What is Single use medical device reprocessing?

Single-use medical device reprocessing is the disinfection, cleaning, remanufacturing, testing, packaging and labeling, and sterilization among other steps, of a used, , medical device to be put in service again. All reprocessed medical devices originally labeled for single use in the United States are subject to U.S. Food and Drug Administration manufacturing requirements and must meet strict cleaning, functionality, and sterility specifications prior to use. Although first regulated in the U.S., the reprocessing of medical devices, particularly those that are labeled “Single Use Device” , is a global practice with countries in Europe, Asia, Africa, and North America actively engaged in reprocessing. Currently, approximately 2% of all SUDs on the U.S. market are eligible for reprocessing by a qualified commercial vendor. Reprocessing industry estimates indicate the amount of revenue saved by hospitals that use reprocessed devices to be $471 million in 2018. Over 8,800 hospitals and surgical centers use reprocessed devices, in the U.S., Canada, Israel, Europe and Japan, according to the Association of Medical Device Reprocessors.