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." Read full statement
• ACC - American College of Cardiology
  "Reprocessing is safe . . ." "Neither the FDA nor the CDC has found reprocessing to be unsafe . . ." Read full statement
• 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." Read full statement
• 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." Read full statement
• 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). Read full statement
• AORN - Association of peri-Operative Registered Nurses
  "Believes certain basic tenets must underpin any reprocessing program." "Believes the FDA’s goal in issuing this regulation is to ensure a reprocessing and reuse regulatory program that is based on good science and protects the public health." Read full statement
• 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. Read full statement
• 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." Read full statement
• IAHCSMM - The International Association of Healthcare Central Service Materiel Management
  "...due to the constant reductions in reimbursements, many healthcare facilities...reduce expenses without compromising quality. One cost-saving alternative...is the reprocessing of specific disposables by a third party reprocessor." Read full statement
• VHA
  "Medical device reprocessing includes all the steps performed to make a medical device patient-ready, including cleaning, function testing, sterilization and packaging."

Agencies Involved in Overseeing Reprocessing of SUDs

• US Congress - United States Congress
  "Oct. 26, 2002 the Medical Device User Fee and Modernization Act of 2002 . . . provided new regulatory requirements for reprocessed single-use devices (SUDs)." Read full statement
• CDC - Centers for Disease Control and Prevention
  [Dr. William Jarvis-Director CDC] "I would just be absolutely amazed if this is a major public health problem and the (leading hospitals) have failed to realize it." "To date, there is no strong evidence in this country that reprocessing medical devices leads to more adverse events than single use." Read full statement
• FDA - Food & Drug Administration
  "[Dr. David Feigal to Congress] . . . FDA does have the tools to ensure the safety, effectiveness, and manufacturing quality of reprocessed SUDs." "Third-party reprocessors are subject to the same regulatory requirements as other manufacturers, including premarket requirements." Read full statement and more
• FDA - Food and Drug Administration
  [Dr. Daniel Schultz to Congress] "Available data show that SUDs can be reprocessed with a reasonable assurance of safety and effectiveness. FDA believes that reprocessed SUDs that meet FDA's regulatory requirements are as safe and effective as a new device. The law and regulations in place are designed to protect the public health by assuring that the practice of reprocessing and reusing SUDs is based on sound science. FDA continues to monitor the performance of these devices and to assess and refine our ability to regulate these devices appropriately." Read full statement
• GAO - Congress - General Accounting Office
  "Single-Use Medical Devices - Little Available Evidence of Harm From Reuse, but Oversight Warranted June 2000 to Congress" Read full statement
• JCAHO - Joint Commission on Accreditation of Healthcare Organizations
  "Surveillance, Prevention, and Control of Infection IC.4.10- Reuse of equipment designated by the manufacturer as disposable in a manner that is consistent with [FDA] regulatory & professional standards." Read full statement
• OSHA - Occupational Safety & Health Agency
  Communication of hazards to employees. Train employees for handling hazardous materials. Title 29 CFR Part 1910.1030 – Blood Borne Pathogens Read full statement