AMDR’s mission is to promote and protect the legal, regulatory and other trade interests of the third-party reprocessing (TPR) industry. As part of that mission AMDR supports:
- The proper reprocessing of medical devices labeled by the original equipment manufacturer for “single-use;”
- Reprocessed devices that are as safe and as effective as original devices;
- Reprocessing as a means of cutting healthcare costs while maintaining patient safety and quality of care; and
- Third-party reprocessing as an environmentally responsible practice.
- The highest possible standards of regulatory and professional conduct by its members
- Third-party reprocessing as an environmentally responsible practice;
- A forum for reprocessing issues;
- Education for healthcare providers, government officials, patients and the media about reprocessing issues.
AMDR defines “third-party reprocessor” as an 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 as 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;
- Unopened devices which have met or exceeded their expiration date.
