Health Canada has taken steps to improve “safety, effectiveness and quality” surrounding medical devices following the Implant Files Scandal.
Concerns were raised worldwide about a number of faulty medical implants potentially harming patients following a media investigation from 58 media organisations, leading to calls to change the rules regarding implants.
Key findings included governments allowing products on the market with little or no human testing that went on to cause great harm, devices that have been pulled off the market over safety concerns in some countries, but which remain on sale in others and the device industry and regulators’ struggling to quickly identify hazardous implants after they are released.
In response to this, a three-part action plan has been launched by Health Canada to: improve how devices get on the market, strengthen monitoring and follow-up, and providing more information to the public – with work beginning this month and continuing for much of 2019.
To improve the way devices get onto the market, the authority aims to increase research by medical professionals and increase patient protection. These proposals will include allowing healthcare professionals and researchers to file an application for authorisation to conduct investigational tests.
In addition, the authority has said it will review evidence requirements and expand scientific expertise. Health Canada has created a division to review medical devices made up of engineers and scientists from various disciplines, will focus on addressing safety issues that involves digital health technologies such as securing private health information and preventing hacking and cyber security threats. The authority said it will review evidence requirements related to higher-risk medical devices with a view to strengthening them – while ensuring alignment with international practices.
By strengthening monitoring and follow-up, the mandatory reporting and expansion of the Canadian Medical Devices Sentinel Network, which will include the requirement of Canadian hospitals to be required to report medical device incidents, as well as improving reporting from healthcare facilities aside from hospitals.
Manufacturers will also be required to provide a greater scope of information to Health Canada, with the watchdog able to compel manufacturers to provide information to address a health risk or to monitor experience with products. The capacity in inspection and enforcement is to be enhanced, with areas of Health Canada’s inspection of and compliance verification programs for manufacturers, importers and distributors of medical devices with more inspectors set to be hired.
The aim of providing more information to the public will be done by improving access to medical device clinical data, with new regulations to be implemented to allow this. The department will also increase information on device approvals and publish medical device incident data by launching an accessible database.
Part of the publication on the Health Canada website read: "Health Canada will promote open communication and engagement with Canadians throughout the implementation of the action plan to ensure that all perspectives, particularly those of the people who use medical devices, are taken into account when developing policies and regulations. It will also keep Canadians up to date with progress on the action plan so that they know what the Department is doing to enhance the safety and effectiveness of the devices they use.”