a tarpaulin or 60 m for a roll
• note the differences in the "comments" column of the report form.
• calculate the exact surface of the sample (length by width) and calculate the specific weight (total weight in grams divided by the surface in square meters), it must be between 209 gr/m² and 231 gr/m²
• scratch the white coating of the sheet with the cutter and check that the yarns are black in the two directions, warp and weft: NB. Light grey is not acceptable
• scratch the blue coating of the bands with the cutter and check that the yarns are black in the two directions, warp and weft: NB. Light grey is not acceptable

2. Mechanical property tests

NB. All the samples tested have to be kept until "quality clearance". In case of failure, the tarpaulin (piece or roll) has to be kept for laboratory control.

Tear test in the sheet (see figure 2).

• The test has to be performed a minimum of 4 times on different samples. Cut 4 samples lengthwise and 4 samples crosswise into the sheet (outside of the reinforced bands!). The dimensions of samples must be 6 x 20 cm² and they must be pre-cut 8 cm down the middle. On each sample note "L" for lengthwise and "C" for crosswise plus the sample reference (Sample description: see figure 2).
• Hang the first clamp with the rope to any support about 2 m high. Insert the sample into this clamp.
• Fix the second clamp to the other end of the sample. Slowly hang a weight of 10 kg (including the weight of the clamp itself) on the second clamp. Release the weight very carefully.
• Each sample should resist the weight of 10 kg. If a sample tears off, do a laboratory test to confirm or to cancel this result. The laboratory test should be a test of tensile strength and tear strength.

Tear test in the band (see figure 3).

• The test should be performed on 3 samples per tarpaulin or roll. Cut 3 pieces on 3 different bands as shown in the drawing (Sample description: see figure 3).
• Roll one end of the sample around the wooden bar several times, clamp it with the second timber and nail it.
• Place both extremities of the wooden timber on a support in order to allow the sample to hang freely (e.g. the raised forks of a forklift).
• Punch a hole of 8 mm diameter in the middle of the band at 20 cm from the border.
• Place the hook in the hole you have punched, and hang a 70 kg weight on it, avoiding any shock. To make a weight of 70 kg you can use one bale of tarpaulins, plus the additional weight you had in the previous test.
• If one of the samples tears off, further laboratory testing is required

Peeling test of the bands.

• Pull off a corner of a band from the tarpaulin with the knife and try to peel the band off just by pulling it by hand. In most of the cases you should be able to peel off the bands. If this is not the case, it means that the band has been welded too strongly, report it into the "comment" column of the report form.
• To check that the resistance to peeling is not too low, you must check that black spots remains on the white side and white spots remaining on the black side. This means that the melting of the band and the base material has been correctly done.
• If one side remains completely white and the other completely black, this counts as a failure and further laboratory testing is required.
• Repeat the whole process on three different reinforced bands.

Peeling test of welding

• If the product has a weld in the middle, perform the same peeling strength control on the weld.

Peeling of the coating

• Try to pull off the white coating from the black fabric, it should be impossible to peel pieces larger than 1 cm² or ¼ square inch.

CARS

MSF has selected the following standard vehicles:

• Toyota Hilux double cabin, pick-up, diesel
• Toyota HiAce minibus, diesel

5 véhicules 4x4:

• Toyota HZJ76 (hard top), 6 seats, diesel
• Toyota HZJ78 (hard top), 11 seats, diesel
• Toyota HZJ79 (pick-up), 3 seats, diesel
• Toyota HZJ79 double cabin, 6 seats, diesel
• Toyota Hilux double cabin, pick-up, diesel

The choice will depend on your needs, the presence of local dealers, the existing MSF fleet, etc.

City car

It is recommended to execute a market survey on national or regional level, in order to validate a city car for the concerned mission, taking into account the specifications you’re looking for, the presence of local dealers, the availability and quality of the proposed options, etc.

PURCHASE OF VEHICLES

The procurement of a vehicle, either new or second-hand should always be discussed with your technical department and approved by them.

There are 2 possibilities for purchasing:

Purchase via an MSF supply centre

Toyota has entered into an agreement to supply vehicles that meet MSF's specifications.

The choice for a standard vehicle, allows you to benefit from prearranged spare part kits and a defined standard preparation developed for each type of vehicle.

Contact your technical department to know more about to what extent the options vary from one operational centre to another.

It is also reassuring to be able to benefit from the technicians expertise on a well-known and approved model.

Finally, the management tools developed especially for these models are available, such as the logbook and a spare parts order tool.

Note

Sea freight can take anything from 15 days (at best) to 2 months, and could costs between € 2200,- to € 7000,- (whereas air freight costs between € 8000,- to € 15000,- or even more). These indicative prices for transport could fluctuate depending for example on the level of access and the stability of the location / country of destination.

Local purchase

Usually more expensive, but shorter wait for delivery, which can be a requirement in emergencies.

Make sure that spare parts are available locally. Do not buy imitations, but only genuine manufacturer's parts.

In case of local purchase of non-standard vehicles, the supply centres cannot guarantee the supply of spare parts.

TOYOTA SPARE PARTS

Missions must establish stocks of spare parts.

Principally, planned spare parts orders (per semester) should be send to your supply centre. It is useful to explore the local market, to investigate the availability and prices of spare parts at local distributors. Even if you are considering importing spare parts, it can be useful to make an arrangement with a local dealer in case of emergency.

Spare part orders

There are 2 types of spare part orders:

• stock orders (every 6 months)
• specific orders for parts which are not stocked (when required)

MSF has developed a small program in Microsoft Excel to help you manage your stock and place orders for Toyota spare parts (see technical department).

To order parts which are not included in the MSF list, see the Toyota spare parts catalogue on paper or digitally if available.

The following must appear on your order:

• complete code of the model (i.e. HZJ78L- RJMRS)
• chassis number (i.e. JTERB71J700059235)

In case of doubt concerning the suitability of a part, attach as much information as you have to your order, and ask your technical department for advice.

Toyota spare parts catalogue

The paper version of this catalogue is no longer produced, however there might still be a copy available in your mission, which is only useful if it covers the production date of the concerned vehicle. It is not easy to use; you should therefore read the introduction very carefully before consulting the main body of the catalogue.

As spare parts are constantly developing, the catalogue quickly becomes outdated.

The alternative is the electronic spare parts catalogue, as long as the installed version covers the specifics such as the production date of the concerned vehicle.

Caution

To define the exact reference of a spare part for a certain model sometimes requires a technical interpretation and knowledge on the options and / or assemblies possible, even when using the digital catalogue.

Consult your technical department in case of doubt or need.

MANAGING THE VEHICLE FLEET

Vehicles are essential to the running of a project and must therefore be properly managed.

See the existing MSF guidelines on the subject.

The cholera kit 001 is specially designed for refugee camps.

It can also be used for urban or rural populations, altough being less adapted (in this case, small kits for 10 or 50 patients are to be made on the spot according to the needs and the available means).

This kit is meant for the treatment of 625 cholera cases, of which 75 % (500 cases) need IV and ORS, and 25 % (125 cases) need ORS only. These proportions are different from those recommended by the WHO and are based on the MSF experience showing an often high proportion of severely dehydrated cases. In urban or rural areas, only 20 % of the cholera cases need IV and ORS.

The antibiotics supplied cover all cholera cases plus 4 close contacts per case (2 500 contacts). MSF does not recommend chemoprophylaxis of close contacts, but supplies antibiotics for this purpose in case local circumstances demand their use (high secondary attack rate, political pressure, strategic reasons, etc.).

