Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 35 - Evidence - March 27, 2013
OTTAWA, Wednesday, March 27, 2013
The Standing Senate Committee on Social Affairs, Science and Technology met this day at 4:13 p.m. to study Bill S- 202, An Act to establish and maintain a national registry of medical devices.
Senator Kelvin Kenneth Ogilvie (Chair) in the chair.
[Translation]
The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
[English]
My name is Kelvin Ogilvie, chair of the committee, and I will ask my colleagues to introduce themselves.
Senator Eggleton: Art Eggleton, a senator from Toronto and deputy chair of the committee.
Senator Cordy: I am Jane Cordy, a senator from Nova Scotia.
Senator Dyck: Lillian Dyck, a senator from Saskatchewan.
Senator Harb: Mac Harb from Ontario.
Senator Eaton: Nicky Eaton from Ontario.
Senator Enverga: Tobias Enverga from Ontario.
Senator Seth: Asha Seth from Ontario.
Senator Martin: Yonah Martin, B.C.
Senator Seidman: Judith Seidman, Montreal, Quebec.
The Chair: Thank you, colleagues.
Today we are beginning the first of two meetings on Bill S-202, An Act to establish and maintain a national registry of medical devices.
The steering committee agreed, and Senator Harb has graciously agreed, that our first session involves Senator Harb, who we welcome to the committee. He is the sponsor of the bill. The first part will be limited to 40 minutes or less.
With that, Senator Harb, I invite you to make your presentation.
Hon. Mac Harb, sponsor of the bill: Thank you very much, chair. This is a good move because I think it best to hear from witnesses rather than hear from me on this matter. Having said that, I would like to thank the committee for studying this bill that would establish and maintain a national registry for Canadians who depend upon medical devices.
I believe the government must ensure that Canadians are not only provided with safe and effective products but that they are kept informed should these devices, or the manufacturers that produce them, fail. Health Canada's Medical Devices Regulations prescribe a system that puts the responsibility for notification of problems on manufacturers and health care professionals — a system that has failed in the past and is not optimal for the future.
As new and more sophisticated medical devices come on the market, the government must ensure that Canadians are not only provided with safe and effective products but that they are kept informed should these devices fail.
Honourable senators, approximately one in ten Canadians have an implanted medical device, ranging from pacemakers to hip joints. Thousands more use prescribed medical devices, such as blood glucose monitors. With our aging population and ever-expanding technology, this number is growing fast. The establishment of a national registry for medical devices will ensure that Canadians have a more robust post-market vigilance system that will support the more than 1.4 million medical devices currently on the market in Canada.
In reports released in 2004, 2006 and most recently in June 2011, the Auditor General concluded that, despite its best efforts, Health Canada is not able to fulfill its responsibility for medical devices as stipulated under the Food and Drugs Act and regulations. 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, therefore, left largely to other stakeholders in medical devices, including the medical device industry itself and our already-over-burdened health care practitioners. The current system compromises Health Canada's ability to protect health and safety, which could translate into a growing risk in terms of both injury and public liability.
Medical device failures are disproportionately costly to the individual and to society. Total health care spending in Canada was expected to reach $207 billion in 2012. We simply cannot afford to not address this issue.
The problems with the current system are that manufacturers of implantable medical devices are required to keep track of patients who have received an implant, such as artificial joints, pacemakers or implantable pumps. The data are also collected by health care facilities.
If a manufacturer closes down or suffers computer failure or other damage to its patient database, any record of the distribution of medical devices could be lost. If a patient moves to another health care practitioner or facility — moving, for example, from a children's facility to an adult facility, or moving to a different city — the medical record associated with the device may not move with the patient.
While some device registries exist, which will certainly help monitor adverse incidents, there is no central registry of the patients who are using those devices.
[Translation]
When an adverse incident occurs, Health Canada issues warnings, public health notices and other notices in relation to the industry. It is a service that the department provides to health professionals and consumers. Some Canadians are able to consult information using the serial number category, the year the device was manufactured, and the exact date when a problem was reported. These online databases exist to allow people to keep abreast of the latest news concerning their devices. However, there are many disabled people whose disability prevents them from having access to the Internet, and people who do not speak the language and are unable to consult such a complex database.
In other words, all Canadians do not use the Internet. We simply cannot take the risk that these Canadians will fall through the cracks. If your car is subject to a recall, you are informed by the manufacturer. Surely we can provide comparable protection to those Canadians who depend on medical devices.
A certain number of medical instrument registries already exist. I understand that Health Canada funds the Canadian Joint Replacement Registry, and similar registries exist in countries such as Sweden, Finland, Norway, Denmark, Hungary, Australia and Saudi Arabia. Generally speaking, those registries use established mechanisms to provide real time information on problems involving devices, and provide immediate feedback to the medical community and to device manufacturers on the functioning of those devices, as well as information for clinical research. The advantages of such registries are undeniable, but the measure I am proposing aims to provide users with information on defective devices as effectively and quickly as possible.
[English]
In my statement in the chamber I shared several heartbreaking stories of Canadians whose lives have been ruined due to defective devices and the subsequent breakdown in communications. Sadly, there are too many to recount here today, but even if we can prevent one of those incidents this bill would be worth it.
Other jurisdictions, such as the United States, are exploring patient registries. We will have to set up a registry such as this at some point. It is inevitable, so why wait until more people have suffered needlessly? A volunteer registry would allow patients to be proactive in their monitoring of the safety of their devices. The registry will help close the existing information sharing gap and allow Health Canada to fulfill its mandate of protecting the health and safety of an ever-growing segment of the population.
Thank you, Mr. Chair.
The Chair: Thank you, senator. I will now open the floor up to questions from my colleagues. I will start with Senator Eggleton to be followed by Senator Dyck.
Senator Eggleton: Thank you very much, Senator Harb, for being here and for your effort in this regard. I know that you are concerned about people who are in circumstances where they may need further information and further help.
The current provisions in section 59 of the Medical Devices Regulations requires that device manufacturers report all incidents of device failure and deterioration, as well as all incidents of death and serious health deterioration of device users. How does that work or not work? How does your bill complement that or add to that?
Senator Harb: Thank you for the question. It is a very valid question. This goes right to the heart of the problem, the fact that we put the onus on the manufacturers to inform the practitioners or the hospitals or Health Canada if there is a deficiency. Let us say, for example, a manufacturer basically goes out of business. All that information is lost because the manufacturer is no longer there. Therefore, if there is a deficiency within the system, the patient is at the mercy of the situation. They are on their own.
I came across a case in point where a child patient was in the Children's Hospital of Eastern Ontario. That patient received an implant at the Children's Hospital of Eastern Ontario. After he became an adult, he continued to have the same device he had when he was a child. That device was manufactured by an American company. It went wrong and had a leak. The American company went to the children's hospital in order to inform them that there is a deficiency in the device, but the children's hospital had no idea where the patient was because the patient was no longer a patient at the children's hospital.
This particular patient, who is 19 years of age, found himself in a very critical condition where he had to go for an urgent operation. His mom went on the website of Health Canada in order to find out whether or not the device was reported as being deficient. She could not find any information on it. She went on the American website and, sure enough, it was reported in the United States. When they went back to the manufacturer, the manufacturer said, "Look, I did what I had to do. I informed the Children's Hospital of Eastern Ontario."
Those are the kind of problems we end up facing. Luckily for this child, he will go and have his surgery and will be okay, I hope, but many others do not have that opportunity. That is why it is important to tell the manufacturers what they need to do. When an implant is done, you have to give the patient the opportunity on a voluntary basis to decide whether or not he wants his device to be registered with Health Canada at the national level. Once it is registered, if there is a problem with it, then Health Canada will have the responsibility and the mandate to notify that person so he or she will know there is a problem. That is something which right now we do not have. On three different occasions the Auditor General has asked Health Canada to take action. In each and every one a report was done. Health Canada agrees with the recommendation, but so far we have not seen any compliance.
