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Central Service - Issue 6/2009

Central Service - Issue 6/2009

Central Service - Issue 6/2009


  • What's New in Standardisation: Steam Penetration Test
  • Requirements and Responsibility for Medical Device Reprocessing. DGSV Congress in Fulda, 15 - 17 October 2009
  • Summaries of the Workshops held at the DGSV Congress in Fulda
  • 10th CSSD-Hygiene Forum. Damp Congress Centre - 31 October 2009


Eric Bertrand* and Joël Schlatter:
Management of the Implementation of an RFID Solution for Ancillaries: Cartography of Risks with the Preliminary Risk Analysis Method

Ancillary surgical materials are medical devices, such as an orthopedic instrument set for reconstruction of the knee used to implant or extract a prosthesis. Their management involves the departments of sterilization and surgery as well as the suppliers. The processing circuit exposes the instruments to potential hazards like a lack of traceability at the suspicion of Creutzfeldt-Jakob disease (CJD). In order to reduce the risk of errors we will propose the implementation of the RFID technology to trace the ancillaries during each step of the supply chain. The objective of our study is to analyze and to map the risks associated with RFID implementation. A preliminary risk analysis (PRA) is conducted to map out the hazards for the implementation of the RFID solution. The PRA identifies 162 scenarios with a maximum risk due to environment and technology. To reduce the identified risks, 22 courses of action are proposed, such as audits, staff training, and internal controls. For each action, a procedure has been designed and evaluated. This preliminary analysis of risks allows targeting the potential dangers for the RFID technology implementation applied to ancillaries and reduces them significantly.

J. Köhnlein, R. Glasmacher, V. Heide, D. Kunde, M. Mohr, D. Otto, M. Pieper, K. Roth, J. Staffeldt, P. Tiarks, S. Wagenknecht, H.-P. Werner, W. Michels*:
Multicentre Trial on Standardisation of a Test Soil of Practical Relevance for Comparative and Quantitative Evaluation of Cleaning Pursuant to EN ISO 15883 - Description of Test Procedure

The ad hoc group "Test soils and methods", part of the standards committee NA Med 063-04-09 of the DIN, had reported in a previous edition of this journal initial results of a multicentre trial with an "in vitro reference system" for the comparative evaluation of test soils for testing the cleaning performance of washer-disinfector appliances (WD) according to EN ISO 15883-1 and ISO/TS 15883-5. Exploratory information about materials and methods was given there. This contribution now gives detailed information on the execution of the tests.


F. Weller*, M. Schäfer, S. Wunder, G. Burandt:
Implications of Reprocessing for Development of Surgical Motor Systems

This paper reports on the state of the art in respect of the development and manufacture of surgical motor systems, while taking account of current reprocessing requirements. Titanium, which is used as a material for motor system casings, can be subjected without restriction to alkaline reprocessing, thus assuring their problem-free integration into the existing sterile-supply processing chain. Novel maintenance concepts serve to increase the availability of such systems as well as their safety when used for treatment purposes.


Outlook of DGSV Quality Task Group's Activities for 2010)

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