The Association of Medical Device Reprocessors (AMDR), the trade association representing the FDA-regulated, third-party medical device reprocessing industry, has released a response to a recent Society of Gastroenterology Nurses and Associates, Inc. (SGNA) position statement on critical reprocessed “single-use” devices.

In its position, SGNA suggests there is an “absence of substantial scientific evidence to provide the safety and effectiveness of reprocessed critical medical devices,” and recommends that single-use devices not be reused.

AMDR’s response:

It is AMDR’s response that the SGNA position mischaracterizes the evidence supporting the safety of single-use device reprocessing, particularly as FDA is the accepted data standard by which all others in this country rely.  The agency’s 510(k) substantial equivalence process, as applied to medical device manufacturers, including reprocessors, is used to acquire evidence to demonstrate that the device in question is “at least as safe and as effective as the legally marketed [predicate] device.”

AMDR’s members fully support FDA regulation, and despite SGNA’s claims, the FDA process ensures that the scientific evidentiary standard in the U.S. has been met for reprocessed devices.  FDA’s conclusions as to medical device safety are well established, well respected by the clinical community, and often recognized as the international standard.

Beyond FDA’s safety and efficacy findings, the U.S. Government Accountability Office (GAO), the investigative arm of Congress, looked at the practice of reprocessing SUDs twice in eight years and found no evidence of increased risk to patients.  The GAO’s first examination yielded a report entitled Single Use Medical Devices: Little Available Evidence of Harm from Reuse, but Oversight Warranted (June 2000), concluding, “the safety of reprocessing some types of devices has been established by well-developed clinical studies.  Studies have shown both that reprocessing procedures can be safely accomplished and that patient outcomes are not adversely affected by the use of reprocessed SUDs.”

Because of strict and beneficial industry regulation, reprocessing has grown from a $20 million industry in 2000 to a $400 million industry today.  Professional and clinical organizations such as the American Hospital Association, American Nursing Association, and the Association for Professionals in Infection Control & Epidemiology have issued statements in support of SUD reprocessing as regulated by FDA.  Outsourcing reprocessing of SUDs from FDA-regulated vendors has become the standard of care among a majority of U.S. hospitals, including 16 of the country’s 17 Honor Roll hospitals, as ranked byU.S. News & World Report. 

These organizations embrace the outstanding safety record of reprocessing and understand it is one of the most important strategies hospitals can implement to contain costs and reduce waste. AMDR encourages SGNA to reconsider its position and join other clinical associations in support of third-party reprocessing.

U.S. healthcare providers have a responsibility to deliver safe and effective medical care, and at the same time attempt to control spiraling costs. Third-party reprocessors empower our hospitals partners to maintain the highest quality of care standards and reduce the costs associated with medical devices and medical waste.


Read AMDR’s article in EndoNurse here

AMDR’s full response is here