Health Canada aims to improve safety of medical devices
Head of cardiovascular society welcomes reforms as 'long overdue'
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 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 higher-risk medical devices.
Health Canada said it will start to 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.
Device registration mandated
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 medical devices to provide more details.
"I would encourage all patients if they're having a procedure to ask if there's a medical device that's involved, to ask what the name of it is, to get that information," Sharma said. "Currently it is mandatory for certain devices, and we're expanding the scope."
Health-care institutions will also be required to report incidents to Health Canada and clinics will be encouraged to do so.
"The principles of what they're trying to achieve are are excellent, " said Dr. Andrew Krahn, a cardiologist in Vancouver and president of the Canadian Cardiovascular Society. "They are long overdue."
Krahn is concerned about Health Canada's "passive approach" to regulating medical devices. For instance, the regulator is increasing the number of inspectors without investing in getting information into a centrally managed system, he said.
The action plan "talks about accessing information sources outside of hospitals, but quite frankly they're not even collecting most of the information from hospitals," he said.
"So adding nursing homes and long-term care facilities and even private clinics, some of which have digital versions but some of them are literally printing paper, or not keeping records on device performance."
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.
Device manufacturers will also be required to notify Health Canada within 72 hours when foreign regulators warn about serious risks related to implants.
Nonie Wideman, 63, of Fort St. John, B.C., said a plastic mesh she had surgically implanted to support her bladder gave her debilitating health problems. Wideman paid to have the device removed and said she had no emotional support or a hotline.
"Without the International Consortium of Investigative Journalists, I would have never got the information that my device was tested on a sheep and a cadaver. And I had been told by Health Canada that my device would have been tested for biocompatibility, so it's going to be hard to convince me that they're going to follow through with everything they say."
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.