The complete kit (KMEDKCHO1--) is composed of a medical part with 2 infusions modules (2000 l each) and a logistic part. If logistic modules are made locally, it is possible to order medical modules only:

• (KMEDKCHO2M-) with 4000 l infusions
• (KMEDKCHO3M-) with 2000 l infusions
• (KMEDKCHO4M-) without infusions module

These two last kits are proposed because of the transport costs of infusions modules. If quality assured Ringer lactate (Hartmann) has been identified and validated by your section pharmacist or if you have quality assured Ringer lactate in your emergency stock, you can consider ordering the following kits: KMEDKCHO3M- or KMEDKCHO4M-.

NOTE

It is mandatory to have minimum 4000 l of Ringer Lactate (Hartmann) to one's disposal for the IV treatment of 500 cholera patients.

An underestimation of needs which could lead to infusion stocks running out during an epidemic is always more expensive than ordering 4000 l in the first place.

Take 10 samples with the sample module 001 (KMEDMSAM1C-) and send them to headquarters for culture and sensitivity.

Supplies to be got locally if possible

• Ringer lactate (Hartmann), after the medical/public health dpt's approval
• Plastic sheeting (for shelters, insulation...)
• Oral Rehydration Salt (ORS)
• Blankets
• Tent 27 m² (white)
• Calcium Hypochlorite (HTH)
• Watertight boots
• Washing product (soap or powder)
• Minimal medicine cabinet
• Tubes (to make stretchers with plastic sheeting)

See Management of a cholera epidemic, MSF, 2018

Cold chain management for thermo-sensitive product

The cold chain is a system intended to keep thermosensitive medical products, within a specific temperature range from the manufacturer until its final use. In MSF settings, the “cold chain” means keeping medical products between +2°C and +8°C (inclusive). Temperature deviations can lead to cold chain ruptures, compromising the quality of therapeutic and diagnostic products and on occasions leading to their destruction, costing time and money.

In MSF, cold chain items can be divided into three main groups:

• Immunization products (vaccines)
• Therapeutic products (e.g. immunoglobulins, insulin or oxytocin)
• Diagnostic products (e.g. blood grouping reagents).

The EU, WHO GDP (guidelines for good distribution practices) for pharmaceutical products, as well as the different national regulations, requires a focus on ensuring proper environmental conditions (as per manufacturer label claim) during storage and transportation.

In the medical catalogues and on the order lists, all thermo-sensitive products are associated to a thermosensitive code listed in the table below.

The products that do not require a temperature control have no thermosensitive code associated.

STORAGE INDICATIONS

A pharmaceutical product, if not stored according to manufacturer’s specifications, might become ineffective or dangerous for the patient.

Controlled Temperature: 2°C-30°C

The storage and transportation of medical items falling into this thermosensitive classification needs to be done in compliance to the Good Storage and Distribution Practices. In the medical storage facilities, the temperature should be monitored and recorded twice a day in a dedicated sheet.

Example of items stored between 2°-30°C: Specialised Food items (NFOS), medical devices of class I and IIa.

Controlled Temperature: 2°C-25°C

The storage and transportation of medical items falling into this thermosensitive classification needs to be done in compliance to the Good Storage and Distribution Practices. In the medical storage facilities, the temperature should be monitored and recorded twice a day in a dedicated sheet.

Example of items stored between 2°-25°C: some Specialised Food items (NFOS), dressings (SDRE), sampling and transport mediums and containers (STSS), medical devices of class IIb and III.

Controlled Room Temperature 15°C-25°C

The storage and transportation of medical items falling into this thermosensitive classification needs to be done in compliance to the Good Storage and Distribution Practices, following the requirements expressed by the World Health Organization and the national drug regulatory authorities (NRAs). The premises and vehicles used for storing or transporting medical products, should be of a suitable size and of a standard that allows for a secure, clean and temperature-controlled storage with a relative humidity below 65 % and no direct sunlight affecting the products. Temperature and relative humidity should be monitored and recorded twice a day in a dedicated sheet, the tool recommended for this purpose is the following: PCOLMONIHLU - THERMO-HYGROMETER recorder (Log Tag Uhado-16) display.

Example of items stored between 15°-25°C: medicines (DORA, DINJ, DINF, DEXT, DEXO), some dressings (SDRE), laboratory reagents (SLAS).

Cold Chain / Refrigerated 2°C-8°C

The transport of items falling in this thermosensitive classification needs to be done in isothermal containers, while the storage requires ice-lined refrigerators (see storage and transportation equipment). Temperature should be monitored and recorded twice a day in a dedicated sheet, with monitoring by FreezeTag and LogTag (see cold chain management).

Example of items stored between 2°-8°C: most of the vaccines (DVAC), some rapid diagnostic tests (SDDT), laboratory tests and controls (ELAE).

Frozen -20°C

The transport of items falling in this thermosensitive classification needs to be done in isothermal containers with dry ice. The storage requires qualified freezers. Temperature should be monitored and recorded twice a day in a dedicated sheet, with monitoring by the PCOLTHER35A - THERMOMETER alcohol (Moëller 104614) -30°C-+50C° (to be kept vertically).

Example of items stored at -20°C: a few laboratory tests and controls (ELAE), a couple of laboratory reagents (SLAS) and antibiotic powder for antibiotic susceptibility testing (SAST).

STORAGE AND TRANSPORT EQUIPMENT

Cold chain equipment is divided into two main groups:

The active cold chain category includes all equipment that require energy to produce and maintain the cold. This kind of equipment is mainly used for the items storage or icepacks production. Under this category we have:

• Fridges
• Freezers
• Cold rooms

The passive cold chain category includes the equipment which, in order to maintain the cold, requires pre-conditioned ice-packs. Under this category we have:

• Isothermal/cold boxes
• Vaccine's carriers
• Icepacks

Selection Criteria

The cold chain equipment must meet the needs of each medical activity, as defined by the medical program with specific regards to storage volume and the icepack production capacity required.

The choice of equipment must meet the following criteria:

WHO Pre-Qualification

The WHO “Performance, Quality and Safety” (PQS) process prequalifies products and devices so that member states and UN purchasing agencies are assured of their suitability for use in immunization programs. Similar to vaccine products, MSF recommends using WHO pre-qualified equipment for cold chain activities because of its reliability standards. The updated list can be found at: https://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/.

Storage volume

For fridges, freezers and cold rooms, the net volume (expressed in litres) indicates the maximum quantity of medical items that the appliance may contain using the storage baskets (or shelves in the case of a cold room). The gross value is the overall volume without the baskets or the shelves. When estimating the storage needs it is crucial to consider the net volume and not the gross volume. The medical activity determines the equipment’s net volume required based on the kind and quantity of products to be stored (per Medical Standard List).

Ice Pack Production

The Medical Activity defines the needs for passive cold chain. The passive chain will require a quantity of ice packs per day to be sustained (at various locations). Combining the ice pack volume (0.4 or 0.6 L) and the quantity of each ice pack needed by the medical activity, the total freezing capacity (in kg/24 hours) can be determined and therefore the correct equipment selected.

Key Equipment Parameters

Storage Volume

For fridges, freezers and cold rooms, the net volume (expressed in litres) indicates the maximum quantity of medical items that the appliance may contain using the storage baskets (or shelves in the case of a cold room). The gross value is the overall volume without the baskets or the shelves. For isothermal/cold boxes and vaccines carriers the storage capacity indicated is normally always the net one (excluding the space occupied by icepacks).

Holdover time

The standard MSF active cold chain equipment has the characteristic of guaranteeing, in the absence of its energy source, that the temperature is kept within range for a period of time (thanks to thermal insulation, Ice-Lining, etc). This cold time extending characteristic is called “holdover time”, and is measured in hours. The holdover time changes according to the equipment brand and model. The holdover time is always specified within an environmental temperature range (e.g. 02-08°C maintained for 48 hours if external temperature is between 15°C and 43°C).

Cold Life

Refers to passive cold chain equipment. Is intended as the time (in hours) that the equipment can keep the medical products between a specific range (e.g. between +2°C and +8°C). The cold life parameter is also only reliable within a specific external temperature range for which the equipment has been qualified.

