The Association of Medical Device Reprocessors (AMDR) represents the worldwide interests of commercial reprocessors (known in Europe as “remanufacturers”) of “single-use” medical
devices (SUDs) as a circular economy solution for healthcare. Commercial remanufacturers are regulated under the EU Medical Device Regulation (2017), and in the United States by the Food and Drug Administration (FDA). FDA has regulated SUD reprocessing now for over two decades and, over 300 kinds of devices labelled for “single-use” by their manufacturer have been evaluated as safe and effective after reprocessing by FDA and now also European Notified Bodies. Over 10,300 hospitals worldwide use professional, commercially available
remanufactured SUDs. Devices range from non-invasive EKG leads, tourniquet cuffs and pulse oximeter sensors, to invasive devices used in laparoscopic surgery and cardiac imaging devices. . .