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Central Service - Issue 2/2009

Central Service - Issue 2/2009

Central Service - Issue 2/2009

NEWS UPDATE

  • What’s New in Standardisation: Globalization
  • Medical Devices & Processes Forum - Users and Experts. 27 February 2009, Berlin
  • 1st Sterilisation Symposium in Heidelberg
  • A Man of the First Hour. Egbert Pfeifer 17 years on the Advisory Editorial Board of Central Service

ORIGINAL ARTICLE

D. Combeau*, N. Texier, M. Sellier, P. Bauvoi, C. Percevaux, A. Petit, J. Leglise, F. Brion:
Methodology for Certification as per ISO 9001:2000 of a Central Sterile Supply Department

Abstract
The Central Sterile Supply Department (CSSD) at the Robert Debré Hospital obtained certification as per ISO 9001, version 2000, on 29 June 2007 for ”reprocessing and distribution of sterile medical devices“, at the time of the audit carried out by the certification body. ISO 9001 certification has many advantages. It serves as a guarantee of quality for the clients who are the recipients of CSSD services, whether they are located within the hospital or in a subcontractor’s establishment. This measure is of strategic importance for the hospital, both internally, in terms of the commitment by management, motivation and recognition of the sterilisation team, and externally. The aim of this article is to describe the methodology employed to obtain certification and to give an update of events up to the time of the first follow-up audit one year afterwards.

NEW PROCESSES

G. McDonnell*, K. Antloga, S. Azad, N. Robinson:
Amsco V-PRO 1: A New Low Temperature Sterilization System

Abstract
There is an increasing need for alternative, low-temperature sterilization processes. Only a small number of chemical biocides can be practically used for this purpose, due primarily to the required broad-spectrum antimicrobial activity; equally important are the requirements for device compatibility, safety (for the patient, operator and environment), costs and overall sterilization time. This report describes a new, low temperature sterilization process based on only vaporized (or gaseous) hydrogen peroxide. The process is designed for sterilization of cleaned, dried metals or non-metal instruments. The vacuum-based process consists of three stages, namely conditioning (to remove residual moisture and air), sterilization with hydrogen peroxide gas and aeration (to remove any residuals and render the load safe for use). The instruments are immediately ready for patient use or sterile storage. The sterilization process and equipment have been validated to ISO EN 14937, to include safety, compatibility and antimicrobial efficacy. Studies have been conducted to understand more about the mode of action of hydrogen peroxide gas, in comparison to liquid or plasma-based hydrogen peroxide systems, with some surprising results.

RECOMMENDATIONS BY THE QUALITY TASK GROUP (AK »QUALITÄT«)

Decontamination of Containers


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