Position Statements

The reprocessing of single use medical devices is becoming an increasingly important initiative for more and more healthcare facilities. This reality has led to a concerted effort on the part of an array of professional organizations and associations to develop position statements regarding Reprocessing. The following links offer the statements issued by prominent entities that are involved in some form or another with reprocessing.

• AAOS - American Association of Orthopedic Surgeons
  " . . . believes that the labeling of a device as 'single-use' should be substantiated." "If a reprocessed device meets established safety and efficacy criteria, then it may be functional for more than one use." For more information on AAOS, click here.
• ACC - American College of Cardiology
  "Reprocessing is safe . . ." "Neither the FDA nor the CDC has found reprocessing to be unsafe . . ." For more information on AAC, click here.
• AHA - American Hospital Association
  "The clinical use of reprocessed medical devices is safe, effective, and efficient. Hospitals have reprocessed devices labeled 'single use' or 'disposable' for years with excellent success." For more information on AHA, click here.
• AMA - American Medical Association
  "The AMA supports the Food and Drug Administration (FDA) guidance titled 'Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals' that was issued on August 2, 2000." "The AMA supports the development of device-specific standards for the reuse and reprocessing of single-use medical devices involving all appropriate medical and professional organizations and the medical device industry." For more information on AMA, click here.
• APIC - Association for Professionals in Infection Control and Epidemiology
  "APIC is in support of the FDA’s requirements for devices meeting the criteria for reprocessing as described in the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). For more information on APIC, click here.
• AORN - Association of peri-Operative Registered Nurses
  "AORN believes the perioperative registered nurse...serve as a steward of the environment by...actively promoting and participating in resource conservation.  [This] includes, but is not limited to...waste...management; recycling; reprocessing of single-use devices according to local, state, and federal regulations; repair/restoration/refurbishment of appropriate medical devices and instruments..." For more information on AORN, click here or visit the AORN website.
  
• ASGE - American Society of Gastrointestinal Endoscopy
  "Properly maintained and reprocessed reusable devices remain safe and effective. Both single-use and reusable accessories function well, and the selection of one or another class of devices must be based upon local purchase costs, reprocessing costs and abilities, storage and disposal facilities, and personal preferences. For more information on ASGE, click here.
• ASHCSP - American Society for Healthcare Central Services Professionals
  " . . . supports the reuse of single use devices." " . . . strongly recommends that reprocessing be performed by a third party reprocessor." For more information on ASHCSP, click here.
• VHA
  "Medical device reprocessing includes all the steps performed to make a medical device patient-ready, including cleaning, function testing, sterilization and packaging." For more information on VHA, click here.