Freezing capacity

Specific for the freezer equipment, it is the capacity of a specific appliance to produce a certain volume of ice in a specific interval of time. The units of measure are indicated in kg/24 hours.

Special Considerations for equipment type selection

Solar models

New solar refrigerator models with or without battery (direct drive) are included in this catalogue. There are many different models and some have certain constraints on their use (maximum ambient temperatures or other logistical/context constraints).

Solar refrigerators are generally up to 5 times more expensive than the equivalent mains powered versions. Therefore they should only be chosen for locations where no electricity is available.

Blood bank and biological sample equipment

Blood bank refrigerators and other specialised refrigeration or storage equipment are considered as medical equipment. For technical support on this type of equipment contact your technical support for Biomed.

Domestic refrigerator models

The use of domestic refrigerators to store thermo-sensitive pharmaceutical products is not recommended for the following reasons:

• lighter insulation
• imprecise temperature regulation
• internal temperature variation
• temperature changes as a result of automatic defrosting
• difficulty of locating the cold and warm zones because of the diversity of models and technologies.

TEMPERATURE MONITORING DEVICES

Temperature monitors are important tools to ensure that thermo-sensitive products are kept at the correct temperature range. There are several types of temperature monitors:

• non-reversible monitors: single use tools, once the alarm is triggered it will have to be replaced
• Temperature recorders: tools with memory storage that sense temperature at specific intervals; that can be reset and reused; that include an alarm. Data and alarm parameters are programmable per OC specifications. The sensing calibration is valid for the life of the original battery.
• Remote temperature recorder: tools that send the actual temperatures to a cloud system for remote visualisation and analysis; they also include alarm settings. Alarm notifications can be send via e-mail or SMS.

Knowing the recommended use of monitoring devices assists with calculating quantities needed:

GENERAL RECOMMENDATIONS FOR COLD CHAIN MANAGEMENT

Evaluation of needs for a new activity

• What is the nature of your activities (laboratory, hospital, routine vaccination, vaccination campaign, outpatient department...)?
• What storage capacity do you need? The volume of vaccines for example varies according to the product, the presentation and the manufacturer.
• Define your storage needs in collaboration with your pharmacist
• To find out the volumes of thermo-sensitive products, refer to the guidelines (Measles guidelines, Meningitis guidelines) and/or contact your supply centre
• How much freezing capacity and storage capacity do you need for the ice packs?
• How many cold-boxes, vaccine carriers and ice packs do you need?
• Which monitoring tools should be ordered?

Assessing the existing cold chain capacity

• Is the quality of the cold chain satisfactory?
• Does the equipment fit your needs in terms of capacity and performance?
• Is the equipment in good working order?
• How reliable is your electricity supply?
• Is the equipment permanently accessible?
• Are refrigerators and freezers located in a cool, clean place?
• Do they have enough capacity to store all the temperature-sensitive products and to freeze ice packs?
• Is the monitoring equipment complete and functional in each refrigerator or freezer?
• Are the monitoring procedures for temperature-sensitive products on arrival and on departure well defined?
• Are the temperature cards properly filled out twice a day?

Contingency plan equipment requirements

• Provide enough passive cold chain equipment (accessible, in good condition) or spare fridges to store the more sensitive products
• Ensure frozen icepacks in a sufficient quantity and their renewal (corresponding to the number and the type of cold box)
• In case of cold chain breakdown, follow your OC specific cold chain indications.
• Distribute the responsibilities of who does what and make sure everyone is properly trained.
• Take contingency plan into account when estimating needs and placing equipment orders.

Transportation Recommendations for Cold Chain Items

• The shipment receiver has to check their storage capacity before green lighting an order of cold chain items. Preclearance or any possible administrative paperwork is completed in advance to avoid transit delays (that are linked to packing cold life).
• The first choice of transport between central and periphery stocks for cold chain items should be by air freight when available.
• In case of road transportation, choose the fastest option, match packing cold life with anticipated delivery times and avoid open vehicles.
• The packaging container should be chosen depending on the type of transport, the lead-time and the means of transport.
• Prior to any shipment, the sender should confirm the volume, date and time of arrival of a cold chain shipment (to ensure adequate storage space upon arrival).

Freezing Prevention while using passive cold chain equipment

• Use only ice packs filled with water! Ice packs pre-filled with coloured refrigerant gel are not suitable since they have a freezing point below 0 ºC
• Always make sure your ice packs are conditioned at 0 ºC, before placing them in the cold-box
• Follow your OC- or mission-specific procedure on conditioning of the ice packs
• Place cardboard between the temperature-sensitive products and the ice packs to prevent them touching
• Always control the temperature inside your cold boxes, before introducing the products

Other Recommendations

• PCOL equipment is not meant for storing or transporting food, blood or biological samples.
• Define written procedures for the transport of thermo-sensitive products (preparation, monitoring tools, labelling and shipping documents) in coherence with HQ recommendations.
• Contact OC Cold Chain Technical Advisor if there are any doubts
• Consult your technical department before ordering cold chain equipment that is not MSF standard.
• For any order of non-standard spare parts, please mention the type and the serial number of the appliance concerned and if possible the reference number of the part to be replaced.
• In case importation (or other) constraints do not allow the procurement of MSF standard equipment, the purchase of any alternative device must be done only after the validation of the OC referent.
• When performing a market assessment, it is recommended to assess the availability of WHO prequalified equipment[1] or specifically certified devices (for the storage of medical items).

​

A minimum level of standardization is needed to keep data processing technologies coherent both in the field and between MSF sections. This is especially relevant for hardware specifications and software applications.

The ICT departments of all sections try to find the best compromise between requirements in the field and the rapidly evolving technology. Do not hesitate to contact them for any information regarding current standards.

COMPUTERS IN THE FIELD

Even though computers are very useful for transmitting information and administering a mission, you should bear in mind that:

• proper measures must be taken to avoid hardware damage (by using an UPS, a power surge protector, etc.)
• computer use is only for professional purpose, not for personal/private tasks
• all locations using data processing techniques should have mechanisms in place to avoid data/communication loss, such as backups, a proper internet connection, a good local network, etc.

As a result of the widely differing levels of computer skills and the particularly high staff turnover of MSF missions, many computer-related problems arise following staff changes. It is therefore essential:

• keep track of your inventory
• if the IT environment grows (too) big, make sure you have enough staff to support it
• always to follow MSF standards regarding software and hardware
• not to personalize the processing of data to the extent that you are the only one who understands it
• to set up a double archiving system for important information,backups to the NAS system and from the NAS to an external hard drive stored in a different location
• to BACK UP YOUR DATA!

DATA MANAGEMENT

Follow the filing system and naming conventions defined by your section.

Each user is responsible for his/her own data and should make sure BACKUPS are made at least once a week after running the antivirus software.

A proper backup should be made on NAS or on an external hard drive, if there is no NAS.

USB memory keys (meant for transporting data) and the additional partitions of a hard disk (often identified with a capital letter) are NOT reliable media for backups. Therefore they should not be used to store backups.

SOFTWARE

The MSF image

Each section has developed an "MSF IMAGE" that contains the standard software [operating system and applications] that is used in the field on USB memory key, external hard disk and/or NAS. This image allows the latest MSF standards to be installed on a computer. Other than in exceptional cases, no other software needs be installed.

When loading the image, first back up your data, then allow about 2 hours to reformat your computer and reinstall software.

The MSF image includes the following software:

• Windows 10 Enterprise English/French/Spanish
• MS Office 2016
• antivirus software (Kaspersky) and email (MS Outlook)
• Internet Explorer, Mozilla Firefox, 7-Zip
• Acrobat Reader, VLC Media Player etc.
• several utilities required for peripherals

Installation of new software under Windows 10 usually requires logging in as an administrator with a username and password (these should be requested from your ICT support).

