To promote and protect the legal, regulatory and other trade interests of the global third-party reprocessing (TPR) industry.
The Association of Medical Device Reprocessors (AMDR) serves as the trade association for third-party 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;
- Third-party 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.
AMDR members reprocess three categories of medical devices labeled for “single-use”:
- Open and unused devices;
- Previously utilized devices; and
- Unopened devices which have met or exceeded their expiration date.