Senator Eggleton: You mention that other countries are already doing this. Is it really very similar to what you are proposing? You mention Australia and Sweden, a number of other countries that you say are already doing this. Is it very similar? Do you have any experiences in their use of it where it has proven to be of value?
Senator Harb: We have not looked at the specifics of it but, through the communication we have with some of these regimes, it is pretty well similar to what I have. In each country, of course, they have their own systems that differ slightly from other places because their system might be different, but the thrust of it is that in every one of those jurisdictions they have something similar to what I have proposed.
Senator Eggleton: Thank you.
Senator Dyck: Thank you, Senator Harb. One thing that occurred to me is when we are talking about medical devices you are talking about implantable and prescribed medical devices, and I am wondering if there is a difference in the terms of the magnitude of problems in the two categories. You would expect there may be more severe problems with implantable devices versus what you call prescribed devices.
Senator Harb: Yes. I am not a doctor, I am an engineer, so I would leave it to the doctors to decide, in terms of the categories of the implants, which ones would qualify to fit where. There are, according to Health Canada, terms and types. In those terms and types, they are associated with risk. They have different categories in terms of which classification of devices pose a risk and which one has more risks than another one. They classify them accordingly.
The bill leaves it open to leave it up to Health Canada, in consultation with the stakeholders, to decide whether or not the bill in its present form deals specifically with those different classifications or if it needs to be amended. We can amend it; however, the bottom line is that it is a proposal that needs to be addressed. This is the opportunity for Health Canada to come to the table and say they would like to amend the bill in order to fit what we are trying to achieve here.
Senator Dyck: The other thing that occurred to me too is using a medical device can be done at home. For example, you use blood glucose monitors at home, or blood pressure monitors, those kinds of things, versus a medical device that might be used in a medical clinic. Does your bill make any distinction between the tracking of devices are used in the home versus those that are used in a medical facility of some kind?
Senator Harb: That is an interesting question. The answer is precisely what needs to be addressed, to decide specifically in terms of which one of the devices really we classify as must be registered because that is vital to the health and safety of the person. It is wide open to decide to say these are the categories we want to be registered but these categories do not have to be registered at all because they do not pose a danger to the health and safety of the person. Obviously we are interested in devices that pose health risks to the safety of the person.
Senator Dyck: I believe that on the market now there are alcohol breath analyzers, for example. I do not know whether that would qualify as a medical device, but in a sense it could be called a medical device. It has safety risks. If the instrument is not working properly, you might get a false reading. Is it your sense that something like that would fall under the provisions of this bill?
Senator Harb: That is precisely where medical practitioners, as well as specialists in the field, would need to say now that we have the general intent of the bill approved and supported, while we develop regulations, in the regulations these are the devices we want to register. The bill, as it is proposed, provides enough flexibility for them to decide what we want to register and what we do not want to register.
Health Canada already has a list in place. All I want them to do is to go one step further and ensure that the patient is aware that he or she has the capacity to register with Health Canada the device that is implanted in his or her body; and that if that device goes wrong, that patient will be notified.
Senator Dyck: While you were speaking, it also occurred to me that that is kind of a post-approval practice. What about when a new device comes on the market?
Senator Harb: Health Canada goes through a rigorous process with that, and I think they will be able to answer in terms of how they agree to a device being on the market or not. I am dealing with the situation where once the device has already been approved by Health Canada to be on the market as an implantable device, I want to ensure that we have the capacity to monitor if something goes wrong with that device so that we can inform the people who already have those devices in their bodies.
Senator Seidman: Thank you, senator. I would like to follow up on Senator Eggleton's question to you. We all know that in the medical field, in health care, we do not generally need to reinvent the wheel. There are many models, probably excellent models, all over the world to follow. I would like to know what model you chose in developing your proposal for a registry.
Senator Harb: To be honest with you, we did not really go after one specific model. Rather, my staff and I did some research. We looked at what different countries are doing. We kept the proposal broad enough but also surgically precise enough to the point where it allowed the committee to consult with the stakeholders if there are stakeholders who prefer, for example, one model over another model. The idea behind my bill is the fact that whatever Health Canada is doing now, all I want them to do is just go the extra step.
Senator Seidman: I guess what I am asking you is from all the research you have done in developing this proposal, what country did you find presented the best example to follow?
Senator Harb: I will have to get back to you on that. One of my colleagues in New Zealand told me that New Zealand has a fantastic system. Without really saying one thing or another, I did not even look at the New Zealand model.
Senator Seidman: Did you look at other countries?
Senator Harb: We will be happy to go back and find out whatever information we have and share that with you through the clerk.
Senator Seidman: Perhaps I should share something with you right here and now. For example, in September 2012, the FDA came out with a report on exactly this issue. They said very clearly that they are not seeking to develop a centralized repository of registry data. The reasons for that are many, including privacy issues and enormous cost issues. Instead, they want to go the route of individual registries.
As you know, here in Canada, as well as in many other countries, there are joint registries. There are many different registries for different types of medical devices. The United States has proposed to do exactly the same thing but to go the route of individual registries, retaining physical and operational control over their own data. This way, there are firewalls to ensure privacy. The U.K. recently published a report saying there is no way they can go forward with a national registry, that the costs are far too great, as has Australia.
I would like to know what is the model we are using here, because that is critical when you have countries like the United States, the U.K. and Australia all saying they are not doing this.
Senator Harb: Two points came out of your question. First, in terms of the privacy issue, the bill dealt with that. The bill clearly states that it is up to the patient to decide whether he or she wants to put their name in the registry.
On the cost issue, I think it will be a lot more costly if you have all these different registries popping up all over the place. You can still have various categories in the registries, but to have one registry with an administration here and another registry with another administration there would be a lot more costly than having a central registry with a central administrator. In terms of the cost, you can always have a mechanism in order to have the manufacturers themselves share part of the cost. There is no reason why you cannot do that.
As it is now, we basically have nothing. We leave it up to the individual, the patient, to go to a website in order to find out whether or not there is a deficiency, or we try to impose on the doctor or the hospital to inform the patient.
Already a number of lawsuits have been launched against Health Canada. Not only that, but the Auditor General, who is an officer of Parliament, has told the government on three different occasions that they have to do something because the system is broken.
What do we do? Every time, Health Canada says, "Yes, we will deal with it; yes, sure." Frankly speaking, the Americans are looking at it, but the Americans agreed to the fact that they have to have registries. The modality of it varies from what we are trying to suggest. As for the Brits, I am not aware they have said they do not want to do it. The Brits are looking at this now, as we speak.
Senator Seidman: The issue is cost. There are enormous costs to maintaining this. I am not going to argue that point right now. There are valid reasons to have registries; there is no question about that. The issue is what kind of registry and who maintains them. What I would really hope for is that if you indeed have used models to develop your proposal, that you might be able to submit to the committee the international models that guided you in developing this proposal.
Senator Harb: I will be delighted, Mr. Chair. If I am given the time, I will bring forward a proposal based on a model.
The Chair: I think all we need are the examples that are being requested.
Senator Harb: I would be absolutely delighted.
The Chair: That would be great, senator.
I want to remind senators that we have agreed we will complete this section within a 40-minute period, and we are within 10 minutes.
Senator Seth: I am coming towards Senator Seidman, what she talked about, the costs associated with the registry and that creating and maintaining such a registry would be quite expensive. Do we have estimated costs?
Senator Harb: The costs of not doing it has outweighed the costs of doing it; I can tell you this much. We spend about $207 billion a year on health care. If we save one life with this registry, it is worth every penny you put in it.
In terms of the cost analysis, obviously this is something that would need to be dealt with. As I said in my previous remarks, there is absolutely no reason why there will not be a cost sharing with the manufacturers of those devices. There is absolutely no reason why it cannot be done. The honourable senator spoke earlier about the fact that the Americans are trying to do individual registries. Individual registries will cost a lot more than a central registry, where you have different components and you manage with one administrator rather than having a dozen different administrations.
