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.

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.

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

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 MSF set of documents that include guidelines and catalogues embody the collective experiences of medical and logistics technicians from all MSF sections, whose years of experience have been compiled with the aim of helping the field staff in their daily work, speed up our interventions, and standardize our practices.

1. GUIDELINES

The guidelines concerning methods and protocols for implementation were the first documents to be produced. They indicate the most effective way to face up to a problem in a limited resources environment. As their use is not exclusively reserved for MSF, they propose a wider selection than what is actually available in the field (e.g.: the MSF guidelines “essential drugs” mentions some products which are not used by MSF, but which are still used in some countries).

2. CATALOGUES (9 VOLUMES)

The catalogues are common to all MSF sections. They propose medical and non-medical products selected by the MSF referents as being the most suitable for a given situation. They are used as reference and technical support for missions and supply centres, as well as specifications for technicians, purchasers and persons in charge of articles’ quality control at reception.

• The LOGISTICS (1 volume) and MEDICAL (7 volumes) CATALOGUES constitute THE REFERENCE regarding the selection, the use, the maintenance and the storage of standard articles which are used in MSF missions.
• The KITS CATALOGUE (1 volume) allows for the planning and quantifying of emergency operations due to a description of the type of use and the detailed content of each kit.

Catalogues are updated during international working/contact group meetings and their content is validated by the medical directors of the five operational centres of MSF. They are bilingual (English/French)

The catalogues can be ordered together (as a set of 7 catalogues) or separately through your OC library focal point (Bibop).

3. PUBLISHING OF MSF DOCUMENTS

The international MSF guidelines are available through the international medical guidelines website
https://medicalguidelines.msf.org/viewport/MG/en/guidelines-16681097.html

Some international MSF guidelines are for internal use and only available for the MSF world. They are posted on the Sharepoint.https://msfintl.sharepoint.com/sites/msfintlcommunities/IGP

The catalogues are edited by SPINCO once a year. They are simultaneously published on paper, electronic format (memory key) and posted on the Intranet (Sharepoint), from the international masterdata platform, UniData, managed by SPINCO.https://msfintl.sharepoint.com/sites/msfintlcommunities/MSFCatalogues

Since 2021, the new platform UniCat is accessible on the web. It also enables to see the articles with their technical sheet/FFF. The advantages of UniCat are the daily updates and the ease of use.
https://unicat.msf.org/

The technical sheets, the Form Fit & Function (FFF) specifications and the photos of articles can also be viewed in UniData at any time.

The electronic version on Sharepoint also includes:

• the international MSF guidelines which are linked to the medical or logistic catalogues
• “Clinical guidelines”
• “Essential drugs”
• “Essential obstetric and newborn care”
• “Management of a cholera epidemic”
• “Management of a measles epidemic”
• “Tuberculosis”
• “Public health engineering in precarious situations”
• “Refugee health”
• “Temporary Health Structures”
• “Blood transfusion”
• “Management of epidemic meningococcal meningitis”
• “Rapid health assessment of refugee or displaced populations”
• “Integrating HIV & TB care in basic health care package in MSF projects”
• “Paediatric HIV Handbook”
• “Neonatal care. Clinical and therapeutic guidelines”
• "Mental Helath and Psychosocial Support Guideline"
• “Laboratory manual”
• "MSF laboratory quality assurance manual"
• "Collection, storage and transport of samples"
• “Electrical Installations and Equipment in the Field”
• “Ultrasound manual. For trained practioners”
• “X-ray manual. Guidelines for implementation and provision of x-ray services”
• the MSF TOOLS: pictures of the surgical sets, medical, food and logistical stationary forms, Excel file with kit contents, summary of changes and some logistical guides

4. FEEDBACK FROM THE FIELD

The MSF documents evolve for the most part thanks to continuous FEEDBACK from the field and from other users. Don’t hesitate to contact SPINCO (spinco.medical@msf.org or spinco.logistics@msf.org) to tell us about your experience !

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

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 ward equipment part contains the necessary material for 20 to 40 beds, the medicines and renewable supplies part if for about 400 patients:

• Inpatient ward, with post‐operative care
• Option: physiotherapy/traumatology

Depending of the activities, in particular surgical ones, the equipment for additional beds must be increased.

It is composed of 3 parts

• Medical equipment part for 20 to 40 beds: this part needs to be ordered the number of times according the number of beds present in the hospital
• Medicines and renewable medical supplies for 400 patients. To be multiplied, like the equipment, according the number of patients expected.
• The Delivery part of the hospital kit is a complementary part to the ward

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

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.

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.

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 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.

You will find hereafter the new organization of the TOOL KITS which includes 4 basic kits and several complementary kits for specific needs.

Basic kits

KPROKTOO1--: KIT TOOLS, basic

Basic tool set, essential in every MSF mission for small logistic jobs. This kit is complementary to KPROKTOO29-.

KPROKTOO29-: KIT TOOLS, maintenance LAND CRUISER

Tool kit essential for the maintenance and the realization of certain repairs of your Land Cruiser vehicle fleet. Could be extended upon request.

KPROKTOO3--:KIT TOOLS, workshop infrastructure

Complete equipment intended for setting up a mechanical workshop allowing vehicles maintenance and certain vehicles repairs.

KPROKTOO4--: KIT, TOOLS, carpentry

Selection of tools for carpentry jobs.

Complementary kits

KPROKTOO21-: KIT TOOLS, consumables

Selection of consumables needed in a mechanical workshop. A periodic order is to be submitted to replenish the stocks.

KPROKTOO23-: KIT TOOLS, complementary for truck

Selection of tools complementary to KPROKTOO029 intended for the maintenance and certain repairs on trucks.

KPROKTOO35-: TOOL KIT installation glued WINDSHIELD

Tools and equipment to take out an old windshield, clean the surfaces and place and hold the new windshield while the glue is drying.

KPROKTOO31-: KIT COMPRESSOR, 100 litres + accessories

Compressor with a tank volume of 100 litre and its module of accessories (to inflate inner tyres, to blow air for cleaning purposes). The module with accessories is identical for 3 different compressor kits.

A compressor is indispensable equipment for a mechanical workshop.

Make sure to check the quality of the power source (starting factor 3 to 5).

KPROKTOO311: KIT COMPRESSOR, <50 litres + accessories

Compressor with a tank volume of less or around 50 litre and its module of accessories (to inflate inner tyres, to blow air for cleaning purposes).

This kit with a compressor of +/- 50 litre (2 HP) is recommended for a mechanical workshop where the starting capacity of a compressor of 100 liters (3 HP) might be difficult.

Make sure to check the quality of the power source (starting factor 3 to 5).

KPROKTOO312: KIT COMPRESSOR, 200 litres + accessories

Compressor with a tank volume of or around 200 litre and its module of accessories (to inflate inner tyres, to blow air for cleaning purposes) as well as a module of painting accessories.

This compressor of 200 litre (3 to 4 HP) is recommended for a mechanical workshop where painting activities are done, which is an operation that requires a constant air flow.

Make sure to check the quality of the power source (starting factor 3 to 5).

KPROKTOO32-: KIT ARC WELDING unit

Arc-welding unit of inverter type and accessories, 230 V and ± 160 A. Make sure to check the quality of the power source, this equipment needs a stable power supply.

KPROKTOODRS: KIT DRILL SCREWDRIVER + accessories

Portable screwdriver/drilling machine supplied with spare battery, set of drill bits to drill in metal and screwdriver bits as well as protective goggles.

KPROKTOODRI: KIT HAMMER DRILLING machine 230V + accessories

Electrical hammer drilling equipment used to make holes. The drilling machine is supplied with a set drill bits for drilling in metal and in concrete, as well as protective goggles.

KPROKTOOGR1: KIT ANGLE GRINDER Ø125mm + accessories

Electrical tool used to cut, trim, brush and polish. Supplied with discs with diameter of 125 mm for different purposes and with protection material.

KPROKTOOGR2: KIT ANGLE GRINDER, Ø230mm + accessories

Electrical tool used to cut and trim. Supplied with discs with diameter of 230 mm for different purposes and with protection material.

KPROKTOOTW-: KIT TIN WELDING ± 80-100W, 230V + accessories

Electric heating device allowing a brazing operation, by the contribution of a metal: tin. It is used to braze electrical contacts and electronic parts.

Remark

All tools are codified according to the MSF codification system, but for certain tools, MSF uses a reference of the supplier Facom at the end of the label. Nevertheless, this does not mean that all tools sent to the field are of the brand Facom. The actual brand selected and sent, varies according to supply centres, the intended use in the field (intensive use or not) and of the availability on the market with regards to the quality-price ratio..

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

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

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.

LONG DESCRIPTION: TECHNICAL SHEET

SHORT PRESENTATION OF ARTICLES: FFF

PARTICULAR CASES

Stopped article

=> an article that is no longer supplied by MSF,
indicated with a grey banner mentioning “OUTDATED”

The article is either obsolete or an item which is no longer produced. Nevertheless, its entry in the catalogue allows the reasons for its withdrawal to be explained, for a potential replacement item to be suggested and for the accessories, consumables and spare parts supply to be continued.

Code ending by “+++”

=> technical sheet describing several articles

This signifies an item which comes in different models or sizes.

WARNING: That code can never be used to place an order! The exact codes of the different presentations of an item are written directly underneath the common label of that item.

Checklists

=> lists of essential articles to set up specific activities

Examples:

• “Laboratory” checklists are intended to help you order the required equipment and reagents to carry out different laboratory tests.
• “Hygiene” checklists aim to highlight the points to be considered in order to improve hygiene of MSF programs.
• “Diagnostic imaging” checklists are intended to help you order all the required articles related to an x-ray machine as well as the related bibliography.
• “Internal fixation” checklists are intended to list all articles for internal fixation with the Stryker Plating System (SPS) or all articles for the intra-medullar Nail of Sign.

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

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

For example, caffeine citrate:

There are therefore two ways to express the active ingredient content of a medicine: either based on the salts contained in the formulation (e.g., 20 mg of caffeine citrate in this case) or based on the base equivalent that contributes to the pharmacological activity of the medicine (e.g., 10 mg of caffeine base).

In English-speaking countries, the content is typically expressed as salt, while in French-speaking countries, it is usually expressed as base. Unfortunately, there is no international standard for this, leading to frequent confusion between the two methods. As a result, it is not unusual for drugs labelled as bases to be used in protocols that express them as salts, and vice versa.

For salts where the non-active part is relatively small compared to the active part, these confusions often result in negligible errors. However, with small active molecules combined with heavy salts (such as phosphates, sulphates, carbonates, citrates, fumarates, etc.), the non-active part can constitute more than half of the molecular weight. In such case, confusions can lead to underdosage (resulting in ineffective treatment or a risk of resistance) or overdosage (increasing the risk of adverse effects). Examples of such products include caffeine citrate solution for injection and chloroquine phosphate tablets.

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 consist of 13 members, elected by the Economic and Social Council for a five-years term, with eligibility for re-election. Ten of these members are elected from a list of candidates nominated by governments, while the remaining three are selected from a list of candidates nominated by the World Health Organisation (WHO), based on their medical, pharmacological, or pharmaceutical experience. INCB members serve in an impartial, personal capacity and are independent of their respective governments.

The production and distribution of controlled substances must be licensed and supervised. Governments are required to provide the INCB with estimates and statistical reports on the drug quantities required, manufactured and used, as well as on quantities seized by police and customs. Each year, the INCB publishes data on the illicit trafficking 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 aim of this list is to regulate and restrict the use of these drugs based on their therapeutic value, potential for abuse, health risks, and to prevent 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. This 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 according to 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 schedule of narcotic drugs and their MSF attribute (Narcotic 1, 2, 3, 4), consult your European Supply Centre website (see below).

Psychotropic drugs

Psychotropic substances are regulated under international control by the 1971 United Nations Convention on Psychotropic Substances. The purpose of this Convention is 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 according to 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 subject to international control under the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988.

The Red List contains the list of precursors under 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

When exporting or importing narcotic or psychotropic drugs, the legislation of all countries involved must be considered.

The exporter typically needs to present an import permit from the destination country to obtain an export permit for these substances.

If importing for re-export (ImpEx) via a third country (e.g. via Kenya for Somalia), the regulations of the third country must also be followed, or the transit regime should be selected.

In some countries, additional controls may apply if these products are considered chemical weapons by the Office of National Security (beyond the oversight of the National Drug Regulatory Authority).

Importing country

Verify the regulations custom clearance procedures with the Ministry of Health, National Medicines Regulatory Authorities (NMRA), etc.

