Ethical and hygiene aspects of the reprocessing of medical devices in Germany.
Based on safety and quality principles, for each medical device (MD), regardless of its declared status as single- or multi-use device, careful considerations must be made. This includes assessment whether reprocessing is economical and ecological meaningful, and technical feasible. So far, however, in Germany reprocessing of declared single use MD is legally allowed, provided that the above aspects are well covered. The purpose of this paper is to elucidate, when circumstances allow reprocessing of declared single-use MD. For reprocessing of single use MD the following preconditions must be fulfilled:The security level of the reprocessed MD must be equivalent to the status of the newly delivered item; this means that a patient is not exposed to a higher risk through a reprocessed disposable MD than through the new, i.e. un-processed product.The reprocessing must be based on a detailed risk assessment and risk analysis, and must be described in detail regarding selection of the reprocessing method. Additionally, all necessary safety- and quality assurance measures must be stated.The reprocessing measure needs to be accompanied with a quality management system which determines and documents the responsibility of all stages of reprocessing; where the corresponding reprocessing procedures are well defined; and the efficacy of the procedure is proven by product-specific or product-group-specific tests and reports. The process must be validated according to recognised methods of science and technology, taking into account potential negative influences of the reprocessing on the properties of the material and the technical and functional safety. For reprocessing of MDs of the category Critical C the quality assurance must be certified by an accredited certifying body.
Kramer
Axel
A
Institute for Hygiene and Environmental Medicine, Ernst-Moritz-Arndt-University, Greifswald, Germany.
Assadian
Ojan
O