Published on : July 31, 2012
Reprocessing “Single-Use” Medical Devices: A Sustainable Solution
In today’s market, healthcare providers are struggling to find reliable, low-cost solutions to reduce the financial and environmental burden of providing excellent care. FDA-regulated reprocessed medical devices are not only safe and effective, but use of such devices saves considerable financial resources, as well as dramatically reduces hospital-generated waste.
Under the strong oversight of the U.S. Food and Drug Administration (FDA), members of the Association of Medical Device Reprocessors (AMDR) reprocess (or clean, test, refurbish, package and sterilize, among other steps) select medical devices labeled by the original manufacturer as for “single-use.” These devices include orthopedic blades, compression sleeves, pulse oximeter sensors, cardiac catheters and laparoscopic surgical instruments. For over ten years, AMDR’s members have been providing America’s hospitals with reprocessed medical devices that are safe, FDA-regulated, lower-cost and environmentally-responsible.
AMDR promotes and protects the legal, regulatory and other trade interests of the nation’s third-party medical device reprocessing industry. As part of that mission, AMDR supports the proper reprocessing of medical devices labeled for “single-use” (or SUDs) ensuring that reprocessed devices are as safe and as effective as original equipment. Further, AMDR promotes reprocessing as a means of cutting healthcare costs and promoting environmental responsibility.
The reprocessing industry has demonstrated an exemplary record of safety over the last decade, when FDA extended its medical device manufacturer requirements to reprocessors. Since that time, informed health care facilities have increasingly supported the practice of reprocessing. AMDR’s members currently serve America’s finest medical facilities, including all institutions ranked by U.S. News & World Report as the nation’s “Honor Roll” hospitals.
Reprocessing is Strictly Regulated by FDA
Reprocessed medical devices are regulated by FDA, and as such have been found to be “as safe and as effective as a new device.” FDA has long considered third-party “reprocessors of devices labeled for single-use to be [medical device] manufacturers.” In 2000, the agency began subjecting reprocessors to all of its requirements for device manufacturers. FDA explained that a “manufacturer can market a device for one more single use from a raw material that was a previously-used, [single-use device] if that device meets the specifications of the device described in the market clearance.”
The reprocessing of medical devices originally labeled for “single use” is subject to a stringent, comprehensive regulatory scheme. In short, “FDA believes that reprocessed [single-use devices] that meet FDA’s regulatory requirements are as safe and effective as a new device.”
Reprocessed Devices Cost Less and Reduce Waste
FDA-regulated reprocessed devices are much less costly – typically about half the cost of an original device. This 50% savings incorporates all of the third-party reprocessors’ costs, including research and development, equipment and materials, staff, and the cost of recycling devices when they have reached the end of their life, among many other operational costs.
As far back as 2000, the U.S. Government Accountability Office (GAO) found that facilities using reprocessed devices saved between $200,000 and $1 million annually, on average. Currently, reprocessors estimate that a typical 200 bed hospital, if taking advantage of a reprocessors’ full product line, can save between $600,000 and $1 million dollars a year, and divert between 5,000 and 15,000 pounds of waste from landfills. The supply chain is typically one of the most costly departments of a hospital and the savings generated by reprocessed medical devices provides healthcare executives the opportunity to allocate limited resources towards other operational needs such as additional nursing hires, upgrades to technology, indigent care offerings, and necessary improvements to infrastructure.
Regulated medical waste (RMW), or “red bag waste,” is another wasteful expenditure that typically costs hospitals 5 to 10 times more to dispose than regular solid waste. Fortunately, many medical devices that end up in a hospital’s RMW are actually eligible to be reprocessed multiple times, eliminating the needless generation of more RMW while also reducing unnecessary waste disposal costs. Also, ninety-five percent (95%) of the reprocessed devices that have reached the end of their life are recycled versus sent to landfills. AMDR’s members recycle a variety of raw materials from devices that cannot be reprocessed or have reached their maximum number of reprocessing cycles, including stainless steel, aluminum, titanium, gold, polycarbonate and polyurethane parts.
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 the American Nursing Association, the Association of periOperative Registered Nurses, and Practice Greenhealth have recognized or endorsed reprocessing as a way to reduce waste.