Some countries prohibit the import of narcotics by humanitarian agencies or allow it only in cases of national supply chain disruptions (exceptional import requests).

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:

• Permit number
• Date of issue
• Expiry date of this permit: should be at least 3-4 months, date by which importation must take place. Note: in some countries, extension may be possible.
• Name and address of the importer: MSF name only (instead of the medical coordinator) to avoid delays from changes in coordinator. Otherwise the MSF procurement centre has to apply for a new address to the concerned European MoH in case the coordinator changes.
• Name and address of the exporter: verify with your procurement centre or medical department.
• Details of the product: number of units (ampoules, vials, capsules, tablets, oral drops, oral solution, patches or rectal tubes), in letters and numbers, with precise volume, dose, total active ingredient content (in mg or g). Example: one hundred (100) ampoules of fentanyl, 0.05 mg/ml, 2 ml, totalling 10 mg of active ingredient). Ensure proper conversion if the product is a salt (e.g. morphine HCl) as some countries request the base content of the drugs. 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: preferably on official letterhead.

Remarks

• Carefully review import permits for errors before sending, as changes cannot be made after issuance.
• Orders should be placed per full pack quantity as specified on the permit. You can import less than what is specified on the permits but not more.
• Some countries require additional information (e.g. name and address of the manufacturer) or documentation (e.g. Certificate of Analysis, cGMP, Proforma INV, etc.) as this is important for the procurement centre re-order process (if stock (picking) reservation is required for example).
• In some countries, a general import permit must be obtained before applying for a Special Import Permit (regulated items) (e.g. Ethiopia and Nigeria)
• The scanned copy of the import permit can be sent to the procurement centre to begin the export permit process, followed by the hard copy. Some countries require the return of the hard copy after after obtaining the export permit (e.g. Uganda).
• The MSF procurement centre will use the import permit to apply for the export permit to their concerned MoH. The import permit can only be used once for this application.
• Review the website of your procurement centre for specific information on which drugs require an export licence, grouping drugs on a single import permit, number of orders per mission (usually one order for the whole mission instead of one per projec,t 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 is 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 certain situations (e.g., civil war, guerrilla-controlled areas), if the competent authority is no longer operational or not a member of the INCB (e.g. South Sudan), or if the local competent authority is under other authority (e.g., KMCA-Kurdistan Medical Control Agency- for Iraq is under Baghadi authorities) and cannot issue import permits, the responsible pharmacist at each European Supply Centre may negotiate with its ministry and the International Narcotic Control Board in Vienna. This may lead to obtaining 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 (e.g., natural disasters). A written request signed by the medical director of the MSF section should be sent to the pharmacist responsible for controlled drugs at the MSF procurement centre. The medical coordinator must promptly acknowledge receipt, which is then used for reconciliation with the NMRA associated with the supply centre.

Transportation of narcotic and psychotropic drugs to missions

Transport will generally be by air, as the import permit is typically valid for three months (though it is often longer). The drugs must arrive in the country before the permit expires.

CONTROLLED SUBSTANCES IN THE KITS

A specific module is created for regulated drugs (code ending with "C") for each kit. However, this module is not automatically supplied when the kit is ordered. These regulated products will not be included in the kit or module and must be ordered separately. An import permit for each of these drugs must be sent to the procurement centre.

Note: this applies only to medical items regulated at the supply centre level (those requiring an export permit in the EU). If the product is regulated (narcotic, psychotropic, or precursor) only in the destination country, these items will not be automatically separated by module in the kit. It is the mission's responsibility to screen the kit contents using the detailed Medical Kit List detailed, available on the MSF Catalogues website.

STORAGE AND HANDLING OF REGULATED PRODUCTS IN THE FIELD

It is essential to adhere to the list of regulated drugs and legal requirements in the country, where MSF operates, as we are not exempt from national law. We work with national staff and MSF pharmacies may be subject to inspection by health authorities for evaluation.

In general

• Identify regulated drugs: confirm what is considered a “regulated drug” by the national authorities, as the list may vary from country to country.
• Designate responsible personnel: appoint 2 or 3 people responsible for the movement and tracking of regulated products.
• Maintain written records: all pharmacies should have a written list of regulated drugs.
• Storage requirements: regulated drugs must be stored securely (under lock and key) in accordance with the country's regulations, under the responsibility of the designated personnel. Drugs included in a kit should be identified by the kit name.
• Ensure proper handling: double-check the different steps of handling (reception, packing, authorisation, dispatch, etc.).
• Follow FEFO principle: The "First Expired First Out (FEFO) principle applies to regulated drugs. Ensure expiry dates are regularly checked, especially for drugs in kits.
• Track and report movements: record the movement of drugs in a separate register. National health authorities may require regular written reports of movements and consumption. If required, ensure that stock movements are officially documented.

The deterioration of medicines depends on various factors, including the product type, manufacturing process, quality of raw material, excipients, etc. Storage conditions also play a significant role. The shelf-life of a product is determined based on an average rate of deterioration under standard conditions of temperature, humidity, and light, as specified by the International Conference on Harmonisation (ICH) for the climatic zone where the medicine will be marketed. The expiry date is set to ensure that, under these conditions, the therapeutic effectiveness remains unchanged (at least 90% of the active ingredients must be present) and that there is no significant increase in toxicity.

Quality is defined as “the suitability of a pharmaceutical product for its intended use”. Each medicine intended for patient use must meet acceptable quality standards, including identity, purity, safety, and efficacy.

If a medicine fails to meet quality standards, the consequences can include:

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

The quality of pharmaceutical products is affected by raw materials, the manufacturing process, packaging, transport and storage conditions. These influences may accumulate over time.

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 had at the time of manufacture” (USP 37).

EXPIRY DATE

Even when stored under proper conditions, medicines naturally deteriorate over time due to various processes.

In many countries, manufacturers are legally required to study the stability of their products under standardised and exaggerated environmental conditions. These studies help manufacturer select the optimal formulation, packaging, storage conditions, and ultimately determine an expiry date for each dosage form in its packaging.

The manufacturer’s expiry date refers to 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. Products containing less stable substances are guaranteed for only 1 or 2 years.

Practical definition of shelf-life: the 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. This means that 1/3 of the shelf-life should remain at the time the product is released from stock (Note: transport and handling may take additional time). For medical kits, which often only have 6 months of remaining shelf-life, they should only be ordered for emergency situations and not for EPREP stock.

The expiry date is clearly indicated on both primary (immediate) packaging and secondary packaging:

The UK MHRA advices pharmaceutical manufacturers that the term ‘expiry date’ means the product should not be used after the end of the month stated. For example, an expiry date of 12/2025 means the product should not be used after 31 December 2025.

On the other hand, the UK Royal Pharmaceutical Society (RPS) clarifies that when a product is labelled ‘Use by’ or ‘Use before’, it means the product should be used before the end of the previous month. For example, ‘Use by 06/2025’ means the product should not be used after 31 May 2025.

Caution

It is important not to confuse the date of manufacture with the expiry date (“Exp. Date”).

SHELF-LIFE - IN-USE SHELF-LIFE

Once a multi-dose drug container is opened, the exposure of the drug to environmental factor can shorten its shelf-life. Repeated opening and closing of the container may increase the risk of microbiological contamination and/or physico-chemical degradation. This risk is particularly high in bulk packaging and for certain medicines, such as anti-tuberculosis medicines, which are sensitive to temperature and humidity.

Some oral or injectable multi-dose products are provided in powder form tat needs to be reconstituted before use. After reconstitution, these products may undergo significant hydrolysis and thus have a limited shelf-life. Some may require refrigeration. For non-sterile medicines, always consult the manufacturer's leaflet for information on the in-use shelf-life. If such information is provided, follow the manufacturer’s guidance. If not, refer to the table below. Always record the date the product was opened and the updated expiry date on the medicine label or, if there is insufficient space, on the outer packaging.

Notes:

• Sterile products: any remaining content should be discarded immediately after the first use.
• Ointments: these are semi-solid, greasy preparations intended for application to the skin or mucous membranes.
• Creams: these are similar to ointments but contain an aqueous phase, making them more susceptible to microbiological contamination.
• Use of jars: a 100 g jar is intended for individual use. A 500 g jar can be used between multiple patients (e.g. in an hospital ward), but carres an increased risk of contamination.

BASIC STORAGE GUIDELINES

Proper storage is essential to maintaining the effectiveness and safety of medicines, as they can be sensitive to environment factors such as light (especially sunlight), oxygen, moisture, and extreme temperatures.

MSF follows manufacturer storage recommendations in alignment with WHO GDP Guidelines and MSF transport policy

• Keep medications in their original containers and outer packaging to protect them from sunlight.clearly
• Ensure the container is tightly closed to prevent exposure to air and moisture.
• Avoid opening containers before use.
• Do not remove desiccant packets (e.g. silica gel) from the packaging, as they help control moisture levels.
• Always check and respect the expiry dates - do not cover them with labels or writings.
• Store medicines according to the manufacturer's instructions.
• Follow the FEFO (First Expired, First Out) policy to manage stock.
• Organise cartons properly, ensuring that arrows are pointing upward and that identification labels, expiry dates, and manufacturing dates are visible.

Protecting products from sunlight:

• Cover windows or use curtains to block direct sunlight exposure.
• Store products in their original packaging and in cartons.
• Avoid storing or packaging products in direct sunlight.
• Use opaque plastic or dark glass bottles for products that are specifically sensitive to light.
• Maintain trees around the facility to provide natural shade, but regularly check for any branches that could potentially damage the facility.

Temperature storage for medical consumables:

• Store frozen: products that require storage at temperatures of -20ºC, such as certain vaccines, should be transported in a cold chain and stored frozen, typically for longer-term storage at higher-level facilities.
• Store refrigerated: store products at a temperature between 2°C and 8°C. This range is suitable for products that are heat sensitive but should not be frozen, such as vaccines. (For further information see Vaccines family).
• Keep cool: store products between 8°C and 15°C. This is for products that need to be kept cool but are not as temperature-sensitive as those requiring refrigeration.
• Store at room temperature: store products at a temperature between 15°C and 25°C. This is the standard temperature range for most of medical products.
• Store at ambient temperature: while not widely used, this term refers to normal storage conditions. Ambient temperatures typically means “room temperature”, ranging from 15°C to 25°C or up to 30°C, depending on local climate conditions. It implies storage in a dry, clean, and well-ventilated area.

Measures to reduce effects of humidity:

• Ventilation: ensure proper airflow by opening windows (with screens and bars) or using air vents. Store products on pallets and maintain space between pallets and walls.
• Secure lids: make sure all container lids are securely closed to prevent moisture from entering.
• Air circulation: use fans to improve airflow and reduce humidity build-up.
• Air conditioning: use air conditioning to control temperature and humidity levels.

Monitoring temperature and humidity in the medical storage area

• Manual monitoring: temperature and humidity should be manually checked twice a day, including on weekends
• Electronic monitoring instruments: use electronic devices for continuous monitoring that can record and track temperature and humidity over time, including minimum and maximum readings. To be monitored twice daily as well.
• Importance of manual checking: while remote monitoring systems are valuable, they should not replace the twice daily manual checks.

DETERIORATION OF MEDICINES

Medicines can deteriorate even if their expiry date has not been reached, particularly if they have been stored under conditions (temperature, humidity, and light) that differ from the conditions used during stability testing. Excessive or accelerated deterioration can also occur due to initial quality defects, such as manufacturing issues. Therefore, it is important to understand the normal appearance and characteristics of each medicine (colour, odour, solubility, consistency) in order to detect any signs of deterioration.

Some forms of deterioration may not show visible changes, but physical changes should be closely monitored. Any medicine showing signs of deterioration should be discarded, regardless of the expiry date. If any doubt, contact the pharmacist for advice.

Signs of deterioration:

• For all products: broken or ripped packaging, missing, incomplete or illegible labels.
• Liquids: discolouration, cloudiness (turbidity), sediment or unsuspended agglomerates in solutions, broken seal on bottles, cracks in ampoules, bottles or vials, moisture in packaging.
• Light-sensitive products: torn or damaged packaging
• Tablets: discolouration, crumbled tablets, tablets missing from blister packs, sticky tablets (especially coated tablets), unusual smells..
• Capsules: discolouration, 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 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 the patient safety.

DESTRUCTION OF EXPIRED AND/OR DETERIORATED DRUGS

Check local regulations regarding medical waste management and environmental protection before implementing a disposal method.

Proper disposal is critical, as incorrect disposal can lead to serious negative consequences, including:

• water contamination
• the diversion and illegal resale of expired or inactive medicines
• toxic pollutants being released into the air due to improper incineration.

