Central Service - Issue 6/2006
- What's New in Standardisation: Bowie & Dick Test
M. Knoll*, J. Richter, A. Kaetzke, J. Weilepp, I. Horn, M. Borneff-Lipp:
Quality Management in a Central Sterile Supply Department: Introduction and Certification
(Zentr Steril 2006; 14 (6): 427-437)
The subject matter of this study was the introduction and certification of a quality management system for the Central Sterile Supply Department of a hospital, offering a maximum range of services, pursuant to DIN EN ISO 9001: 2000 as well as DIN EN ISO 13485:2003.
The University Hospital of the Martin-Luther University Halle-Wittenberg has a Central Sterile Supply Department with 46 staff members, working in several shifts.
For analysis of the current situation, which served as the basis for assessment of the sterile supply situation, we carried out structured observation followed by categorisation and fishbone analysis.
An analysis of the current situation revealed some shortcomings that could be overcome. The Quality Management Manual (QMM) was restructured. No weak points were detected in the management of the records kept, and the software-based documentation had proved to be up to its task. As regards the "Provision of resources", "Quality targets and client requirements" as well as "Procurement", it was noted that the provisions of the standards had been met. The certificate was handed over on 6 December 2006.
Certification as per DIN EN ISO 9001:2000 and DIN EN ISO 13485:2003 enables one to verify the quality management system (QMS). It is not the outcome of the decontamination process that is checked, but rather the decontamination process itself. This gives the client (user) a guarantee that the system will be continually updated while taking into account the client’s wishes.
quality management, DIN EN ISO 9001:2000, DIN EN ISO 13485:2003, sterilisation, Central Sterile Supply Department, certification
N. Rörup, N. Aschenbrenner*, C. Conrad, M. Pem, B. Schmid:
Quality Management System for the Central Sterile Supply Department
(Zentr Steril 2006; 14 (6): 438-445)
In view of the stringent quality demands stipulated by the legal provisions of the Swiss Medical Devices Regulation (MepV), the Regulation for Prevention of Creutzfeldt-Jakob Disease during medical and surgical procedures (CJKV) and the guidelines and standards of the Swiss and German statutory authorities, a working group was set up at the Kantonsspital Schaffhausen hospital. The task assigned to this working group was to devise a quality management system (QM system) for the Central Sterile Supply Department (CSSD) and the Central Bed Department (CBD).
Once a student (of infection control and food technology) had investigated and documented all procedures and working steps, a quality management document (QM document), serving as the basis for the QM system for the CSSD/CBD and assuring ongoing development of this system, was compiled within a period of 6 months. The QM documentation is broken down into specified documents: Quality Management Manual (QM Manual), Procedures, Quality Instructions and Standard Operating Instructions) and supporting documents such as Forms, Checklists, etc.
Once this QM documentation had been completed, an implementation schedule was devised to put into practice the QM system and provide for initial internal and external verification of this system. This QM system was introduced into the CSSD/CBD of the Kantonsspital Schaffhausen in order to document and enhance the quality of decontamination processes, reduce infection risks and portray and document specialist, impeccable decontamination of medical devices in a transparent manner.
quality management system, CSSD, sterilisation, standards
P. A. de Vries*, P. de Haas, J. de Geus:
Trending of Air Leakage Test Results
(Zentr Steril 2006; 14 (6): 446-451)
The BD test, the ETS and the air leakage test is performed daily on our steam sterilizers. Although every individual test result met the requirements, a slumbering fault in one of the sterilizers was present that could only be detected with the use of trend analysis of the results of the air leakage test and the BDvalues of the ETS. Because the tests were performed daily the problem could be found early and corrected before the air leakage test failed and corrective maintenance had to be done.
trend analysis, air leakage test, daily test, ETS
Argumentation about the Need of a Standard for the Sterilization of Hollow Devices
(Zentr Steril 2006; 14 (6): 452-457)
Over the last 30 years the load configuration of materials reprocessed by steam sterilization in Italian hospitals has changed dramatically.
Today particular attention has to be addressed to narrow lumened hollow instruments; it has to be checked if the cleaning procedure and sterilization process have been carried out successfully inside the lumen.
Today some tests are offered on the market that guarantee the requested performance to assure that sterilization is carried out successfully in the most difficult places.
hollow devices, standard, EN 285, EN 13060
Quality Management in the CSSD - Standard Surgical Instruments (1):
RECOMMENDATIONS BY THE QUALITY TASK GROUP (AK »QUALITÄT«)