Statement made on 19 October 2011 by Senator Mac Harb
Hon. Mac Harb:
Honourable senators, I rise today to ask for your support for Bill S-202, An Act to establish and maintain a national registry for medical devices. This bill has twice received approval at second reading and has twice been referred to the Standing Senate Committee on Social Affairs, Science and Technology for further study only to be interrupted when parliamentary sessions ended.
I thank you, honourable senators, for your past support, and I trust we can once again agree on the national importance of this legislation to the health and well-being of Canadians. It is indeed a matter of national importance. This is a matter that impacts, directly or indirectly, the health and safety of all Canadians.
Simply put, there is no foolproof mechanism in place at this time for users of medical devices to be contacted if something goes wrong with their device. Current regulations fall short, and people are suffering as a result. A voluntary registry that holds contact information for medical device users would close this gap and protect the health and safety of a growing number of Canadians.
Allow me to explain. Medical technology is transforming health care and improving the lives of Canadians. However, as more sophisticated medical devices come on the market, the government must ensure that Canadians are provided with safe and effective products and are informed should these devices fail. Without a national registry, we simply cannot fulfill this responsibility.
Honourable senators, Health Canada is responsible for regulating the safety and effectiveness of all medical devices marketed in Canada. There are approximately 1.4 million different medical devices currently on the Canadian market, with many more awaiting approval. Among these devices are the Class III and Class IV high risk devices such as artificial hips and pacemakers, devices that will be covered by this registry.
Canada's orthopaedic surgeons are performing 100 per cent more hip and knee replacements than they were ten years ago. In the United States, the number of knee replacements is expected to increase by 673 per cent and hip replacements by 174 per cent over the next 20 years.
It is not just the use of implants that is on the rise. Every year, thousands more Canadians use prescribed medical devices such as blood-glucose monitors and portable oxygen tanks. An aging population, increased obesity and improved medical technologies are expected to contribute to even more widespread use of medical devices.
As the number of devices rises, we have also seen a corresponding rise in the number of warnings and recalls relating to medical devices. During the period 2001 to 2010, 6,648 medical devices were recalled by Health Canada. There were 848 recalls last year and 763 the year before that. Honourable Senator Eaton pointed out when we last discussed this bill that not all of those recalls relate to the higher risk devices. However, it is safe to assume that even if one recall concerned a piece of medical equipment you had implanted in your body, you would be very interested in knowing about it.
While Health Canada keeps track of the devices it licences, there is no central registry for the patients who are using those devices and, thus, no way to ensure that a Canadian affected by a faulty device is notified when a problem arises.
This bill, if approved, will establish and maintain a national registry of medical devices. This registry will also contain the names and addresses of people who use certain implantable or prescribed home-use medical devices. The information will be provided voluntarily by the users of the devices.
This bill also requires manufacturers and distributors of medical devices to notify the registrar if a medical device poses a risk to the health or safety of a user. The registrar is then required to notify registered users.
Honourable senators, the current system is not working. The Office of the Auditor General has repeatedly called on the government to take action. In reports issued in 2004 and 2006, and, most recently, in June 2011, the Auditor General concluded that, despite its best efforts, Health Canada is still not able to fulfill its responsibilities for medical devices as stipulated under the Food and Drug Act and Regulations.
The Auditor General noted unacceptable delays in getting urgently needed new products onto the market, and a failure to adequately manage the risks related to medical devices once they are approved for use. Health Canada increased its financial allocation toward the direct costs of the Medical Device Program to $10.1 million in the 2009-2010 fiscal year, up from $2.7 million in 2002-2003. Despite this increase in resources, the Auditor General found that the program continued to face challenges in meeting its responsibilities.
We cannot pretend to be surprised by these findings. Health Canada's responsibilities in this sector are enormous. It needs resources, such as a national registry, to help it meet its goals.
Given the rapid growth of the medical device industry and the complexity of the technology, Health Canada is faced with increasingly complicated submissions for approval and inspection programs. Incident reporting and risk management are largely left to the other stakeholders in medical devices, including the medical device industry itself and health care facilities and practitioners. That is not acceptable. Both have proven to be problematic links in the communication chain responsible for reporting adverse incidents in a timely manner.
Current regulations call on manufacturers to notify health care practitioners and users if something goes wrong with a medical device, but these regulations can fail due to such common occurrences as simple human error, a medical practitioner who moves out of the country, a lost patient database, or a device manufacturer going out of business.
Health Canada does not have patient information at its disposal, counting on individuals to monitor its website or the media in hopes of coming across a product recall or related information. Case studies abound of individuals who were not notified, despite the requirement for manufacturers to contact affected individuals.
Let me give honourable senators an example of such a case that occurred despite the revised Medical Device Regulations that, as Senator Eaton pointed out previously, were put in place in 1998 to ensure that medical devices sold in this country are safe, effective and high quality.
In January, 2011, a Canadian woman, Joanne Scharf of Nova Scotia, was the latest to file a lawsuit against DePuy Orthopaedics, a Johnson and Johnson company. She says the company waited at least two years before reporting that a high number of their ASR hip implants were failing and causing harm to patients.
The hip device is now known to break down, allowing metal shavings to make their way into a patient's bloodstream. The resulting cobalt poisoning can increase the risk of a number of health problems, including dementia and heart failure. The company recalled the product in August, 2010, after having received reports, for several years, regarding early failures of the implant. Ms. Scharf is now faced with the prospect of early revision surgery to replace the implant, as well as a future of possibly dire blood-related complications.
