• Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Dec 2014

    [Safe reprocessing of medical devices with a view of the entire process chain. Recommendations of the VDI 5700 guidelines].

    • M Kraft, F Wille, J Attenberger, and U Müller.
    • Institut für Konstruktion, Mikro- und Medizintechnik, Fachgebiet Medizintechnik, Technische Universität Berlin, Dovestraße 6, Berlin, Deutschland, marc.kraft@tu-berlin.de.
    • Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2014 Dec 1;57(12):1393-401.

    AbstractThe reprocessing of medical devices for low pathogen or sterile use is in itself potentially risky even though the aim of reprocessing is the avoidance of hygienic or technically functional risks. The methodological principles of risk management for medical devices are described in the standard DIN EN ISO 14971. The recommendations of the Commission for Hospital Hygiene and Infectious Disease Prevention (Kommission für Krankenhaushygiene und Infektionsprävention KRINKO) of the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (Bundesinstituts für Arzneimittel und Medizinprodukte BfArM) "hygiene requirements for the reprocessing of medical devices" clarify numerous reprocessing-specific risks and are structured with reference to the different steps of reprocessing. The aim was a practical combination of the normative risk management methodology with the process-oriented KRINKO/BfArM recommendations, which has provided an interdisciplinary group of experts moderated by the Association of German Engineers (VDI). The main contents of the VDI 5700 guidelines on "hazards associated with the reprocessing--risk management in the reprocessing of medical devices--measures for risk control" and the process of the development of these guidelines is described.

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