Mr. Speaker, I would be remiss if I did not begin by highlighting our government's recent passage of Vanessa's Law, which received royal assent just a few weeks ago. It will help quickly identify dangerous drugs and ensure the quick recall of unsafe drugs. It requires the reporting of serious adverse reactions so we are aware of new risks.

I would also like to point out, and this is critical to the hon. member's debate, that the purchase and use of single-use medical devices are part of the practice of medicine and thus fall under provincial and territorial jurisdiction, not federal jurisdiction. I simply cannot agree that the federal government is absent from regulating this activity. In fact, I am pleased to report that Health Canada has licensed its first reprocessed medical device.

Health Canada received an application from a reprocessor to sell a reprocessed device and authorized it under the existing federal Food and Drugs Act and medical devices regulations. Our government will apply this regulatory framework to incoming licence applications from commercial reprocessors of single-use devices that wish to sell reprocessed instruments to Canadian health care facilities. In doing so, we will obviously hold reprocessed devices to the same standards of safety and effectiveness as brand new devices.

We will also, obviously, hold commercial reprocessors to the same regulatory requirements as new device manufacturers. This means that commercial reprocessors seeking market authorization in Canada must meet requirements for licensing, labelling, maintaining distribution records, investigating and handling complaints, conducting recalls, reporting problems to Health Canada and informing Health Canada of any changes to the information in their device licence application, and being subject to quality system inspections or audits.

Under the existing regulations, devices are classified into classes based on the type of risk they pose. The evidence requirements to support a given licence application are proportional to the risk of the device. On the label of the reprocessed device, Health Canada will request that the single-use symbol be removed and replaced with clear instructions, for example, on where to send the device for reprocessing to ensure the appropriate safety oversight.

The department itself began raising awareness of the reuse of medical devices in 1985. Since that time, it has taken steps to mitigate the potential risks. For example, it issued letters to the health care facilities, established a scientific advisory panel on the reprocessing of medical devices, and co-chaired a federal-provincial-territorial working group of infection control specialists that reviewed safety data and developed a pan-Canadian framework statement.

The framework provided direction to the provinces and territories, and was used to help inform the development of their respective policy or regulatory positions on single-use devices. Traditionally, medical device reprocessing was done in-house by hospitals. More recently, reprocessing models have evolved to include greater use of commercial reprocessors and service providers to hospitals. Health Canada has been closely following this business model evolution and actively engaging on this with its partners in the health care system.

Canadians can be assured that we have a rigorous regulatory framework in place to oversee the activities of commercial reprocessors seeking to sell reprocessed single-use devices to Canadian health care facilities. While Health Canada applies existing regulations to incoming licence applications from single-use device reprocessors, we continue to encourage medical device manufacturers to design devices according to their intended use. It is the responsibility of the manufacturer to provide the necessary safety information to Health Canada for review, as required by regulation.

Eve Adams

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