Health Canada announces oversight plan to improve safety of medical devices

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Health Canada says it is revamping the way medical devices are approved and monitored in order to protect Canadians from potential safety problems.

In an announcement Thursday, the department said it will conduct more inspections of foreign plants where devices are manufactured, create a women’s advisory committee to focus on vaginal mesh and other contentious medical devices and make clinical data used to approve devices available to the public. The government would also be able to order companies to conduct further tests or safety studies if problems with their medical devices emerge.

Other changes included in the announcement, such as a requirement for hospitals to report side effects or other problems with medical devices to Health Canada, are part of Vanessa’s Law, which was passed in 2014 with a goal to protect Canadians from unsafe drugs and devices. But the department is still in the process of finalizing the regulations needed to enforce the law. In an e-mail, Health Canada spokesman Eric Morrissette said the department is still determining when those regulations will be completed.

Health experts have been calling for Canada to strengthen oversight of medical devices for years. Unlike drugs, which individuals can stop taking if problems develop, some medical devices are implanted in people and can be difficult to remove, said Vladimir Iakovlev, director of cytopathology at St. Michael’s Hospital in Toronto. He added that problems with some medical devices don’t surface immediately after they are implanted.

“You cannot discontinue implants. Sometimes, you cannot remove it,” he said. "It’s in you for life and side effects can only appear years later."

Until now, Canadian regulators have had a limited ability to monitor the safety of devices after they hit the market.

Vaginal mesh has emerged as one of the most prolific examples of why Canada needs a more robust system for medical devices. Used to treat pelvic organ prolapse or stress urinary incontinence, women would have a type of mesh surgically implanted through the vagina to lift and support the bladder. But many later report agonizing pain, infections and other complications, including mesh that perforated other organs. Without a national database of side effects or requirements for health professionals to inform Health Canada when these problems arise, it has been difficult for women to get the full picture about the potential risks and benefits of surgical mesh.

Supriya Sharma, Health Canada’s chief medical adviser, told reporters Thursday that the women’s advisory committee will be given the task of looking at devices, such as mesh and breast implants and other issues in order to understand how to help improve women’s interactions with the health-care system.

While it’s possible that better regulation of devices, as well as monitoring and enforcement, will change under the new system announced by Health Canada, Dr. Iakovlev said it will only be clear once the department reveals more of the nuts and bolts details and starts to roll out its plans.

However, the department is stopping short of creating a national registry of medical devices, which could be used to identify problems with devices and track users in order to alert them of safety issues. Dr. Iakovlev said it would be relatively easy for Canada to set up such a system. It could start, he said, by focusing on those devices that are permanently implanted in people, as they may be more likely to cause significant harm than devices that are only intended to be used for a short time.