Senator Seth: What process is currently in place for notifying the public when the department becomes aware that a medical device may pose risks to the health or safety of users?
Senator Harb: Now, all Health Canada does is put a public notice on their website, and it is up to you, as a patient, if you have a problem, to go on the website and find out there is a problem with it. In addition to this, the manufacturer, if there is a deficiency in the device, will have to notify Health Canada and the hospital where the operation has taken place. However, as I said earlier, if the manufacturer goes bankrupt, there is no mechanism for the patient to ever find out.
Senator Seth: However, is it not correct that a variety of devices that can be in the body could be taken home? Is there a definition somewhere in your bill as to what those devices should be?
Senator Harb: Yes. Those normally are the kinds of things you do in regulations. When you develop a bill, you put in the guidelines what you want to do. You want to establish a national registry in order to ensure that patients who run into problems with their devices are notified. It is then up to the administration to decide the devices that I want to register and the different classes of devices I want to register. Do I want to register all of the implants — heart implants, stents, hearing aids? What do I want to register? They decide those things in regulations. It is not in the bill itself. The bill normally would give you the general objective of what you are trying to achieve, what you set out to achieve, and then you develop the regulations in consultation with the industry and medical communities. That is where you decide in terms of what kind of devices I want to register.
As it is now, Health Canada already has a mechanism in place. All I want them to do is expand on it in order to ensure that whenever there is a problem, as a patient, you are notified of the problem with the device and do not have to go on your own and find out through a website. What if you do not use the Internet?
Senator Seth: Is it not in your opinion that with most devices, pacemakers and knee transplants, that the patient, if there is danger, would directly go to their physician rather than going to the website and all that?
Senator Harb: Sometimes they may not even have that time. In the case in point I was speaking about with the young child, he had a pump that was installed in his system. If there was a leak in the pump, he could die. He would not have the time if there was a leak. Actually, the manufacturer of that device had recalled the device, put out a recall on it, but it did not arrive to the patient and was not on Health Canada's website and did not go to the right hospital. His practitioner was not notified.
We will have situations that repeat themselves everywhere if we put the onus on the patients to find out. That is morally wrong. We have a responsibility as a nation, as a government, to inform patients who have implants whenever there is a deficiency in them. It is our legal and moral obligation to do that.
Senator Cordy: Thank you, Senator Harb, for all the work you have done on this. You are certainly very knowledgeable about it. This government really has not been particularly favourable for national registries of any kind related to health. Good luck to you. You have certainly done a lot of work on this.
I am interested because of your comments today and your comments when you spoke in the chamber on the Auditor General's reports. It was 2004, 2006 and then again in 2011 when the Auditor General concluded that despite its best efforts, Health Canada is not able to fulfill its responsibilities for medical devices as stipulated under the Food and Drugs Act and regulations. You have sort of brushed over that when answering a question earlier.
The Auditor General also spoke about unacceptable delays in getting new products to the market and the failure to manage the risks related to medical devices, which is what you have spoken mainly about today. However, there seems to be two issues here.
I recall a few years ago that this committee heard from the department who said, just as you are saying," Yes, we will deal with it," but three different reports have spoken about this as being a major problem. In fact, I think fees were increased quite significantly so that the approval process would be faster, but that was a few years ago and I have not heard how that has gone.
Would you comment on the problems that the Auditor General recognized and that your bill seems to address?
Senator Harb: To sum it up, in one of the Auditor General's reports, she said:
However, we found that Health Canada does not assess whether incident reports on specific devices have been reviewed according to the risks identified for that device or that incident reports are reviewed in a timely manner. Without this information, it is difficult for Health Canada to know if the risks identified are being adequately mitigated . . .
The recommendation was:
Health Canada should regularly assess whether resources have been allocated to the identified risks . . .
Health Canada responded. "Is that agreed?" "We agree." It is the same thing all across the board. It said:
In addition, the Department will evaluate incident reporting through the Sentinel system and establish performance standards consistent with other product lines by the 2011-12 fiscal year.
We have not seen that yet.
Data from medical device incident reports, other post-market activities, and associated performance measures will be used to identify high-risk areas requiring risk mitigation activities.
It is same thing repeated in every single one of the reports, and Health Canada every single time says yes, yes, yes, and the problem is that they do not have the resources. That is the fact. What is needed here is an executive decision to say, "We want to deal with it, and here are the resources." We cannot expect Health Canada to do it without having the tools, and that is the unfortunate problem that we have in this particular case.
Senator Cordy: At a meeting that took place on March 22 of the Institute for the Advancement of Technology for Health, according to the summary of their meeting, they talked about the problems with metal-on-metal hip replacement, and that was identified by the registries in the U.K. and in Australia. The U.K. and Australia have registries for these medical devices, and that is how this came to be, because of the registries. Do you feel that the registries would help to identify things earlier?
Senator Harb: Absolutely. Senator Seidman mentioned the fact that it is really important to have individual registries, so we agree on the fact there is a need for registries, so therefore the principle of what we are trying to achieve here is something we all agree to. I am trying to advance it by saying that if we agree, let us say we agree, but also let us put it in a law, and that is why this bill is before you now. It will take all of those statements that we are hearing in corridors that we agree on having different registries and put all those registries under one umbrella, which is Health Canada, and let us give Health Canada the resources. I personally believe it all comes back to the question of allocation of resources to Health Canada for Health Canada to be able to comply and do the job they want to do, because I know Health Canada wants do the job but does not have the tools.
Senator Cordy: What happens if we do nothing? What happens if we keep the status quo?
Senator Harb: There is already a number of lawsuits that I am aware of that have been reported in the public domain. I suspect there will be a lot more. People looking at what has been reported by the Auditor General and what has been responded by Health Canada to the Auditor General will say, "Look, you, the government, through your agencies, have agreed to do something about it, and you have not. I am a victim, I have been impacted individually, and therefore I am launching a lawsuit." We already have a number of lawsuits against the Government of Canada specifically as a result of the fact that they were not properly notified. With the number of people who are getting implants on an exponential basis, and there will be a lot more with the advancement of technology, we will have the problem multiplied 1,000 fold.
Senator Enverga: I am thinking about the analogy of a car. Is it better that the surgeon should be keeping all the stats? If there is something wrong with your device, is it not best to go to your surgeon to fix your problems with a device? Do we not have that kind of registry existing already?
Senator Harb: Yes, for as long as the doctor is practising, but if the doctor retires, what happens to that doctor's registry? It is gone. That is where the problem is. The issue here goes right to the heart of the matter.
The patients need to be given the opportunity to go to the national registry, to the registry that is with Health Canada, and decide for him or herself to register with the Government of Canada that they do have a device. "If that device goes wrong, please notify me." Do not put the onus on the nurse or on the doctor, because they are already overwhelmed and have plenty of things to do rather than become administrators of individual registries. They may have 100 or 200 patients. They may move from one hospital to the next. They do not take those records with them. That is the problem.
We have a massive problem, and it will be magnified as we move forward because more and more devices will come on the market, and more and more people will use them, and more and more we will have problems. We cannot bury our heads in the sand and do nothing about it because, whether we like it or not, eventually someone will force us to do it. If the public cannot do it through Parliament, will the court force us to do it? Eventually, some justice or court somewhere will say, "I am sorry, government, you are wrong" and then you have to compensate for the liability. We will lose lives. We are losing time. This is the time to do it, right now. We do not have to wait forever in order to do it. We have to do it now.
The Chair: I believe Senator Seidman wanted to clarify a comment she made with regard to one of the countries she referred to.
Senator Seidman: I did. Actually, technology is wonderful, and you mentioned New Zealand wherein someone had told you New Zealand had a wonderful registry system. I would like for the record to add that indeed New Zealand has a registry, but it is a joint only registry, much like other countries have.
Senator Harb: Yes, but there is a registry.
