From the April 2016 issue of HealthCare Business News magazine
By: Dan Vukelich
Health care systems worldwide continue to look for ways to reduce costs and waste while maintaining high-quality care.
One tactic long used by hospitals in the U.S. and Germany to stretch limited resources is the reprocessing of “single-use” medical devices (SUDs). The Association of Medical Device Reprocessors (AMDR) is the international trade association representing the legal, regulatory and other trade interests of the commercial SUD reprocessing industry. With lessons learned from successfully establishing and promoting regulated SUD reprocessing in the U.S. and Germany, AMDR is advancing its mission to promote the proper reprocessing of SUDs in more countries. To ensure effective expansion, an emphasis is first put on educating about the three main driving forces of the practice — safety, savings and sustainability.
The foundation supporting rapid acceptance and growth of SUD reprocessing has been the reprocessing industry’s commitment to safety and regulatory compliance. In 2000, the Food and Drug Administration (FDA) implemented strict regulations for SUD reuse. Shortly thereafter, in 2002, the Recommendation of the Commission for Hospital Hygiene and Infection Control at the Robert Koch Institute in Germany, followed suit. The result of regulation has been proven device safety and efficacy from a regulatory standpoint, and ultimately, broad clinical support.
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In fact, sources such as the FDA, the U.S. Government Accountability Office (GAO) and a German (Bundesregierung) report to a parliamentary inquiry join a broad range of peer-reviewed clinical literature that has indicated that reprocessors in compliance with regulatory requirements produce devices that are as safe and as effective as new equipment. SUD reprocessing is now a best practice in the U.S. and Germany. Members of AMDR serve the majority of U.S. hospitals, including 13 of the 15 “honor roll” hospitals as listed by U.S. News & World Report (2015-2016), and over 1,000 German hospitals (including 35 university hospitals). The practice has earned validation from many professional clinical organizations, including the American Hospital Association (AHA), American Nursing Association (ANA) and the Association for Professionals in Infection Control and Epidemiology (APIC). Each of these organizations has issued statements in support of the FDA’s regulation of SUD reprocessing.
With regulation providing legitimization, reprocessing has grown dramatically. In 2000, the year the FDA began regulating SUD reuse, the commercial SUD reprocessing industry was estimated to be valued at $20 million. Today, one estimate from Transparency Market Research places the global SUD reprocessing market at over $750 million. Buying reprocessed devices provides significant savings for hospitals in terms of medical device costs and device waste disposal fees. In the U.S. and Germany, the average cost of a reprocessed device is a fraction of the cost of buying a new device, but savings could be more than 50 percent as most products can be reprocessed more than once. Hospitals also save when original equipment manufacturers (OEMs) lower their price to compete with reprocessors.