Particular attention must be given to the disposal of certain categories of pharmaceuticals, including controlled substances (e.g., narcotics and psychotropic drugs), anti-infective drugs, cytotoxic anti-cancer drugs, toxic drugs, aerosols, antiseptics, and disinfectants.

Normally, MSF should obtain authorisation for destruction from the relevant local authorities and ensure that the destruction method adheres to both WHO and MSF guidelines, as these may differ from local guidelines (if any). In specific cases, such as batch recalls, MSF must also obtain a certificate of destruction.

INTRODUCTION

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

Any proposed packaging system must be proven to be suitable for its intended use: it should adequately protect the dosage form (against light, moisture, oxygen, contaminants, etc.); it should be compatible with the dosage form (without adsorption of the active pharmaceutical ingredient, etc.); it should be made from materials considered safe for use with both the dosage form and its route of administration (without migration of potential toxic substances); and it should function as intended (performance features).

Child-resistant closures are designed to make it difficult for young children to open drug packaging while still allowing easy access for adults. The use of child-resistant packaging has been shown to effectively reduce child mortality due to intoxication from oral prescription drugs. The three most common common types of reclosable child-resistant closures are “press–turn”, “squeeze–turn” and a combination lock (WHO TRS 902).

Tamper-evident packaging refers to a system where access is impossible without visible destruction of the seal or some part of the packaging (USP 659) or one that “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, typically liquids in the form of solutions, emulsions, suspensions, or dry solids that must be reconstituted with an appropriate vehicle to obtain a solution or suspension. They are classified as small-volume parenterals (SVPs) if the volume is 100 ml, or less, and as large-volume parenterals (LVPs) if the volume exceeds 100 ml.

SVPs (DINJ family) may be packaged in disposable cartridges, disposable syringes, vials, ampoule, flexible bags, or semi-rigid bottles. Only single-ended ampoules are accepted by MSF.

• Cartridges, syringes, vials, and ampoules are usually made of Type I or II glass or polypropylene. Specific glass types for each pharmaceutical form can be found in the European Pharmacopoeia (EP), British Pharmacopoeia (BP), or United States Pharmacopoeia (USP).
• Stoppers and septa used in cartridges, syringes, and vials are typically made from elastomeric materials. Closures for injectable preparations must meet 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 to maintain the integrity of the seal under normal conditions of transport, handling, and storage during the product's shelf-life. These caps are usually made of aluminium may include a plastic top for easier opening. Caps also provide evidence of tampering.

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

Flexible bags are typically made of multi-layer plastic.

• Cyclo-olefins offer an alternative to PVC or glass; they are flexible and have low permeability.
• Flexible bag ports (for input of medication and output for administration) are made from plastic and/or elastomeric materials. These bags usually include a hanging part to withstand tension during use.
• Depending on the plastic used, IV fluid bags may have a protective pouch/overwrap that protects against solvent loss (which can lead to increased concentration), oxygen ingress, and dust. The over pouch is made from material with low permeability to water and gases.

Semi-rigid plastic bottles are typically made using Blow-Fill-Seal (BFS) technology and come with a sealed top that can be fitted with various types of closures. Some manufacturers offer open-neck bottles fitted with rubber stoppers and a flip-off caps.

• BFS bottles with a nipple head are not appropriate, as the base of the nipple head is fragile and the small cap does not provide adequate protection, leading to potential fatigue points and micro-holes during transport. Additionally, they lack an injection or administration site, requiring the top of the nipple to be pierced by the IV set or the needle. If alternative is available, experts recommend using larger caps for better head protection.
• Euro head caps are acceptable, but present some risks, including contamination of the top before welding if not done in an aseptic environment, and the potential for the space between the bottle top and cap to remain unsterilised due to insufficient penetration of water vapour.
• Newer generation caps have two access ports for the IV set and admixture, typically protected by an aluminium seal or a plastic cover (Twincap^®, Duocap^®).

CONTAINER CLOSURE SYSTEMS FOR OPHTHALMIC PRODUCTS (DEXO)

Ophthalmic preparations are sterile products, avaiable in liquid, semi-solid, or solid forms, specifically designed for application to the eye. These preparartion can be categorized into eye drops, eye lotions, semi-solid eye preparations, and ophthalmic inserts.

Liquid preparations for ophthalmologic use are typically packaged in sterilised single-dose (often preservative-free) or multi-dose containers. Multi-dose products are most commonly packaged in polyethylene (PE) or polypropylene (PP) bottle with an integrated dropper on the neck, sometimes referred to as "droptainers". For some eye drops, glass containers may be used when there are stability or compatibility concerns with flexible plastics. The container must be tamper-evident and contain a maximum of 15 ml of the preparation. Single-dose containers are generally made from . PP manufactured using the Blow-Fill-Seal (BFS) technique. Some preparations may be indicated for both ophthalmic or otic use (e.g., DEXTCIPR1D- : a preparation for eye and/or ear).

Semi-solid eye preparations are packaged in small, collapsible sterilised tubes, with or without an ophthalmic cannula or tip. These tubes are typically made from metal, though ophthalmic ointments that react with metal may be packaged in tubes with an epoxy or vinyl plastic coating inside. The packaging must be tamper-evident and contains no more than 5 g of the preparation³.

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

CONTAINERS FOR TOPICAL PRODUCTS⁴ (DEXT)

Topical dosage forms include aerosols, creams, emulsions, gels, lotions, ointments, pastes, powders, solutions, and suspensions. These forms are typically intended for local (non-systemic) effects and are usually applied to the skin or oral mucosa. Topical products also include ceratin nasal and ear preparations, as well as vaginal and rectal pharmaceuticals.

Semi-solid or liquid preparations are commonly packaged in multi-dose containers, such as jars or collapsible tubes.

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

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

Liquid ear preparations⁵ are supplied in multi-dose containers made from glass or suitable plastics. These containers often have an integrated dropper or a screw cap from appropriate materials, which may incorporate a rubber dropper or plastic teat, sometimes provided separately.

Vaginal and rectal products are usually packaged in aluminium/aluminium strips or blisters, or occasionally 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, such as solutions, syrups, or suspensions, require protection from solvent loss, microbial contamination, and sometimes Exposure to light or reactive gases (e.g., oxygen). These liquid dosage forms can be supplied in either multiple-dose (bottles) or single-dose (sachets) containers.

• Bottles are usually made of glass or plastic (e.g., PET, HDPE), often featuring a screw cap (made of aluminium or polypropylene) with a liner, and may include a tamper-resistant seal or an overcap welded to the bottle.
• Each dose from a multi-dose container is administered using a device suited for measuring the prescribed volume, such as a measuring cup, dosing spoon (for volumes of 5ml or more), oral syringe (for other volumes), or a dropper.
• 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. These products may be supplied in either 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 upon activation of an appropriate valve.
• Liquid preparations for inhalation: Administered using nebulizers, these are usually packaged in a PP (polypropylene) single-dose containers.
• Inhalation powders: Delivered by dry powder inhalers, which are loaded with pre-dispensed powders in capsules or other suitable dosage forms, or with a powder reservoir and a metering mechanism
• Nasal sprays: designaded for nasal administration

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

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.

Essential for harmonizing supplies on the field, the standardization process consists in clearly defining the most suitable equipment and supplies for a given situation, according to the following criteria:

• observance of the policies defined by the MSF medical and logistic directors
• quality and efficiency within the framework of MSF programmes
• easy maintenance and supply of spare parts/consumables
• “international agreement”: validation by all MSF sections
• purchasable by at least one European Supply Centre (ESC)

Therefore, a standard article has gone through a standardization process, supervised by SPINCO and is the best choice for field use.

1. OPEN / CLOSED ARTICLES

Normally, articles are OPEN => “open articles” refer to a GENERIC PRODUCT, which corresponds to a set of technical specifications fulfilling a given function.

This means that all products with the technical specifications as described in the technical sheet are liable to be purchased regardless of their brand. Each MSF section may choose the product to be supplied as long as the required technical specifications are met.

E.g.: Several manufacturers make an external hard disk which meets the technical specifications of the article

EXTERNAL DRIVE, 320 Gb (ADAPMEMOEG3I)

Occasionally , some articles are CLOSED => “closed articles” refer to a SPECIFIC PRODUCT of a certain model and brand.

This means that the article is a particular model of a particular brand, and all MSF centres must supply exactly the same model of the same brand. Closed articles have been selected due to quality and/or safety reasons by international working groups, including technicians of different sections. They are mainly (electrical) apparatuses where maintenance and supply of spare-parts, accessories and consumables are mandatory, and adapted to specific MSF conditions (dust, heat etc.).

E.g.: The article “CONCENTRATOR O2 (DeVilbiss 525KS)” refers only to the 525KS model manufactured by DeVilbiss.

2. KITS AND MODULES

Although every medical response should be specifically planned based on information provided by the exploratory mission and reliable data, a kit containing essential items is nonetheless useful for an emergency. Intended for emergency contexts, the kits are ready to be delivered within a very short timeframe.

A module is a set of articles which is either a part of a kit or the optional complement to a kit.

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.

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).

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.

EN 13795-1: Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns (2019)

General

Surgical drapes, including the intended use as a sterile field, and surgical gowns are used to minimize the spread of infective agents to and from patients’ operating wounds, thereby helping to prevent postoperative wound infections.

The performance required of coverings for patients, clinical staff and equipment varies with, for example, the type and duration of the procedure, the degree of wetness of the operation field, the degree of mechanical stress on the materials and the susceptibility of the patient to infection.

The use of surgical gowns with resistance to the penetration of liquids can also diminish the risk to the operating staff from infective agents carried in blood or body fluids.

Critical – less critical areas

Performance requirements are specified depending on product area and performance level.

Critical product area: area with a greater probability to be involved in the transfer of infective agents to or from the wound, e.g. front and sleeves of surgical gowns. The other areas are called “less critical product area”. EN 13795 does not include provisions for the size and position of critical and less critical areas. The user has to decide whether these are suitable to meet the anticipated challenges of a certain surgical procedure.

The American standard ANSI/AAMI PB70 provides more specifications: the critical zone of a surgical gown shall, at a minimum, comprise the front area of the gown from chest to knees and the sleeves from the cuff to above the elbow.

For drapes the identification of critical product area is not mentioned in the standards, but in literature it is mentioned: “The critical zone is usually the centre of the drape, around any fenestrations or openings. This area is often reinforced with additional fabric, which may be fluid absorbent”

If the manufacturer does not differentiate product areas, all areas shall meet the requirements for critical product areas. If there is such differentiation, the manufacturer must supply the information to allow identification of these areas by the user.

The manufacturer must provide information on the performance level to the user.

Characteristics to be evaluated and performance requirements for surgical gowns & drapes

• The biocompatibility of the product shall be evaluated and approved for acceptable risk
• Information on the flammability of the product and fire risks must be provided by the manufacturer on request.
• testing according to EN 13795: Summary see table below
• CA = critical product area
• LCA = less critical product area
• IB = Barrier index

Microbial penetration - dry:

• determine the ability of dry fabric to resist penetration of particles carrying micro-organisms.
• Measure: CFU = number of colonies formed after incubation
• Result: only required for the less critical areas: ≤ 300

Microbial penetration – wet

• Determine a fabric’s resistance to penetration of bacteria in liquid while being subjected to mechanical rubbing
• Measure: number of colonies formed after incubation, expressed in barrier index (BI) 6,0 = no penetration (maximum achievable value)
• Result: only required for the critical areas: ≥ 2.8 (standard performance) or ≥ 6.0 (high performance)

Cleanliness microbial / bioburden

• Estimate the bioburden or number of viable micro-organisms on the fabric prior to sterilization.
• Measure: CFU = number of colonies formed / dm²
• Result : ≤ 300 / dm² for all areas, gowns & drapes (based on the experience of manufacturers and what is routinely available)

Particle release

• = release of fiber fragments and other particles during mechanical stress simulating handling and use. Estimate linting of the fabric in a dry state. Particle release is a concern during surgery: foreign body contamination can cause an increased frequency of postoperative complications. An indirect effect is also observed: fibres and particles can deposit on surfaces in the operating room providing a potential vector for microorganisms to be carried into wounds. Particles smaller than 3µm are too small to carry microorganisms and particles larger than 25µm are too large to remain airborne because of gravity.
• Measure: number of particles 3 – 25 µm generated after twisting ad compressing, expressed as log10 of the count value.
• Result: ≤ 4 for all areas, gowns & drapes

Liquid penetration

• = hydrostatic head test: estimate the resistance of fabrics to liquid penetration by water under constantly increasing hydrostatic pressure
• Measure: the head height results are recorded in centimetres of water pressure on the fabric sample.
• Result:
• less critical areas: ≥ 10 cm H₂O
• critical area standard performance: gowns: ≥ 20 cm H₂O, drapes: ≥ 30 cm H₂O
• critical area high performance: ≥ 100 cm H₂O for gowns & drapes

Bursting strength - dry / wet

• Determine the resistance of a fabric to puncture under dry & wet conditions
• Measure: strength at burst, in kPa
• Results: gowns & drapes: ≥ 40 kPa, not required for the less critical area in wet state

Tensile strength - dry / wet

• Determine the ability of a product to withstand fabric tearing under dry and wet conditions
• Measure: amount of force applied to break the strip, in Newton
• Results (not required for the wet less critical areas)
• gowns: ≥ 20 N
• drapes: ≥ 15 N (standard performance) or ≥ 20 N (high performance)

Guidance for selecting products

Comfort is based on several factors: thermal resistance, air permeability, drapeability, stretchability, weight, size, fit, tactile comfort (softness = highly dependent on fibre smoothness and finish technologies), fibres and manufacture. Discomfort properties such as rustling tendency and skin irritation are difficult to measure.