Senator Seidman: It is joint only.
Senator Harb: It is joint only, but that does not mean you do not develop it in order to have more.
The Chair: It is an example of a registry. Thank you very much, Senator Harb, for being here and answering all of our questions.
Senator Harb: Thank you.
The Chair: I will now formally welcome to the meeting Dr. David Urbach, who is with the Division of General Surgery at Toronto General Hospital; and Dr. Tony Easty, who is in Design and Engineering Health, Techna Institute/ University Health Network. Both are with us by video conference. Gentlemen, we welcome you to the meeting.
Is one of you going to make the presentation, or are you both going to speak in the form of a presentation?
Dr. Tony Easty, Design and Engineering Health, Techna Institute/University Health Network: First, thank you very much for inviting us to present. We discussed it and decided that I would make the presentation — I am Tony Easty — and then we will both offer comments. Can you hear us okay?
The Chair: Yes. Everything is fine, and I will get back to you when I invite you to make your presentation.
I want to next introduce our other panelists who are here in the room, but before I do that, we have Barbara Sabourin, Director General, Therapeutic Products Directorate, HPFB, and so my colleagues know, she will only be answering questions for clarification. She will not be making a presentation. If there are questions we need to direct to her for clarification of issues, she will try to help us in that regard.
Then we have from the Canadian Nurses Association, Karima Velji, President-elect; and Sandra Lauck, Clinical Nurse Specialist. I understand, Ms. Velji, that you will be making the presentation. I will invite you to present first. We will then invite Dr. Easty to present, and then I will open the floor up to questions.
Karima Velji, President-elect, Canadian Nurses Association: Thank you very much and good afternoon. My name is Dr. Karima Velji. I am President-elect of the Canadian Nurses Association, CNA, the national professional voice of registered nurses in Canada. Representing nearly 150,000 RNs, the CNA advances the practice and profession of nursing to improve health outcomes and strengthen Canada's publicly funded and not-for-profit health system.
Joining me today is Sandra Lauck, a clinical specialist at St. Paul's Hospital in British Columbia. From her extensive experience as a cardiac leader, she will offer insights into the current monitoring and reporting system on patient safety issues for implanted medical devices and raise some of the practical challenges presented by this bill.
The opportunity to speak to this bill allows us to highlight several existing gaps in current practices for the monitoring and management of implantable medical devices. Creating the kind of registry the act proposes could, in our opinion, be an improvement on the diverse systems currently in place. As it stands, these systems are not sufficiently standardized and patient-centred, and they rely too heavily on industry for tracking, monitoring and the reporting of risks. A centralized system would address this shortcoming, both through resources to evaluate device outcomes and through vigilant attention to device performance outside local approaches and manufacturer programs.
Often, it is up to manufacturers to tell health care facilities and hospitals when an advisory or recall is issued or when a new risk is identified. Only after such industry notification does the facility inform patients who have a medical device implanted at their location.
While Health Canada also receives notification from manufacturers and makes sure that health care facilities have been notified, no one is uniformly responsible for tracking the notification of patients, and this is a clear risk to patient safety. A standardized and patient-centred system of monitoring and tracking would support our ability to convey device-related issues at the clinical level and ensure a continuity of communication and intervention.
Relying on industry to identify and advise of new risks with medical devices is a hindrance to adequate oversight because of potential conflicts of interest. By establishing a national independent registrar, not only could such conflicts be avoided, but the reporting of newly identified risks would be taken more seriously and ensure appropriate notification.
Despite these advantages, certain challenges exist in the bill's current form, and to outline these, I will turn to my colleague, Dr. Lauck.
Sandra Lauck, Clinical Nurse Specialist, Canadian Nurses Association: The first challenge in the current bill is that, for several reasons, it is inappropriate that the registrar be the first person to inform the patient of potential risk. In my experience, in the event of an advisory or recall, patients may feel significant anxiety, uncertainty and confusion. To communicate an advisory or recall clearly, we must include the consensus understanding of risk and recommended interventions. These in turn require the interpretation of expert medical societies, such as one in my experience, for example, the Canadian Heart Rhythm Society, and the patient's most responsible clinical team, who provide for their care.
There is an inherent risk when we needlessly increase the patient's distress by separating the communication of the advisory or recall from the treatment plan. In addition, a patient's capacity to fully understand the nature of consenting to inclusion in a national registry, their personal risk in the event of an advisory or recall and the implications for their care can be impeded by literacy, language, cognitive capacity, cultural and other barriers.
The second challenge of the existing bill is the problem of collecting medical devices registration information at the point of care, which is to say in clinical practice. In the absence of national electronic health records with the capacity to scan device information, responsibility for data collection may be assigned to clinical resources — for example, operating room nurses — and this will likely negatively affect the time available for direct patient care that nurses provide.
The third challenge is the bill's vague definition of a "medical device." To more clearly define the classes that need to be captured under this legislation, we advise including new, complex and high-cost or high-risk devices in this definition, and regularly updating these in conjunction with Health Canada.
It might surprise some committee members that rapid innovation and technological advancements in the medical devices field sometimes lead to implantation and use prior to complete Health Canada approval. While such a practice may be the most medically-effective course of action for a particular patient, it can also lead to increased risks because of unknown factors with a particular device. Failing to set out clear class definitions for medical devices under this bill may lead to the unnecessary registering of devices with a lower level of risk, which would cause an equally undue burden for the task of reporting them.
Finally, treating implanted medical devices in the same fashion as prescribed medical devices for in-home use has potential problems. While there is little question about who owns an implanted heart valve or knee joint, the same cannot be said for a prescribed morphine-drip machine supplied by a home care nursing organization. If a new risk is identified with the morphine-drip machine, which may be used for multiple patients over time, then who must the registrar notify — the patient who then notifies their home care provider, or the home care provider who then assesses the situation and works with the patient to determine whether the machine needs to be replaced or exchanged?
CNA strongly advises separating legislation related to implanted medical devices from prescribed medical devices for in-home use.
Ms. Velji: While not yet perfect, this legislation raises critical questions about patient-centeredness and patient safety, issues CNA views as a shared responsibility for all health care professionals, health care organizations and governments.
It is clear that more must be done if we are to ensure adequate information for patients on the risks associated with medical devices to help reduce these risks through additional government oversight. On behalf of CNA, we appreciate the opportunity to highlight our concerns and recommendations on this issue, and we look forward to your questions.
The Chair: Thank you very much. I will now turn to Dr. Easty to make his presentation on behalf of his team.
Dr. Easty: Thank you very much. To just briefly explain, we assembled a team of people based here at University Health Network in Toronto with expertise in medical device design and development, medical device research and also physician practitioners. This is a consensus perspective we are bringing forward from this team.
In general, the idea of a medical devices registry for the devices that have the potential to cause critical and severe outcomes for Canadian patients using a centralized database for medical device tracking is supported by us all. As examples, problems with metal-on-metal hip implants and implantable pacemakers and their associated leads have been picked up early through registries in other countries, such as the United Kingdom and Australia, and it would be nice if we in Canada had a similar mechanism for detecting these problems at an early stage. Specifically, we see that a registry will be able to assist in driving a recall of any medical device, once a problem with a device has been identified and subject to the comments you just heard about regarding who would actually perform the notification.
Second, it would also very importantly allow for continuous post-market research on medical devices. Most medical devices are approved without going through the rigours of large scale clinical trials testing applied to pharmaceuticals, for example, and there would need to be a close tie-in to an effective incident reporting system so that early evidence of adverse outcomes could be identified and acted upon.
As a footnote to that, I would point out that we have relatively low levels of medical device incident reporting here in Canada. Therefore, we would need to consider how we would effectively get this early warning from the field in such a way that it could drive an early recall of a problematic device.
