Our Mission

Our Mission

AMDR Mission: 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.