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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:

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

Expand 'Hospital-based reprocessing' section: "Health Canada distinguishes between hospital-based reprocessing (for internal institutional use) and commercial third-party reprocessing. Hospital departments that reprocess SUDs exclusively for internal use are not required to obtain a Device Licence, provided they follow Health Canada's guidance on validated processes, maintain detailed records, and do not distribute the reprocessed devices. However, if a hospital sells or distributes its reprocessed devices to other facilities, it must obtain a Device Licence and comply with all commercial reprocessor requirements. All reprocessors, whether hospital-based or commercial, must maintain comprehensive validation documentation and traceability records."