We did identify a number of issues of concern with the proposed bill. The first one is the whole question of the inclusion of home care devices. It is certainly not clear to us why home care devices have been included in the bill, and we are not aware of any evidence to suggest that home care devices represent a significant threat to patient safety in Canada. The bill as structured assumes that these devices are practitioner-prescribed but in reality in our experience, this is rarely the case. Home care devices are not necessarily linked to one specific person. They may be shared within the home or passed on over time, and some devices are not person-specific and, therefore, would not be tracked appropriately by the registry.
It would be our recommendation to remove home care devices from the bill and focus instead on implantable devices and other devices that have the capacity to cause critical and severe outcomes for Canadian patients.
As we understand it, the information submitted to the registry would be confidential. Therefore, scientists and clinicians who do research and monitor success in this area would not have access to it. It weakens the power of a registry if the data cannot be mined and used to their full potential. Suitably anonymous data should be made available for the purposes of ongoing monitoring and analysis.
Finally, the scope of implantable devices addressed by the bill needs to be limited. Basic devices that have been used for many years without issue should not have to be registered; for example, screws and plates used in orthopaedic surgery. The registry should be used, in our view, for devices that create departures from long-standing practices where the potential for serious adverse outcomes to the patient is present. Devices whose performance is based on software are especially important to track since they have been shown to have significant failure and recall rates.
That is our formal presentation to you. We would be happy to answer any questions or enter into any discussion that you might want to have.
The Chair: Thank you all very much. We will open up the floor to my colleagues. I normally have Senator Eggleton to go first. Is that agreeable to Senator Harb, or would he as the sponsor like to take the floor.
Senator Harb: Absolutely. First, let me thank the Canadian Nurses Association for their excellent presentation. Frankly, those are the kind of suggestions we require to have as an input. From your presentation, you made the exact same point that we have heard from Dr. Easty; namely, that you want to be included as part of the notification because of the fact that you are a stakeholder in it and because of the psychological impact it may have on the patient.
You also brought up the fact that not every device needs to be registered, and I think Dr. Easty made the very same point. As somebody who is a proponent of the bill, I support both concerns, and I would be open to seeing the committee make an amendment in order to incorporate both the suggestions of the Canadian Nurses Association as well as the excellent suggestion of Dr. Easty. All of his recommendations, in fact, were excellent, and I recommend that the bill be amended. I think it would be very easy to do that in order to deal with those two points. Thank you.
The Chair: Thank you, senator.
Senator Eggleton: What I have heard in the submissions is certainly a case for a registry, and I have also heard the case for a national registry. As Senator Harb has pointed out, there are some concerns about what is or what is not in the bill and what some of the details are and how it would be carried out.
I will ask a question of Health Canada. What is the matter with a national registry? Why is Health Canada not pursuing that?
Barbara Sabourin, Director General, Therapeutic Products Directorate, HPFB, Health Canada: I will start with saying that I think that the importation and sale of medical devices in Canada has been regulated for quite a long time and that improvements have been made over the course of that time for certain.
In terms of some of the comments about the post-market safety of medical devices and the need for incident reporting, that did start with just the manufacturers, but now we have systems in place to allow for patients to respond and tell us when things go wrong for them. We also have a Sentinel network with health professionals in a group of institutions to try to get more information on issues such as device problems so that we are constantly evolving over time.
We believe that the system we have right now for regulating medical devices is adequate for regulating the safety, effectiveness and quality of devices in Canada. It incorporates a component such as regulatory control over mandatory problem reports from manufacturers. It incorporates things like making sure that the manufacturers issue recall notices. We think that, with the use of the Internet that we have done where you can find a list of all registered devices in Canada, as well as all the recalls that are published and Health Canada's posted notices to hospital on behalf of companies so that Canadians can find them in one place, we have gone a long way to supporting transparency and also safety for these devices.
I would add that there is also some concern about privacy. Even with the voluntary nature of the bill, there still remain a couple of things in that area. As well, there is the issue of costs, especially in this economic climate, about how much it would cost for us to develop such a registry, including determining, as you heard earlier, what the needs really are, what the scope really is, and how we would make that work.
Senator Eggleton: The question of cost, though, has to be measured in terms of public safety. If these devices are failing from time to time, and there is not a proper procedure to assist people who have a failed device, then saving lives is a very important factor in all of it. You cannot just put it down to a few dollars as making it too expensive.
You think what you have now is pretty well okay. You make improvements, you say, over time. I do not know if they are as fast as the Auditor General has indicated he wants them, but I would like to get an indication from the others.
If we do not have a national registry, what are the potential improvements? I am certainly hearing from you that some improvements are needed. I would like to hear from Ms. Velji and Dr. Easty or their associates on this. Quite aside from this question of a national registry, what improvements do we definitely need now?
Ms. Velji: The predominant improvement would be if we keep patient safety as the predominant priority here and the public safety of Canadians as the standardized approach to register the devices and to issue notices on devices using a standardized means. While it may be currently handled using many systems, it is done in individual and non- standardized ways with a heavy reliance on patients themselves, health care providers and industry partners. To us, a standardized system converges all of those liabilities and accountabilities in one place for the benefit of patients.
Ms. Lauck: I will use an example from my clinical practice. A few years ago there was an advisory issued for one of the leads for an implantable defibrillator. This is a device that is used to resuscitate the heart in the event of sudden cardiac arrest for patients who have severe heart failure or who have already survived an event. In this case, about 300 patients in my hospital were affected by this recall. It was issued through what I see as the regular channels, the Canadian Heart Rhythm Society, but also the manufacturer who was quite supportive of this.
Having said that, though, time is one of the components that is of essence here in whatever process we are proposing to improve. Because of the time required to identify all of the patients with this lead, not just the ones who were still in British Columbia but those who had moved across the country, which was hugely problematic at our end, it resulted in a fair amount of patient distress, having heard about this recall on the news, for example, and not having a clear idea of the communication. Had we been able to have a system where we were able to confidently get the list of patients with the exact nature of their device, it could have sped up and clarified the communication to decrease patient distress.
Dr. Easty: I will turn it over to my colleague, Dr. Urbach, to comment first.
Dr. David Urbach, Division of General Surgery, Toronto General Hospital, Techna Institute/University Health Network: On one issue that is particularly important, there has been a lot of discussion about the need to identify and potentially notify individual patients who are exposed to devices that are problematic, but I think an equally important concern that a registry or similar structure could address is the ability to identify problems with devices early on so that they do not continue to be used in people going forward.
Underlying this is the fact that people have alluded to the fact that devices make it to market generally with not a lot of information about their long-term safety and effectiveness. This is very much in distinction to the process we have for market approval of pharmaceuticals where generally we have large clinical trials done with many hundreds or thousands of human subjects and generally have a very good idea of their safety profile and their effectiveness.
Devices are engineered products. Their behaviour is often quite predictable based on mechanical or other engineering properties and, as a result, we do not do a lot of the human testing that are typically done with drugs.
That leaves us with the fact that devices will be brought to market often with some very rudimentary information about their long-term safety and effectiveness, and we desperately need an effective way to monitor them in the post-market space. Right now the procedures that are in place at Health Canada are not comprehensive. A lot of these are worthwhile, such as the Sentinel reporting process, but we do know that the rate reporting of device problems by physicians and by users is extremely low.
We need a much more effective procedure to monitor the safety and other aspects of the performance of devices after they have been approved for market and widespread clinical use.
Senator Eggleton: I would just like to hear from Ms. Sabourin again about these suggestions that have been just offered.
Ms. Sabourin: I will start with the standardized approach. I can certainly see the utility in having a standardized approach for reporting problems and also providing risk communications. We have tried to do that in Health Canada. We have worked with manufacturers to develop a template that can be used so that people can find the information at the same spot as much as we can and also, at the same time, to ensure that the risk communications we use will help alert readers to the level of risk to some extent so that we can try to encourage a more safe environment.
As was recognized by the Auditor General, we have not gone back and looked at the effectiveness of our risk communications. That is a project we are currently undertaking in order to try to improve some of those risk communications.
