Quality management for the processing of medical devices

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 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".

Keywords: certification; processing of medical devices; processing procedure; processing requirements; quality management; risk management.

Table 1. Example of a risk chart

Table 2. Risk analysis for an arthroscopic scraper (excerpts)

Figure 1. Process model for Vanguard AG (Special Processing)

Figure 2. Pictogrammes on processing (excerpt)

Figure 3. Processing procedure

Figure 4. Example of a user’s learning curve

Figure 5. Schedule of the development process

Figure 6. Identification procedure