Expert & Leader of department: Prof. Dr.-Ing. Marc Kraft
The reprocessing of medical devices is a cornerstone of quality medical treatment, both in economic and ecological terms. The issue of reprocessing relates to complex and costly medical devices that cannot be reprocessed in hospitals and which previously had to be disposed of at great cost. However, thanks to new tried and tested product-specific procedures, even products as complex as minimally invasive instruments or heart catheters can be processed for re-use. This leads to considerable cost savings for hospitals and medical practices, allowing patients to be part of the advancement in medicine. As a result, modern operating techniques like laparoscopy can continue to be affordable. In terms of risk assessment, the task is to ensure strict observation of the Joint Directive of Recommendations of the Kommission für Krankenhaushygiene und Infektionsprävention [Commission for Hospital Hygiene and the Prevention of Infections] at the Robert-Koch Institute (RKI) and the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) [Federal Institute for Drugs and Medical Devices]. This calls for expertise from hygienists and medical lawyers, in particular.
- An-Overview-of-Medical-Device-Law-in-Germany.pdf (148.9 KiB)
- Framework-Conditions-and-Requirements-to-Ensure-the-Technical-Functional-Safety-of-Reprocessed-Medical-Devices.pdf (123.7 KiB)
- Legal-Framework-Conditions-for-the-Reprocessing-of-Medical-Devices.pdf (142.6 KiB)
- The-Risks-are-Controllable-Reprocessing-of-Medical-Devices-commented-by-German-experts.pdf (88.2 KiB)
- Ultracision-scissors-New-single-use-instruments-vs-resterilised-single-use-instruments.pdf (116.8 KiB)
- Using-Reprocessed-Devices-Does-Not-Impair-Patient-Safety.pdf (1.7 MiB)