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URINARY CATHETER, FOLEY 2 way, SI, baloon, ster, s.u., CH18

https://unicat.msf.org/cat/product/68353
STD SCTDCAURS18

Valid Article

Former Code(s): SCTDZBD0103
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.
U010201 - Urethral prostatic and bladder catheters, Nelaton, with balloon
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.
IIb
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
CT3+
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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URINARY CATHETER, FOLEY, SILICONE

Definition

A sterile, flexible tube made of silicone, with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder to function as an indwelling therapeutic device for urinary incontinence (e.g., following a urological surgery procedure), or as a means to void for non-ambulatory patients.

Specifications

Quality standards

ISO 20696, 2018, edition 1, (confirmed 2023) Sterile urethral catheters for single use

Technical specifications

  • ​2 way urinary catheter with balloon:
    • central canal for drainage of urine: straight distal end, conical shaped, with lateral openings
    • lateral canal is for inflating the balloon (Luer connection)
    • the amount of sterile water to be inserted into the balloon is usually printed on the side of the nozzle end, usually 5 - 15 ml for catheters CH 14 - 18
    • the nozzle is equipped with a valve mechanism, the water will remain trapped inside the balloon
  • Length: 30 - 40 cm
  • The colour of the connecting piece or the filling opening of the balloon in Foley-type catheters represents a colour-code and designates the external diameter of the catheter
sizeext diam mmcolour
CH144.7 mmgreen
CH165.3 mmorange
CH186.0 mmred
  • Sterile, for single use
  • Material: silicone:
    • More resistant to wear and tear than the siliconized latex type.
    • A little more rigid than the siliconized latex catheters, which may prove to be of benefit when an obstruction (like a prostate) has to be passed. ​
    • Common disadvantage is the fact that the balloon, when empty, often forms a slight thickening, thereby increasing the diameter of the catheter by a CH or two, which may sometimes be just too much to get it passed a stricture.
    • The plain silicone Foley catheters are often transparent, although they also come in white, blue, green and other colors.

Packaging & Labelling

Double sterile packaging per unit in peel-open pack

(Cf Introduction: Packaging and labelling)

Instructions for use

Please consult the “Manual of nursing Care Procedures, MSF, 2020” available online via the Nursing care working Group sharepoint page.

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Precautions for Use

A silicone Foley catheter can be left in the bladder for 6-8 weeks.

Encrustrations tend to form at the tip of the catheter which may lead to narrowing of the hole or an increased diameter, that may cause pain and bleeding upon removal. Therefore, it is advised not to stretch the time the catheter is left inside the bladder

The balloon should be inflated with sterile water, never with air. Physiological saline (NaCl) is not recommended as it may degrade the balloon.

Since the balloon tends to empty itself by loss of water due to a semi-membranous effect of the wall of the balloon, it will need to be refilled every now and then if remaining for long periods.

If necessary, the catheter may be lubricated in order to make its insertion easier. Use sterile lubricant jelly (see related articles below) or, failing that, sterile water.

MSF requirements

Silicone catheters should be used specifically for preventing obstructions and crusts (larger internal lumen) in long-term catheterization.

Adapted for patient with latex-sensitivity.

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