The standard does not provide further essential requirements regarding flammability. However, manufacturers are required to supply information regarding fire risks in relation to the use of their products.

Specific tests for electrostatic discharge (ESD) re not required as no reports were made of patient safety incidents related to ESD.

EN 13795 does not specify requirements for the functional design of surgical gowns & drapes.

The products should be tested practically in clinical situations where the end-user is going to apply them, to ensure that they are suitable from all important aspects including functionality and comfort. The practical trials should be evaluated before choice of products.

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

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.

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

• Safety measures: ensure that safety equipment, protocols, and instructions are available in all areas where cytotoxic drugs are stored, handled, prepared, administered and disposed of.
• Minimise handling and movement of cytotoxic drugs from reception to preparation.
• Medicines should remain in their original secondary or tertiary packaging (sealed plastic bag and/or cartons), as the outside of many commercial vials may be contaminated, presenting an exposure risk to anyone handling them.
• Cytotoxic vials are usually well-packaged by pharmaceutical companies, so no specific Personal Protective Equipment (PPE) is required for staff transporting cytotoxic agents, as long as the original packaging is intact and there are no signs of damage or leakage.
• For vials that have not 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 handling the product, wearing gloves is advisable when handling cytotoxic agents.
• Centralise the preparation of cytotoxic agents:A
• 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 with a 60ml Luer syringe (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 according to the manufacturer's specific requirements. Be aware that storage conditions may vary between from manufacturers for the same.
• Store cytotoxic drugs centrally in the main pharmacy, avoid storing them in the preparation room.
• Cytotoxic drugs should NOT be stored near or on top of other medicines or medical equipment. They must be stored securely to minimise the risk of breakage and contain any spillage. Ensure clear, visible labelling for easy identification.
• The best storage option is a closed cupboard. Lower shelves mat be used as an alternative, but the storage area should limit the risk of contamination or exposure.
• Labelling and storage directions:
• Mark boxes with arrows on the outside to indicate the box proper storage orientation (to prevent the box from being turned upside down).
• Apply a "hazardous" sticker to the box.
• Ensure that all labels are clear and understandable for all staff involved in handling of the cytotoxic products.
• Reception: visually inspect cytotoxic drugs upon receipt to check for any damage or leakage during transport. In damage or leakage is detected, appropriate PPE should be worn, and proper actions must be taken immediately.

CYTOTOXIC SPILL KIT

A Cytotoxic Spill Kit must be available in all areas where cytotoxic substances are used. All staff 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 covers (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 such as cotton rolls, compresses, toilet paper, or kitchen paper. Enough to absorb up to 1 litre.
• Absorbent towel with a 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 bags.
• Instruction card for safely mopping up spills on surfaces.
• Instruction card for wearing / removing PPE.

Remark on gloves

All gloves have some degree of permeability to cytotoxic drugs, and 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 specifications:

• Gloves should be made from materials that minimise drug permeability, such as nitrile, polyurethane, or neoprene.
• Gloves must be powder-free, as powder can absorb contaminants, increasing the risk of aerosolization and contact contamination
• Gloves should be long enough to cover the gown sleeves when the wearer's arm is fully extended

SPILL MANAGEMENT

A system must be in place to promptly report spills or contamination of staff. The incident report should include the following information:

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

PROCEDURE FOR LARGE SPILLS

• Alert and notify:
• Alert people in the immediate vicinity that a hazardous spill has occurred and direct them to stay clear.
• Request assistance from an additional person to provide materials, read the instruction cards, and handle the waste bag.
• Secure the area:
• Cordon off the spill area and, if possible, close windows and doors to contain the spill.
• Turn off any fans or ventilation system that may spread the spill or aerosolised particles.
• Open the Cytotoxic Spill Kit and display hazard signs around the perimeter of the spill area.
• Don PPE in the following order:
• respiratory protection
• goggles
• cap
• first pair of gloves
• gown
• overshoes
• second pair of gloves
• the assistant should also wear two pairs of gloves, goggles, and respiratory protection
• Contain the spill:
• For a liquid spill: cover the spill with an absorbent waterproof plastic-lined towel.
• For a powder spill: cover the spill with absorbent towels to minimise dust production. Carefully wet the towel with water (without flooding the pill), allowing the powder to dissolve and be absorbed by the towel.
• Collect and dispose of the spill:
• Use the scoop and scraper to gather the absorbed material and any broken glass.
• Discard the collected cleaning materials into the first 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.
• Clean the area:
• Wash the area several times with water and detergent, rinsing thoroughly each time with water. Always work from the outside of the spill toward the centre.
• Remove PPE in the following order:
• outer gloves
• overshoes
• gown
• goggles
• cap
• respiratory protection
• inner gloves
• place used disposable items into the secondplastic bag.
• place the protective glasses into the third 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 into the "biohazard" bag.
• Wash hands with soap and water.
• Wash goggles in hot, soapy water while wearing non-sterile gloves, then dry 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 the transport and disposal of the biohazard bag.
• Ensure the Cytotoxic Spill Kit is replaced and fully stocked for future use.

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

• If not already done, don the appropriate PPE as described above.
• Immediately cover the affected area with absorbent material.
• If the spill involves a powder, gently cover with it an absorbent towel to minimise dust production. Wet the towel to dissolve the powder and allow it to absorbed by the towel.
• Carefully collect the absorbed material, making sure to use forceps to pick up any broken glass.
• Discard the collected waste into the appropriate waste bin (solid container dedicated to cytotoxic waste, such as vials, needles etc.).
• Wash the affected area with water and detergent, then rinse thoroughly several times with water.
• Dry the cleaned area using absorbent towels or cloths.
• Discard the waste into the cytotoxic waste bin.
• Remove and dispose of gloves safely, then replace them with clean ones.

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 due to the small vial size. If respiratory symptoms occur, move the victim away from the source into fresh air.
• Skin exposure:
• If splashes, drops, or contaminated surface come into contact with healthy skin or a wound, irritation, allergic reaction, itching, burning, and skin lesions (particularly with vincristine) may occur.
• Remove any contaminated clothing or shoes immediately.
• Flush the affected area with a large volume of water for 10-20 minutes, then wash thoroughly with soap and rinse with running water.
• If the skin is damaged, apply a clean dressing.
• Eye 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 (unlikely via splashes, contaminated food, drink, or hand-to-mouth contact).
• Do not induce vomiting.
• Clothing contamination:
• 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.

Everytime a respirator is put on, PERFORM A SEAL CHECK

Stand in front of a mirror and fully open the respirator

STEP 1: Cup the respirator in your hand with the nosepiece at your fingertips

STEP 2: Position the respirator under your chin with the nosepiece up in order to cover the chin, the mouth and the nose

STEP 3: Pull the top strap over your head resting it high at the back of your head. Pull the bottom strap over your head and position it around the neck below the ears

STEP 4: Mould the nosepiece (using two fingers of each hand), to the shape of your nose

STEP 5: Cover the respirator with both hands, being careful not to disturb the position of the respirator

• Inhale deeply in order to create an air vacuum: if the seal is good, the respirator will cling to your face
• Exhale sharply: if the seal is good, the respirator will slightly expand
• Inhale and exhale several times: no leakage of air between the face and the respirator may be detected

If problems are met (the respirator does not collapse neither expand or if air leak is detected), adjust the respirator and retest the seal. In case the problems persist, replace the respirator and/or try another model or size. Once the respirator is correctly fitted, don't manipulate it any longer.

Protection is vital to ensure safety and performance in challenging conditions, and understanding NIJ ballistic levels is essential for choosing the most appropriate ballistic levels of protection for your application.

The NIJ provides five armor protection level classifications — IIA, II, IIIA, III and IV. The “A” in some levels refers to the fact that the vest offers more protection than the level before but cannot meet the standard of the next level, so it’s generally a half-step up. Although there is an armor level one, it’s now outdated and no longer approved by the NIJ because of its weak resistance level.

Soft body armor is typically level IIIA and below, while hard body armor and ballistic protection equipment are generally level III and up with body armor plates included. Each of the five armor levels has distinct advantages against different types of ammunition:

• Level IIA: This soft body armor is light and undetectable. The wearer is protected from 9mm and .40 Smith & Wesson bullets.
• Level II: Level II is still easy to conceal and light yet offers greater protection than level IIA. It’s designed to protect the wearer from 9mm and .357 magnum ammunition from short-barrel handguns.
• Level IIIA: Level IIIA is soft for easy flexibility but offers excellent protection against .357 SIG and .44 Magnum ammunition from longer-barrel handguns.
• Level III: This hard body armor uses metal plates or other composite materials to withstand rifle rounds. The NIJ tests this armor to withstand 7.62mm FMJ lead core rifle ammunition.
• Level IV: Level IV is the most powerful body armor available. It’s designed specifically for military applications and can withstand .30cal steel core armor-piercing rifle ammunition.
  NIJ standard levels

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

The U.S. Food and Drug Administration (FDA) is concerned by the increasing number of adverse events associated with surgical staplers and staples for internal use.

The FDA believes that many of the problems identified in these reports can be primarily attributed to surgical staplers for internal use because proper staple formation is largely contingent on proper function and use of the stapler. Some of the most commonly reported problems in these adverse event reports include:

• opening of the staple line
• malformation of staples
• misfiring
• difficulty in firing
• failure of the stapler to fire the staple
• misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue).

Stapler and/or staple malfunctions or misuse may result in prolonged surgical procedures or unplanned, additional surgical interventions, which may lead to other complications, such as:

• bleeding
• sepsis
• fistula formation
• tearing of internal tissues and organs
• increased risk of cancer recurrence
• death.

Recommendations

• Read and carefully follow the stapler manufacturer’s instructions for use.
• Have a range of staple sizes available and select the appropriate size cartridge for the tissue type and thickness.
• If you have difficulty squeezing the handle of the stapler, you may need to select a different size staple.
• Avoid using the stapler on tissue that is too thick or too thin for the selected staple size, as this could result in staple malformation.
• Be aware that different companies may use different colour schemes on the cartridges to indicate different staple sizes.
• Consider other options if the patient’s tissue is edematous, friable (tissue that readily tears, fragments, or bleeds when gently palpated or manipulated), or necrotic, as the staples may be less likely to securely approximate tissue.
• Be familiar with the structures around the intended staple site.
• Check that unintended structures, such as urinary bladder, or foreign objects, such as clips, are not in the staple line.
• Avoid using on large blood vessels, such as the aorta.
• Avoid clamping the stapler on delicate tissue, as clamping can still cause injury even if no staples are fired.
• If a malfunction of the stapler occurs while applying staples across a blood vessel, then clamp or ligate the vessel before releasing the stapler, while the stapler is still closed on the tissue.
• Check to ensure that the staples are compatible with the stapler.
• Be aware that there is a risk of increased leak rates when staple lines are crossed, even if there may be clinical circumstances when it is clinically necessary or appropriate to do so.

CATEGORIES OF THERMOSENSITIVITY

Vaccines as well as most drugs and diagnostic products are very sensitive products (light and temperature). Exposure to heat and / or freezing can have a negative impact on the quality, safety and efficacy

In 2020 the Thermosensitive Classification Codes changed. The previous codes *0(F), *A(F), *B(F), *C(F)… represented a mixture of temperature storage requirements and excursion management thresholds. 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.

