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CENTRAL VENOUS CATHETER SET, 2 lumens, CH4-4.5 x 8-10cm

https://unicat.msf.org/cat/product/45166
STD SINSCVCAD408

Valid Article

Former Code(s): SINSZBD0027 SINSCVCAD4-
The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
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.
C01020202 - Central venous double-lumen catheters, non-tunneled
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.
III
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
PM
The order of this product needs to be justified and is only acceptable under certain conditions.
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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CENTRAL VENOUS CATHETER SET

Definition

A sterile, flexible tube intended to be introduced into the subclavian or the jugular vein and advanced into the superior vena cava for various infusion procedures including the intravenous administration of fluids or drugs, and blood transfusion. The proximal end of this central venous catheter (CVC) is fixed to the patient for long-term use. It includes supportive devices associated with introduction.

Specifications

Quality standards

  • EN ISO 10555-1, 2013, edition 3, +A1 2017 Sterile, single-use intravascular catheters - Part 1: General requirements
  • ISO 10555-3, 2013, edition 2, (confirmed 2018) Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters
Image

Technical specifications

Non-tunneled catheters are fixed in place at the site of insertion, with the catheter and attachments protruding directly. (Tunneled catheters are passed under the skin from the insertion site to a separate exit site.)

The set is sterile, for single use and consists of:

  • central venous catheter with extension tubes, a clamp and needle-free connector per lumen
    • double lumen (SINSCVCAD+++) or triple lu​men (SINSCVCAT+++)
    • soft catheter tip
    • X-ray detectable, opaque polyurethane
    • length markings for accurate catheter placement
    • no antibacterial components included in the catheter material
  • Material for insertion (Seldinger technique): varies according the manufacturer
    • kink-proof guide wire (stainless steel or nitinol) with advancer and flexible J-tip
    • percutaneous insertion needle
    • subcutaneous needle
    • syringes: Luer-lock 5ml, Luer-slip 3 and 10 ml
    • medicine cup / galipot x 2
    • needle holder
    • scalpel (safety version is preferred)
    • antiseptic sponge swab
    • gauze
    • fixation dressing
    • drape adhesive with transparent fenestration
codeexternal diameterlengthuse for

SINSCVCAT720

CH 7 - 7.515 - 20 cmadults
SINSCVCAD511CH 5 - 5.510 - 13 cmchildren
SINSCVCAD408CH 4 - 4.58 - 10 cmnewborns

Packaging & Labelling

Sterile set in a tray peel open pack.

Instructions for use

  • The location of the vein is identified with the use of an ultrasound device. A hollow needle is advanced through the skin until blood is aspirated.
  • The line is then inserted using the Seldinger technique: a blunt guidewire is passed through the needle, which is then removed. A dilating device may be passed over the guidewire to expand the tract. Finally, the central line itself is then passed over the guidewire, which is then removed.
  • All the lumens of the line are aspirated (to ensure that all are positioned inside the vein) and flushed with either saline or heparin.
  • A chest X-ray may be performed afterwards to confirm that the line is positioned inside the superior vena cava and no pneumothorax was caused inadvertently.
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Precautions for Use

Guidelines for the prevention of Intravascular Catheter-Related Infection (CDC 2002)

  • Hand hygiene:
    • before and after palpating catheter injection sites
    • before and after inserting, replacing, accessing, repairing or dressing an intravascular catheter.
  • Aseptic technique during catheter insertion and care: sterile gloves should be worn for the insertion of central catheters
  • Sterile dressing for the central venous line. Changing of the dressing depends on the type of dressing:
  • Replace administration sets no more frequently than at 72-hour interval.
  • Clean injection ports with chlorhexidine 2% / alcohol 70% before use: scrub the port creating friction for 15-30 seconds. Use different parts of the wipe/gauze, allow to dry

MSF requirements

Use in ICU for long term venous access, monitoring of central venous pressure, infusion of certain medications.

All-in-one package is preferred.

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