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ERTAPENEM, 10μg, clsi, eucast, disc [BioRad-67518]

https://unicat.msf.org/cat/product/75245
STD SASTDISCETP1B

Valid Article

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.
W0104080502 - Impregnated disks, multi-disks & tablets
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.
SP
The order of this product needs to be justified and is only acceptable under certain conditions.
0208
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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ANTIMICROBIAL SUSCEPTIBILITY TESTS DISCS - 2ND CHOICE

CAUTION

This article is worded and codified by unit to make the order easier, but is always packaged in kit of 200 or 250 discs

Definition

A susceptibility testing disc impregnated with a defined amount of a specific antibacterial is intended to be used to determine the susceptibility of a specific bacterial organism (excluding mycobacteria) isolated from a clinical specimen by culture, using an agar diffusion method.

Specifications

The following list details all 2nd choices antibiotic discs with their manufacturer references

SASTDISCCTZ1BCEFTAZIDIME, 10μg, eucast, disc [BioRad-67298]
SASTDISCIPMBIMIPENEM, 10μg, clsi, eucast, disc [BioRad-66568]
SASTDISCMEMMEROPENEM, 10 μg, clsi, eucast, disc [BioRad-67048]
SASTDISCMUP3MUPIROCIN, 200µg, clsi, eucast, disc [BioRad-67078]
SASTDISCPIP1BPIPERACILLIN, 100μg, clsi, disc [BioRad 67228]
SASTDISCTMLTOBRAMYCIN, 10μg, clsi, eucast, disc [Liofilchem-9044]
SASTDISCETP1BERTAPENEM, 10μg, clsi, eucast, disc [BioRad-67518]
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Quality Standards Comment

This method is based on a standardized procedure published by the WHO and adopted as consensual standard by the CLSI (Clinical and Laboratory Standard Institute), CA-SFM (Comité de l'Antibiogramme, Société Française de Microbiologie), and EUCAST (European Committee on Antimicrobial Susceptibility Testing).

Technical specifications

  • Paper discs
  • Absorbent paper impregnated with precise concentrations of antimicrobial agents.
  • The discs are clearly identified by a code: 1 to 3 letters for the antimicrobial agent and 1 to 3 figures for the concentration of the antimicrobial agent, printed on each side of the disc.
  • Discs dispenser needs ideally to be from the same brand as the discs to fit the cartridges

Packaging & Labelling

  • Bio-Rad: 4 x 50 discs
  • Liofilchem : 5 x 50 discs. Each discs cartridge is individually packed in a desiccant envelope

To be Ordered Separately

  • Forceps
  • Culture media
  • Bacterial strains for quality control
  • Densitometer

Instructions for use

  • Follow the instructions in the leaflet.
  • Follow the instruction of the current guidelines (CLSI, CA-SFM, EUCAST).
  • Susceptibility testing quality controls should be done with the quality control strains detailed in the SBQC chapter, with the frequency described in the SOP.

Please consult the “Bacteriology laboratory procedures and resources” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Bacteriology-Laboratory-Resources.aspx

For offline access, contact your laboratory advisor

Precautions for Use

All biological samples must be considered as potentially infectious and handled with the usual precautions (compulsory wearing of gloves, hand washing, etc.).

Storage

  • Shelf life :
    • Liofilchem: Tobramycine - 36 months;
    • Bio-Rad : Ceftazidime, ertapenem, mupirocin, meropenem, piperacilline - 24 months;
    • Bio-Rad : Imipenem - 12 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life.
  • Not to be used beyond the expiry date.

Liofilchem:

  • The unopened package can be stored in most cases at -20°C to 8°C. Some products have to be stored at −20°C as maximum storage temperature (see external packaging)
  • Leftover discs from an opened cartridges need to be stored at 2-8°C for no more than 7 days with desiccant.
  • Discs in a CANISTER can be used for up to 2 months from first opening.

Bio-Rad:

  • Cartridges of disks must be stored in their containers at a temperature between +2°C and +8°C in a dry place.
  • The stability of the disks, of open cartridges placed in distributors (preserved according to the recommendations with desiccants) was validated in routine conditions during 6 weeks (with exception - to be checked).
  • If the cartridge remains in a disc distributor after dispatch, it is necessary to preserve at +2-8°C in a dry place with desiccants inside.

(Cf Introduction: Thermosensitive products)

Waste management

After use, sterilise the cultures and all contaminated material. Please contact your watsan referent for advice on proper disposal.

MSF requirements

Reserved to bacteriology programmes.

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