Non-standard software

Ask your HQ ICT support for permission before installing software that is not included in the MSF standards.

Antivirus software

Update your antivirus software at least once a day and scan your files at least once a week.

HARDWARE

Laptop computers

Laptops can be easily carried as hand luggage without having to undergo customs formalities.

The battery, charged using an external power supply, provides up to 8 hours of use. The external power supply partially protects the computer against voltage spikes.

Printers

The current MSF standard is a laser printer.

Using a non-standard printers is not advised. It makes use of the standard software more difficult and requires the computer to be reconfigured.

INTERNET AND MAIL

MSF makes sure internet and email addresses are available in the field and usage is subject to a policy.

NETWORKS

More and more MSF missions are using Client/Server (C/S) applications and with this comes the need to instal and use networks, with the capabilities to share a broadband internet connection, share files, applications, printers, etc.

Networks should be installed according to the standards set by your OC.

When a wireless network is installed, it must be configured properly in order to prevent access by unauthorized users. At least, WPA2 (Wi-Fi protected access) security should be installed and enabled.

Always be sure to appoint a competent network administrator.

ELECTRICITY UNITS, SYMBOLS AND LAWS

Remark

A unit preceded by a "k" is multiplied by 1000.

(e.g. 1 kW = 1000 W).

Basic laws

I = U/R

P = U x I

Connection in parallel (connection + to + and - to -)

U = U1 = U2 = …

I = I1 + I2 + …

P = P1 + P2 + …

Connection in series (connection + to - and - to +)

U = U1 + U2 + …

I = I1 = I2 = …

P = P1 + P2 + …

Relation between W and VA

As a rule of thumb, 1 VA = ± 0.8 W

ELECTRICAL POWER TRANSFORMING DEVICES

Apart from the difference between AC and DC, a source of electricity can take various forms. Below is an overview of the devices which can modify the form of the power supply.

Transformer

Mains voltage differs from country to country. Europe uses 230 or 240 V AC, the USA uses 110 V AC, and some other countries use 127 V AC. In order to use a device which is not designed for the locally available voltage, a transformer is needed. Please note that the frequency in the USA’s (and a couple of other countries) can be 60 Hz. All the equipment in this catalogue is primarily compatible with the ‘normal’ 50 Hz.

AC/DC adaptor (or "power supply")

Many electrical devices (laptop computers, HF or VHF radios etc.) run on DC within a range of 3 to 20 V. These devices can be powered from the mains by means of an adaptor which converts AC to the required DC voltage. Such an adapter is also called an AC/DC converter or power supply, and is usually supplied together with the device.

Battery charger

A battery charger also supplies DC from an AC source, but the DC current and voltage are suitable for charging a battery.

Caution: even though both supply DC current from an AC source, an AC/DC adaptor and a battery charger are never interchangeable!

A good quality charger will have 3-stage automatic charge management (boost,absorption, float):

• During the first stage (boost), the charger supplies the maximum current allowed by the battery (0.2 to 0.5 A per Ah capacity, depending on the battery type) until the voltage reaches 14.5 V (for a 12 V battery). This maximum current defines the current rating (in A) of the charger to be installed. This maximum current may be adjustable to enable different batteries to be charged by the same charger.
• During the second stage (absorption), the voltage is maintained at 14.5 V, while the current slowly decreases.
• The third stage (float) begins once the current drops below 0.5 A. Then the voltage applied by the charger is reduced to 13.6 V. At this point, the battery is supposed to be fully charged. The voltage applied by the charger maintains the charge and it supplies the low current that is necessary to do so.

A good quality charger must also be equipped with a temperature sensor. If the voltage is too high for a given temperature, the battery will slowly deteriorate by losing water, which is irreversible in the case of a sealed battery. Charging voltage must be adjusted to battery temperature (decrease of ± 0.025 V per increase of 1 ºC). If the temperature sensor is installed, this voltage correction is automatic.

DC/AC inverter

A DC/AC inverter produces an AC output from a DC input. This is the only way to get AC when other sources (mains, generator) are not available. The DC source usually consists of batteries that have to be charged either from AC sources through a battery charger, or from DC sources (solar panels etc.) equipped with a charge regulator.

DC/DC converter

A DC/DC converter enables a DC voltage to be converted into another DC voltage. This kind of converter is useful for example to obtain 12 V DC on board a truck which has a 24 V DC electrical system.

Solar panels

The production of DC electricity from sunlight is clean, quiet, requires little maintenance and is durable. The energy produced daily by a solar panel will depend on the location's mean daily solar irradiance. This information is essential to size an installation: it will vary accordingly to the season. It is expressed in kWH/m²/day.

Solar panels are rated in Wp (watt-peak). Their actual production when the sun is bright is approx. ¾ of that figure. They often come in 12 volt and 24 volt panels.

They will often be used to charge batteries. You will have to use a regulator in-between the battery and the panel. We now only supply so-called MPPT regulators that give the best results.(Maximum Power Point Tracking)

MPPT regulators can convert panel voltages and can be used for various battery voltages (12, 24 or 48 volt).

ELECTRICAL PROTECTION DEVICES

1. Protection against overloading

The main protection devices in an electrical circuit are fuses or thermal-magnetic circuit breakers. These devices protect the installation against overloading or short circuits by cutting off the supply if the current gets too high. The value of an overload protection device is given in amperes and indicates the maximum current that can be permanently allowed into the circuit.

Fuses

Fuses consist of a cartridge containing a metal wire that melts when the current reaches a defined value for a given time. They can be used once only and must be replaced once they have blown. Fuses come in different types (slow, normal, or fast) and must be chosen according to the device or circuit to be protected.

Thermal-magnetic circuit breakers or MCB

Thermal-magnetic circuit breakers (MCBs) combine thermal and magnetic protection.

The thermal protection causes the device to trip in case of overloading. The trip time varies according to the size of the overload.

The magnetic protection causes the device to trip instantaneously in case of a short circuit.

There are three main types: B, C and D-curve.

B-curve: The circuit breaker has a relatively low magnetic trip (between 3 and 5 xIn) and eliminates short circuits of very low value. This curve is also used for circuits having long cable lengths, in particular in TN mode.

C-curve: This circuit breaker covers a very large majority of needs (inductive receivers) and is used especially in domestic electrical installations. Its magnetic trigger is between 5 and 10 xIn. This is the most commonly used curve in MSF.

D-curve: This curve is hardly used. It could be used for the protection of circuits where there are very high current peaks at power-up. The magnetic trip of this circuit breaker is between 10 and 20 xIn.

Thermal-magnetic circuit breakers can be manually reset after tripping.

Circuit breakers are installed at the head of an electrical installation (distribution box or board) and protect each circuit individually. They are selected according to the cross-section of the electrical cabling to be protected.

2. Protection against AC supply faults

There are 3 types of AC disturbance that can damage connected equipment.

• Voltage variations: The voltage supplied is too low (brownout), too high (surge) or fluctuates too much.
• Voltage spikes: The supply exhibits brief high-voltage pulses.
• Power cuts: The supply is intermittent, fuses have blown, or the generator tank is empty…

Voltage limiter

An electrical appliance will work normally as long as the input voltage remains within a certain range called the "input tolerance". Most electrical appliances intended for 230 V AC have an input tolerance that ranges from 185 to 250 V AC. These appliances should be protected by a voltage limiter which interrupts the supply when the voltage goes beyond the tolerance range. MSF uses voltage limiters on most electrical appliances.

Lightning protector or surge suppressor

Most electrical appliances are quite vulnerable to voltage spikes.

During a thunderstorm, these spikes can reach several thousand volts and cause significant physical damage. A lightning protector or surge suppressor is a protection device that can eliminate surges and divert the current to earth. Contact your technical department for selection and installation of a lightning protector or surge suppressor.