In terms of the comment about monitoring in the post-market space, we recognize that we do not live in a perfect world in that area. One of the things we have done is to work with other countries, and the regulators in other countries, to ensure that we are quicker on sharing risk information between countries so we can act on it. As an example, the information on the metal-to-metal hip implants came to us from the TGA in Australia. We were able to work with that very quickly.
Senator Eggleton: Can you give us timetables on these improvements?
Ms. Sabourin: I do not have that in front of me right now.
Senator Eggleton: Could you provide them to the clerk, please?
Ms. Sabourin: Yes, I think we can probably provide something on that.
Senator Eaton: This is fascinating. Dr. Velji, in your presentation you say it is clear that more must be done if we are to ensure adequate information for patients on the risks associated with medical devices and help reduce these risks through additional government oversight.
Perhaps you can explain to me: I do not see how a national registry will help a patient. If I, as a patient, get an implantable pump or something to do with a heart monitor, I would think it is my relationship with my doctor that will help me decide whether the risks are worth it. I do not understand what a national registry has to do with it.
Ms. Velji: That is a good question, actually. It is our position that if there were a recall or a problem with a defective device, the vehicle of communication should be the hospital, the health care organization or the clinician, the clinical team. That should be the hub of the communication. However, the way in which the clinician or the health care organization will obtain information in a timely and standardized manner, that is where we see the value of a national registry. Such a registry would then allow that information to be communicated in a more timely, standardized and aggregated way, where the risks are understood earlier than they are currently. That information would then be conveyed to the patient through a clinician, using the stipulations that Dr. Lauck identified, with a clear understanding of the risks involved, the context that needs to be communicated to the patient, and so on.
Senator Eaton: Senator Harb was careful to point out — and I think you talked about the 300 patients — that this is a voluntary thing because of privacy laws. Therefore, it would be up to the patient, if he moves away from your hospital or a doctor in your jurisdiction, and moves across Canada. If I, as a patient, move to Nova Scotia, how will a national registry help?
Ms. Lauck: I think that level of patient education is integral to the process. As it stands right now, as part of the patient education, for any situation where a patient will receive a device, there are existing local solutions to the problem that we are debating today. In my experience, most patients are highly agreeable to the tracking of their device. In my nursing experience, there has not been a barrier to obtaining that kind of consent, given the proper patient education.
I would mention that given our reliance on industry now, who have been formidable partners in many respects to support some of this, part of the consent at times has been for devices where the storage of data will not be in Canada, for example, to educate the patient around the storage of data being in the U.S. and the implications with the current Patriot Act. We are well versed in the clinical setting in addressing the patient privacy issues and how that impacts the patient's rights over time and the ongoing care.
Senator Eaton: I accept your answer. I guess I still see it as a relationship with my doctor rather than with a national registry.
Dr. Easty, it seemed to me you were not talking so much about a registry for medical devices as much as you were bemoaning the fact that we do not have better post-market research or information on how well these devices are working. Is my understanding correct?
Dr. Easty: Let me speak to that. The purpose of the registry, as we see it, is primarily to drive a recall of a device in the event that evidence emerges that shows us that that device is problematic and potentially harmful to patients. Having the registry itself does not generate that knowledge. It simply tells us who has a particular device. Therefore, to us it seems essential to have information being fed into a registry of this kind that actually tells us what the patient experience is out in the field.
I hear the comment from Health Canada about relying on information from other agencies in places like Australia, but I think in Canada it would be nice if we could do better ourselves and actually attempt to more effectively gather information from the field as devices are used by our patients, and then to be able to tie that information to the registry and determine the point at which enough information is being collected to indicate that we do have a serious problem with a device and we need to go back and notify patients and their care providers. That was really the point.
Senator Eaton: Would you care to comment, Ms. Sabourin?
Ms. Sabourin: I will start by saying that our pre-market evaluation requirements are fairly rigorous compared to other regulators in other jurisdictions. There was a comment about the lack of clinical data, and certainly there is not as much clinical data for devices as there would be for drugs. However, our requirements are fairly comprehensive and do include investigational and clinical testing, especially for higher-risk devices. I just wanted to mention that part.
Although some of the privacy concerns have been addressed, there still remain some privacy concerns. In terms of better research on pinpointing problems earlier, which I think is your question, that is why we are trying to move forward with this Sentinel network and to get into the facilities to get the reports back on how the devices are functioning in the real world.
Senator Eaton: May I just say, doctor, that I think the current regulations require the manufacturer to be able to trace the distribution of their devices to health care facilities and physicians. If there were a recall, it could be done from the manufacturer, to the physician, to the patient, and I am sure doctors do not throw out their records.
Dr. Easty: I think the real challenge, though, is how the manufacturers actually learn of the problems in the first place. Often these problems are identified patient by patient, on a one-off basis, and so the patient himself or herself has no knowledge of the broader scope of the problem. Even the treating physician may have a relatively small population of patients with a particular kind of implant, and so it is not obvious to him or her that his or her patients are suffering as a result of a particular medical device. It is only when you aggregate the information across a country like Canada that the pattern begins to emerge.
We do see the value in a centralized registry, but it does, in our view, have to be linked to the aggregation of this data on a timely basis from the front end of the clinical system, which really means a comprehensive and quite aggressive reporting system for any incidents that occur with critical devices.
Senator Martin: It is interesting listening to your testimony in that there is some agreement, but I also feel that each of you has outlined a very different reason for a registry, but it is all connected and it will improve our system.
In terms of Health Canada, we heard you say that the system we have at this time is sufficient, but would you speak to what additional tools may be needed? A national registry, to me, is sort of a big-blanket solution potentially, but we are questioning that and we are trying to make a determination.
With the system that is working at this time, are there tools that are currently being considered to be added to strengthen the current system? Is the national registry the be-all and end-all? We are hearing slightly different perspectives on this.
Also, in terms of this bill, there are merits of the bill, and we heard Senator Harb's passion that he has invested in this bill. However, there are concerns and there are some grey areas.
What tools can we add to the current system in lieu of a national registry, which to me is a very big task?
Ms. Sabourin: I will start with a few things that we are trying to do to make the system work more efficiently.
We are trying to make it easier for people to report, whether it is adverse reactions or incidents with devices or problems they are having, not only for the health professionals, who are very busy people, but also for patients, so that we can start to collect that information more robustly.
We are wanting to improve the Sentinel network that I mentioned earlier. It has been a pilot, so we are looking at how well it is functioning and how far we should be going with that.
I also mentioned earlier evaluating our risk communications to see how effective those are and what we can do better in that area.
There are a few pilots, and I am sorry that I do not have full information for you, on using social media more, and again making it easier, so whether we could we use an app on a smart phone or something to help with the reporting as well.
Also, we are working even more with other countries in a new medical device regulators' forum to try to strengthen the systems worldwide. The device industry, like the pharmaceutical industry, is a global one, and so we need to recognize that in our regulatory frameworks.
Dr. Easty: I would add one thing to the question posed a moment ago. Something I think we could look at doing that I do not believe would consume a huge amount of extra cost, although everything comes at a price, would be to look at steps to increase the level of reporting that goes on at the moment. It is important that we do everything we can to try to gather information from the field, because that is the information at the end of the day that will reveal to us emerging problems with medical devices.
I totally agree with Health Canada's position that no matter what we do to examine health devices when we licence them, no matter how diligent we are, there will inevitably be some devices that all the same come to market and then subsequently problems are uncovered. That is despite the best efforts of everyone involved in device regulation. Many medical devices are extremely complex and difficult devices to design and build. Just as with other products that come to market, there will inevitably be some devices that come into use and then subsequently are found to be problematic. Really, the test is how we effectively build for ourselves a Sentinel system, a warning system, that comprehensively and effectively gathers that information in a timely and effective way and allows us to act earlier rather than later.
