Health Canada announces new reporting requirements for hospitals

Regulations will require hospitals to report serious adverse drug reactions and medical device incidents to Health Canada

June 26, 2019 - Ottawa, ON - Health Canada

Drugs and medical devices are an important part of Canada’s health care system, helping Canadians treat and prevent a variety of conditions. However, all drugs and devices involve risks, including the potential for serious side effects leading to emergency room visits and hospital admissions. Serious adverse drug reactions and medical device incidents are significantly under-reported, both in Canada and internationally.

The Honourable Ginette Petitpas Taylor, Minister of Health, today announced new regulations that will require hospitals to report serious adverse drug reactions and medical device incidents to Health Canada. The regulations will come into force in late 2019. 

Hospitals will be required to provide Health Canada with a report of a serious adverse drug reaction or medical device incident within 30 days of the documentation within their institution. The regulations will improve the quality and increase the quantity of reports Health Canada receives on serious adverse drug reactions and medical device incidents, allowing the department to better monitor the safety of drugs and devices on the market,and to take action when needed to protect Canadians.

These new regulations are part of Health Canada’s Action Plan on Medical Devices, which was announced in December 2018. The plan aims to improve the safety, effectiveness and quality of medical devices for Canadians by focusing on patient needs, modernized regulations and innovative technology.

Since the launch of the Action Plan:

To improve how medical devices get on the market, Health Canada has:

• created a Scientific Advisory Committee on Health Products for Women to provide timely advice on current and emerging women’s health issues including breast implants and transvaginal mesh; and
• published guidance to industry on the regulation of 3D printed medical devices which will make it easier for Canadians to access personalized treatments for many procedures including tooth replacements and bone repairs.

To strengthen monitoring and follow up on medical devices already on the market, Health Canada has:

• completed a safety review on breast implants, which led to a license suspension on macro-textured breast implants to help protect women from a risk of breast implant-associated anaplastic large cell lymphoma;
• engaged with patient groups to learn first-hand of their experiences with medical devices;
• increased the number of medical device compliance and enforcement inspections in Canada and abroad by 10% to better protect Canadians from potential risks;
• expanded the Canadian Medical Devices Sentinel Network to include more than 18 healthcare facilities, expanding the reach and increasing high-quality data reported on adverse events with medical devices; and
• engaged Canadians and encouraged them to talk to their healthcare providers about drugs and medical devices, and to report adverse drug reactions and medical device incidents.

To provide Canadians with more information about the medical devices they rely on, Health Canada has:

• published regulations and launched a new portal for the public release of clinical information on drugs and medical devices to support research and help Canadians make more informed choices about their health; and
• created a searchable database on recalls and medical device incidents reported to Health Canada.

Throughout the implementation of the action plan, Health Canada is engaging with Canadians to ensure that all perspectives, particularly those of the people who use medical devices, are taken into account in the department’s policies and regulations. Health Canada will continue to update Canadians on developments under the action plan to enhance the safety, effectiveness and quality of the devices they use.