European Hospital reports, The Risks are Controllable; Report by the European Commission on the issue of the reprocessing of medical devices- commented by German Experts (10/01/10):
The reprocessing of single use medical devices is well-established in Europe. However, questions about the risk for patients and users arise constantly. The European Commission presented recently a kind of risk survey. The report strikes German experts as basically accurate but unbalanced…
…Now, those experts from Germany rise to speak, who engage themselves since years with the risk assessment of reprocessing of medical devices: the Expert Group for Safety in Medical Devices Reprocessing (smdr). The experts welcome the central claim of the European Commission for the improvement of patient safety. Notwithstanding, they think the report is unbalanced in many points. “It is good and important to allude to the risks, however, to be fair one has to say that professional reprocessing service providers control those risks”, states Prof. Axel Kramer, spokesman of the smdr and director of the Institute for Hygiene and Environmental Medicine at the University Clinic of Greifswald. “That though, the European Commission did not do.”
Thus claims the report the evaluation and validation of the entire reprocessing process of single use devices, but does not mention that in Germany it is regulated by law for a long time. “This claim is already included in the Medical Devices Operator Regulation and applies for the reprocessing of single use as well as reusable devices”, tells Axel Kramer….