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PERITONEAL DIAGNOSTIC LAVAGE SET, ster. s.u.

https://unicat.msf.org/cat/product/87114
STD SCTDPERI2D-

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.
A060206 - Peritoneal drainages and kits
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
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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PERITONEAL DIAGNOSTIC LAVAGE SET

Definition

The Diagnostic Peritoneal Lavage (DPL) set contains a specific catheter needed to instill fluid into the peritoneal cavity that will be drained afterwards for analysis. The set includes some material used for the catheter placement using the Seldinger method. DPL is an invasive emergency procedure used to detect hemoperitoneum and help determine the need for laparotomy.

Specifications

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Quality standards

ISO 20697, 2018, edition 1, (confirmed 2023) Sterile drainage catheters and accessory devices for single use

Technical specifications

Components of the set:

  • Peritoneal lavage catheter
    • 90 sideports
    • CH 09, length = 20 cm
    • catheter material is radiopaque (x-ray visualization)
  • Percutaneous entry needle
    • 18G, length = 7 cm
  • Straight fixed core wire guide
    • PFTE coated
    • Ø 0.9 mm, length = 40 cm

The set is sterile and for single use

Packaging & Labelling

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

(Cf Introduction: Packaging and labelling)

Instructions for use

A Foley catheter and a nasogastric tube are inserted to decompress the bladder and stomach.

After the application of local anaesthesia, a vertical skin incision is made one third of the distance from the umbilicus to the pubic symphysis. A catheter is inserted towards the pelvis and aspiration of material attempted using a syringe. If no blood is aspirated, 1 litre of 0.9% saline is infused and after a few (usually 5) minutes this is drained and sent for analysis. Adequate fluid analysis requires at least 30% of the original amount infused.

Microscopic examination of lavage fluid may refine the diagnostic value, rather than merely characterizing the colour of the fluid as “salmon pink”

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Precautions for Use

Use reserved for doctors properly trained in diagnostic peritoneal lavage.

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