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FILM DRESSING, semi-permeable, adhesive, IV, sterile, M

https://unicat.msf.org/cat/product/70199
STD SDREFIDS1IVM

Valid Article

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.
M04010202 - Polyurethane fixing dressings
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
CT25
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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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FILM DRESSING, semi-permeable, IV

Definition

A sterile, transparent, adhesive and semi-permeable (i.e. impermeable to fluids, permeable to vapours and gases) covering. It is applied to secure to skin vascular catheters, or infusion ports and is intended to provide protection to fluids and external contaminants.

Specifications

Quality standards

EN 13726-2, 2002, Test methods for primary wound dressings. Moisture vapour transmission rate of permeable film dressings

Technical specifications

  • Transparent film made of synthetic polymer (e.g., polyurethane based), latex- and PVC-free
  • Breathable: allows moisture vapor and gas exchanges
  • Moisture Vapour Transmission Rate ≥ 500g/m²/24h
  • Waterproof: impervious to liquids and body fluids
  • Protection against all external contamination
  • Barrier against bacteria and viruses ≥20nm
  • Adhesive:
    • must adhere to the skin during 7 days minimum
    • hypoallergenic latex-free adhesive
  • With frame for easy positioning
  • Documentation tape strip : preprinted for documenting dressing changes (optional)
  • Securement tape strip to enhance stabilization of the catheter (optional but practical)
  • Design of dressing allows aseptic application using a non-touch technique
  • Split ensuring an efficient closure around the IV catheter
  • Sterile, for single use
  • Without anti-microbial agents
  • Approximate size:
    • small: 4 x 5 cm
    • medium: 6 x 9 cm
    • large: 10 x 11 cm

Packaging & Labelling

Each dressing is packed in a disposable peel pack allowing effective sterilization, safe handling, and storage until needed for use and facilitating proper aseptic presentation.

Instructions for use

Used to cover and protect catheter sites.

  • Small: for pediatric use
  • Large: use in critical contexts such as VHF or for Central venous catheters and PICC lines.

Precautions for Use

To ensure adequate dressing adhesion, the skin around the puncture site should be clean, dry and free of moisturizers and grease.

Caution is required when removing the dressing: stretch the film horizontally away from the wound to avoid damage to the skin

Storage

  • Store below 25°C
  • Protect from sunlight ‐ Protect from humidity

MSF requirements

The transparent dressing, easy to apply and remove, provides complete visibility of the site during application. It also allows continuous monitoring of the I.V. site without disturbing or removing the dressing.

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