The new thermosensitive codes are defined for storage and transport temperature requirements only. They are aligned with general (or targeted) storage facilities in the field (freezers, fridges, pharmacies, medical warehouses or transport vehicles) and their targeted temperature ranges. A wider application of temperature sensitivity codes for medical devices and therapeutic food will bring more clarity for the field in terms of (additional) storage needs from a quality perspective.

In the medical catalogues and ordering tools, all thermosensitive 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.

In any case, IT IS ALWAYS CRUCIAL TO RESPECT THE STORAGE INDICATIONS REQUIRED BY THE MANUFACTURER (stated on the packaging or on the leaflet).

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 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 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 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)

DEFINITIONS

See Cold Chain Management guideline, MSF, 2022

• Cold Chain: 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)

• Active Cold Chain: includes all devices that require electricity to produce and maintain the cold. This kind of equipment is mainly used for medical item storage or icepack production. Examples include fridges, freezers, cold rooms.

• Passive Cold Chain: includes the equipment which, in order to maintain the cold, does not require electricity, however requires pre-conditioned ice-packs. Examples include isothermal/cold boxes, vaccine carriers

• 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).
• 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).
• 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.)
• Cold Chain Breakdown: 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.)

TEMPERATURE MONITORING DEVICES

Thermosensitive items require continuous temperature monitoring throughout their lifecycle using standard articles included in the PCOL catalogue such as:

• Alcohol thermometer
• Freezing Indicator ( FreezeTag®)
• Historical Data Logger (LogTag®)
• Remote monitoring and Alerts (BluLog®)

Refer to the OC Specific guidance and protocols for more information regarding their usage and configuration.

COLD CHAIN STORAGE AND TRANSPORTATION EQUIPMENT

MSF supplies mainly equipment pre-qualified by WHO (PQS). Consult your Technical Department before ordering cold chain equipment as an incorrect choice may result in substantial losses of vaccines/medicines/rapid diagnostic tests, delays in the program, or worse, in the use of ineffective products.
Maintenance is important for all equipment and should be carried out regularly to keep the equipment in good condition. Details of these tasks can be found in technical documentation and guidelines.

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. This category contains:

• Ice Lined Refrigerators
• Freezers: used for ice pack production or F-20 item storage.
• Cold rooms

The passive cold chain category includes the equipment which, in order to maintain the cold, requires pre-conditioned ice-packs. This category contains:

• Isothermal/cold boxes
• Vaccine’s carriers.
• Icepacks

The choice of PCOL equipment is determined by: vaccine storage capacity needed, the cold life needed, weight and volume of the box (depends of mode of transport) and number of ice-packs needed. Refer to PCOL family in the logistic catalogue for manufacturer specification and item details.

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).

IN CASE OF COLD CHAIN BREAKDOWN

Follow your MSF section specific cold chain protocol. In general take following steps:
dentify the product clearly and keep it separate in a refrigerator (between 2ºC and 8ºC).

• Keep the temperature recorder as evidence after stopping the recording.
• Contact your OC or Supply Centre focal point to find out what action to take.
• Information to be given:
• Product: name, code, batch number, expiry date
• Temperatures: temperature ranges, duration of exposure, temperature monitor readings.
  

GENERAL RECOMMENDATIONS FOR TEMPERATURE-SENSITIVE PRODUCTS

• Pay attention that storage and transportation conditions complies to the IFU of the manufacturer.
• Prevent the risk of cold chain item freezing by following ice pack conditioning procedures.
• Implement a cold chain contingency plan and provide continuous training per OC recommendations.
• Keep all vaccines in their original packaging during storage as this is printed with the expiry dates and batch numbers and protects the vaccine from light and damage.
• Diluents should be at the same temperature as the vaccines (between 2º C and 8º C) at the time of reconstitution. It is not necessary to store them in the refrigerator, but the required quantity of diluent should be placed in the refrigerator or in some cool box 24 hours before use. Diluents must never be frozen. Only the specific diluent recommended for the vaccine can be used. Replacement diluents can be ordered using the specific diluent code mentioned in MSF catalogue and specifying the manufacturer required.
• Do not store food, drinks or biological samples in medical refrigerators or freezers.

The regulations concerning Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVDMD) are intended to protect the patient, the user or any other person against the risks associated with their design, manufacture, packaging and use. Such regulations differ across countries, but all use a risk-based approach.
MSF purchases medical devices mainly from the European Union and from the United States.

DEFINITIONS

The following definitions are taken from the EU legislation, but the ones of the US Food and Drug Administration (US FDA) are not significantly different.

Medical Devices according to the MDR 2017/745

‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
• providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The following products shall also be deemed to be medical devices:

• devices for the control or support of conception;
• products specifically intended for the cleaning, disinfection or sterilisation of devices.

‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s)

‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.

‘active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Software shall also be deemed to be an active device.
‘implantable device’ means any device, including those that are partially or wholly absorbed, by clinical intervention and which is intended to remain in place after the procedure (for at least 30 days).

‘invasive device’ means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.

‘single-use device’ means a device that is intended to be used on one individual during a single procedure

In Vitro Diagnostic Medical Devices according to the IVDR 2017/746

‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:

• concerning a physiological or pathological process or state;
• concerning congenital physical or mental impairments;
• concerning the predisposition to a medical condition or a disease;
• to determine the safety and compatibility with potential recipients;
• to predict treatment response or reactions;
• to define or monitoring therapeutic measures.

Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices.

‘specimen receptacle’ means a device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

‘accessory for an in vitro diagnostic medical device’ means an article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s).

‘device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services.

‘device for near-patient testing’ means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional.

Products for general laboratory use are not in vitro diagnostic medical devices, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examinations.

REGULATORY PATHWAY

The market authorization systems for medical devices in the US and EU are different but the basic concept of the legislation is similar. In both systems, the effort to obtain market authorization increases with the perceived risk of a device.

Safety and performance of MDs are assessed through a balance of pre-market scrutiny, adequate manufacturer quality management systems, and the implementation of effective post-market surveillance. The assessment body typically follows rules for this evaluation (in the form of laws, regulations, guidance, standards from internationally recognized organizations, or other documents) that address the specific information that is needed for a given product, typically based on the risk that the product poses to the end-users and/or patient. It then assesses the documentation to determine if it conforms to the rule or standards it follows. This activity is sometimes referred to as conformity assessment.

A common framework for medical device regulations

LEGISLATION

In the EU

The Medical Devices Directive (MDD) 93/42/EEC and the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC were introduced in early 1992. These directives were repealed by the Medical Devices Regulation (MDR) 2017/745, formally published in May 2017.
Directive 98/79/EC constitutes the Union regulatory framework for in vitro diagnostic medical devices. However, a fundamental revision of that Directive was needed to bring EU legislation into line with technical advances, changes in medical science and progress in law-making. It was repealed in April 2017 by the IVD Regulation 2017/746.

The transition periods Directive to Regulation were 3 years for the medical devices and 5 years for the IVD, starting from May 2017, but the Covid pandemic slowed down these transitions.

According to the applicable Directive / Regulation, a manufacturer must, prior to marketing its MD/IVD, fulfill four requirements:

• Assign the MD/IVD to a category of products (see Classification chapter below).
• Ensure that the MD/IVD meets defined “Essential Requirements”
• Follow the conformity assessment procedure corresponding to the type of device.
• Depending on the category of the device, ensure that an independent certification body, called a “Notified Body,” is involved in the conformity assessment procedure.

Notified bodies:

A Notified Body is an organization designated by an EU country to assess the conformity of certain products before they are placed on the market. These bodies perform tasks related to conformity assessment procedures defined in the applicable legislation, where a third party is required.
The MDR strengthens the rules for the surveillance of Notified Bodies.
The authorities responsible for Notified Bodies must reassess their compliance with the requirements of the new European Medical Device Regulation (MDR) at least once a year. They must carry out a full reassessment three years after the first notification and then every four years.
The MDR strengthens the position of Notified Bodies vis-à-vis manufacturers by introducing the obligation to perform unannounced on-site audits and to perform physical or laboratory testing of devices to ensure continued compliance.
Notified Bodies:

• Are free to offer their conformity assessment services to any economic operator inside or outside the EU
• Must operate in a non-discriminatory, transparent, neutral, independent, and impartial manner
• Must employ the necessary personnel, with sufficient knowledge and experience to carry out the conformity assessment in accordance with the law(s) in question
• Must make adequate arrangements to ensure the confidentiality of the information obtained in the course of conformity assessment
• Must provide information to their notifying authority, the market surveillance authorities, and other notified bodies.

Manufacturers are free to choose any notified body that has been legally designated to carry out the conformity assessment procedure.
The competence of the notified body should be subject to verification carried out at regular intervals and following the practice established by the accreditation organisations.
Lists of Notified Bodies can be found on the NANDO website (New Approach Notified and Designated Organisations). The lists include the identification number of each notified body and the tasks for which it has been notified.

CE marking

The CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. It is mandatory to be affixed on a medical device before being placed on the European market, but this does not necessarily mean that the MD is marketed in the EU. Sometimes manufacturers get a CE marking in order to facilitate the registration of their product(s) on other non-EU markets (e.g. Africa or Middle-East).

• If the CE marking is reduced or enlarged the proportions given in the graduated drawing must be respected.
• The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm;
• The C and E are not formed by perfect semi-circles, i.e. the top and bottom arms extend one square beyond the semi-circles, and the middle arm of the E stops one square short.

Registration of medical devices

The European legislation does not require registration of the medical devices with the each European authority, except for class I medical devices, custom-made and kits (procedure packs) and IVD. For this type of products, the manufacturers or their European representatives have to register the products in the countries where they have the registered offices. Few other European Authorities require class II and III medical devices be registered as well before being placed on the local market. This is the case with France, Italy, Germany, Portugal, Latvia, and Bulgaria.

Eudamed – European Databank on Medical Devices

Eudamed is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in-vitro diagnostic medical devices.

Eudamed will include 6 interconnected modules, they will become available on a gradual basis as soon as they are functional. It is envisaged that all the modules Eudamed and the audit of the system will be completed before Q1 2023

• Actor registration (voluntary module now available)
• UDI/device registration (voluntary module now available)
• Notified bodies and certificates (voluntary module now available)
• Clinical investigations and performance studies (Q4 2022)
• Vigilance and post-market surveillance (Q4 2022)
• Market surveillance (Q4 May 2022)

In the US

The US FDA allows for two regulatory pathways that allow the marketing of medical devices.
The first and by far the most common is the so-called 510(k) process. A new medical device that can be demonstrated to be “substantially equivalent” to a previously legally marketed device can be “cleared” by the FDA for marketing as long as the general and special controls, as described below, are met. The vast majority of new medical devices (99%) enter the marketplace via this process. The 510(k) pathway rarely requires clinical trials.
The second regulatory pathway for new medical devices is the Premarket Approval process, which is similar to the pathway for a new drug approval. Typically, clinical trials are required for this premarket approval pathway.
The FDA may also issue export certificates for unapproved products in the United States, but manufactured within their territory, which have therefore no quality value.

Main differences

• In the USA, the market authorization is granted by a governmental agency, whereas in Europe this responsibility has been delegated to designated third-party companies, so called Notified Bodies.
• The large variation in time to the market in Europe and the USA, mainly for the highest risk devices, appears to be due to the stricter requirement to perform more elaborate clinical studies for medical devices going through the PreMarket Approval (PMA) procedure in the USA.
• There is no explicit requirement for post market surveillance in the USA legislation, although the FDA can require this for specific devices.
• The essential requirements for products are well described in the EU legislation, whereas this is less clear in the USA.
• The FDA makes most information on medical devices, related to market authorization and post-market activities publicly available, whereas such transparency does not exist in Europe.

Mutual recognition

The CE mark has no official status in the USA and an FDA-approved device has no official status in Europe.
Mutual Recognition Agreements are in place between Australia and the European Union, Memoranda of Understanding with both Canada and Switzerland, and other agreements with countries such as Japan, China, and Malaysia. FDA and regulatory agencies in Australia, Brazil, Canada, and Japan put in place the Medical Device Single Audit Program (MDSAP) with the goal to develop a process that allows a single audit to ensure the medical device regulatory requirements for all five countries are satisfied. The FDA will accept MDSAP audits as a substitute for routine FDA inspections, typically done every two years for all classes of medical devices and including in vitro diagnostic devices.

