AMDR’s mission is to protect the trade interests of the global commercial reprocessing industry and promote reprocessing as a healthcare strategy that increases quality, reduces costs and improves patient care.
WHO WE ARE
AMDR is the global trade association for the commercial single-use device reprocessing and remanufacturing industry. We advocate for reprocessing as an important healthcare advancement that improves patient care, reduces costs, and helps hospitals and healthcare providers increase quality. We advance the interests of our members in regulation, legislation and standard-setting world-wide and promote the benefits of a well-regulated, professional reprocessing industry. Having helped guide the establishment of the reprocessing industry since 2000, we continue to lead the way for reprocessing to play a defining role in the evolution and use of new device technologies that cost less, perform more safely and produce less waste.
Our paramount responsibility is to help healthcare institutions, including hospitals and clinicians, provide the best possible care for patients by ensuring that reprocessed single-use devices are as safe or safer than original equipment, while lowering costs. To meet this responsibility, we work to better align the medical device industry with the fundamental interests of patients, hospitals and healthcare providers by making single-use device reprocessing and remanufacturing a better understood and transparent supply chain strategy for all hospitals. We advocate for the same or similar levels of regulatory oversight for reprocessed devices as is applied to any other medical device manufacturer so that patients and our healthcare provider partners are assured that reprocessed devices are safe and effective.
THE ROLE OF REPROCESSING
Single-use medical device reprocessing plays a crucial role in helping hospitals achieve the triple aim of increasing quality, reducing costs and improving patient care. Use of regulated reprocessed SUDs ensures the highest possible quality, and lowers overall cost per device use, thereby enabling hospitals to access new technologies and serve a growing patient population.
Single-use device reprocessing is one of the most effective healthcare sustainability strategies available to hospitals and healthcare providers. Our members help to simultaneously reduce the environmental impact from discarding used medical devices and enable hospitals to enhance their financial sustainability.
WHAT THE FUTURE HOLDS
The use of reprocessed medical devices should be maximized in all hospitals and healthcare facilities, and we are committed to growing reprocessing in terms of volume as well as scope so that healthcare can continue to increase the responsible and safe reuse of medical devices.
We believe that the future of healthcare requires the medical device industry to enter a new paradigm where the focus is on providing value to healthcare rather than pursuing one-sided profit goals. This means that reprocessing should be an integrated element in medical device technology development and marketing.
You can find more about AMDR’s Code of Conduct here.
The Association of Medical Device Reprocessors (AMDR) serves as the trade association for commercial reprocessors of “single-use” medical devices. Based in Washington, DC, AMDR advocates on behalf of industry trade interests, which include, but are not limited to:
- The proper reprocessing of medical devices labeled by the original equipment manufacturer for “single-use;”
- Reprocessed devices that are as safe and effective as original devices;
- Reprocessing as a means of cutting healthcare costs while maintaining patient safety and quality of care;
- Commercial reprocessing as an environmentally responsible practice;
- The highest possible standards of regulatory and professional conduct by its members;
- A forum for reprocessing issues; and
- Education for healthcare providers, government officials, patients and the media about reprocessing issues.
Definition of Third-Party Reprocessor: Any FDA-regulated entity that, at the request of a provider customer, inspects, refurbishes, function tests, cleans, packages, and sterilizes medical devices labeled as “single-use” in such a manner that:
- The quality, physical characteristics, and functionality of the devices are not adversely affected, or such characteristics are improved;
- The devices remain safe and effective for an additional single-use; and
- The devices are reprocessed in full compliance with FDA regulations.