Single use medical devices (SUD) are devices that are intended to be used only once and then disposed of. However, due to costs savings associated with the reuse of these devices hospitals and other organizations are reprocessing them through cleaning, disinfecting and sterilization.
In 2000 FDA published the guidance document “Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals” which describes FDA’s enforcement priorities to third parties and hospitals that reprocess SUDs. Other countries have similar regulatory reprocessing requirements including Canada which recently under the existing Food and Drugs Act and Medical Devices Regulations established requirements for organizations, other than hospitals, that engage in reprocessing of SUDs. Health Canada will continue to allow oversite provided at the provincial and territorial levels to hospitals.
For organizations other than hospitals Health Canada states the following:
Under the federal regulatory framework, companies that reprocess and distribute medical devices originally authorized and labelled for single use to Canadian healthcare facilities will be held to the same requirements as manufacturers of new devices.
These companies must be in compliance with the following requirements:
- Quality system management
- Investigating and handling complaints
- Maintaining distribution records
- Conducting recalls
- Reporting incidents
- Informing Health Canada of any changes to the information in their license application
The Health Canada initial transition period for compliance of these companies was September 1, 2016 but has since extended this period by 12 months to September 1, 2017. At that time Health Canada expects all commercially reprocessed devices to be in compliance with the regulation whether they are reprocessed domestically or outside of Canada.