CLASSIFICATION OF MEDICAL DEVICES

In the EU

In Europe, medical devices are assigned to one of four regulatory classes: Class I (with subclasses sterile, and measuring function), IIa, IIb and III. The classification of a device is governed by classification rules, described in the MDD or MDR.
There are rules for medical device classification based on factors such as:

• Intended use of the device: means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials (not the particular technical characteristics of the device, not the accidental use of the device, not the class assigned to other similar products)
• Device’s duration of contact with the patient for normal use:
• Continuous: uninterrupted
• Transient: less than 60 minutes
• Short term: not more than 30 days
• Long term: more than 30 days.
• Degree of invasiveness: Invasive device = a device which, in whole or in part, penetrates inside the body, either through a body orifice (any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma) or through the surface of the body.
• Surgically invasive device: an invasive device which penetrates inside the body through the surface of the body, with the aid of or in the context of a surgical operation. A surgically invasive device always implies that it enters through an artificially created opening. This can be a large opening, such as a surgical incision, or it can be a pinprick opening created by a needle
• Part of body contacted by the device: higher classes are attributed to devices directly in contact with the heart or central nervous system or certain parts of the circulatory system.
• If a given device can be classified according to several rules, then the highest possible class applies
• If the device is not intended to be used solely or principally in a specific part of the body, it must be considered and classified on the basis of the most critical specified use.

Classification remains essentially the same under the MDR.

• Rule 6 keeps the reusable surgical instruments in Class I but at the same time involvement of a NB is required: Class Ir.
• Surgical meshes are Class III
• New rule for classification of software: they can fall under any risk class, Class I is the exception
• Rule 20 places devices intended for inhalation of medicinal substances in risk Classes IIa or IIb
• Rule 22 places active therapeutic devices with an integrated diagnostic function, which provides data on patient management in Class III (e.g., automated external defibrillators).

In the US

Under the Food, Drug, and Cosmetic Act, the U.S. Food and Drug Administration (USFDA) recognizes three classes of medical devices, based on the level of control necessary to assure safety and effectiveness. The classification procedures are described in the Code of Federal Regulations, Title 21, part 860 (usually known as 21 CFR 860).
In the USA legislation, no explicit rules about the classification could be identified. Device types and specific devices have been assigned by the FDA to one of these three risk classes. FDA has organized 18 medical specialty panels, in which over 1700 distinct types of devices are described. For each of these type of devices, a general description including intended use, the class to which the device belongs and information about marketing requirements are specified. For a completely new device, the risk class cannot be established from these lists and the FDA will have to be contacted to establish the risk class.

• Class I: Devices not purported to be for a use, which is of substantial importance in supporting, sustaining or preventing impairment of human life or health, and the devices do not present a potential unreasonable risk of illness or injury.
• Class II: Devices for which it is necessary to establish a performance standard, in order to provide reasonable assurance of safety and effectiveness.
• Class III: Devices for which insufficient information is available to establish a performance standard. The devices are purported to be for a use which is of substantial importance in supporting, sustaining or preventing impairment of human life or health, or the devices present a potential unreasonable risk of illness or injury.

CLASSIFICATION OF IVDs

In regards to the classification of in-vitro medical devices, the Directive 98/79/EC groups IVDs into four categories according to the perceived risk associated with the relative danger to public health and/or patient treatment by an IVD failing to perform as intended.

1. List A: for determining the blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell or for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D
2. List B: device for self-diagnosis: for the measurement of blood sugar
3. IVDs for self-testing: Pregnancy RDT
4. General IVDs: (Non A / non B): any IVD not identified in Annex II List A or List B or for self-testing

• Tropical diseases: Malaria RDT, Cholera RDT, Cryptococcus RDT, Leishmaniasis RDT, Dengue RDT, Meningitis RDT, Trypanosoma RDT
• Non tropical disease: Syphilis RDT, Rotavirus test, Adenovirus test, Biochemistry Urine strips

In the new classification system, IVDs will be divided into four classes of risk: A (lowest risk), B, C and D (highest risk).

Class Risk level Examples

Under the current IVD directive 10-15% IVD’s require Notified Body assessment but under the new Regulation 85-90% will require Notified Body assessment.
FDA classifies IVD products into Class I, II, or III according to the level of regulatory control that is necessary to assure safety and effectiveness. The classification of an IVD (or other medical device) determines the appropriate premarket process.

QUALITY MANAGEMENT SYSTEM (QMS) FOR MEDICAL MATERIAL

Harmonized standard

European Directives & Regulations related to medical devices set out the “essential requirements” which must be met by the manufacturers in order to have the authorization to affix the CE marking.

The technical specifications to be complied with in order to meet the essential requirements of a directive are referred to as “harmonised standards”. Compliance with harmonised standards applicable to medical devices will provide a presumption of conformity with the essential requirements of the above-mentioned Directives.

US FDA published guidance for industry on the recognition and use of national and international consensus standards
Some standards are transversal or horizontal and cover many categories of medical devices such as EN ISO 10993 series on Biological evaluation of medical devices or EN ISO 11607 series on Packaging for terminally sterilized medical devices. Others are specific to a type of product called vertical standards such as EN ISO 4074 on Natural latex rubber condoms - Requirements and test methods or EN 455-1 on Medical gloves for single use.

ISO standards

ISO, the International Organization for Standardization develops and publishes International Standards: documents that provide requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose. Regulators and governments count on ISO standards to help develop better regulation, knowing they have a sound basis.

ISO 13485 – Medical devices Quality management systems: is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It is designed to be used by organizations throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services.

ISO 13485:2016 responds to the latest QMS practices, reflecting the evolution in medical device technology and changes in regulatory requirements and expectations. This ensures that the standard remains compatible with other management system standards, including the new edition of ISO 9001.

Standards used in the US

All medical device manufacturers supplying medical devices to the U.S. are required to maintain a quality management system in compliance with the Code of Federal Regulations (CFR) Title 21, otherwise known as 21 CFR 820. The quality management system requirements cover a broad range of areas, including production and process controls, corrective and preventive actions, product development and management.

ASTM International, formerly known as American Society for Testing and Materials, is an international standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. ASTM International has no role in requiring or enforcing compliance with its standards. In the United States, ASTM standards have been adopted, by incorporation or by reference, in many federal, state, and municipal government regulations. The National Technology Transfer and Advancement Act, passed in 1995, requires the federal government to use privately developed consensus standards whenever possible. The Act reflects what had long been recommended as best practice within the federal government.

The U.S. Pharmacopeial Convention (USP) is a scientific, nonprofit organization that sets standards for the identity, strength, purity, and quality of food ingredients, medicines, medical materials and dietary supplements manufactured, distributed and consumed worldwide. Their standards are enforceable in the United States by the Food and Drug Administration (FDA), and they are also used in more than 140 countries.

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.

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

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

The International System of Units is known by the international abbreviation SI in all languages. The SI comprises a coherent system of units of measurement starting with seven base units, which are the second (symbol s, the unit of time), metre (m, length), kilogram (kg, mass), ampere (A, electric current), kelvin (K, thermodynamic temperature), mole (mol, amount of substance), and candela (cd, luminous intensity).

ABBREVIATIONS OF UNITS OF MEASUREMENT

Abbreviations for most units of measurements use small letters and periods.

Temperature abbreviations use capitals because they come from proper nouns.

CONVERSION FACTORS

Distances

Temperature

The Kelvin scale is an absolute thermodynamic temperature scale using as its null point absolute zero, the temperature at which all thermal motion ceases in the classical description of thermodynamics. The Kelvin is the base unit of temperature in the International System of Units.

Pressure

Pressure is the amount of force applied perpendicular to the surface of an object per unit area. The SI unit for pressure is the pascal (Pa), equal to one newton per square metre. In the English system, pressure is usually expressed in pounds per square inch (psi).The torr (symbol: Torr) is a unit of pressure based on an absolute scale, defined as exactly 1/760 of a standard atmosphere.
1 bar = 1 atm = 1 kg/cm² = 100 kPa = 14.5 psi = 750 Torr

UNITS OF MEASUREMENTS FOR INJECTION SUPPLIES

Simply gauge, G or GA generally refers to Birmingham gauge or British gauge Calibre, where an increasing gauge corresponds to a smaller diameter needle.
The Birmingham gauge is a wire gauge system, and is also used to specify the outside diameter of hypodermic needles, catheters, cannulae and suture wires. Birmingham gauge is often simply termed Gauge, with the abbreviation G. Smaller gauge numbers indicate larger outer diameters. Inner diameter depends on both gauge and wall thickness.
The gauge starts at the lowest gauge number 5 corresponding to the largest size of 12.7mm. The highest gauge number 36 corresponds to the smallest size of 0.102mm. Size steps between gauges range from 0.025 mm between high gauge numbers to 1.17 mm between the two lowest gauge numbers and do not correspond to a particular mathematical pattern, although for the most part the steps get smaller with increasing gauge number.
Note: The gauge/mm correspondence may vary, due to figures being rounded off in conversion from inches to mm

Sizes of hypodermic needles

UNITS OF MEASUREMENT FOR CATHETER SUPPLIES

The French scale or French gauge system is commonly used to measure the outer diameter of a catheter. It is most often abbreviated as Fr, but can often be seen abbreviated as Fg, FR or F. It may also be abbreviated as CH or Ch (for Charrière, its inventor).

• A round catheter of 1 French has an external diameter of 1⁄3 mm,
• D (mm) = Fr / 3 or Fr = D (mm) x 3
• An increasing French size corresponds to a larger external diameter.

DEFINIITION

Shelf life is the term or period during which a commodity remains suitable for the intended use. ”Shelf life” refers to the durability under specified storage and transport conditions defined by the manufacturer until the immediate packaging is opened for the first time.

An expiry date (“use-by” date) is the termination of shelf life, after which a percentage of the commodity, e.g., medical devices, may no longer function as intended.

To determine if a particular device requires an expiry date, there are a number of different parameters that must be considered. The device must be analyzed to determine if

• it is susceptible to degradation that would lead to functional failure
• the level of risk that the failure would resent

For some devices, e.g., tongue depressors, it is not reasonable to assign a shelf life because of the small likelihood of time-dependent product degradation and the lack of serious consequences if it did fail to perform as designed. For devices intended to treat life-threatening conditions, the failure rate should approach zero within the labeled shelf life.

SHELF LIFE TESTING OF DEVICES AND PACKAGING

For CE marking of Medical Devices, as a part of the Technical File, manufacturers need to define the shelf life of their device, which is also mandatory as a component of Risk assessment. Shelf life refers to the durability under specified storage and transport conditions defined by the manufacturer until the immediate packaging is opened for the first time.

Essential requirements are set forth in the MDR and in the ISO 13485

Based on the type of the device, chemical, physical, microbiological, toxicological, technological as well as packaging aspects have to be considered while determining the shelf life of a product. This also applies to the storage and climatic conditions: compliance to the climate zones of the target markets have to be taken into consideration also. In case of Active medical devices the lifetime of the device is calculated by a compiled calculation of all the critical components of the device.

Testing should be conducted on a minimum of three to four batches to eliminate the variability related to the raw material and production processes. Also the intervals between tests conducted need to be risk based and has to be distributed throughout the shelf life of the product.

• Product testing: ease of assembly, simulated use and ease of use, dose accuracy, tamper evidence, visual inspections, dimensions, connection compatibility
• Packaging testing: ISO 11607 package validation, integrity, seal strength, sterile barrier system, transport simulation

The shelf life can be determined by either a real time or an accelerated ageing test where Arrhenius Law is applied in a simulated environment.

EXPIRY OF MD WITH LIMITED SHELF LIFE

Sterile medical devices (ex: injection supplies)

A sterile item with a passed expiry date cannot be considered as sterile anymore and must be eliminated. If the expiry date only mentions the month and the year, it is the end of the month which has to be considered the use-by date. The evolution with time of the constituent materials of medical/surgical equipment can only be determined by the manufacturer who knows exactly its composition.

The period of validity only applies if transport and storage are carried out under good conditions (protected from heat, humidity and light) and for items of which the sterile primary packaging is intact. The item cannot be considered sterile any more if the primary packaging is deteriorated (cracks, moldy).

Non sterile medical devices (ex: adhesive tape)

An item with a passed expiry date does no longer have the properties required for its use and should not be used. The period of validity only applies if transport and storage are carried out under good conditions (protected from heat, humidity and light) and for items of which the primary packaging is intact.

TERMS & DEFINITIONS

State of sterility

The concept sterile is referred to as a state completely free of any viable microorganisms, and sterilisation is defined as the process which will destroy all viable microorganisms.

“Sterile” is an absolute term, but the assurance that any given item is sterile, i.e. free from viable microorganisms, is a probability function. The Sterility Assurance Level (SAL) is defined as the probability of a medical device being non-sterile after exposure to a validated sterilization process. The SAL defined by the norm EN 556 is 10-6, i.e. the probability of a viable organism being present after sterilization must be less than 1 per 1 million.

