Health Canada encourages Canadians to report incidents involving medical devices to help strengthen patient safety

Starting date:
January 15, 2019
Type of communication:
Information Update
Subcategory:
Medical Device
Source of recall:
Health Canada
Identification number:
RA-68858

Reason

OTTAWA – Medical devices are vital to the health and well-being of hundreds of thousands of Canadians—many of whom could not survive without these devices. More than 100,000 medical devices are licensed for sale in Canada, ranging from everyday items such as bandages to complex implantable technology such as pacemakers.

Canada has one of the most stringent regulatory systems in the world for medical devices. Still, all devices pose risks. The reporting of incidents involving medical devices allows Health Canada to more quickly identify, communicate and act on new or increased medical device safety concerns. With that in mind, Health Canada is asking Canadians who use medical devices to report any incident they experience to Health Canada and their healthcare provider.

As part of Health Canada’s Action Plan on Medical Devices, announced in December 2018, the Department is taking steps to strengthen the monitoring of these devices and follow up on incidents. This includes strengthening regulations and taking action to improve the reporting of medical device incidents by industry, healthcare providers and Canadians.

We encourage Canadians to talk to their healthcare providers about the use of medical devices. Health professionals play a key role in helping patients fully understand the potential benefits and risks of different treatment options, and therefore in helping them to make informed choices about their health and well-being. We also encourage Canadians to report to their healthcare provider and Health Canada if they experience a safety issue with a medical device.

What you should do

  • Discuss treatment options and the potential benefits and risks of medical devices with your healthcare provider.
  • Contact your healthcare provider if you have any health concerns related to your use of a medical device.
  • Report adverse events involving health products to Health Canada by calling toll-free at 1-866-234-2345, or by reporting online, by mail or by fax.
  • Stay connected with Health Canada and receive the latest advisories and product recalls.

Media enquiries

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Send us your feedback

(613) 957-2991
1-866 225-0709

What Health Canada is doing

Health Canada will continue to update Canadians on progress against its Action Plan on Medical Devices, including as it receives more information on incidents from Canadians, healthcare professionals and industry.