The reprocessing of medical devices labeled for “single-use” has been standard practice in United States hospitals for years. Medical device reprocessing emerged over two decades ago, when original equipment manufacturers (OEMs) began to change the labels on certain devices from “reusable” to “single-use,” without making significant structural changes in the devices. Hospitals recognized that the “single-use” label was often motivated by economic objectives, rather than patient safety concerns. Thus, rather than needlessly discarding such devices after one use, hospitals began to reprocess them.
Historically, the majority of reprocessing had been conducted at in-hospital reprocessing centers. In the last decade, however, the third-party reprocessing industry emerged at the request of hospitals that were seeking a way to outsource their reprocessing needs.
Today, third-party reprocessing is a small but expanding industry. Approximately 95% of the third-party reprocessing done in the United States is performed by two companies, which comprise the membership of the Association of Medical Device Reprocessors (AMDR).