Sterilization batch

Items are grouped in sterilization batches (= packaging units sterilized during the same operation) to guarantee their traceability and allow the post-marketing monitoring.

Sterilization controls

These include the sterilization control (tests on the process) and the sterility control (tests on the finished product).

STANDARDS USED IN STERILIZATION OF MD

ISO 13485

Medical devices -- Quality management systems -- Requirements for regulatory purposes, Parts related to sterilization of medical devices:

• Sterile Medical Device Clause 3.20 states that sterility requirements of each medical device can be subject to applicable regulatory requirements.
• Contamination control (Clause 6.4.2) addresses the prevention of contamination after the devices are sterilized.
• Particular requirements for sterile medical devices (Clause 7.5.5) sets two direct requirements:
• Records of process parameters of sterilization of each batch
• Traceability of all batches
• Requirements for validation of processes for sterilization and sterile barrier systems (Clause 7.5.7)

EN 556-1

Sterilization of medical devices - Requirements for medical devices to be designated “STERILE” - Part 1: Requirements for terminally sterilized medical devices (+ AC:2006)

ISO/Technical Committee 198 : Sterilization of health care products

Scope: Standardization of processes and equipment for sterilization of health care products.

• ISO 11135: Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO 11137 set: Sterilization of health care products -- Radiation
• ISO 11138 set: Sterilization of health care products -- Biological indicators
• ISO 14161: Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results
• ISO 11139: Sterilization of health care products -- Vocabulary of terms used in sterilization and related equipment and process standards
• ISO 11140 set: Sterilization of health care products -- Chemical indicators
• ISO 15882: Sterilization of health care products -- Chemical indicators -- Guidance for selection, use and interpretation of results
• ISO 11607 set: Packaging for terminally sterilized medical devices
• ISO 11737-1: Sterilization of health care products -- Microbiological methods
• ISO 13408 set: Aseptic processing of health care products
• ISO 14937: Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
• ISO 15883 set: Washer-disinfectors
• ISO 17664: Processing of health care products -- Information to be provided by the medical device manufacturer for the processing of medical devices
• ISO 17665 set: Sterilization of health care products -- Moist heat
• ISO 25424: Sterilization of health care products -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices

MAIN MEDICAL STERILIZATION METHODS IN INDUSTRY

DISINFECTION AND STERILIZATION IN THE FIELD

Disinfection and sterilization of reusable medical devices are mandatory procedures to prevent nosocomial infections (infections acquired by the patients or the medical staff in a health care facility, also called hospital-acquired infections or health care-associated infections.

Disinfection, sterilization or single use MD according to the level of infection risk

(For detailed procedures, please refer to ‘Disinfection and sterilization protocols for MSF projects, 2010 – updated OCP version = 2013)

! SINGLE-USE EQUIPMENT MUST NEVER BE REUSED OR RE-STERILISED !

Steam sterilization

Steam sterilization is the only recommended method for sterilization of immersible thermo-resistant MD in health care facilities. It is a reliable, simple and not toxic procedure. It requires a steam autoclave, a source of energy (electricity, fuel, gas), water with a checked or controlled quality and a basic training. All these conditions must be fulfilled, including in emergency situations.
Protocol:

• pre-disinfection by immersion in a detergent-disinfectant solution (Anios®Clean type) for minimum 15 minutes
• cleaning-disinfection with a detergent-disinfectant solution (Anios®Clean type) for 15 minutes
• sterilization by steam autoclave

Important: The maximum shelf life recommended for medical devices wrapped in a double layer of sterilization paper (non-woven or crepe paper) is 2 weeks after sterilization.

High level disinfection

“High-level” disinfection concerns a very restricted number of medical devices, non-autoclavable, immersible and thermosensitive MD, likely to be reused. It consists in temporarily eliminating the vegetative forms of bacteria and viruses (but not bacterial spores) by immersion in a strong disinfectant solution.

Comment on boiling (not recommended)

Boiling for 20 minutes (+ 5 minutes / 1000 m altitude) in a recipient eliminates vegetative forms of bacteria and viruses, including hepatitis and HIV, but does not destroy bacterial spores. Boiling is not a recommended method and is only acceptable in situations where steam sterilization and “high” disinfection are impossible (e.g. traditional birth attendants in remote area).

Procedures according to the level of disinfection

Steps of steam sterilization

By “CLEAN WATER “ is meant FILTERED, non salt, low or non chlorinated water, as drinking water, tap water or rainwater if quality is controlled.

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

1 Legal provisions

Biological samples are considered “dangerous substances” whose transport is subject to strict regulation based on the United Nations “Recommendations on the Transport of Dangerous Goods”.¹

The International Air Transport Association (IATA) has incorporated these recommendations into its “Dangerous Goods Regulations,” to which many airlines are subject, including express transporters like DHL. These regulations are updated annually.

International air transport regulations (IATA) are the most restrictive.
Whatever the type of transport – national or international, road, rail, maritime, or air – all MSF shipments of potentially infectious samples must comply with those regulations.

According to the “Recommendations on the Transport of Dangerous Goods”, all biological samples fall into the “6.2-Infectious Substances” risk class.

¹ UN Library, 2019. Recommendations on the Transport of Dangerous Goods: Model Regulations. https://doi.org/10.18356/7c03b465-en

2 Sample classification

Infectious substances are divided into three categories according to risk

Information regarding the danger category for each of the pathogens described in the MSF guideline 'Collection, storage and transport of samples from field to reference laboratory', chapter 2. A table of all Category A infectious substances – UN2814 can be found in Section 6.1.

A declaration is also required when using dry ice as a cooling agent, because it is a dangerous substance. The following must be added to the packages in question: UN1845 “Carbon dioxide, solid” (+ specific hazard label). The following must also appear on the Air Waybill (AWB): UN1845 “Carbon dioxide, solid”, the number of packages, and the net quantity of dry ice added per package. This must also appear on the Dangerous Goods Declaration, if it accompanies UN2814 infectious substances.

Every type of international transport has specific documents and conditions regarding:

• The packing instruction
• Marking and labelling
• Transport mode
• Administrative documentation

It is therefore necessary to:

• Assign the dangerous substance to be transported to one of the three categories (UN2814, UN3373, or exemptions). It is up to the medical staff to determine which categories the samples in question belong to.
• Know the recommended transport temperature: ambient temperature or cold chain (positive or negative).
• If there is any doubt or question, consult the laboratory advisor.

2.1 Special case of dried blood spot (DBS) shipments

According to the IATA, DBS shipments are exempt.²

The completely dry DBS should be placed in its own bag with desiccant, and the bag placed in an envelope and shipped by a rapid transporter with shipment tracking (e.g., DHL, UPS, or FedEx).

DBS samples shipped via transporter must meet the following criteria:

• Triple packaged, with two waterproof inner packagings (individual bags and then a zip-lock bag).
• A third (outer) packaging (envelope or cardboard box) measuring at least 10 x 10 cm.
• “Exempt Human Specimen” appears on the package (outer packaging) and on the Air Waybill.

The transporter may ask for documentation proving that the samples are exempt.³ Check with the laboratory advisor.

3 Biological substance, Category B - UN3373

3.1 Transport materials, transport temperature, and packing instruction

Regardless of transport temperature, the packaging must consist of the following three components:

• A primary receptacle
• A secondary* packaging, and
• A rigid outer packaging

* For liquid biological substances, enough absorbent material should be placed between the primary receptacle(s) and the secondary packaging to absorb the entire contents in case of leakage. Each primary sample should be individually wrapped so that there is no contact between samples.

The maximum volume of the primary receptacle is 1 litre, and the outer packaging should contain no more than 4 litres of dangerous liquid substances, e.g., blood or urine samples, or 4 kg of dangerous solid substances (e.g., swabs or Trans-Isolate). This weight or volume does not include ice packs or dry ice.

Note: depending on the quantity of dangerous substances to be shipped, check the maximum weight or volume for which the packaging was manufactured, which may be less than the quantities above.

The manufacturer will provide the product characteristics.

• Ambient temperature transport: IATA packing instruction 650. Two items available in the MSF catalogue:
• BOX, triple packaging, biological substance UN3373 +pouch [STSSUN62DS-] (Figure 6.1)
• BOX, triple packaging, biological substance UN3373+container [STSSUN62DS2]
• + POUCH, polyethylene, for transport of samples, 20 x 30 cm [ELABPOUP203]
• Cold chain transport between +2 and +8 °C: IATA packing instruction 650. Two items available in the MSF catalogue:
• BOX ISOTHERMAL, triple pack., biological subst. UN3373 +pouch [STSSUN62DSI] [Figure 6.2]
• BOITE ISOTHERME, triple emb, substance biologique UN3373 + récipient [STSSUN62DSI2]

[Figure 1 - Shipping material UN3373]

[Figure 2 - Shipping material UN3373] Ambient temperature Cold chain

The temperature is controlled by four ice packs that are pre-frozen and placed between the secondary and outer packaging.

With four ice packs, the insulated box should keep the samples between +2 °C and +8 °C for 48 hours at an ambient temperature of +28 °C.

Additional materials available:

• CONTAINER, PROTECTION, transport of sample, plastic, Ø 30 mm [STSSCONP030P]
• CONTAINER, PROTECTION, transport of sample, plastic, Ø 44 mm [STSSCONP044P]
• CONTAINER, PROTECTION, transport of sample, plastic, Ø 130mm [STSSCONP130P]

3.2 Marking and labelling

The regulations on marking and labelling for ambient temperature transport and cold chain (+2 °C to +8 °C) transport are the same. Additional information and a hazard label are required on outer packaging containing dry ice (see Section 6.2).

The outer packaging should display the following information:

• The following pictograph, measuring at least 50 mm a side, with the text “Biological substance, Category B” in letters at least 6 mm high adjacent to the pictograph.

[Figure 3 - Pictograph UN3373]

• The name and physical address of the recipient must be entered in the spaces provided (no post office boxes but any details that might facilitate direct delivery).
• The name and physical address of the sender should be entered in the spaces provided.
• The name and telephone number of someone in the field who can be contacted 24 hours a day should be entered in the spaces provided.
• Shipments to the Institut Pasteur laboratory in France must bear the Institute’s own shipping label (voir Section 6.5).

3.3 Transport modes

DHL: biological substances, Category B - UN3373 can be shipped via DHL or other transporters or airlines.

For cold chain shipments, the transporter must be informed so that the package is placed in a refrigerated cargo container, if available.

Notes:

• DHL can transport refrigerated packages but does not maintain the cold chain (i.e., it does not replenish ice packs or add dry ice for cold chain shipments). The sender is responsible for ensuring that the cold chain system used (ice packs or dry ice) is sufficient for the entire duration of shipment.
• Some transporters/forwarding agents do monitor the cold chain, replenish ice packs, or add dry ice (World Courrier, for example). It is the sender’s responsibility to enquire about the options ahead of time

​3.4 Administrative documents

These are the responsibility of the supply and logistics departments.

Shipments of Biological Substances, Category B – UN3373 do not require dangerous goods declarations (DGD), even when shipped with dry ice.

• A donation certificate with the recipient’s and sender’s addresses, the exact name of the suspected pathogen and the quantities being shipped (completed by the supply department (see Section 6.3).

• A “custom invoice” specifying the monetary value of the product (prepared by the supply or logistics department) with the recipient’s and sender’s addresses, the number of packages, detailed contents, and weight.
• A Material Transfer Agreement issued by the Ministry of Health or other competent authority in the country.
• For some countries, an import permit is required and should be furnished by the receiving laboratory.

A paper copy of these documents is given to the forwarding agent in the originating country. If there is a forwarding agent involved in the destination country as well, all the documents must be provided to him in electronic form (logistics/supply department responsibility).

• An anonymised packing list (without patient’s name) should be inserted between the secondary and tertiary packaging of the package in question
• A copy of the packing list and the package’s anticipated arrival date should be emailed to the receiving laboratory.

The forwarding agent: an essential service provider for all air shipments of infectious or biological substances (UN2814 and UN3373). If shipment with DHL, DHL takes the role of forwarding agent.

• Is commissioned by MSF.
• Is the intermediary between MSF and the airline at departure and between the airline and the receiving laboratory.
• When shipping via DHL, DHL manages the entire shipment (“door-to-door” service). If not shipping via DHL, a forwarding agent is needed at departure and a second forwarding agent may be needed to collect the package at arrival and facilitate its passage through customs.
• Completes the air waybill (AWB) (see Section 6.4) :
• The AWB should show “UN3373 Biological substance, category B” but not the name of the infectious agent. It should also include the number of packages.
• An accredited DHL account number must be used for UN3373 shipments. Contact the supply centre, laboratory advisor, or mission to get that account number.