Voltage regulator/stabilizer

Appliances which have a narrow input tolerance will not be properly protected by a voltage limiter when the input voltage goes outside the tolerance range.

Such appliances need to be protected by a voltage regulator which takes an input voltage that is too low, too high or too fluctuating and corrects it.

Some protection devices (called voltage stabilizers, constant voltage transformers or line conditioners) combine the functions of voltage limitation and regulation, but as there are no standard designations or specifications it is extremely difficult to select the right device without testing it.

MSF has selected a voltage regulator/stabilizer that incorporates all the above mentioned protection functions.

Uninterruptible power supply (UPS)

Power cuts do not pose a problem for some appliances (e.g. lighting). But for other devices (e.g. computers), power cuts can cause loss of data. These devices need to be protected by an offline UPS.

A UPS combines a battery, a battery charger and a DC/AC inverter into one device. It provides an uninterrupted 220 V AC power supply and gives a limited independent operating time in the event of a power cut.

The commercially available UPSs are designed for desktop computers. They provide around 10 minutes of power after a power cut, but they do not protect against voltage spikes.

A special UPS is included in the catalogue for critical/essential medical and laboratory equipment. This is referred to as double conversion (also called online) UPS. This UPS is primarily intended for protection of the equipment.

Power supply module

If the mains supply is of very poor quality and/or the appliances to be protected require significant independent operating time, it is better to instal a power supply module. This module combines the functions of a battery, a battery charger, a limiter and an inverter:

• Energy storage in the batteries
• 12 V DC supply
• 230 V AC supply
• AC regulation and stabilisation by double conversion (AC=>DC=>AC)
• UPS: uninterrupted AC power supply with ample independent operating time

3. Protection against insulation faults or shocks

Besides earthing, there is one protection item very important for safety: the RCD or Residual Current Device, also know under a number of other abbreviations like RCBO, ELCB, RCCB RCTD. The RCD measures if there is ‘leakage current’ and if over 30 mA , it will switch off. RCD’s work correctly with earthed but also with not-earthed systems. Quality is an issue with local purchase so only buy from accredited suppliers (ask your support department).

Electrical consumption

INGRESS PROTECTION RATING (IP)

Ingress Protection (IP) ratings are developed by the IEC for specifying the environmental protection the enclosure provides.

The IP rating has two numbers:

1. Protection from solid objects or materials

2. Protection from liquids (water)

Example - IP Rating

With the IP rating IP 54, 5 describes the level of protection from solid objects and 4 describes the level of protection from liquids.

An "X" can used for one of the digits if there is only one class of protection, i.e. IPX1 which addresses protection against vertically falling drops of water e.g. condensation..

The food products in this chapter of the catalogue can usually be bought locally. Brands and packaging might vary, as well as the exact (net) volume.

QUALITY SHEET

Caution!

This document as well as the technical sheets of non specialized food products are intended to provide information on what we consider to be ideal with regard to products, packaging, and purchase conditions. Depending on the amount purchased, the frequency of purchase and the supplier, you should come as close as possible to this ideal by demanding the maximum number of guarantees (certificates,monitoring agency services, sampling,analysis, phytosanitary treatments, etc.).

• If the project’s basic foodstuffs do not require storage (e.g., small quantities bought daily on the local market), it will be difficult for you to follow the quality sheets recommendations. In this case, we recommend that:
• you buy in this way only those foodstuffs that warrant it, that is, which don’t lend themselves to storage (fresh produce, meat, etc.)
• you choose the same quality you would for consumption by MSF staff (to avoid dubious, inexpensive products)
• On the other hand, once food stocks are organized, each sheet should be read and followed. The larger the volumes, the more closely the recommendations should be followed. If some of them are hard to follow, discuss your alternatives with your coordination team/ headquarters, and come to a joint decision on a purchasing strategy. We recommend prioritizing quality guarantees over purchase location (local supermarket vs.capital, for example). Get as close as possible to the product’s source, and avoid intermediaries.

To sum up

• product that is hard to store: purchase locally, choosing products as if you are buying for the MSF team
• storable product: buy from a supplier who can provide quality guarantees

SPECIFICATIONS

MSF specifications and national specifications

MSF specifications have been written for each product. They are based on the codex alimentarius

The implementation of the recommendations of the codex alimentarius vary upon countries. We recommend that you consult the authorities to know the local specifications before purchase

Importations of foodstuffs are always subject to prior authorization by national authorities.

Consider the potential impact on local, national or regional market availability and prices before purchasing large quantities of basic foodstuffs.

Packaging and labelling

2% empty bags should be added to the shipment without additional charges.

Standard labelling

• Supplier initials/year/order no./section initials/ program code
• Médecins Sans Frontières
• Product
• Net Weight in kg
• Crop year
• Might be added the note: "Humanitarian donation".

PRECAUTIONS FOR PURCHASE

• In case of local or sub-regional availability of products outside of MSF standards, we recommend contacting headquarters for approval prior to purchase
• All products should be clearly labelled as being wholesome, sound, of market quality, and fit for human consumption. Getting a certificate of origin is a plus for guaranteeing the traceability of the product. The Cartagena Protocol requires producers/exporters to indicate whether their products do or do not contain GMOs (Genetically Modified Organisms).

Local purchases and inspection company

• Use and fill the appropriate "Contract for local purchase" (1 per product) ref. NSFOPURC++.
• In case of purchase of big quantity, make an inspection company (SGS, Cotecna, Véritas, FAIDEX, etc.) perform an inspection before loading. Use and fill the appropriate "Inspection contract" (1 per product) ref. NSFOINSP++.

Transport

• Check the transport modes used before shipping (cleanliness, protection, etc)
• Check the contract of carriage: the carrier must promise to take responsibility for any deterioration of goods during shipping (dirty trucks that previously transported hydrocarbons or other products incompatible with foodstuffs, trucks not covered despite the risk of rain, etc

Receiving

• Check the goods (for quantity/quality) upon receipt. Use and fill the "check list for the control upon receipt": NSFOCRECOSE (English), NSFOCRECOSF (French).

STORAGE AND MAIN RISKS FOR DETERIORATION

Storage

Follow the procedure QA-NFOS-SOP2 "Storage and stock management of food".

• Always store on pallets or groups of pallets
• Food products must always be separated from other products
• FEFO (first expired first out) inventory management
• Under humid tropical conditions, most insects can multiply by a factor of 50 in six weeks. Limit storage time is therefore a way to minimize insect infestation.

Humidity

• The relative humidity indicates the amount of water vapour in the air. It is expressed as a percentage and depends primarily on the precipitation pattern and atmospheric pressure (which increases with temperature).
• It is essential that stocks be kept at the lowest possible temperature and humidity (air humidity < 70%).
• An increase in the product’s moisture content due to high ambient air humidity promotes the growth of fungi which secrete toxins.
• The ability of microorganisms to multiply in foodstuffs increases in the presence of free moisture.

Insects, rodents and birds (pest control)

• Temperatures between 10 and 45ºC are most favourable to completion of their reproductive cycle.
• Rodents (rats and mice) represent an important risk factor for foodstuffs, packagings, buildings and staff.
• Prevention is the key word, it is necessary to treat in case of infestation.

Treatment

• It is essential to take action at the first sign of infestation in order to minimize reproduction of insects and damage to the foodstuffs. Follow the procedure MSF-NFO-SOP3.1: "Pest control".
• Fumigation is the main method of treating staple foods. Caution, phytosanitary treatments may only be performed by authorized organizations to prevent excessive quantity of residual pesticides. Safety conditions must therefore be met before any operation of fumigation, and only national organizations authorized and trained to handle such substances can perform fumigation.
• The decision to distribute mildly infested foodstuffs (1 to 2 living insects per kg of product) will depend upon the circumstances. Such a decision is acceptable if the product is consumed quickly. Higher infestation levels are acceptable for distributions if the product is intended to be ground prior to consumption.

