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U.S. Department of Health and Human Services

Medical Devices

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How are Reusable Medical Devices Reprocessed?

Adequate reprocessing of reusable medical devices is a critically important step in protecting patient safety. Reprocessing is intended to remove blood, tissue, and other biological debris and to inactivate infectious microbes so that devices are safe for the next patient.

Reprocessing is labor-intensive and time-consuming. Each reusable medical device requires a specific reprocessing regimen.

Reprocessing is performed by trained staff at:

  • Large health care facilities
  • Small inpatient and outpatient facilities
  • Small medical office suites
  • Stand-alone provider facilities such as ambulatory surgery centers
  • Stand-alone reprocessing service facilities

In general, reprocessing reusable medical devices involves three steps:

  1. At the point of use, such as in the operating room, devices receive initial decontamination and cleaning, and steps are taken to prevent drying of blood, tissue, other biological debris, and contaminants on the device.
  2. The device is then transferred to the reprocessing work area where it is thoroughly cleaned.
  3. Finally, the device is either disinfected or sterilized, depending on the intended use of the device, and the materials from which it is made, and it is stored or routed back into use.

A more detailed description of reprocessing is included in Appendix A of FDA's Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.