Statement made on 24 November 2009 by Senator Mac Harb
Hon. Mac Harb:
Honourable senators, it is my pleasure to rise to ask for your support for Bill S-243.
This bill was formerly known as Bill S-221. It received approval at second reading and was referred to committee. Unfortunately, an election or two interrupted the bill's progress, but I trust, honourable senators, that we will be able to come together and once again agree on the importance of the purpose of this legislation to Canadians and ensure it is sent on to committee for further study.
Some new faces have joined the chamber since this bill was first introduced. Therefore, I would like to take a few moments, with honourable senators' permission, to provide the necessary background information.
The subject of medical devices hits painfully close to home for many of us. Reports indicate that one in ten Canadians is walking around with some form of medical implant. Canada's orthopaedic surgeons are performing significantly more hip and knee replacements than they were 10 years ago, up over 100 per cent, in fact. Statistics from the Biomedical Research and Education Foundation show us that this trend will continue. By 2030, the number of knee replacements in the United States is expected to increase by 673 per cent, and hip replacements are expected to grow by 174 per cent.
It is not just the use of implants that is on the rise. Thousands more Canadians every year use 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 60 per cent as 37,259 more types of devices became available in the marketplace. As the number of devices has risen, so too has the number of warnings and recalls relating to these devices. Unfortunately, during the same period of 2005 to 2009, more than 2,500 defective medical devices were reported to Health Canada.
The goal of this bill is to establish and maintain a national registry of medical devices. This registry would contain the names and addresses of people who use implantable or prescribed home-use medical devices. The information would be given voluntarily by the users of the devices.
This bill would also require manufacturers and distributors of certain medical devices to notify the registrar if a medical device could pose a risk to the health or safety of a user. The registrar would then be required to notify registered users.
Let us look for a moment at the situation today. As my colleague Senator Keon pointed out when we last spoke to this legislation, we have regulations in place that cover certain medical devices and that contain specific protocols for patients and physicians to follow. These regulations include mandatory problem reporting and require all high-risk implantable devices to be registered.
He also commented on the fact that sometimes, despite the regulations, devices are flawed and patients are not notified. Referring to a tragic case, he mentioned a surgeon who failed to notify a patient about a serious problem with a jaw implant. This unfortunate example of a surgeon who failed to comply with the regulations does not criticize in any way the regulations themselves. While he did not know the particulars in this case, the fault appears to have been with the individual surgeon and not with the system. Sadly, this is true. Despite current regulations which, on paper, could adequately protect Canadians, common occurrences — such as simple human error, a medical practitioner moving out of the country, a patient database being lost or a device manufacturer going out of business — can result in users of medical devices falling through the cracks. When they do, there can be a very high cost to the individual and their quality of life, as well as to our already-overburdened health care and legal systems.
A national registry can mitigate the impact of device failures. Experts and some impressive statistics back this up.
Dr. William Maloney from the Department of Orthopedic Surgery at Washington University's School of Medicine is an ardent supporter of a national registry of medical devices in the United States. His research has shown that if a registry led to an annual decrease of even 5 per cent of the total number of hip replacement repairs, it would save more than $30 million a year. That is for hip replacement repairs alone. Multiply that by the number of devices and complicated repair procedures that could be prevented by an efficient registry system and the savings for Canadian taxpayers would become that much more apparent.
The cost of health care in Canada is expected to reach $183 billion 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 for certain: this process alone is not a good substitute for a device registry.
Our current system needs a backup. Canadians need to know that if they take the time to voluntarily submit their contact information to the registrar for medical devices and they keep that information up to date, they will be notified. No ifs or maybes; they will be notified should something go wrong with their device.
Honourable senators, putting a national medical device registry in place would allow Health Canada to be proactive and specific in the dissemination of information about medical devices that have been approved for use in this country. The registry would ensure that individuals receive quick and reliable information regarding possible life-threatening malfunctions or the failure of a device from a centralized source.
Let us look for a moment at how the national medical device registry would work. The registry would contain, with their consent — it is important to note that registering on this database would be totally voluntary and up to individual patients — the names and addresses of persons who use implantable medical devices or prescribed home-use medical devices. Individuals would be given the option of providing contact information for safety alerts and/or for medical device follow-up and evaluation. Personal data in the registry would never be disclosed for any reason without the written permission and informed consent of the person. At the end of the day, the registry would give Health Canada officials the necessary information for contacting patients quickly in the event of a recall or defective device.
Medical devices are divided into four classes, with Class I being the lowest risk and Class IV being the highest. Class I devices, such as surgical instruments, are not licensed. Class II devices, such as contact lenses and pregnancy tests, Class III devices, such as glucose monitors and orthopaedic implants, and Class IV devices, such as pacemakers, must currently be licensed by Health Canada before they are allowed to be sold or advertised.
Obviously the scope of the devices covered by the registry would require consideration. The legislation allows for regulations defining the scope and class of devices involved.
There are a number of medical devices 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.
The health bill recently passed by the United States House of Representatives includes a clause on a national medical devices registry. The FDA is very interested in the possibility of keeping a national registry that includes more than orthopaedic implants.
Generally speaking, these medical devices registries are established to provide information in real time about problems with devices and give immediate feedback to the medical community and device manufacturers about the performance of these devices, as well as providing 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.
Aaron Moskowitz is the Executive Director of the Biomedical Research and Education Foundation, or BREF as it is called. In an email to my office he said:
User notification, for all devices, is of great interest to BREF. 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.
I look forward to discussions on how the registry could possibly be rolled in with Health Canada's praise-worthy efforts to harmonize licensing and labelling regulations with other countries. Imagine for a moment, if you will, a national medical device registry with links to warnings and recalls around the world. However, as one would say, one step at a time.
Canada is on the cutting edge of research and development in the field of information technology. We have not only the technology needed to create these incredibly complex and oftentimes life-saving devices but, as well, we have the technology that will help us track it and provide up-to-date and accessible information to Canadians in a timely manner.
We have a good system with excellent people doing the very best they can, given the tools and resources at their disposal. However, there is no doubt in my mind that it can be a better system and that Canadians can be better protected when it comes to a device that has gone bad.
Health Canada's stated mission is to protect the health and safety of Canadians. It already has responsibilities to approve medical devices in the first place. It currently gathers information about adverse events and does it best through press releases and a web page to pass on warnings should something go wrong. A registry would allow Health Canada to take its responsibility "the last mile," ensuring timely notification to registered users. It is vital that we meet with stakeholders and ensure that this legislation meets the urgent needs of Canadians. If we do it right, Canada will be among the frontrunners, not only in the research and development of medical device technology, but in the protection of its citizens when that technology fails.
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