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Implant Files Impact in Candada

IMPACT

‘Deeply concerned’ by Implant Files, Canada vows to strengthen medical device oversight

Health authorities in Canada announced an action plan to improve oversight of medical devices, days after the Implant Files investigation revealed broad failures to protect Canadian patients from flawed and dangerous medical implants.

The Implant Files, the first ever global examination of the medical devices industry, featured extensive reporting from the Toronto Star, CBC and Radio Canada, and was led and reported on by International Consortium of Investigative Journalists.

“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,” said Health Minister Ginette Petitpas Taylor in a statement on Thursday.

“I am deeply concerned by recent reports of serious issues Canadians have been facing with implanted medical devices,” she said.

The action plan released by Health Canada is focused on three areas: strengthening processes for premarket approval of devices, enhancing post-market surveillance, and making both systems more transparent to members of the public.

To improve premarket approvals, Health Canada said it would review the scientific requirements needed get high-risk devices greenlighted for the market, including requirements for clinical evidence. Petitpas Taylor also pledged increase consultation with outside experts on medical device safety issues.

In the area of surveillance once a device is on the market, Health Canada said it would require companies to inform it when key foreign health agencies issue safety warnings and to increase its capacity for conducting inspections of medical device facilities.

The agency said it would enhance transparency by providing public summaries explaining decisions on whether to approve higher-risk devices. In addition, Health Canada said it would provide greater access to clinical data used to support its approval of devices.

The agency said that it would publish the full details of its action plan, which was only briefly summarized in the Nov. 29 announcement, within coming weeks.

The move by Canada’s health agency follows closely on calls by government regulators and consumer advocates in Europe are calling for stepped up measures to protect patient safety after the publication of the Implant Files.

The U.S. Food and Drug Administration also said on Monday that it would enact the “most significant modernization” in a generation of how the agency clears most medical devices for sale.