Canada has a 'big blind spot' on medical device safety: study
A new study has found more than 7,200 medical devices were recalled in Canada between 2005 and 2014, ranging from hospital beds to major joint implants to hernia mesh.
“A lot of us think this is actually quite urgent and a big blind spot in health products that are used every day on millions of Canadians,” study co-author Dr. David Urbach, senior scientist at Women's College Hospital in Toronto, told CTV News.
Published in the “International Journal of Technology Assessment in Health Care,” researchers in Toronto, Montreal and Calgary reviewed medical device records filed with Health Canada.
They found more than 24,000 medical devices were approved for sale in Canada over 10 years.
As for the recalls, most issues were minor. But 300 recalls, or five per cent, were considered severe enough to cause “serious adverse health consequences” or death.
Shirley Houle is an example. The Port Hope woman relies on an implantable pacemaker defibrillator to keep her heartbeat steady. Last October she received a warning letter about her device, made by St. Jude Medical -- it had a battery that could suddenly stop working.
The news, she said, was terrifying.
“I was afraid to go anywhere... afraid my heart my battery would go dead,” Houle said.
The anxiety left her unable to sleep, or even leave the house, she said.
It took six months before she got a new device.
Unlike medications, which undergo rigid pre-market testing, medical devices are often approved with little or no clinical testing in Canada.
Halifax resident Rod Desborough is another one of the thousands of Canadians whose medical device has been subject to a recall. His hip implant suddenly broke in two while he was gardening.
He had emergency surgery to replace the implant -- and repair the bone that shattered along with it.
“My leg is an inch-and-a-half shorter,” Desborough says. “It took me six months to learn to walk half-decent.”
The Wright Profemur Hip Implant was later recalled and taken off the market. Desborough is now part of a class action lawsuit.
Shirley Houle has also joined a class action against St. Jude Medical, the makers of her implanted pacemaker defibrillator.
But lawsuits aren't the best way of dealing with medical device recalls.
Halifax-based personal injury lawyer Raymond Wagner said more formal oversight of medical devices is needed in Canada.
Wagner, whose firm is handling several medical device cases, says makers are often under intense pressure from investors to quickly get their new products in the hands of doctors.
“We see that there is a rush to market,” he said. “There is a lot of money involved.”
Wagner said he has seen that push to sell turn into pain for a number of his clients.
“For instance, on a hip implant. They are designed to last 15 to 20 years. We were receiving failures from our clients of 18 months to two years, to three years after the product was implanted,” he said. “That is a huge impact on their well-being.”
Wagner feels the current practice of relying on the industry for self-regulation isn't working.
“We see there is strong pressure within the companies to say their failure rate is low … and to show that it’s not their product, just an incidental occurrence.”
“They don’t want to be reporting a whole lot of failure rates that may impact their economic relations that sit in the background, which really creates conflicts of interest that are a concern,” he added.
The researchers found that the onus falls primarily on the medical device industry to issue recalls when problems are identified, although Health Canada can impose a recall independently.
A recent study also found Canadian doctors are reluctant to report medical device adverse events.
“Physicians are actually expected to report problems with devices or other types of health products, but most physicians aren’t aware of that. Everyone seems to think it’s everyone else’s responsibility," said Dr. Urbach, who also co-authored this study.
Canada’s medical community still has a lot to learn about medical device recalls and their impact on patients and the health care system.
“We don’t yet understand what sort of devices are most often subject to these recalls, and what the reasons are for the recalls . . . and what the consequences are,” said Dr. Urbach. A formal tracking system for high risk medical devices may be required in order to spot problems like failing batteries or fracturing implants quickly -- before more people are harmed.
“If we take the mindset that we can’t be assured 100 per cent of their safety, then we have to be constantly vigilant.”
Patients can themselves report adverse events or side effects from medical devices -- but most aren't aware of this.
Health Canada has a website for reporting medical device-related complaints.
Some doctors advise patients to ask about what medical devices are being implanted in their bodies. Doctors can supply the brand and model number.
While this information is in a patient’s medical file, it's advisable they also keep a copy in the event there are issues with a device.
With files from CTV’s medical affairs specialist Avis Favaro and Elizabeth St. Philip