The “Triple Bottom Line” on Reprocessing and Savings
The benefits of reprocessing medical devices are truly multi-fold; device users get a “single-use” device that, in terms of aesthetics and functionality, is equivalent to its predecessor; healthcare executive are able to generate savings for the hospital and reduce medical waste; and patients receive the latest in surgical care technology with uncompromised safety and at the same time allow for the maximization of limited healthcare resources.
The ongoing paradigm shift in healthcare – to provide the highest quality service at the lowest affordable cost – has substantially raised expectations for hospitals. The third-party reprocessing industry has been a catalyst for such a change since its inception, and AMDR is confident that reprocessed SUDs will continue to play an increasingly important role in our healthcare system.
1. For more information on AMDR’s members, see: http://www.amdr.org/about-amdr/members/.
2. See http://health.usnews.com/sections/health/best-hospitals; AMDR (2011).
3. Testimony of Dr. Daniel Schultz, Director, Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA), before the U.S. House Committee on Government Reform (26.9.2006) [hereinafter Schultz Testimony]. For a more detailed discussion of FDA’s requirements for medical device reprocessors, the “single-use” label, and the safety record of reprocessed devices, see AMDR’s Best Clinical Practice Background paper.
4. Letter from Melinda K. Plaisier, Associate Commissioner for Legislation, FDA, to The Honorable Thomas J. Bliley, Jr. (November 29, 2000), at 2 [hereinafter Plaisier letter]. See also Letter from D. Bruce Burlington, M.D., Director, Center for Devices and Radiological Health (CDRH), FDA, to Nancy Singer, Special Counsel, Health Industry Manufacturers Association (HIMA, now AdvaMed) (July 15, 1998), stating “reprocessors are inspected in accordance with the current Quality System regulation [QSR], Title 21, Code of Federal Regulations (CFR), Part 820, and they are subject to the labeling requirements of 21 CFR part 801. . . . In fact, FDA has considered such reprocessing firms to be manufacturers under the GMP regulations [which preceded the QSR] . . .” (emphasis added). Further, See also, CDRH, FDA, Guidance for Industry and FDA Staff: Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Medical Devices (Sept. 25, 2006), at 15. See also, Guidance for Industry and for FDA Staff, Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals (August 14, 2000), at 1 [hereinafter FDA Guidance of 2000].
5. This includes establishment registration and medical device listing (21 U.S.C. § 360 and 21 C.F.R. Part 807, subpart B), medical device reporting (21 U.S.C. § 360i(a) and 21 C.F.R. Part 803), medical device tracking (21 U.S.C. § 360i(e) and 21 C.F.R. Part 821), reports of corrections and removals (21 U.S.C. § 360i(f) and 21 C.F.R. Part 806), the quality system regulation (QSR) (21 U.S.C. § 360j(f) and 21 C.F.R. Part 820), and labeling requirements (21 U.S.C. § 352 and 21 C.F.R. Part 801).
6. Plaisier letter, supra note 4, at 2.
7. Schultz testimony, supra note 3. “FDA believes that reprocessed SUDs that meet FDA’s regulatory requirements are as safe and effective as a new device.”
8. U.S. Government Accountability Office, GAO/HEHS-00-123, Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but Oversight Warranted (June 2000), at 5 [hereinafter 2000 GAO Report].
9. Id, at 19.
10. Individual hospital results will vary. Savings and waste reduction estimates are based on averages achieved by actual customers using the full line of reprocessed devices. Contact a third-party reprocessor to complete a facility analysis and get a more accurate estimated savings potential based on your facility’s device usage data.
11. American Nursing Association, Resolution: Safety and Effectiveness of Reprocessed Single-Use Devices in Healthcare (2010); Association of peri-Operative Registered Nurses, AORN Position Statement on Environmental Responsibility (2006); Practice Greenhealth, Regulated Medical Waste.
About the Author
Daniel J. Vukelich, Esq. is the President of the Association of Medical Device Reprocessors (AMDR). Mr. Vukelich has been with AMDR since 2000. AMDR represents approximately 95 percent of the third-party medical device reprocessing done in the U.S. today. In addition to representing the reprocessing industry in the U.S., Mr. Vukelich also has represented the device reprocessing industry before state regulatory agencies, the European Commission and Parliament, Health Canada, and other international bodies.