When shipping via DHL, you must also notify the headquarters transport manager and forward the DHL tracking numbers (Air Waybill) (MSF-OCBA, MSF-OCG and MSF-OCP: MSF-Log focal point in Bordeaux; MSF-OCA: the transport officer at the APU and the mission laboratory advisor; MSF-OCB: laboratory advisor).

Other conditions may be required for cargo shipments. Contact the supply/logistics advisor and notify the medical department.

​4 Infectious substance, Category A - UN2814

4.1 Transport materials, transport temperature, and packing instruction

Regardless of transport temperature, the packaging must consist of the following three
components:

• A watertight, leak-proof primary receptacle(s)
• A watertight, leak-proof secondary packaging*
• A rigid outer packaging

* For liquid infectious substances, enough absorbent material should be placed between the primary receptacle(s) and the secondary packaging to absorb the entire contents in case of leakage. Each primary sample should be individually wrapped so that there is no contact between the sampless.

Maximum allowable volume per package:

• 50 mL or 50 g for passenger plane transport,
• 4 litres or 4 kg for cargo plane transport

This weight or volume does not include ice packs or dry ice.

• Ambient temperature, IATA packing instruction 620
• One item available in the MSF catalogue:
• BOX, triple packaging, infectious substance UN2814 [STSSUN62IS-]

[Figure 4 - Shipping material UN2814 - Ambient temperature]

[Figure 5 - Triple packaging box UN2814 - Ambient temperature]

• Cold chain transport between +2 and + 8 °C, IATA packing instruction 620
• The temperature is controlled by four ice packs that are pre-frozen and placed between the secondary and outer packaging.
• One item available in the MSF catalogue:
• BOX ISOTHERMAL, triple pack., infectious substance UN2814 [STSSUN62ISI]

[Figure 6 - Shipping material UN2814 - Cold chain]

[Figure 7 - Triple packaging box UN2814 - Cold chain]

Insulated box that keeps the samples between +2 °C and +8 °C for 48 hours (at an ambient temperature of +28 °C).
Additional materials available:

• CONTAINER, PROTECTION, transport of sample, plastic, Ø 30 mm [STSSCONP030P]
• CONTAINER, PROTECTION, transport of sample, plastic, Ø 44 mm [STSSCONP044P]
• CONTAINER, PROTECTION, transport of sample, plastic, Ø 130mm [STSSCONP130P]
• POUCH, polyethylene, for transport of samples, 20 x 30 cm [ELABPOUP203]

4.2 Marking and labelling

The regulations on marking and labelling for ambient temperature transport and cold chain (2 °C to +8 °C) transport are the same. Additional information and a hazard label are required on outer packaging containing dry ice (see Section 2).

The outer packaging should display the following information:

• The following pictograph (infectious substance symbol) (pre-printed on MSF materials) with UN2814 “Infectious substance, affecting humans”.

[Figure 8 - Pictograph infectious substance]

• The name and physical address of the recipient must be entered in the spaces provided (no post office boxes but provide any details that might facilitate direct delivery).
• The name and physical address of the sender should be entered in the spaces provided.
• The name and telephone number of someone in the field who can be contacted 24 hours a day should be entered in the spaces provided.
• Shipments to the Institut Pasteur lab in France must bear the Institut’s own shipping label (see Section 6.6.5).

4.3 Transport modes

• Infectious substances, Category A – UN2814 can be transported by an airline or possibly other transporters accredited by the IATA for UN2814 shipments (enquire locally). They cannot be transported by DHL.
• For cold chain shipments, the transporter must be informed so that the package is placed in a refrigerated cargo container, if available.
• Transporters can transport refrigerated packages, but not all of them maintain the cold chain (i.e., they do not replenish ice packs or add dry ice for cold chain shipments). The sender is responsible for ensuring that the cold chain system used (ice packs or dry ice) is sufficient for the entire duration of shipment.

4.4 Administrative documents

These are the responsibility of the supply and logistics departments.

• A dangerous goods declaration (DGD): must include “Infectious substance, affecting humans (+ scientific name of the substance, if known, in parentheses)” or “Infectious substance, affecting humans (+ suspected Category A infectious substance, in brackets” (for example: “Infectious substance, affecting humans (Ebola virus)” or “Infectious substance, affecting human (suspected Category A infectious substance)”) + the net quantity. (see example, Section 6.2).
  Note: the DGD must be completed and signed by an IATA-accredited person. If this is not the case for MSF personnel or the local forwarding agent, contact the supply/logistics department and your laboratory advisor to get a list of accredited people within the departments.
• A donation certificate with the address of the sender and the recipient, the exact name of the suspected pathogen, and the quantities contained, completed by the supply department (see, Section 6.3).
• A custom invoice (with the monetary value of the product) prepared by the supply department or logistics coordinator, with the sender’s and recipient’s addresses, the number of packages, their contents, and their weight.
• A Material Transfer Agreement (MTA) issued by the Ministry of Health or other competent authority of the country.
• For some countries, an import permit is required in the recipient’s country; this will have to be furnished by the receiving laboratory.

A paper copy of these documents is given to the forwarding agent in the originating country. If there is a forwarding agent involved in the destination country as well, all of the documents must be provided to him in electronic form (logistics/supply department responsibility).

• An anonymised packing list (without patient’s name) should be inserted between the secondary and tertiary packaging of the package in question.
  A copy of the packing list and the package’s anticipated arrival date should be emailed to the receiving laboratory.

The forwarding agent: an essential service provider for all air shipments of infectious or biological substances (UN2814 or UN3373).

• Is commissioned by MSF.
• Is the intermediary between MSF and the airline and/or between the airline and the receiving laboratory.
• In some cases, a second forwarding agent may be needed to collect the package on arrival and facilitate its passage through customs.
• Completes and signs the DGD if he has been accredited by the IATA for less than two years.
• Completes the AWB (Air Waybill) (see Section 6.4):
• The “handling information” box on the AWB must state “dangerous goods as per associated DGD”.
• The AWB should include “UN2814 Infectious substance, affecting humans”, but not the name of the infectious agent.

Other conditions may be required for cargo shipments. Contact the supply/logistics advisor and notify the medical department.

5 Cold chain preparation

The insulated boxes available in the catalogue will keep the temperature between +2 °C and +8 °C for 2 days at an ambient temperature of 28 °C. It has not been tested at higher ambient temperatures.

5.1 Shipping at +2 °C to +8 °C with 0.6-litre ice packs

The procedure for samples that have to be sent at +2 °C to +8 °C using ice packs is as follows:

• Prepare an insulated triple-packaging box.
• Prepare the four ice packs:
• Remove them from the freezer and leave them in a +20°C location, protected from the sun.
• After 15 minutes, check the amount of liquid in the ice packs. To ensure that the ice packs are at the right temperature, they should have 5 cm of water visible in the bottom when held vertically. When the ice packs are shaken, the sound of water can be heard.
  ! If there is less than 5 cm of water or no water at all, the packs are too cold, and the samples might freeze early in transport !
  ! If there is more than 5 cm of water, the packs are too warm, and the temperature might get too high during transport !
• If the ice packs are not at the correct temperature after 15 minutes, leave them for another 15 minutes, protected from sunlight, and then check again.
• Once all four ice packs are at the correct temperature, place them in the insulated box.
• Put the samples, in their packaging, into the box.
• Close the insulated box.

6. Documentation

6.1 IATA : Category A - UN2814

Indicative examples of infectious substances included in Category A in any form unless otherwiseindicated

Adapted from Guidance on regulations for the transport of infectious substances 2021-2022. Geneva: World Health Organization; 2021. Licence: CCBY-NC-SA3.0IG

6.2 Sample dangerous goods declaration (DGD)

6.3 Sample donation certificate

6.4 Sample Air Waybill (AWB)

6.5 Institut Pasteur shipping label

Available at the following address:

https://www.pasteur.fr/fr/file/3157/download?token=Evu6jsP5

Regardless of the mode of transport, fill out and affix a label as above to the outer packaging of all shipments destined for the Institut Pasteur's National Reference Centers.

Sender:

• Name
• Hospital/Laboratory/Unit
• Address
• Postal code
• City
• Country
• Phone number
• Fax number

Storage conditions: choose one

• Ambient temperature
• + 4 °C
• -20 °C

Recipient:

• Institut Pasteur
• National reference laboratory of _______________________________
• For the attention of _________________________________________
• Address: already added
  

References

1. Guidance on regulation for the transport of infectious substances 2021-2022/WHO
https://apps.who.int/iris/handle/10665/339825

2. Exempt Human/Animal specimens shipping guidelines. Retrieved from :
https://www.cancertrials.ie/wp-content/uploads/2018/05/DHL_Exempt-Human-Animal-Specimen-Customer-2015.pdf

3. IATA document. Dangerous Goods Regulations (DGR). 62nd Edition. 2021. Retrieved from

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": NSFOCRECOOE (English), NSFOCRECOOF (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).

Specialised food products

Unlike basic food products (NFOO family), such as cereals (millet, sorghum...) or legumes (beans...), specialised food products‌ (NFOS family) are specifically designed to meet the needs of malnourished people in crisis situation.

These products are enriched with proteins, minerals, and vitamins according to the nutritional requirements of patients, considering factors such as age, the severity of malnutrition, associated pathologies, local dietary habits.

A global strategy for responding to a nutritional crisis can only be developed after assessing the nutritional situation and identifying the intervention goals and target population. The response can be general or selective, including options such as general distribution, blanket feeding, supplementary feeding programs,or therapeutic feeding programs.

THE DIFFERENT TYPES OF SPECIALISED FOOD PRODUCTS

Specialised foods can be categorised into different categories, each designed to meet specific nutritional needs:

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 during the rehabilitation phase for treating severe acute malnutrition. It should not be used in the initial phase due to its iron content.

Examples: 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 used for treating Moderate Acute Malnutrition (MAM) and can also be used for nutritional support in emergencies or as part of nutritional programmes to prevent malnutrition.

Examples: Plumpy'Sup, eeZeRUSF

Note: RUSF are sometimes referred to as LNS LQ (Large Quantity)

LNS: Lipid-based Nutrient Supplement (LNS MQ and LNS SQ)

• LNS MQ (Medium Quantity) is a ready-to-use product used to prevent Moderate Acute Malnutrition (MAM) in children aged 6 to 36 months. When consumed as a supplement to the regular diet, it balances the daily intake of micronutrients.

Examples: Plumpy doz, eeZee50

• LNS SQ (Small Quantity) is a ready-to-use product used to prevent malnutrition and provided nutritional support in emergencies.

Examples: Nuttributter, eeZee20

Micronutrients (fortified paste with vitamins and minerals)

Micronutrient supplements are used to address dietary deficiencies, particularly the lack of animal-based products.

Examples: QBmix

Emergency food ration

Compressed biscuits used as nutritional substitutes or food supplements in crisis situations, especially in the initial phase of an emergency before general ration distribution.

Examples: BP5, NRG5

Infant formulas (infant milks) and breast-milk fortifiers

These are substitutes for breast milk or fortifiers to enhance the nutritional quality of breast milk, depending on the needs of the infants.

Food for Special Medical Purposes (FSMP) (e.g. VHF patients, burn victims, HIV patients, etc.)

FSMP‌ products are specially designed for patients with specific medical conditions requiring tailored nutrition. They should be used under medical supervision and vary in terms of calories, protein, and other nutritional contents, as well as form (oral, enteral feeding, or both).

Types:

• adults or children
• isocaloric or hypercaloric
• normoprotein or hyperprotein
• semi-elemental
• with or without fibres
• available as powders for reconstitution, ready-to-use drinks, or ready-to-use bags for enteral (tube) nutrition (ready to hang).

Powders generally have a longer shelf-life (24 months) and are more cost-effective than ready-to-use products, reducing the number of product references and simplifying stock management and orders.

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, supplementary feeding programs, and blanket feeding programs.

They are made from 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 newer versions containing milk and are better adapted for children's nutritional needs.

Examples of Super Cereals Plus: CSB++

PURCHASE / ACCEPTANCE OF DONATION OF SPECIALISED FOOD PRODUCTS

It is essential to manage stocks of specialised food products by batch and shelf life. A batch is defined as a quantity produced under homogeneous conditions, although its exact definition may vary depending on the supplier's internal organisation.