In the wake of the Implant Files investigation, a growing number of countries have said they will better track medical implants and warn patients faster by creating or expanding medical device registries.
The international series revealed that tens of thousands of medical devices distributed worldwide — like pacemakers and artificial hips — were approved for sale with little scientific evidence, and that several countries had failed to warn patients once they were recalled.
In the U.K., the Royal College of Surgeons called for « urgent and drastic changes » to protect patient safety, including a registry so doctors can know if new products are causing harm.
The German government announced that all implantable devices would have to be formally registered in a system independent from the industry, which will notify patients and collect data on the lifespan of products.
Italy said it would make it mandatory for all regional health bodies to register devices.
Meanwhile, the United States and the European Union have been working to assign unique barcodes to devices, as a first step to eventually tracking them through the supply chain.
That’s in addition to Sweden, Finland, Norway, Denmark, Hungary and Australia, which have similar versions of mandatory registries for specific products or all devices.
Registries find problematic devices faster, said Dr. Stephen Graves. The Australian orthopedic surgeon told the International Consortium of Investigative Journalists that the nationwide mandatory joint replacement registry he created in the late 1990s has identified more than 150 poorly performing joint replacement products, including some sold in Canada.
30 years of failed proposals
In Canada, after three decades of failed proposals, Ottawa seems to be warming up to the idea.
« Is the registry a good idea? Yes, » said Health Minister Ginette Petitpas Taylor.
« But what type of information should be collected for that registry? That’s the conversation I’m having right now with our officials. I want to make sure that information is useful to Canadians. »
Documents obtained by CBC News show Ottawa has wavered on the issue for decades, despite 16 petitions, as well as recommendations, motions and private member’s bills calling for change.
In a letter exchange dating back to 1988, the federal department Health and Welfare Canada, Health Canada’s predecessor, said it was looking into creating a national breast implants registry, but it warned « costs could be considerable. »
In 1992, a committee of national health-care leaders charged with reviewing medical device regulations also recommended the creation of « registries to identify problems with high-risk devices. »
In 1992, a committee of national health-care leaders recommended the creation of ‘registries to identify problems with high-risk devices.’ Four years earlier, the federal government said it was looking into creating a national breast implants registry, but warned ‘costs could be considerable.’ (Craig Chivers/CBC)
Retired politician Mac Harb unsuccessfully introduced legislation, the Medical Devices Registry Act, six times — once as a Liberal MP and five times as a senator. He resigned in August 2013 during the Senate expenses scandal.
In an interview with CBC News about his efforts, he said, « It’s a national security issue. It’s health and safety. It’s a must-do. It’s not if. It’s when. »
During Senate hearings in early 2013, the proposed legislation was endorsed by the Canadian Nurses Association, as well as various physicians and researchers, while the industry trade group MEDEC testified that registry would be no better than the existing system.
The Canadian Cardiovascular Society has been lobbying for a registry for more than a decade.
After facing major recalls of cardiac devices, CCS created its own reporting system: they keep in touch with manufacturers and have an expert committee review advisories, issue guidelines for surgeons and survey hospitals across Canada about failure rates.
Carolyn Pullen, chief executive officer of the Canadian Cardiovascular Society, says the lack of communication about medical devices is ‘a big gap in our health system.’ (Marc Robichaud/CBC)
« It’s clear that this transparency, accountability and really important communication mechanism is a big gap in our health system », said Carolyn Pullen, chief executive officer of the society.
Encouraged by Petitpas Taylor’s comments to CBC News, the cardiovascular society said it had contacted a senior official at Health Canada to offer input and expertise. But there was little interest — a reaction the society called « alarming. »
Like ‘a giant Walmart with no cash registers’
Nova Scotia surgeon Dr Alex Mitchell said there’s « no reliable medical device identification in Canada at present. »
Mitchell said when a device is recalled it can take months to review hospital records, usually paper-based, to find and contact affected patients. That delay puts them at greater risk.
He said one the challenges with a device registry is the lack of a standardized barcodes for individual devices that can be scanned and entered into the system.
« Health care facilities are like giant Walmart stores with no cash registers and no transactions. We open up the front doors and people come in and things leave. Then at the end of the day we run around with clipboards and try to figure it out. »
Tech entrepreneur Louis Roy says a registry could be built in five to 10 years, but it depends on collaboration among manufacturers, distributors, hospitals, doctors and patients. (Optel Group)
Tech entrepreneur Louis Roy said the technology to track medical products already exists.
His Quebec City company tracks everything from gold to coffee and dental implants.
« When you get all this data, it’s a clinical trial in real time, deployed to an entire country. … It’s worth so much for [companies] to be able to design the right product. »
He said a registry could be built in five to 10 years, but it depends on one factor: collaboration.
« We are talking about manufacturers, distributors, hospitals, doctors and patients, which are usually all disconnected. … That’s the main challenge. »
‘You have to make sure people actually do the hard work of analyzing the data,’ says Matthew Herder, director of Dalhousie University’s Health Law Institute. (Submitted by Matthew Herder)
Then there’s the question of who will analyze that registry, said Matthew Herder, director of the Health Law Institute at Dalhousie University.
« You have to make sure people actually do the hard work of analyzing the data … and ensure that whatever you learn will inform clinical decisions and patient choices about a given device. »
‘It took me everything I had to survive’
Scott McFie, 61, of Richmond. B.C., said a registry could have changed his life.
In March 2007, he was driving on the Coquihalla Highway in British Columbia with his four-year-old daughter when he was blinded by sudden and intense chest pain.
« I went black. I couldn’t see, » said McFie. « I thought a rock had come through the windshield. »
He found out later that the Sprint Fidelis electrical wires that connected a cardiac implant device to his heart were broken, shocking him 51 times in two hours.
« It took me everything I had to survive, » said McFie, who has joined a class action against Medtronic, the maker of the wires.
The lawsuit alleges that doctors started reporting problems as far back as 2005, but the device wasn’t recalled in Canada or the U.S. until October 2007.
Health Canada sent an urgent notice asking surgeons to stop using Medtronic’s Sprint Fidelis electrical lead with implantable cardioverter-defibrillators (CDI), warning the wires could break and deliver « multiple inappropriate shocks. » The recall said the defective lead « might have contributed » to five deaths in the U.S.
At the time, nearly 6,000 leads were in use in Canada.
In its statement of defence, Medtronic denies any negligence and says that, at the time of implant, all patients assumed the risk that their lead may fail.
« It’s another bureaucratic failure, » said McFie. « Where is the government in demanding regulatory notifications by the manufacturers and the physicians themselves? »
His lead was replaced, but he said his family suffered long-term trauma from his experience.
Learn more about your medical device by searching our database of Health Canada records. If you’re using the CBC News app, you can access the page here.
Optel Group headquarters in Quebec City. The company tracks everything from gold to coffee and dental implants. (Marc Robichaud/CBC)