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U.S. Department of Health and Human Services

Medical Devices

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Reprocessing of Single-Use Devices

Reprocessing and reusing single-use devices (SUDs) can save costs and reduce medical waste. But before medical devices can be reprocessed and reused, a third-party or hospital reprocessor must comply with the same requirements that apply to original equipment manufacturers, including

  • Submitting documents for premarket notification or approval
  • Registering reprocessing firms and listing all products
  • Submitting adverse event reports
  • Tracking devices whose failure could have serious outcomes
  • Correcting or removing from the market unsafe devices
  • Meeting manufacturing and labeling requirements

 

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