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URINARY CATHETER, FOLEY 2 way, balloon, sterile, s.u., CH12

https://unicat.msf.org/cat/product/18293
STD SCTDCAUR12F

Valid Article

Former Code(s): -X
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.
IIa
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.
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
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

Definition

Foley urinary catheters are sterile, flexible tubes with an inflatable balloon at the distal tip intended to be inserted through the urethra and retained in the urinary bladder to function as an indwelling therapeutic device: they drain the bladder but block the urethra.

They have double lumens, or separate channels, running down it lengthwise = two-way catheters.

They are used in case of urinary incontinence (e.g., following a urological surgery procedure), or to void for non-ambulatory patients.

Synonym

Foley catheter, urethral catheter with balloon

Specifications

Quality standards

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

Technical specifications

  • Silicone coated latex
  • 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
CH62.0 mmlight green
CH82.7 mmblue
CH103.3 mmblack
CH124.0 mmwhite
CH144.7 mmgreen
CH165.3 mmorange
CH186.0 mmred
CH206.7 mmyellow
  • Two-way catheter:
    • central channel for urinary drainage:
      • straight distal end with side eyes
      • proximal end with funnel shape connector
    • side channel for balloon inflation ending in a non-return valve with Luer connection
  • Balloon capacity: the amount of sterile water to be inserted into the balloon is usually printed on the side of the nozzle end.
    • 3 - 5 ml paediatric balloon
    • 5 - 10 ml balloon for routine drainage in adults
  • CH 6, CH 8, CH 10 size has a guide to facilitate catheterization
  • Length: 30 to 45 cm
  • Sterile, for single use

Packaging & Labelling

Double sterile packaging per unit in peel-open pack

(Cf Introduction: Packaging and labelling)

Supplied with the Article

The Foley Catheters CH6, CH8, and CH10 are supplied with an introduction stylet

From a practical and clinical standpoint, the inclusion of a stylet is both logical and beneficial:

  • It facilitates a smoother and more controlled insertion, particularly in pediatric patients where urethral anatomy can make placement more challenging.
  • It helps prevent kinking or bending of the catheter during insertion, ensuring that the catheter reaches the bladder correctly before balloon inflation.
  • The IFU highlights that the stylet must always be removed before inflating the balloon, and that it should be withdrawn smoothly once correct placement is confirmed, thereby maintaining patient safety and minimizing the risk of urethral trauma.

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

  • Do not use in case of allergy to latex: use the silicone ones
  • If clamping is required, clamp only the drainage channel. Clamping the whole catheter could obliterate the balloon channel causing difficulties with deflating the balloon.
  • The balloon should be inflated with sterile water, never with air. Physiological saline (NaCl 0.9%) is not recommended as it may degrade the balloon.
  • Do not inflate the balloon over the indicated maximum capacity.
  • Never inflate the balloon without visualisation of urine drainage and advancing the catheter as this can cause urethral damage and pain.
  • Consider a skin protection device and the type of tape to use for patients with a high-risk of developing a pressure ulcer or being injured by tape
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