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Reprocessed Single-Use Devices

Overview​

Reprocessing of single-use devices (SUDs) refers to the cleaning, disinfection or sterilisation, testing, relabelling, and repackaging of a used SUD so that it can be used again. Reprocessing SUDs is a regulated activity in Canada.

Who reprocesses SUDs?​

  • Hospital-based reprocessing departments (reprocessing for internal use)
  • Third-party commercial reprocessors (reprocessing for distribution to healthcare facilities)

Regulatory position​

Health Canada considers a reprocessed SUD to be a new medical device requiring its own Device Licence. The reprocessor is treated as the manufacturer of the reprocessed device.

Requirements for reprocessors​

Reprocessors of SUDs must:

  1. Obtain a Device Licence for each reprocessed device they distribute (Class II, III, or IV)
  2. Demonstrate that the reprocessing cycle does not adversely affect the device's safety, effectiveness, or performance
  3. Validate the cleaning, disinfection/sterilisation process for the specific device
  4. Validate that the device's functionality is maintained after reprocessing
  5. Relabel the device to identify it as reprocessed, including the reprocessor's name and address
  6. Maintain a QMS and hold an MDEL

Validation requirements​

Reprocessing validation must demonstrate:

  • Effective removal of soil and biological contamination (cleaning validation)
  • Effective killing of pathogens (sterilisation validation)
  • Device functionality and performance post-reprocessing (functional testing)
  • Maintenance of device material integrity

Hospital-based reprocessing​

Hospitals that reprocess SUDs for internal use only (not for distribution) may operate under a different framework. Health Canada has published guidance on hospital-based reprocessing. Hospitals must still follow validated processes and maintain records.

Legislative source: Medical Devices Regulations, SOR/98-282; Health Canada Guidance on Reprocessing Single-Use Medical Devices