February 5, 2015

 

Notice to Stakeholders – Health Canada’s Regulatory Approach to Commercial Reprocessing of Medical Devices Originally Labelled for Single Use

 

Single-use medical devices are those labelled by their manufacturers to be used only once. For years, hospitals have reprocessed – cleaned, sterilised and disinfected – some of these devices for reuse to save costs.  More recently, hospitals have begun contracting companies to perform this service. Through discussions on the new patient safety legislation (Bill C-17), Health Canada has concluded that it has authority under the existing Food and Drugs Act and Medical Devices Regulations to require that these commercially reprocessed devices meet appropriate standards for safety, effectiveness and labelling. With regard to reprocessing on-site by hospitals, however, Health Canada will continue to respect the current oversight provided at the provincial and territorial level.

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. This means they must meet requirements for licensing, quality system management, labelling, investigating and handling complaints, maintaining distribution records, conducting recalls, reporting incidents and informing Health Canada of any changes to the information in their licence application. To fulfil labelling requirements, reprocessed devices should clearly identify the reprocessor as the manufacturer and contain instructions for safe reuse, such as how or by whom the device should be reprocessed. In addition, the single-use symbol should be removed from the label.

Over an anticipated 18-month transition period, Health Canada will work with the commercial reprocessing industry to bring their activities and products into compliance with the Regulations. To begin, the department will meet with industry associations in the next few months to promote awareness of the regulatory requirements and determine their readiness to meet them. Companies will be expected to apply for device and establishment licences as appropriate, and prepare to phase out the supply of non-compliant devices. Reprocessed devices that have obtained licences must meet the terms of their market authorizations, including labelling.  By September 1, 2016, all commercially reprocessed devices are expected to be in compliance with the Regulations, whether they are reprocessed domestically or outside Canada. Non-compliant devices and activities will continue to be subject to risk-based compliance enforcement.