Posted on 24 November 2009
(OTTAWA) A bill tabled in the Senate by Senator Mac Harb and seconded by Senator Terry Mercer, will establish the National Registry of Medical Devices to be overseen by Health Canada.
“If something goes wrong with your car, you get a notice right away,” says Senator Harb. “But if a medical device fails, there is no fool-proof system to make sure the users depending on that device are notified.”
Approximately one in ten Canadians have an implanted medical device, ranging from pacemakers to hip joints. There has been more than a 100% increase in the number of implanted hip and knee replacements alone in the last ten years. Thousands more use prescribed medical devices such as blood glucose monitors.
Since 2005, more than 37,000 new types of medical devices have received market authorization from Health Canada. A total of 2,505 faulty devices were reported to Health Canada during that same period. And the odds are some users may never learn their device is faulty because while there is a registry for devices, there is no central registry of the patients who are using those devices.
“Health Canada's stated mission is to protect the health and safety of Canadians. It is doing a commendable job testing and licensing the medical devices in the first place and getting them to the patients who need them,” said Senator Harb. “A registry would allow Health Canada to take its responsibility 'the last mile', ensuring timely notification to registered users should something go wrong with the device.”
This voluntary registry will contain, with their consent, the names and addresses of persons who use medical devices, allowing Health Canada to contact individual Canadians in the event of a device recall, malfunction etc. Canadians will be able to rest assured that they will receive quick and reliable information and Health Canada's ability to protect our health and safety will be enhanced.
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Office of the Hon. Senator Mac Harb
613-996-2379