Bibliography

Food logistics. Practical guide intended for logisticians and medical personnel involved in managing food products in the field (L046FOOM01E-P).

MSF Specifications

MSF provides PVC-free containers for use in anaesthesia and emergency care and for the injection of drugs (including cytostatics) and additives.

PVC containers cannot be used for the preparation and administration of cytostatics, nor in neonatology, obstetrics and paediatrics.

Containers

Infusion containers should be unbreakable and collapsible (closed system).

• PVC is not recommended as it releases phthalates (DEHP) and can adsorb certain medicines, e.g. it is incompatible with cytostatics and certain drugs such as amiodarone. Its use is not recommended in neonatology, obstetrics and paediatrics. Since 2020, the PVC flexible bags are no longer MSF standard.
• Flexible PVC-free bags have the most advantageous logistic properties: low volume and low weight.
• Semi-rigid PVC-free bottles in PE (polyethylene) or PP (polypropylene) remain standard for specific products for which there is no or a limited number of sources available in PVC-free flexible bags. They also offer advantages in specific situations: the need to inject larges volumes into the infusion solution or the need for a container that can stand upright.

Injection sites

Containers should have two injection sites protected from contamination:

• 1 site for adapting the infusion set
• 1 additional site for the possible addition of medicines (beware of incompatibilities). Use the specific labels to indicate the medicines added to the infusion.

Container closure system

• The elastomer closure should be firm enough to allow a needle to pass through with the minimum release of particles.
• The Eurohead cap system offers the best option against the risk of contamination. The blow-fill-seal bottles are manufactured with a flattened head; the Eurohead device is then inserted, in non-aseptic class and the whole is then autoclaved.
• The Nipple head system should be avoided due to the risk of microbial contamination through micro-leaks in the primary packaging.

Secondary packaging

In order to prevent the containers, and in particular the flexible bags, from being compressed under their own weight and to avoid fatigue points at the closure system (which can lead to the formation of micro-holes), the secondary packaging (carton box) should meet some specifications:

• Strong enough to withstand transport conditions.
• The box should be tested for compressive strength and bursting strength according to the height of the stack and the weight of the box.
• The manufacturer should provide documentation of the compressive strength value of the packaging.

Infusion set

The infusions are supplied without infusion sets.

• Infusions sets should be ordered separately.
• Infusion fluids and infusion sets are supplied in separate packages. The corresponding quantities should be packed together before delivery to health facilities.

Categories of insulin

The insulins available are either human insulin and/or analogues of human insulin.

Human insulin is a synthetic insulin whose structure is identical to that of natural insulin. However, when injected under the skin, it differs from natural insulin (aggregates and longer absorption time).

Insulin analogue is also a synthetic insulin designed to mimic the body's natural insulin release process. The amino acid sequence of insulin analogues is modified in comparison with human insulin in order to alter its pharmacokinetic properties. Once absorbed, it acts in the same way as human insulin, but is absorbed more predictably. Insulin analogues are more expensive than human insulin.

Characteristics of Insulin

Insulins are classified according to their mode of action:

• Onset of action: time when insulin begins to act
• Peak action: time when insulin reaches maximum effectiveness
• Duration of action: time during which the insulin acts

Types of insulins

There are three main groups of insulins: Rapid-acting (or short-acting), Intermediate-acting and Long-acting.

Rapid-acting insulin (or short-acting)

• Rapidly absorbed from fat tissue (subcutaneous) into the bloodstream.
• Intended to provide the necessary bolus or prandial insulin.
• Used to control blood glucose levels during meals and snacks and to correct hyperglycaemia.

Includes:

Regular Human Insulin

• onset: approx. 30 min
• peak: in 2 to 4 hrs
• duration: 6 to 8 hrs
• The higher the dose, the faster the onset of action, but the longer the time to peak and the longer the duration of effect.
• Regular human insulin is less predictable than rapid-acting insulin analogues.
• Administered at least 30 minutes before meals to reduce the postprandial rise in glucose levels.
• e.g Actrapid^®, Humulin R^®

(ultra-) Rapid-Acting Insulin Analogues (insulin Aspart, insulin Lispro, insulin Glulisine)

• onset: 5 to15 min
• peak: in 1 to 2 hrs
• duration: 4 to 6 hrs
• Whatever the dose, high or low, the onset of action and the time to reach the maximum effect (peak) are similar.
• The duration of action is affected by the dose: a few units may last 4 hours or less, while 25 or 30 units may last 5 to 6 hours. As a general rule, these insulins are considered to have a duration of action of 4 hours.
• Administered at mealtimes to correct high blood glucose levels.
• e.g Humalog^® (insulin Lispro), Novorapid^/® (insulin Aspart), Apidra^® (insulin Glulisine)

Intermediate-acting insulin

• Absorbed more slowly, with a longer duration of action.
• Intended to provide the necessary basal insulin (when administered at bedtime) or prandial insulin (when administered in the morning).
• Used to cover blood glucose levels between meals and to provide insulin requirements during the night.

Includes:

Isophane (NPH) Human Insulin

• NPH : Neutral Protamine Hagedornis
• A fish protein, protamine, has been added to regular human insulin to delay its absorption. As NPH is a suspension of different sized crystals, its rates of absorption and action are highly unpredictable.
• onset: 1 to 2 hrs
• peak: in 4 to 12 hrs
• duration: 14 to 18 hrs
• A small dose given before meals will have an earlier peak and a shorter duration of action (to cover needs between meals), while a higher dose given at bedtime will have a longer peak effect and a longer duration of action.
• e.g. Insulatard^®, Humulin N^®

Premixed Insulin (or biphasic insulin)

• NPH premixed with regular human insulin or a rapid-acting insulin analog.
• The insulin action profile is a combination of rapid-acting and intermediate-acting insulins:
• onset: 30 to 60 minutes
• peak: in 2 to 8 hrs
• duration: 10 to 16 hrs
• Includes various combinations:
• NPH mixed with regular human insulin in a 70:30 ratio (70% NPH, 30% Regular). e.g. Mixtard 30^®
• NPH mixed with a rapid-acting insulin analogue Lyspro in a 75:25 ratio (75% NPH, 25% insulin Lyspro). e.g. Humalog Mix 75/25^®
• NPH mixed with a rapid-acting insulin analogue Aspart in a 70:30 ratio (70% NPH, 30% Aspart). e.g. NovoMix 30^®

Long-acting insulin (or prolonged-acting)

• Absorbed slowly, with minimal peak effect and a stable plateau effect that lasts for most of the day (8 to 24 hours).
• Intended to provide the basal insulin needed throughout the day and especially at nighttime.
• Used to cover blood glucose levels overnight, while fasting and between meals.

Includes:

Long-acting insulin analogues (Glargine insulin, Detemir insulin, Degludec insulin)

• onset: 3 to 6 hrs (Glargine insulin)
• peak: over the next few hours
• duration: relatively stable from 12 to 24 hours for Detemir insulin and 24 hours for Glargine insulin
• e.g. Levemir^® (Detemir insulin), Lantus^® (Glargine insulin), Tresiba^® (Degludec insulin = ultra-long-acting)

Storage

Any unopened insulin container should be stored in a refrigerator between 2°C and 8°C.

Insulin vials or pens in use may be kept at room temperature, between 15°C and 30°C, for approximatively 1 month. Insulin detemir can be stored at room temperature for up to 42 days.

Do not freeze, protect from light.

Exposure to high temperatures may result in a loss of insulin efficacy and a deterioration in glycaemic control.

Regular insulin, basal insulin analogues (glargine, detemir, and degludec) and rapid-acting insulin analogues (lispro, aspart, and glulisine) are clear and colourless and should not be used if cloudy or viscous.

