Dan Vukelich
Reprocessing: Safety, savings, sustainability
April 20, 2016
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.
Safety
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.
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.
Savings
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.
The downward pricing pressure brought to the device market by reprocessors has helped to lower the cost of new devices. American hospitals alone generate over 4 billion pounds of waste a year and regulated medical waste (RMW) can cost five to 10 times more to dispose of than regular solid waste. Many medical devices can be reprocessed multiple times, eliminating the needless generation of more RMW, but also reducing a hospital’s waste disposal costs.
Reprocessing has allowed some hospitals to divert over 8,000 pounds of RMW from landfills each year, while larger systems can divert more than 50,000 pounds. Groups like ANA, the Association of periOperative Registered Nurses (AORN) and Practice Greenhealth have recognized or endorsed reprocessing as an effective waste reduction strategy.
The AMDR believes that the basis for the dramatic growth of SUD reprocessing, and broad clinical support, has been regulation. However, many countries do not yet have controls for proper SUD reuse. SUD reprocessing should not be taking place in the shadows without validated cleaning protocols or regulatory oversight. Thus AMDR supports worldwide efforts to regulate SUD reuse as a manufacturing activity, and a trend may be emerging. In 2015, both Canada and the United Kingdom released notice of their intentions to regulate SUD reprocessing as manufacturing, and the European Union is currently contemplating similar rules.
While AMDR is promoting regulating SUD reprocessing as manufacturing outside the
U.S., the recipe isn’t perfect yet — a few barriers to maximizing savings still exist for hospitals stateside. Reprocessing champions primarily need help navigating contracting hurdles from OEMs trying to limit reprocessing in an attempt to recoup profits lost to the practice. Even though competition is increasing between third-party reprocessors and OEMs, it’s an exciting time to be involved with, and advocating for, reprocessing growth. By restricting the reprocessing of SUDs to entities that can meet stringent manufacturing standards, subject to inspection and enforcement, health care regulators across the globe can stop inappropriate hospital reuse and give hospitals access to safe, regulated, lower-cost and environmentally friendly reprocessed devices.
Dan Vukelich, Esq., is president of the Association of Medical Device Reprocessors.
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.
Safety
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.
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.
Savings
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.
The downward pricing pressure brought to the device market by reprocessors has helped to lower the cost of new devices. American hospitals alone generate over 4 billion pounds of waste a year and regulated medical waste (RMW) can cost five to 10 times more to dispose of than regular solid waste. Many medical devices can be reprocessed multiple times, eliminating the needless generation of more RMW, but also reducing a hospital’s waste disposal costs.
Reprocessing has allowed some hospitals to divert over 8,000 pounds of RMW from landfills each year, while larger systems can divert more than 50,000 pounds. Groups like ANA, the Association of periOperative Registered Nurses (AORN) and Practice Greenhealth have recognized or endorsed reprocessing as an effective waste reduction strategy.
The AMDR believes that the basis for the dramatic growth of SUD reprocessing, and broad clinical support, has been regulation. However, many countries do not yet have controls for proper SUD reuse. SUD reprocessing should not be taking place in the shadows without validated cleaning protocols or regulatory oversight. Thus AMDR supports worldwide efforts to regulate SUD reuse as a manufacturing activity, and a trend may be emerging. In 2015, both Canada and the United Kingdom released notice of their intentions to regulate SUD reprocessing as manufacturing, and the European Union is currently contemplating similar rules.
While AMDR is promoting regulating SUD reprocessing as manufacturing outside the
U.S., the recipe isn’t perfect yet — a few barriers to maximizing savings still exist for hospitals stateside. Reprocessing champions primarily need help navigating contracting hurdles from OEMs trying to limit reprocessing in an attempt to recoup profits lost to the practice. Even though competition is increasing between third-party reprocessors and OEMs, it’s an exciting time to be involved with, and advocating for, reprocessing growth. By restricting the reprocessing of SUDs to entities that can meet stringent manufacturing standards, subject to inspection and enforcement, health care regulators across the globe can stop inappropriate hospital reuse and give hospitals access to safe, regulated, lower-cost and environmentally friendly reprocessed devices.
Dan Vukelich, Esq., is president of the Association of Medical Device Reprocessors.