Medical devices for single use
BASG statement on media reports on the reprocessing of medical devices intended for single use.
The current Austrian legal situation requires that medical devices are used in accordance with the manufacturer's intended purpose.If a medical device intended by the manufacturer for single use is reprocessed, the reprocessor becomes the manufacturer. The latter assumes responsibility for the legal conformity of the reprocessed product and ensures its safety and effectiveness. Otherwise, reprocessing is prohibited.As part of the preparatory work for the new European Regulation on Medical Devices, the European Commission proposes the strictest rules for the reprocessing of single-use devices in order to ensure a high level of safety and health protection, while allowing this real practice of reprocessing to develop within the framework of clear provisions for the benefit of patients. The European Commission relies on the opinion of the Scientific Committee on Emerging and Newly Identified Health Risks ("SCENIHR") of April 15, 2010, which, in analogy to the already existing Austrian regulation, considers the reprocessing of single-use devices as the manufacture of new products. Therefore, reprocessors of single use devices must comply with all requirements applicable to manufacturers. It is under discussion that the reprocessing of single-use devices used in particularly sensitive areas (for example, devices for surgical interventions) should be prohibited in principle. Since certain member states may have particular concerns about the safety of reprocessing single-use devices, they are to retain the authority to prohibit this practice altogether, as well as the transfer of single-use devices to other member states or third countries for the purpose of reprocessing and the import of reprocessed devices.The exact wording and date of entry into force of the new European Medical Devices Regulation are not yet known. Inquiries - Press: Christian Eisnerpresse@ages.atTel.: +43 (0) 50555 25212Inquiries- technical: Institute Monitoring Tel.: +43 (0)50 555-36401 E-mail: firstname.lastname@example.org