Insulin therapy

The insulin dose is expressed in units.

It is not recommended to switch the patient from one type of insulin to another. Changes in concentration, brand (manufacturer), type, origin (human insulin or human insulin analogue) and/or method of manufacture may require a change in dose.

Insulin is administered by subcutaneous injection using either a syringe marked with insulin units and a needle, or a pre-filled pen. Insulin pumps are not MSF Standard.

For pre-filled pens, use only the pen-specific needles.

MSF codes and labels for insulins

All insulins have a concentration of 100 IU/ml, mentioned in the label (but not in the code).

• Type of insulin
• DINJINSA+++: analogue insulin
• DINJINSH+++: human insulin
• Duration of action
• B = biphasic: the ratio is identified in the label: fast / long-acting
• L = long-acting analogue insulin
• U = ultra-rapid analogue insulin
• I = intermediate / isophane human insulin
• R = rapid-acting human insulin
• Volume / Quantity
• 1 = 10 ml
• 3 = 3 ml
• Insulin presentation:
• V: 10 ml vial
• C: 3 ml cartridge, for use with a reusable auto-injector
• AP: 3 ml pre-filled pen (single-use insulin pen)
• Manufacturer: last letter of code and label
• L = Lilly
• N = Novo Nordisk
• S = Sanofi

A laboratory should be adapted to the specific needs of a project. As there are many different set-ups and activities there is no standard kit for a complete laboratory.

Select and combine standard laboratory modules to start laboratory activities according to the projects needs.

Modules generally can contain different types of items;

• equipment or investment material, to be ordered once
• renewable supplies for sample collection and transport and carrying out the tests
• specific reagents for each test

When ordering the modules initially, make sure all 3 components are selected (equipment + renewable supplies + reagents). Afterwards items can be separately ordered according to the actual consumption.

There are different types of laboratory modules:

• sample collection and transport
• general laboratory tests, including basic analysis in epidemic contexts
• transfusion
• bacteriology laboratoire, Mini-Lab

Compact fluorescent or "energy-saving" bulbs offer the same energy efficiency as fluorescent tubes yet are a similar size to incandescent bulbs.

COMPACT FLUORESCENT BULBS

Advantages compared to incandescent bulbs

• Lower energy consumption (- 80%)
• 10 times the lifespan (8000 - 15000 hrs)

Advantages compared to fluorescent tubes

• More compact
• Easy maintenance
• No external holder or ballast (integrated)

Although compact fluorescent bulbs are more expensive, they are becoming more and more widely used by MSF missions. The savings achieved are all the more significant for the fact that MSF pays a very high price per kWh of electricity because of the specific costs related to the use of generators.

Instructions for use

• It takes some time (several tens of seconds) for compact fluorescent bulbs to reach their optimal light intensity, which can be a nuisance when the lamp is used only for short periods (e.g. lighting a corridor or toilet).
• The fluorescent powder and mercury vapour in the tube, while not dangerous in the course of use, mean that used bulbs are dangerous waste items requiring special disposal.

LED

Energy saving bulbs are more and more becoming available in LED versions, be it mainly for the lower wattage models.

ADVISE FOR LOCAL PURCHASE

Caution: bulbs available on local markets are often of poor quality, and you can pay a lot for a bulb that will last no more than a few hours to a few weeks.

To avoid unpleasant surprises, it is therefore strongly recommended that you:

• buy only brands of known quality
• test a small number of bulbs before buying a bigger quantity, since counterfeit bulbs or those of a lower standard intended for local markets are widely sold
• in case of doubt, order compact fluorescent bulbs through the supply centres.

Only the most widespread models are included in the catalogue (E14, E27 and HG 57 type bulbs, from 7 to 23 W). Equivalents exist for other types of socket (bayonet) and in higher wattages.

MOTORCYCLES

As a general rule, motorcycles are not recommended for use in MSF missions because of the danger they pose to the rider.

In some situations, motorcycles may nevertheless be a good choice: for example in rural areas, where there is little traffic, for short journeys at low cost, for EPI, etc.

In all cases, the choice of model should be made in collaboration with your technical department, in accordance with the following points:

• Avoid larger cylinders, as more powerful models encourage higher speeds.
• Choose a model which is well-known and has a good network of dealers in the country.
• The use of good quality helmet and personal protection equipment (elbow, knee, boots & gloves) is mandatory.

PURCHASE OF MOTORCYCLES VEHICLES

The procurement of a vehicle, either new or second-hand should always be discussed with your technical department and approved by them.

There are 2 possibilities for purchasing:

Purchase via MSF supply centre

The choice for a standard vehicle, as proposed by your operational centre, gives you the advantage of the technicians expertise on a well-known and approved model.

In this case the management tools developed especially for this model, are available, such as the logbook and a spare parts order tool.

Contact your technical department for more information.

Local purchase

Make sure that spare parts are available locally. Do not buy imitations, but only genuine manufacturer's parts.

In case of local purchase of non-standard motorcycles, the supply centres cannot guarantee the supply of spare parts.

MANAGING THE VEHICLE FLEET

Vehicles are essential to the running of a project and must therefore be properly managed.

See the existing MSF guidelines on the subject.

These kits contain the necessary equipment to set up a nutritional programme.

NB: Certain conditions must be met beforehand. It is essential to have an adequate infrastructure, to organise the supply of food and water and to ensure the medical follow up of the beneficiaries.

The two kits were designed in 2021 and replace the previous ones:

• nutrition inpatient kit
• nutrition outpatient kit

Modules and/or items which are optional must be ordered separately. They are NOT automatically sent with the kits.

Psychotropic drugs and narcotic should be ordered separately (Cf Introduction in the Medical catalogue: Narcotic and psychotropic medicines under international control).

See the checklists for the medicines included in the outpatient kit.

SAFETY IN THE FIELD

The direct and indirect protection of staff in the field depends on 3 key principles:

• the knowledge of hazards, or risks associated with carrying out a specific activity
• the provision of specific protective equipment to protect against these dangers, as well as the protocols and/or the procedures on using dangerous equipment and products
• the establishment of a culture of prevention and of protection of people and assets involved in missions

GENERAL SAFETY MEASURES

• Make sure that:
• tools and equipment are properly maintained and used only by authorised persons
• users are trained on the risks involved in activities or handling hazardous equipment
• safety instructions are well respected
• first aid kits are available in the workplace and are properly maintained
• Keep a register of accidents/incidents
• Store flammable materials correctly and away from buildings

PERSONAL PROTECTIVE EQUIPMENT (PPE)

PPE includes "any device or means intended to be worn or held by a person to protect him/herself against one or several risks likely to threaten his/her health and physical integrity.

There is a vast range of PPE. The choice of PPE depends in particular on:

• the protection required in terms of the danger associated with the activity:
• body protection
• respiratory protection
• hearing protection
• eye protection
• the seriousness of the danger
• the frequency of exposure to the danger.

PPE is supplied by MSF and its use is compulsory. Staff must be trained to use PPE.

Caution

• MSF, as employer, must ensure that staff wear or carry suitable individual protective clothing and material other PPE during work
• staff must be responsible for protective equipment issued to them
• if protective equipment deteriorates, it must be exchanged for new equipment
• PPE and other protective equipment should preferably be kept in the workplace: a changing room and lockers should be provided
• work clothing should be washed regularly
• PPE and work clothing have a limited lifetime

FIRE PROTECTION

• heck regularly that all building openings (doors, windows, ventilation etc.) are in working order
• define and post evacuation plans for buildings and their enclosure
• establish every member of staff's responsibilities in case of fire and evacuations from the building
• designate fire assembly points outside buildings in case of fire
• organise regular fire drills
• equip buildings (flash points) and vehicles with fire extinguishers and/or other means of fire fighting materials and train staff to use them
• make sure that fire-fighting equipment is known, easily accessible and well maintained
• instal smoke detectors and alarms

5 PREREQUISITES FOR INSTALLING SHELTERS

1. Definition of needs

• Evaluate the needs together with the medical team.
• Propose suitable responses in logistic terms: construction, water and sanitation, human resources etc.

