[Safe reprocessing of medical devices with a view of the entire process chain. Recommendations of the VDI 5700 guidelines]. / Aufbereitung von Medizinprodukten unter Einbeziehung von Risikomanagementprozessen. Empfehlungen der Richtlinie VDI 5700.

The 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.

[Experiences with drinking water ring trials and consequences for assessment and control of drinking and bathing water]. / Erfahrungen aus Trinkwasser-Ringversuchen und Konsequenzen für Beurteilung und Beanstandung von Trink- und Badewasser.

Collaborative studies of comparative investigations of standardized drinking water were performed within Lower Saxony since two years. The results show that the precision of the measurements even in the reference laboratories is substantially less than the measuring tolerance given by the Federal Drinking Water Regulation. Therefore, the standard deviation of the different parameters, variation coefficients, respectively, are to be used for the internal statistical quality control as well as for the judgment of water. Protests against drinking water, bath water, respectively, due to parameters exceeded should be made just if the guide or imperative values are exceeded by the threefold standard deviation experimentally determined in reference laboratories.