Health Care: Reprocessed Medical Single-Use Devices in DoD
Abstract
Medical single-use devices are manufactured to be used on one patient during one medical procedure Multiple-use devices are intended to be used more than one time and include instructions for decontamination and resterilization. The emergence of new materials and sterilization methods, and the increasing costs of health care, resulted in the development of medical single-use devices and the practice of reprocessing the devices. The practice of reprocessing medical single-use devices increased when hospitals realized that reuse produced up to a 50 percent savings compared with purchasing new single-use devices, Over time, the complexity of medical single-use devices increased and third-party reprocessors evolved to meet the increased demand of making used single-use devices patient-ready, The DoD worldwide military health system operates an extensive system of military treatment facilities (medical centers, hospitals, and clinics), As of September 2002, there were 27 Army, 25 Navy, and 22 Air Force medical centers and hospitals and approximately 460 clinics in the United States and overseas, The Food and Drug Administration regulates medical single-use device reprocessors, On August 14, 2000, the Food and Drug Administration issued regulatory guidance for third-party and hospital reprocessors regarding their responsibility as manufacturers engaged in reprocessing devices labeled for single use, Under the Food and Drug Administration guidance, third-party and hospital reprocessors are required to undergo the same scrutiny as original medical device manufacturers.
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 30, 2002
- Accession Number
- ADA406557
Entities
Organizations
- Office of the Inspector General, U.S. Department of Defense