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ADMINISTRATION SET EN, gravity, ENPlus/ENFit, ster.,s.u.

https://unicat.msf.org/cat/product/65476
STD SCTDAENG1--

Valid Article

Former Code(s): SCTDZBE0098
The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
A03010301 - Enteral feeding gravity controllers
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
I sterile
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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ADMINISTRATION SET, enteral nutrition, gravity

Definition

A device intended to enable connection of components of an enteral feeding system. It is typically a small plastic device containing a lumen to facilitate enteral administration of feeds after connection; it has no additional functionality and is dedicated to enteral feeding applications by gravity.

If a feeding pump is used, another specific administration set is needed (see enteral nutrition pump).

Specifications

Image

Quality Standards Comment

See information onnasogastric and enteral tubes

Technical specifications

  • TUBING:
    • Transparent PVC, DEHP free, latex free
    • Ø 3.0 x 4.1 mm
    • Length: 175 – 200 cm
  • DROP-COUNTING CHAMBER
  • THUMB WHEEL REGULATOR: Allows to adjust feeding flow rate between 0 and the maximal value.
  • PROXIMAL CONNECTOR (to the feeding pouch):
    • ENPlus
    • non compatible with Luer
  • ADMINISTRATION PORT: For medication, hydration and flushing of the tubing
    • ENFit connection
    • Located near the distal end
  • DISTAL CONNECTOR (towards the gastric tube):
    • ENFit
    • non compatible with Luer
  • COLOUR of the connections: purple is often used for enteral feeding medical devices, but the specific ISO norm does not specify the colour.
  • STERILE
  • FOR SINGLE USE: Bacterial contamination has been associated with the re-use of feed bags and administration sets. As evidence suggests re-use is not advisable, the administration system should be considered single use only and discarded after each intermittent feeding session.

Packaging & Labelling

Unit sterile packaging in peel-open pack

(Cf Introduction: Packaging and labelling)

Instructions for use

Connect the set to the feed container as instructed on the packaging of the pump set.

Change the administration set for enteral feeding systems every 24 hours (open system) or 48 hours (closed system) or according to manufacturer's instructions.

IV giving sets have a drop-factor = number of drops of DISTILLED WATER / ml. The viscosity is an important factor in the determination of the number of drops /ml, and the enteral food is vary variable in viscosity. Hence it makes no sense to add a drop factor (calculated on water) to have a precise quantity of enteral food.

Precautions for Use

For patient safety, be aware that the feeding set tubing can get wrapped around a child's neck, which can lead to strangulation or death. (FDA safety communication Febr 2022)

Preventing misconnection errors

See information on nasogastric and enteral tubes

MSF requirements

Part of necessary materials for providing enteral nutrition without electricity (enteral feeding pump) to patients where oral intake of calories and/or proteins is not possible or not sufficient.

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