[ad_1]
Canada's Health Minister says she is "deeply concerned" about the medical device issues revealed by investigative journalists who are committed to making changes.
"The Government of Canada agrees that more can be done to strengthen surveillance of medical devices and to be more open and transparent with Canadians about Health Canada's regulatory activities," said Minister of Health , Ginette Petipas Taylor, Thursday afternoon.
"I asked Health Canada to present an action plan to accelerate these efforts as a priority and work with partners on behalf of Canadians."
His statement fits into a series of stories detailing injuries and deaths resulting from various medical devices – including plastic meshes, bad implants, pacemakers, hip replacements and bad pumps. insulin – while highlighting the gaps in the regulations applying such devices. The investigation revealed that the safety testing protocols were very different from those required for the drugs.
Nonie Wideman is one of many Canadians who shared their stories about wounds and diseases related to medical devices for The Implant Files. As a result of the investigation, Federal Health Minister Ginette Petipas Taylor pledged Thursday to strengthen surveillance of such devices. (Craig Chivers / CBC)
The investigation, titled The Implant Files, is the result of a global media collaboration between CBC News, the CBC, the Toronto Star and the Washington-based International Consortium of Investigative Journalists, which examined tens of thousands of medical devices and their manufactured, approved and monitored by regulators around the world.
Petipas Taylor said that all details of Health Canada's action plan for medical devices would be published in the coming weeks and that it would focus on three areas:
- Review policies and scientific requirements for the approval of medical devices prior to release, "including clinical data requirements". The Minister also asked Health Canada to "allow health professionals to conduct more research on medical devices and to develop the use of external medical and scientific experts to advise the Department on device-related issues." medical. "
- Enhance "post-market surveillance of medical devices", including by proposing "new rules requiring companies to promptly notify Health Canada when key foreign regulators issue device warnings so that we can inform Canadians more quickly ".
- Make "the approval and monitoring system of medical devices more transparent". Petitpas Taylor is committed to providing Canadians with more information about their medical devices "so that they can make more informed decisions" and "improve access to clinical data at the same time." based on our authorizations, so that health professionals can better badess the benefits and risks of devices for their patients. "
Complete 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 problems facing Canadians with implanted medical devices.
Canada has one of the best regulatory systems in the world for medical devices. Canadians can rest badured that medical devices available in this country meet high standards of safety and effectiveness. Health Canada has taken steps to strengthen its regulation of medical devices and I have asked for this work to be expedited.
Beyond these existing efforts, however, the Government of Canada agrees that more can be done to strengthen surveillance of medical devices and to be more open and transparent with Canadians regarding regulatory activities. from Health Canada. I asked Health Canada to present an action plan to accelerate these efforts as a priority and to work with partners on behalf of Canadians.
I asked the ministry to strengthen its activities in three key areas:
1. Strengthen pre-market certification processes for medical devices: this will include a review of the scientific policies and requirements for the registration of higher risk medical devices, including medical device requirements. clinical data. I have also asked Health Canada to take steps to enable health professionals to do more research on medical devices and to expand the use of external medical and scientific experts to advise. the ministry on medical device issues.
2. Improving post-market surveillance of medical devices: Health Canada will work with partners to improve reporting of medical device incidents by industry, health professionals and Canadians and make these reports available to the public. The ministry will propose new rules requiring companies to notify Health Canada as soon as key foreign regulators issue device warnings so that we can inform Canadians more quickly. The ministry will also strengthen its compliance and enforcement activities by modernizing its existing tools and increasing its inspection capacity to better identify problems before they affect Canadians.
3. Make the medical device approval and monitoring system more transparent: Health Canada will take steps to provide Canadians with additional information so that they can make more informed decisions about their use of medical devices. The ministry will provide summaries of regulatory decisions when it approves more complex medical devices (called Clbad III and Clbad IV devices). Health Canada will also work to improve access to clinical data in support of our authorizations, so that health professionals can better badess the benefits and risks of instruments for their patients.
The full details of Health Canada's Medical Devices Action Plan will be released in the coming weeks.
The world of medical devices is constantly evolving and the Government of Canada is ensuring that our regulations and guidelines are in place so that Canadians can have confidence in the medical devices they need. "
Source link
