AMDR's
mission is to:
• Promote
the proper reprocessing of medical devices labeled for single-use;
• Ensure the highest possible standards of regulatory and
professional conduct by its members;
• Reduce the cost of health care while maintaining patient
safety and care;
• Advance the right of medical professionals to have choices
in the use of reprocessed devices;
• Provide a forum for reprocessing issues; and
• Educate patients, health care providers, government officials,
the news media and others about reprocessing issues.
AMDR
defines "third-party reprocessor" as an
entity that, at the request of a customer, inspects, functionally
tests, cleans, packages, and sterilizes medical devices labeled
for single-use in such a manner that:
• The quality, physical characteristics, and performance functions
of the device are not significantly affected; and
• The device remains safe and effective for its appropriate
clinical use.
AMDR
members reprocess three categories of medical devices labeled for
"single use:"
• Opened and unused devices;
• Previously utilized devices; and
• Unopened devices whose expiration date has passed. |