Ms. Velji: I agree with those points. Regardless of the system that exists, whether we continue to use the current system and tweak it and enhance it or we create a national registry, some of the enhancements you speak about need to be done regardless. People have to have the ability to report in an easy way, to extract data in an easy way and so on. It reminds me of the incident reporting systems that I have implemented in organizations I have worked in as a health care executive. Even after doing all of that, if you do not have a central repository where the aggregate data can be present and extracted and learned from and the near misses are reported and so on, it defeats the purpose. You can do minor tweaks here and there all over the place but, without a central registry and a standardized system, all of that will not be achieving the potential to patient safety that a centralized registry would offer.
Ms. Lauck: I want to caution the committee about over-reliance on self-reports on the part of patients. You must remember that these patients, in addition to having one device, are also burdened by significant, multiple co- morbidities, and it is often unclear to patients what is causing what. Maybe having a new heart valve or a hip joint or anything like that is just in addition to other multiple problems. There is also huge vulnerability related to fear and anxiety and the power differentials that we have in our health care systems that do not often favour patients speaking up for all sorts of cultural and other reasons. The reliance on some of those great ideas about social media and website utilization are all limited by patient capacity, and that is the person we are talking about here.
Senator Martin: I have a question of provincial and federal jurisdiction and what challenges there would be going forward with some sort of national registry in that it is a shared responsibility. We would have to have the provincial- territorial buy-in. I was wondering about that whole process and what challenges there may be.
The Chair: I will turn to Ms. Sabourin on that question.
Ms. Sabourin: It is a big question.
The Chair: In terms of experience in this area, if others have actual experience, they can come in, but this is an important technical question, and I do not want you to ad lib on this. That is why I am turning to Health Canada. I know they would never ad lib.
Ms. Sabourin: Thank you so much. Certainly the safety of medical devices in Canada is a shared responsibility. The federal government is responsible for regulating the sale and importation for sale of medical devices, and provinces and territories have responsibility for delivery of health care services, including licensing of health care professionals. The provinces and territories regulate physicians in practice of medicine, including direct dealings with patients.
In the context of the proposed bill, any requirement for physicians or any other health care professionals to maintain or provide patient information to a national registry would go much beyond the federal role and would certainly need to be supported by provincial and territorial governments.
The Chair: Does that answer your question, senator?
Senator Martin: Just on the surface, but that is fine. I know have I limited time, so I may go for round two.
The Chair: I do think she answered your question in terms of the difference between the licensing of the devices and the involvement of the medical practitioners. You can think about it, and I will put you on round two.
Senator Seidman: Dr. Easty, I would like to pursue something with you. You cautioned us to differentiate between lists of patients in a registry and being able to actually draw any conclusions about adverse outcomes. There are some who say that there are great limitations to voluntary registries. In fact, very recently, in England and Wales, I believe it was, it was said that unless compliance is well over 95 per cent, there will never be confidence in data from any registry. Could you comment on that, please?
Dr. Easty: The registry itself, I am assuming, certainly as framed in this draft bill, is simply a record of the implantation or use of a device for a particular patient by a particular physician and treatment organization, so the value of the registry taken at that value is simply to be able to then go back and contact the people. If one has a response rate of 90 per cent, one can say that 90 per cent of the people who have such a device can be contacted through a centralized registry of this kind. For the remaining 10 per cent, we will have to use other means to bring them in in the event of a recall of the device.
My point, and I keep going back to it, is just that the registry in and of itself tells us nothing about the safety and effectiveness of the device. We need to fold in the incident information that is coming to us from other sources and match it up against the device registry to know how often the incidents are occurring and how many Canadians potentially are affected, which is where the registry comes into play. I am not sure I have answered your question, but I have tried to.
Senator Seidman: You have done a good job of differentiating and reissuing the caution that a registry is just a list of patients and we cannot draw conclusions about outcome from it. The two are different, and I understand that.
I would like to go back to the issue of a voluntary registry, because that is where my question comes in. The issue of 95 per cent compliance has to do with an incomplete list of patients who have these implants. If it is voluntary, you could have 20 or 30 per cent of people who have the implant agreeing to volunteer their name, and that means that you are missing an enormous amount of data. It makes it much more difficult, probably impossible, to draw any real conclusions about some severe adverse effect of an implant if you only have perhaps 20 per cent of those who actually have the implants.
Dr. Easty: My response would be that the information that will allow you to come to the conclusion that there is a device that is problematic will come from other sources anyway. Therefore, if I were to place emphasis on any component of the system, I would honestly rather see a very aggressive approach taken to the reporting of adverse events and outcomes within our system and the analysis of it.
To Dr. Velji's point, it is great to accumulate data, but if you do not analyze it and interpret it, then you do not understand what the data is telling us and we cannot act upon it.
The real information comes from the field as a device goes into use and is used progressively over a number of years. The value of the registry as it is framed in this bill is simply in the event that we identify there are problems, the higher the percentage of patients who are in the registry, the more effectively we will be able to go back and contact them, in the worst case, in the event of having to remove the pacemaker lead, as was talked about in an earlier example.
It would certainly be nice to have as many people as possible participate in a registry, but we need to look at the reporting side of things to ensure that the value of the registry is there for us.
Senator Seidman: Thank you.
Senator Enverga: This question is for Dr. Easty. Usually when you go to the hospital to have a device implanted, you see all the information, such as patient name and what kind of device is being implanted. I was just thinking if there is currently a repository or registry that would provide the best information, it would be the hospital. Am I right about that? Can the hospital be the right place to go for registry information?
Dr. Urbach: Right now, generally the hospital does keep information on implantable devices among patients who are treated in the hospital. The problem is that all the dots are not connected. For example, once a patient is treated in hospital, they leave the hospital and they may not be followed up at the same hospital. Their doctor who follows them may not know exactly what device was implanted.
Generally, patients themselves do not really know exactly what device is implanted. They may know what class of device was implanted or that they have a stent in an artery, for example, or a pacemaker, but they may not know the exact model. If they had a hip joint implanted, they may not know if it was a metal on metal or a conventional hip or the model. Should there be a problem, how does that information ultimately get back to a hospital where it was implanted? The cycle is not necessarily complete, but in answer to the question, currently the hospital does have to maintain records.
Senator Enverga: Are you saying you do not have all the records, such as what type of implants are used or what type of surgery was done in the hospital? You do not have that type of information?
Dr. Urbach: The hospital does have that information in the hospital medical records.
Senator Enverga: That is good. In that case, then, would you think that the hospital should be more like a registry instead of having a national registry?
Ms. Velji: If there are a thousand hospitals in Canada, there are a thousand such different systems that exist, so the issue of standardization is really at risk with a hospital-based system. Once you consider the mobility of people, if they move from jurisdiction to jurisdiction, out of country or they change physicians, then the ability to connect the information on a particular patient to that device becomes suspect over time, as mobility occurs.
Then the ability to aggregate information from a thousand individual systems to derive your learnings and actions is also compromised with such individual hospital-based solutions. Ms. Lauck can elaborate from her experience.
Ms. Lauck: Does that answer your question?
Senator Enverga: Your concern is mostly about the registry and the monitoring of these devices. Is that correct?
Ms. Lauck: The concern is primarily about rapid access to standardized data that is accurate and available in a way that we can then go on to the next step.
I cannot speak to the outcomes piece as my physician colleagues can, but certainly in terms of rapid communication in a systematic way, a hospital-based system is not well suited to tracking that kind of information. It would require going chart by chart, for example, depending on what kind of device. Again, it would lead fundamentally to delays in communication and to lack of clarity in communication.
When we think of potential solutions, unless it is a standardized approach with systematic input that is available at the clinical level, regardless of where the patient is, it is challenging to come up with a different model.
Senator Enverga: Mr. Chair, what I am driving at now is that since there is a need for a registry for implantable devices, could we maybe do the same to off-label pharmaceuticals, the other study we are doing?
The Chair: No, senator, our order of reference is absolutely specific. We are dealing with prescription pharmaceuticals. These are not pharmaceuticals.
