The medical device industry is a $400-billion global industry helping more than 70 million people each year. Medical devices present valuable lifesaving and life-enhancing functions. However, this industry has recently come under attack in Canada for failing to properly monitor, inspect, and report on medical devices.
Health Canada has recently announced that it will be increasing the policing of medical devices, such as pacemakers and breast implants.
This initiative follows an investigation by Toronto Star/CBC/Radio-Canada last year that disclosed federal data revealing at least 1,400 Canadians have died since 2008 in incidents involving various medical devices, and another 14,000 Canadians reported injuries related to medical devices.
The investigation also revealed that devices were placed inside Canadians without testing in humans, which were related to serious health issues.
RESULTS OF INVESTIGATION INTO MEDICAL DEVICES IN CANADA
In November, 2018, it was reported that Toronto Star/CBC/Radio-Canada completed an investigation into Health Canada’s system of regulating medical devices, which was described as a “secretive regulatory system”. This investigation was part of a global examination of the medical device industry, including more than 250 journalists at 58 news organizations in 36 countries who spoke with hundreds of doctors, researchers, industry insiders, and patients.
The investigation revealed the following results:
- Some high-risk devices are approved based upon evidence from older products and animal studies, not current studies completed on humans;
- There is no independent oversight of medical devices in Canada once they reach the market;
- Warnings by Health Canada regarding medical devices may be delayed by weeks, months or years in comparison to other countries; and
- There is no medical device registry to report to or refer to regarding developing health problems related to medical devices.
HEALTH CANADA’S ACTION PLAN
Unlike prescription medication, which may be discontinued by its users if problems develop, medical devices are implanted in patients and may be difficult to remove. To date, Canadians have had a limited capacity to scrutinize the safety of medical devices once they reach the market. Health Canada is hoping that the reforms that it intends on instituting this year will improve the safety of medical devices for all Canadians.
Improving How Devices Get on the Market
Health Canada has undertaken to be more rigorous in approving new medical devices for implantation in Canada. In 2019, Health Canada is committed to reviewing its approval process to strengthen “the evidence requirements” for devices approved based on previous versions.
Strengthening Monitoring of Devices
Currently, Health Canada requires that manufacturers and importers submit medical device incident reports, however hospitals, patients, and healthcare providers are merely “encouraged” to submit reports.
Beginning in February 2019, all 776 hospitals in Canada will be required to report all incidents that arise involving medical devices. Health Canada is currently working on an educational campaign to help practitioners and hospitals to identify and report on all medical device incidents.
Health Canada will have the authority to compel manufacturers to conduct safety assessments, tests, and studies on their products. Manufacturers will be required to inform Health Canada within 72 hours if foreign regulatory agencies issue warnings about serious risks in reference to their medical devices. They will also be required to notify Health Canada of any information regarding label changes or licence suspensions.
Health Canada has also committed to increase its inspection and compliance verification programs for manufacturers, importers, and distributors of medical devices. A greater number of inspectors will be available to respond to high-risk incidents and there will be an increase in the frequency of inspections and compliance endorsements, including foreign inspections.
Provide More Information to the Public
By early 2019, Health Canada has promised that it will implement new regulations to release clinical information on medical devices. This will allow Canadians access to all information regarding the medical device in question to allow for independent consideration.
Health Canada will also continue to publish summaries of decisions made for licence applications for new Class III and Class IV medical devices (those providing a greater potential risk), including any amendments.
Currently, Canadians only have access to incident reports regarding medical devices through Access to Information requests. In the near future, Health Canada will be launching a database containing medical device incident reports online. This database will also contain access to information regarding Health Canada inspections and the results, including any suspensions or cancellations of licences.
If you or a loved one have suffered injuries as a result of a medical device, you may require surgery and rehabilitation, and you may suffer from pain, disability, and expenses. At Cuming & Gillespie LLP, we will review your case and consult with medical experts to provide you with an honest evaluation of a potential claim. We provide free consultations for new clients to review your case and discuss potential options. Contact our office today online or call 403-571-0555 to make an appointment to speak with our experienced personal injury lawyers. We look forward to helping you obtain the compensation that you deserve.