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Mission Statement
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.
Code of Conduct
Style Guide
REPROCESSING/REMANUFACTURING INDUSTRY VERBIAGE
Use “single-use medical device reprocessing industry” or “single-use medical device reprocessors” on first use; thereafter, “reprocessing” or “reprocessors” is acceptable.
When speaking of AMDR industry data, our credo, code of ethics or other member related products, use “AMDR member single-use medical device reprocessors” on first use; “AMDR member reprocessors” thereafter.
Note that “reprocessors” is used in North America for both hospital and professional operations; “professional remanufacturers” is the developed nomenclature for regulated commercial firms. Reprocess refers to hospital reuse.
Thus, for EU only materials, use “single-use medical device professional remanufacturers” or “professional remanufacturers.”
AMDR Suggested SUD Definition Language (US)
Although most SUDs cannot be safely re-used, some can be without added patient risk or loss of functionality. The reprocessing of SUDs requires strict FDA oversight and exhaustive documentation to prove to FDA that the SUD can be safely cleaned, tested, inspected, and reused.
In other words, the single-use label does not necessarily mean the SUD can only be used once.
AMDR Suggested SUD Definition Language (EU)
Although most SUDs cannot be safely re-used, some can be without added patient risk or loss of functionality. The remanufacturing of SUDs requires strict notified body and competent authority oversight and compliance with the EU Medical Device regulation to prove that the SUD can be safely cleaned, tested, inspected, and reused.
In other words, the single-use label does not necessarily mean the SUD can only be used once.
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