Canada’s health minister says she is “deeply concerned” by problems with medical devices that have been revealed by investigative journalists and has pledged to make changes.
“The government of Canada agrees that more can be done to further strengthen the oversight of medical devices and to be more open and transparent with Canadians about Health Canada’s regulatory activities,” Health Minister Ginette Petitpas Taylor said in a statement on Thursday afternoon.
“I have directed Health Canada to bring forward an action plan to accelerate these efforts on a priority basis and to work with partners on behalf of Canadians.”
Her statement comes in the midst of a series of stories detailing injuries and deaths that have resulted from a variety of medical devices — including plastic meshes, breast implants, pacemakers, hip replacements and insulin pumps — as well as highlighting gaps in Health Canada regulations and enforcement of such devices. The investigation has revealed vastly different safety testing protocols than those required for drugs.
The investigation, called The Implant Files, is the result of a global media collaboration between CBC News, Radio-Canada, the Toronto Star and the Washington-based International Consortium of Investigative Journalists. It examined tens of thousands of medical devices and how they’re made, approved and monitored by regulators worldwide.
Petitpas Taylor said full details of Health Canada’s action plan for medical devices will be published in the coming weeks, and it will focus on three areas:
- Reviewing the policies and scientific requirements for pre-market approvals of medical devices, “including requirements for clinical data.” The minister said she has also directed Health Canada to “enable more medical device research by health professionals, and expand the use of outside medical and scientific experts to advise the department on medical device issues.”
- Improving “post-market surveillance of medical devices,” including proposing “new rules requiring that companies inform Health Canada promptly when key foreign regulators issue warnings about a device, so that we can inform Canadians more quickly.”
- Making “the system for medical device approvals and surveillance more transparent.” Petitpas Taylor pledged to give Canadians more information about their medical devices “so that they can make better informed decisions” and “work to improve access to the clinical data that support our authorizations, so that health professionals can better evaluate the benefits and risks of devices for their patients.”
Doctors who had expressed concerns about medical devices in Canada said on Thursday that they were glad the health minister was acknowledging issues, but whether patients will benefit depends on the specific actions Health Canada takes.
“This is just a general statement. I mean, the devil will be in the details,” said Dr. Vladimir Iakovlev, a Toronto pathologist who has investigated hundreds of devices that have been surgically removed from patients, including meshes, artificial hips, heart valves and breast implants.
For example, effective “post-market surveillance” of issues that may arise requires the establishment of an independent registry, Iakovlev said. It should be mandatory for health care providers and researchers to report any potential issues they observe with medical devices into that registry, he said.
Currently, the onus is on manufacturers, not doctors or hospitals, to report problems and patient complaints to Health Canada.
“It’s unfortunate that Health Canada required media attention to this issue in order to realize that there were gaps in the regulatory system related to medical devices,” said Dr. Nav Persaud, a Toronto family doctor and researcher who frequently advocates for greater transparency in the health care system.
Persaud welcomed the minister’s announcement that the department would make clinical data more available to patients and physicians, but said it’s not clear from Thursday’s statement what that information would be.
“Exactly what clinical data is going to be made publicly available? Is it the data that’s already in the public domain? Is that going to exclude adverse event reports?” Persaud said.
“In my experience, industry pushes back and says, you know, reporting all of these things and providing all of these things is onerous and they’ll also raise concerns about clinical data being made available because of patient confidentiality. And in the end, you know, these regulations end up getting watered down.
“Time will tell.”
Full statement from Health Minister Ginette Petitpas Taylor:
“As Minister of Health, protecting the health and safety of Canadians is my top priority. I am deeply concerned by recent reports of serious issues Canadians have been facing with implanted medical devices.
Canada has one of the best regulatory systems in the world for medical devices. Canadians can be confident that the medical devices available in this country have met high standards for safety and efficacy. Health Canada has been taking steps to strengthen its regulation of medical devices, and I have asked that this work be accelerated.
Beyond these existing efforts, however, the government of Canada agrees that more can be done to further strengthen the oversight of medical devices and to be more open and transparent with Canadians about Health Canada’s regulatory activities. I have directed Health Canada to bring forward an action plan to accelerate these efforts on a priority basis and to work with partners on behalf of Canadians.
I have asked the Department to enhance its activities in three key areas:
1. To strengthen processes for the pre-market approvals of medical devices: This will include a review of the policies and scientific requirements for the approval of higher-risk medical devices, including requirements for clinical data. I have also directed Health Canada to take action to enable more medical device research by health professionals, and expand the use of outside medical and scientific experts to advise the department on medical device issues.
2. To enhance post-market surveillance of medical devices: Working with partners, Health Canada will take steps to improve the reporting of medical device incidents by industry, health professionals and Canadians and make these reports publicly available. The department will propose new rules requiring that companies inform Health Canada promptly when key foreign regulators issue warnings about a device, so that we can inform Canadians more quickly. The department will also strengthen its compliance and enforcement activities by modernizing its existing tools and increase its inspection capacity to better identify problems before they affect Canadians.
3. To make the system for medical device approvals and surveillance more transparent: Health Canada will take steps to give Canadians additional information so that they can make better informed decisions about their use of medical devices. The department will provide summaries of regulatory decisions when it approves more complex medical devices (known as Class III and Class IV devices). Health Canada will also work to improve access to the clinical data that support our authorizations, so that health professionals can better evaluate the benefits and risks of devices for their patients.
The full details of Health Canada’s Action Plan for Medical Devices will be published in the coming weeks.
The world of medical devices is constantly evolving, and the government of Canada is working to ensure that our regulations and guidance keep pace so that Canadians can have confidence in the medical devices that they need.”