Better oversight needed

It seems naive to rely solely on the manufacturers of medical devices to report on injuries and deaths related to their products.

But that’s what Health Canada does. And it leaves Canada lagging behind others when it comes to oversight of the $400-billion global industry that makes everything from artificial hips and implantable defibrillators to breast implants.

Indeed, an investigation by the Toronto Star and CBC found examples of devices being implanted in patients that had only been tested on animals or cadavers. Others were still being used in Canada after they had been pulled from the market in other countries because of injuries. And Health Canada delayed issuing warnings about potential problems for some devices for weeks, months and even years after other countries flagged serious risks.

That must change. And the quicker the better.

After all, at least 1,400 Canadians have died and14,000 more were injured in the past 10 years in incidents involving devices that were supposed to help them. And that may be the tip of the iceberg because there’s little transparency around the efficacy of each medical device.

New regulations to make it mandatory for Canadian hospitals to report incidents involving drugs and medical devices should be introduced sooner than late 2019, as currently planned. That would help identify any problems that medical device manufacturers are slow to report to Health Canada.

Creating a registry of patients who have received implants — with privacy safeguards in place — would also help ensure they can be quickly alerted if there’s a problem with a device. And Health Canada must be quicker to pull devices from the market when safety concerns are flagged elsewhere.

Canadians undergoing operations to have a medical device implanted should feel assured that what they’re receiving is safe and reliable. Health Canada must take the necessary steps to make that happen.

Canadians should feel assured that what they’re receiving is safe and reliable