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Reprocessed Single-Use Devices

Overview​

Reprocessing of single-use devices (SUDs) is a defined process consisting of cleaning, disinfection and/or sterilization, functional testing, relabeling, and repackaging of a used device to restore it for subsequent use. Reprocessing is regulated in Canada as a manufacturing activity, and reprocessors are subject to the same pre-market and post-market requirements as original device manufacturers.

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:

Reprocessors of SUDs must: Obtain a Device Licence for each reprocessed device they distribute. The Device Licence classification will depend on the risk profile of the reprocessed device, which is typically equivalent to or higher than the original device's classification.

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