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- Title
Quality management for the processing of medical devices.
- Authors
Klosz, Kerstin
- Abstract
Rules on the reprocessing of medical devices were put into place in Germany in 2001. The present article explains the background situation and the provisions that are currently in force. The implementation of these statutory requirements is described using the example of the quality management system of Germany's market Management Manager, leader, Vanguard AG. This quality management system was successfully certified pursuant to DIN EN ISO 13485:2003 for the scope "reprocessing of medical devices", including class "critical C", in accordance with the recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert-Koch-Institute (RKI) and the German Federal Institute for Drugs and Medical Devices (BfArM) on the "Hygiene requirements for reprocessing of medical devices".
- Subjects
GERMANY; MEDICAL equipment safety measures; QUALITY control; PRODUCT quality; CONSUMER protection; PATIENT safety; MEDICAL equipment industry; WOUND infections; VANGUARD Group of Investment Cos.; PREVENTION
- Publication
GMS Krankenhaushygiene Interdisziplinaer, 2008, Vol 3, p1
- ISSN
1863-5245
- Publication type
Article