MedTech Summit Preview: AMDR’s Dan Vukelich Talks Reprocessing, Europe & MDRs
Dan Vukelich, President at the Association of Medical Device Reprocessors (AMDR), USA, who will be presenting at the MedTech Summit in June, explains that for single use devices: “Everything is set to change in Europe with regard to the reuse of “single-use” devices (SUDs). Practices vary by country. Some hospitals, such as in Germany, reuse SUDs under regulations. Others, such as France, have banned it altogether. The bulk of SUD reprocessing, overtly or covertly, lawful or unlawful, has been happening within hospitals. With the adoption of the MDR, a more harmonized approach is going to take shape which will, in AMDR’s view, steer hospitals to reprocess SUDs through regulated, commercial remanufacturers which demonstrate conformance to all medical device manufacturer requirements.” Access the complete MedTech Insight interview with Dan in the December 7, 2016 edition here (subscription required).
Dan Vukelich, President at the Association of Medical Device Reprocessors (AMDR), USA, who will be presenting at the MedTech Summit in June, explains that for single use devices: “Everything is set to change in Europe with regard to the reuse of “single-use” devices (SUDs). Practices vary by country. Some hospitals, such as in Germany, reuse SUDs under regulations. Others, such as France, have banned it altogether. The bulk of SUD reprocessing, overtly or covertly, lawful or unlawful, has been happening within hospitals. With the adoption of the MDR, a more harmonized approach is going to take shape which will, in AMDR’s view, steer hospitals to reprocess SUDs through regulated, commercial remanufacturers which demonstrate conformance to all medical device manufacturer requirements.” Access the complete MedTech Insight interview with Dan in the December 7, 2016 edition here (subscription required).