Authors: B. Amann, T. Appel, D. Diedrich, C. Diekmann, B. Früh, J. Graf, M. Härtel, M. Kamer, G. Kirmse, M. Kostrzewa, S. Krüger, R. Otzmann,
K. Roth, M. Schick-Leisten, M. Schreiner, T. Schwibbe, U. Zimmermann
E-mail: qualitaet@dgsv-ev.de
1. Introduction
Measures must always be in place to ensure tracking of the process used to reprocess
medical devices (MDs) for initial use or reuse.
The following preconditions must be met for ➜ EFFECTIVE TRACKING:
–– Unambiguous identification of the MD
–– Documentation of the reprocessing process (IT-based state of the art)
–– Data archival and data backup
–– Reprocessing with validated processes
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