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
  "Appropriate reprocessing poses little or no risk to the public, as evidenced from the findings of the GAO report, the FDA, the CDC, infection control officials, risk managers and quality consultants. It represents responsible waste management and appropriate use of scarce health care resources."
  
  John Clough, M.D.
  Chairman, Health Affairs
  Cleveland Clinic Foundation, Cleveland, Ohio.
  Testimony of the American Hospital Association before the Health, Education, Labor and Pensions Committee of the United States Senate on the Reuse of Medical Devices
  
  AHA Position Statement: "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.
• ANA - American Nurses Association
  RESOLVED, that the American Nurses Association supports improved end-of-use management including the reprocessing of appropriately identified FDA-labeled single-use devices based on law and regulations; and
  
  RESOLVED, that the American Nurses Association supports best practices for the various reprocessing methods and the safety of single-use devices for patients and healthcare workers
  For full resolution issued by ANA, 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.
• FDA - U.S. Food & Drug Administration
  "FDA believes that reprocessed SUDs that meet FDA's regulatory requirements are as safe and effective as a new device"
  
  September, 2006: Director CDRH
  (FDA’s Center for Devices & Radiological Health)
  
  "FDA officials have concluded…that the available data… does not indicate that reprocessed SUDs present an elevated health risk. FDA has analyzed its data on reported adverse events related to reprocessed SUDs and has concluded that there are no patterns that point to these devices creating such risks".
  
  January, 2008
  Randall B. Williamson
  Acting Director, Health Care
  United States Government Accounting Office
  
  For more information on FDA, click here.
• GOA
  "None of the representatives of MedSun hospitals who participated in the FDA focus groups reported being aware of any infections related to the use of reprocessed SUDs" furthermore, participants stated: "that there were actually fewer performance problems with reprocessed SUDs than with new SUDs. According to FDA, all participants believed that reprocessing establishments are more stringently regulated by FDA than are the manufacturers of the original devices, and this provided them a sense of confidence in the reprocessing process."
  
  2005 Medical Product Safety Network study (MedSun)
  GAO Report, January, 2008
  
  For more information on GOA, 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.