Current Position Statements

• ACC—American College of Cardiology
  "Reprocessing is safe . . ." "Neither the FDA nor the CDC has found reprocessing to be unsafe . . ." more
• 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." more
• 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." more
  
• 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." more
• 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." more
• 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." more
• 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." more
• H2E—Hospitals for a Healthy Environment
  ". . . affirm the Congressional goals and principles set forth in the Pollution Prevention Act . . . particularly the goal of reducing the generation of pollution at its source, preferentially to [recycle]." " . . . will reduce the waste disposal costs incurred by the health care industry." more
• VHA
  "Medical device reprocessing includes all the steps performed to make a medical device patient-ready, including cleaning, function testing, sterilization and packaging." more

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)." more
• 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." more and more
• 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." more
• 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 more
• DOT—Department of Transportation
  Devices for reprocessing must be source separated from biohazardous medical waste. Reprocessed sharps must be shipped in 510(k) cleared sharps container. Title 29 CFR Part 1910.1030 – Blood Borne Pathogens 1910.1030 (d) (4) (iii) Regulated Waste more
• GAO—Congress—General Accounting Office
  "Single-Use Medical Devices—Little Available Evidence of Harm From Reuse, but Oversight Warranted June 2000 to Congress" more
• 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." 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." more