Another example is Canadian Kristie Pells, who had a device called the Kugel Mesh implanted in 2003 to repair an abdominal hernia. Five years later, she almost died as a result of infection and damage caused by the breakdown of the patch. A family friend did some research and noticed that these Kugel Mesh patches had in fact been recalled. That was the first Ms. Pells heard about the recall, although some of the patches had been pulled off the Canadian market two years before Ms. Pells ended up back in hospital. Her lawyer contacted her surgeon, who confirmed she did indeed have one of the recalled patches.
There is now a class-action lawsuit under way on behalf of Ms. Pells and other Canadians who are dealing with serious complications.
Like Joanne Scharf, Kristie Pells did not receive timely warnings from the manufacturer, her surgeon, or Health Canada. For all we know, thousands more Canadians are suffering health problems but simply do not realize the symptoms are linked to a recalled or banned product.
Health Canada is trying its best. As Senator Eaton mentioned, Health Canada has set up a hotline for patients to report medical device problems and has initiated a pilot project to improve adverse incident reporting by health practitioners. There are some good ideas here that may be useful in improving device related reporting, but these initiatives are simply not designed to get information about medical device failure to the individual affected.
Medical device failures are disproportionately costly to the individual and to society. In 2010, public and private health care spending in Canada totalled $191.6 billion, up almost $10 billion from 2009. We simply cannot afford not to address this issue.
When an adverse incident occurs, Health Canada issues warnings, public health notices, and other industry notices, as a service to health professionals and consumers.
While there are some Canadians who might be capable of navigating the online databases necessary to stay on top of the latest news about their particular device — with appropriate product class, serial number, year of manufacture and the exact date a problem may have been reported — there are many more, for reasons of infirmity, lack of Internet access, language barriers, et cetera, who would be unable to navigate such a complex database. In short, not every Canadian uses the Internet. We simply cannot take the chance that these Canadians fall between the cracks.
If your car is affected by a recall, you are notified. Surely we can provide similar protection to Canadians who depend upon medical devices.
Senator Eaton raised the issue about privacy in her statement. I would like to assure honourable senators that patient privacy will be strictly respected, and I trust that through committee consultation and working with experts from the Department of Health, this will not prove to be an onerous task.
Health Canada has great experience protecting the privacy of Canadians and I do not expect this to change.
MEDEC is the national association representing Canada's medical device and diagnostic industry. After this bill passed second reading the last time, MEDEC wrote a letter to the Standing Senate Committee on Social Affairs, Science and Technology that said the "robust Health Canada post-market vigilance system" makes a user registry unnecessary at this time. Obviously, MEDEC's idea of robust is different than mine, and the Auditor General's as well.
Yet, in response to the June 2011 Auditor General's report, MEDEC acknowledged that
. . . (t)he OAG report clearly shows that Health Canada is not fully meeting its obligations in relation to medical devices. There is more work to be done . . .
I agree. MEDEC did pledge to look for ways to enhance its support for the post-market activities of Health Canada, and this is welcome news. Its continued cooperation will be essential once the medical registry is up and running.
I note as well that my honourable colleague Senator Eaton suggested that the establishment of a national registry would weaken the existing duty of care on the part of manufacturers. How so? The Food and Drugs Act and medical devices regulations place the responsibility for safety, effectiveness and quality of medical devices sold in Canada on the manufacturer. This bill does not change that. It simply ensures that when the manufacturer advises Health Canada about a problem, the department can go beyond posting a flyer on a virtual billboard.
The manufacturer remains very much a responsible partner in this cooperative post-market surveillance process. The consumer must be notified.
Partnership is a cornerstone in a new national medical device registry launched by the Biomedical Research and Education Foundation, BREF, in the United States. Users voluntarily register their contact and device information to this registry. BREF says its registry will improve patient outcomes well as the flow of information between patients, physicians and members of the medical community.
The American registry is a collaboration between academia, medical associations, industry and government. It is apparent to me that Canada could benefit from a similar multi-partner approach to the establishment of a medical device registry.
There are a number of medical device registries already in existence. For example, Health Canada funds the Canadian Joint Replacement Registry. There are also registries in other countries, such as England, Sweden, Finland, Norway, Denmark, Hungary, Australia and Saudi Arabia.
Generally speaking, these registries are established to provide information in real time about problems with devices and to give immediate feedback to the medical community and device manufacturers about the performance of these devices, as well as to provide information for clinical research purposes.
Canada's single device registries are valuable partners that could work with this national registry to ensure that information flows to the user should a problem be identified.
I was gratified by the support I received from stakeholders when I first introduced this bill. The College of Physicians and Surgeons of Alberta wrote:
The stated intention of this bill . . . is very worthy and is generally supported.
The chief surgeon of the oncology division of the Tom Baker Cancer Centre in Calgary wrote:
I would certainly agree with your approach of having a federal registration of these products as one cannot rely on solvency of the industry or rely, without a lot of bureaucracy, that the industry in fact is compliant with regulations about notification of individual devices.
That is a fact.
Finally, this letter from the Riverside Health Care facilities in Fort Frances, Ontario:
I agree that there is a problem with our current system. We rely on the manufacturers to report a recall to us, but in the recent past this did not happen . . . Good luck with this endeavour . . .
Canada's medical technology companies are second to none, and the devices they create have dramatically improved the lives of Canadians and patients around the world. Canada's health professionals provide the vital link between Canadians and the medical devices that can maintain and enhance their lives.
Health Canada is working very hard against difficult odds to tackle the tremendous responsibilities it has been given to protect the health and well-being of Canadians. However, when the unthinkable happens and a device fails, I believe that the central registry for medical device users will prove to be an essential element in fulfilling the mandate to protect the health and safety of Canadians.