Health Canada announced new measures Thursday to improve the safety, effectiveness and quality of medical devices.
Following the Implant Files investigation, a growing number of countries have said they will better track medical implants and warn patients of potential problems faster by creating or expanding medical device registries.
Health Canada did not mention a registry but said its three-part strategy aims to improve:
- How medical devices get on the market.
- Monitoring and followup for devices already in use.
- How much information Canadians have about the medical devices.
Health Canada said it will create a new expert advisory committee on women’s health issues for drugs and medical devices by January. Patients will be invited to participate.
The women’s health committee will first examine devices such as breast implants, vaginal meshes and contraceptive implants, Dr. Supriya Sharma, chief medical adviser for Health Canada, told reporters.
Currently, some manufacturers give patients a card when a device is implanted that gives information. Sharma said it will add terms and conditions to the licensing of a “larger scope of devices” to provide more details about the device.
Health-care institutions will also be required to report incidents to Health Canada and clinics will be encouraged to do so.
The regulator has also proposed to allow health-care professionals to conduct “investigational testing” of medical devices by June 2019. This brings medical devices in line with how drugs are regulated, Sharma said.
CBC News is part of a global media collaboration with Radio-Canada, the Toronto Star and the Washington-based International Consortium of Investigative Journalists that examined tens of thousands of medical devices and how they’re made, approved and monitored by regulators worldwide.
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