2. Site selection

• Identify a site in agreement with the local authorities.
• Take into consideration formal and customary law, and respect local customs.
• Find out about geographical and climatic conditions (whether in an earthquake zone, flood-risk area or basin; strong winds; high ground; rainfall and rainy season; winter conditions etc.)
• Check that water is available nearby.
• Check that there is easy access for supplies and patients.
• Select a larger site than needed.
• Select a site on a gentle slope to facilitate drainage.
• Fence the site off quickly and have it guarded.
• Draw up overall and specific building plans (ground plan, medical facilities, sanitation, access etc.).

3. Technical considerations

• Identify the type of shelter to be used on the basis of timescale, cost, available human resources, means and conditions of transport, existing buildings, locally available materials etc.
• Consider the various standardised solutions: tents (tunnel, winter...), plastic sheeting, local shelters, partitioning of collective centres etc.

4. Human resources

• Identify available national human resources (site foremen, piece-workers, labourers etc.).
• Enquire about the legislation governing hiring of staff.
• Monitor the size of the payroll.

5. Organisation of the work

• Organise the work teams.
• Manage the supply of materials.
• Draw up a phased work plan, based on medical priorities.
• Monitor the site's financial transactions and accounting.

Temporary health facilities

During the emergency phase, the general MSF policy is to instal health facilities under tents.

In the post-emergency phase, it is important to plan the construction of facilities that will improve the level of care provided.

These facilities must be suitable for healthcare, and suited both to the environment (in climatic, ecological, social and political terms) and to the context (building techniques, available skills etc.).

The roof cover must be able to resist wind and bad weather. The walls, light and non-load bearing, can be made of plastic sheeting, corrugated iron, straw, bamboo etc. The floor is either of rammed earth, with or without plastic sheeting, or is covered with smoothed concrete. The lifespan of the building should be at least 2 years, without maintenance during the first year.

MSF REFERENCE DOCUMENT

"Temporary Health Structures Guidelines"

This guide contains all the information you need to set up and maintain temporary health facilities. It contains ground plans and specific sanitation plans for each type of facility, as well as an estimate of the materials required. These plans are examples, designed with the input of medical and logistical experts. Putting them into practice will often require having the skills to adapt them.

This guide has two distinct and complementary functions. On one hand, it can assist the decision-making process during the development of a health facility project and facilitate communication between the field and the capital. On the other hand, it serves as a technical aid for field logisticians regarding site choice, construction methods and sourcing of materials.

FIELD LIBRARY

• L020EMEM02E-P Emergency preparedness - The spirit and the toolkit
• L020EMEM03E-P The priorities - Situations with displacement of population
• L043BUIM07EFP Temporary Health Structures
• L043BUIM06E-P Shelter - Situations with displacement of population
• L043BUIX02E-P Plastic sheeting
• L043SHEX01E-P Transitional settlement for displaced populations
• L043SHEX02E-P Tents, a guide to the use and logistics of family tents
• L043SHEX03E-E Shade nets: Use, deployment and procurement

Specialised food products

Unlike basic food products (NFOO family) such as cereals (millet, sorghum...) or leguminous plants (beans...), specialised food products‌ (NFOS family) are designed to meet the needs of malnourished people in crisis situation.

These products are fortified with proteins, minerals and vitamins according to nutritional needs of the patients (age, severity of malnutrition, associated pathologies or even local diets).

The global strategy to respond to a nutritional crisis can only be determined once the nutritional situation has been assessed and the intervention objectives and target population have been identified. The response can be either general or selective: general distribution, blanket feeding, supplementary feeding programme or therapeutic feeding programme.

THE DIFFERENT TYPES OF SPECIALISED FOOD PRODUCTS

Specialised foods can be classified in different categories:

Therapeutic milks F75 and F100

Therapeutic milks are used in the initial (F75) and rehabilitation (F100) phases of treatment for severe acute malnutrition.

RUTF: Ready-to-Use Therapeutic Food

RUTF is used in the rehabilitation phase of treatment for severe acute malnutrition. Due to its iron content, it should not be used in the initial phase of treatment for severe acute malnutrition.

Examples of products: Plumpy’nut, eeZeepaste, Valid Nutrition, Insta paste, BP100

Caution: RUTF should not be used in children under 6 months of age.

RUSF: Ready-to-Use Supplementary Food

RUSF is a ready-to-use product used for the treatment of Moderate Acute Malnutrition (MAM). RUSF can also be used as nutritional support in emergency situations or as part of nutritional programmes to prevent malnutrition.

Examples: Plumpy'Sup, eeZeRUSF

Note: RUSF are sometimes called LNS LQ (Large Quantity)

LNS: Lipid-based Nutrient Supplement: LNS MQ and LNS SQ

• LNS MQ (Lipid-based Nutrient Supplement Medium Quantity) is a ready-to-use product used for the prevention of Moderate Acute Malnutrition (MAM) in children aged 6 to 36 months. When consumed as a supplement to the regular diet this product balances the daily intake of micronutrients.

Examples: Plumpy doz, eeZee50

• LNS SQ (Lipid-based Nutrient Supplement Small Quantity) is a ready-to-use product used to prevent malnutrition. LNS SQ can also be used as nutritional support in emergency situations.

Examples: Nuttributter, eeZee20

Micronutrients (fortified paste with vitamins and minerals, to be added to normal meals)

Micronutrient supplements are used in the case of deficient diets. They mainly compensate for the absence of animal-based products.

Examples of products: QBmix

Emergency food ration

Compressed biscuits used as nutritional substitutes or food supplements in crisis situations, especially during the first phase of an emergency before the organisation of a general ration distribution.

Examples of products: BP5, NRG5

Infant formulas (infant milks) and breast-milk fortifiers

Breast-milk substitute for infants, or fortifier for breast milk.

There are different types, described in this catalogue, depending on the needs of patients.

Food for Special Medical Purpose (e.g. VHF patients, burn victims, HIV patients, etc.)

Food for Special Medical Purpose (FSMP‌ in codex classification) are specially designed for patients with specific nutritional requirements due to their pathology. They should be used under medical supervision.

Different products are available, depending on the nutritional needs of the patients:

• adults or children
• isocaloric or hypercaloric
• normoprotein or hyperprotein
• semi-elemental
• with or without fibres
• for oral nutrition (drinks), enteral feeding by tube, or both, in different forms:
• powders for reconstitution into oral drink or enteral nutrition
• ready-to-use drinks
• ready-to-use bags for enteral (tube) nutrition (ready to hang)

Powders have a longer shelf-life (24 months) and are often less expensive than ready-to-use products. As they are often versatile (they can be used for oral and enteral tube feeding, and some can even be reconstituted to different concentrations), this reduces the number of references and facilitates stock management and orders.

Please contact your nutrition advisor before ordering these products. These products can be used as a sole source of food or as a meal supplement for VHF/Ebola patients unable to follow a normal diet or suffering from severe anorexia, for example.

Super Cereals (Pre-cooked fortified flours )

Super Cereals are used for general (WFP) and family ration distributions, as well as in supplementary feeding programmes and blanket feeding programmes.

Super Cereals are composed of corn flour (CSB+) or wheat flour (WSB+) and soya cooked by extrusion or micronization, and fortified with minerals and vitamins.

Examples of Super Cereals: Unimix (MSF-UNICEF-UNHCR), CSB/CSB+ (WFP), WSB (WFP).

Super Cereal plus (+) are the new generation of Super Cereals. They contain milk and are better adapted to the needs of children.

Examples of super cereals plus: CSB++