Statement made on 21 April 2010 by Senator Mac Harb
Hon. Mac Harb:
Honourable senators, I rise to ask for your support for Bill S-217, An Act to establish and maintain a national registry of medical devices.
This bill was formerly known as Bill S-221 and, as such, it received approval at second reading and was referred to committee before the session ended. It was reintroduced as Bill S-243 last fall, but died on the Order Paper in December when Parliament was prorogued.
Despite these delays, I trust that we will be able to come together and once again agree on the importance of this legislation to the health and well-being of Canadians and ensure it is sent on to committee for further study.
Many of us and many of those about whom we care will depend upon a medical device at some point in our lives. Reports indicate that one in ten Canadians has some form of medical implant. Canada's orthopaedic surgeons are performing 100 per cent more hip and knee replacements than they were ten years ago. Along with the rise in the use of implants, thousands more Canadians are using prescribed medical devices such as blood glucose monitors or portable oxygen tanks.
Health Canada is the body responsible for reviewing and licensing medical devices to assess their safety, effectiveness and quality before authorizing them for sale in Canada. Between 2005 and 2009, the number of devices licensed by Health Canada rose by 62 per cent as 37,259 more types of devices became available.
As the number of devices has risen, so has the number of warnings and recalls relating to these devices. During the same period, 2005 to 2009, more than 2,500 defective medical devices were reported to Health Canada.
While there are records for licensed devices, there is no central registry for the patients who are using those devices. 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 then is required to notify registered users.
Let us look for a moment at the current situation. 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.
Case studies abound of individuals who were not notified, despite the requirement for manufacturers to contact affected individuals. 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.
Take as an example the case of Jodi Logan of Hamilton. She received a Proplast implant in 1985 to treat a jaw disorder. Her pain became worse, but it was not until eight years later that her periodontist told her about the problems with some implants. She called Health Canada but was told that they had no information.
In 1990, the manufacturer had issued a voluntary recall of the implant but then declared bankruptcy. In the United States, the regulator, the Food and Drug Administration, followed up and contacted all patients who received the implant. Health Canada did not follow suit nor could it without the necessary contact information required. To compound the problems, Ms. Logan's surgeon said later that he did not feel the recall was important, and besides, he had moved out of the country.
The current regulations depend upon this tenuous connection between the manufacturer, the health practitioner and the patient. We have seen too often that the regulations are only as strong as their weakest link.
Unaware patients who otherwise could seek immediate treatment to remove or repair the defective device may continue to experience ever more serious symptoms, compounding the personal and financial costs of eventual treatment.
Unaware patients who could otherwise be seeking immediate treatment to remove or repair the defective device may go on experiencing ever more serious symptoms, compounding the personal and financial costs of the eventual treatment.
According to the Canadian Institute for Health Information, the public sector spent $129 billion on health care in 2009. The registry will allow us to cut costs, as well as reduce the pain and suffering of users.
When an unfortunate incident occurs, Health Canada issues warnings, public health notices and other industry notices as a service to health professionals and consumers. When Health Canada receives a notice, it posts the warning on its website and issues a notice.
Does the consumer stay informed? There is no way to be sure. However, one thing is certain: this process alone is not a good substitute for a device registry.
My colleague, Senator Raine, brought up an interesting point when this issue was raised last fall. She pointed out that the user of the medical device will be motivated to stay abreast of news on their particular device, and she proposed that the onus be placed on the individual to stay in touch with the registry. While this legislation leaves the decision up to the individual whether to voluntarily provide his or her name and contact information to this central registry, the registrar will have the responsibility, and I believe must have the responsibility, to contact the individual if their device fails.
While some Canadians might be capable of navigating the online data necessary to stay on top of the latest news about their particular device by product class, serial number, year of manufacture, or specific date a problem may have been reported, many more Canadians who, for reasons of infirmity, lack of Internet access, language barriers, or what have you, will be unable to navigate the complex device identification information. We cannot take the chance that they will fall between the cracks.
Canadians need to know that if they take the time to submit their contact information voluntarily to the registrar for medical devices, and they keep that information up to date, they will be notified if something goes wrong with their device.
If a car is affected by a recall, the owner is notified. Surely we can provide similar protection to Canadians who depend upon medical devices.
I have also heard concerns expressed that somehow Health Canada will face heightened liability if it is responsible for this registry. Health Canada will have no increased exposure to liability after this legislation is in place. Health Canada is already responsible for reviewing and licensing these devices, as well as for posting recall information provided by manufacturers on its website and through the media. I am confident that it is possible to ensure that this legislation is limited to its intended purpose, that is, the timely and direct notification of those affected if a device they depend upon is found to have problems. The registrar's obligations relate to informing registered users, and that is all.
Honourable senators, Health Canada's stated mission is to protect the health and safety of Canadians. Creating a national medical device registry will allow Health Canada to be proactive and specific in the dissemination of information about medical devices that it has approved for use in this country. A national medical device registry will allow Health Canada to take its responsibility "the last mile," ensuring timely notification to registered users.
As honourable senators may be aware, medical devices are divided into four classes, with Class 1 being the lowest risk and Class IV being the highest risk. Obviously, the scope of devices covered by the registry requires consideration. The legislation allows for regulations defining the scope and the class of devices involved.
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 Sweden, Finland, Norway, Denmark, Hungary, Australia and Saudi Arabia.
In the United States, the Food and Drug Administration is very interested in the possibility of maintaining a national registry that includes more than orthopaedic implants.
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. There is no question that such registries are beneficial. However, for the time being, the measure I am proposing is designed to provide users with information on defective devices as efficiently and quickly as possible.
As I mentioned when I rose to speak to this issue last fall, there is a push for a device registry for users in the United States as well. Aaron Moskowitz is with the Biomedical Research and Education Foundation. In an email to my office recently, he said:
User notification, for all devices, is of great interest . . . . There is a lack of information making its way to purchasers, doctors, and patients. A fast recall and warning system for devices could save a lot of money, time and improve patient safety. A registry should work at both the population and individual level.
Here are a few more of the supportive comments 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 of the surgical oncology division at 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.
Finally, this letter is from the Riverside Health Care facility 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. . .
Honourable senators, Canada is a world leader in the development of life-saving medical technology. Canada is a world leader in the field of information technology. Let us commit to using these tools to ensure that we are world leaders in the protection of the health and safety of our citizens as well.