Senator Enverga: Well, it would help.
The Chair: The issues that we are dealing with for pharmaceuticals cover a wide range of health issues, including diagnostics. Therefore, one cannot cover the entire world in one study; one has to focus on each area. I am agreeing with you that this could be an area of focus, but I have to point out it cannot be an area of focus within our current study, to answer your question.
Senator Cordy: Thank you. I think each of you has certainly indicated that a national registry would be an asset to gathering information and to having it standardized, but you have also offered some really good suggestions for amendments to the bill. I thank you very much for the thoughtfulness you have put into it.
Dr. Easty, your comment that it is great to rely on information from other countries, particularly you mentioned the U.K. and Australia, certainly it is good to discuss related issues with other countries, but it is certainly better to have our own information and to be able to share that information with other countries and become full-time partners.
Ms. Lauck, I was interested in one of the challenges that you spoke about, and that was about feelings. You being a front-line worker would understand the anxiety, uncertainty and confusion experienced by a patient when they hear that something is being recalled.
How could the national registry be a partner in ensuring that the information gets out? I do not think the registry can be the be all and end all, but it would certainly be a great start in having all of the information together and having it standardized. That would be the starting point.
I think you raised an excellent challenge. When you hear about a recall for a pacemaker, it is not like hearing about a recall for your television. Stress will not help it, either.
How could we work in partnership with using a registry for data collection and then working from the registry for communication? I would think Health Canada is certainly large enough that it could be a partner; they could determine that the registry should be with CIHR or whoever it happened to be. How would you see it moving from there to avoid the challenges that you rightfully pointed out?
Ms. Lauck: As we have talked about with the range of devices, we also need to be aware of the range of what we are calling recalls. In clinical practice, we tend to call those "advisories" or "alerts." We add finesse to the messaging because, as you said, the patients are very sensitive to that, and rightly so.
One of the wins of this potential registry would be to work collaboratively with Health Canada to delineate the nature of the advisory or recall, whatever we are calling it, so that we are all singing from the same songbook and alleviate patients' anxiety around that. I think that is one step, first by clarifying the nature of the issue. This is done very collaboratively, and Health Canada is a clear partner in that.
Regarding the second component that you talked about, which is the partnership, I think that is where CNA supports a system that puts the clinicians right in the loop rather than sitting outside, so that this does not become just a two-way between Health Canada and the patient. Trust me, the first person they will call is the hospital. Therefore, it is essential that the implanting centre or the responsible physician be clearly in the loop. That piece is pivotal to improving what the bill could do. Having that loop closed between patient, implanting centre and Health Canada could achieve the type of rapid communication that we are aiming to facilitate.
Senator Cordy: When Senator Harb made his presentation to us he gave the example of a device recall that was not on the Health Canada website but rather found on the website in the United States. Would a registry help those kinds of things, so that they are available to Canadians who may have an implanted device?
Ms. Lauck: I cannot speak to the particulars of that situation. My physician colleagues can. Sometimes there is a delay, because we try to achieve medical consensus and to ensure that the professional society of that medical discipline is involved. Maybe I should turn it over to Dr. Urbach to comment on that.
Dr. Urbach: There are two overlapping issues that we have to keep clear of. One is that there is the potential usefulness of a registry for an instance when it has become clear there is a problem with a device in order to be able to contact individuals who have been implanted with that device so that appropriate treatment of those individuals can occur. The information telling you there was a problem with that device would need to come from somewhere, and that could come from other monitoring systems or registries in other jurisdictions. It could come from published scientific research, independent of any registry, and that happens periodically as well.
There is that process on the one side.
The other issue that I think has to be kept separate is to what extent a registry can be useful to identify — act as an early warning system — problems with devices that have not been recognized or recorded in other jurisdictions. As Dr. Easty and others have mentioned, the registry by itself cannot do that; it is just a list.
However, it could do so in conjunction with other sources of information, which requires an active process; you have to be able to identify persons in whom the device was implanted and then link that data somehow to, for example, sources of provincial health information in the provinces to see if there are subsequent adverse events that have been linked to that device. Then you can very quickly get useful information about something as simple as what proportion of people have a major problem or subsequent surgery, for example, to have an implant removed.
This information is not routinely developed. It remains in its various silos, because there is no comprehensive, systematic way of tracking the use of and problems with devices that have been implanted.
Our vision of the use of a registry is to be able to link it to other sources of information to be able to provide any stakeholders with information about devices that are problematic.
Senator Cordy: Dr. Easty, I thought you made an excellent point in saying that the home care devices could be removed from the bill to focus on the implantable devices. I thought that was an excellent suggestion.
You also said it would be nice if we had a registry that would allow for post-market usage, so I would assume that would be post-market safety. Could you expand on how the registry would help with that?
Dr. Easty: Our vision of the registry would be that it would serve as a repository of information regarding the device itself, who has received the device and who has been involved in the care of that patient receiving the device, so that the appropriate people are recorded. As Dr. Urbach just said, the information key to all of this is the information that emerges after any piece of technology goes into use.
The test of effectiveness of any registry system for patient safety around devices will be our ability to collect data in a timely, accurate and comprehensive fashion from the field information about the performance of the device. None of us know ahead of time that a device will be problematic. If we did, we would not use it. Sadly, we do not. Inevitably, we are in the position of needing to gather as quickly as possible early warning signs that a device is problematic. We can then pay closer attention to it and focus in and research can be undertaken to examine various aspects of a device.
There are a number of responses in the scientific and health care communities that can occur once the early warning signs start to go off that a particular device is problematic. The key to this is having a reporting system that is effective, efficient and aggregated into one spot where these early trends can be identified.
The Chair: I would like to come in on this issue. There is one term that has not come up this afternoon that I am kind of surprised has not arisen, and that is the famous electronic health record. We have been looking into health issues, as some of you may know, across the wide range of circumstances. This is the theoretical world of electronic health records, because to a large degree, that is where we still are, although there are many examples of electronic health records and there are locations where there are electronic health records.
In principle, would not a genuine electronic health record system accomplish nearly all of these objectives? An electronic health record system has to have a database somewhere. You can get into issues of privacy and all that; you have the same issues with regard to a registry. Let us not go down those roads and stick to the possibilities. A truly effective electronic health record system would be one where all the data that several of you have been speaking about today would be entered; it would be tied to the individual in that the individual's electronic health record goes with them wherever they are by location; and the treatment of the patient for a problem with regard to the device comes back into the system in a collection kind of form.
I will go to Dr. Easty first on this, but to sum up, we are really hearing two aspects. One, a registry is clearly identified for what it is. It is a list of people with certain types of implants. We have heard the benefits of having that list, such as at least being able to contact those people, so I am not denigrating that particular use. The other thing that several of you have been appealing for is now to make that list truly effective in terms of learning about the problems associated with a particular device is to be able to move further in terms of the use of that list.
Dr. Easty, you folks are engaged in electronic medical records and electronic health records, probably practically as well as theoretically or conceptually. Could you respond to this general comment I have made?
Dr. Easty: Thank you for the comment. In principle, I would agree with you that it ought to be possible to put together a medical record-keeping system, a portion of which would be used specifically to track implanted or critical devices and create a registry for that particular patient.
To my knowledge, most record-keeping systems at the moment do not have that kind of specific sub-content within them; in other words, information about a particular pacemaker and its model and serial number might well be entered into a text description of treatment for a patient, which then makes it very difficult to search and retrieve that information afterwards. Even if you do, you will only be able to do it on that local system, which brings me to the second problem in terms of where we are with electronic health care records.
We do not have a national integrated health care records system. For it to function effectively as a registry, we would need to be able to take all of that information, capture it in a standard way, reach patients and be able to share it across platforms in a unified way. People like Dr. Urbach, I and others, who want to look at those data and understand trends, would then be able to access the data in a consistent way. Manufacturers, and physicians and nurses, who want to treat patients, would be able to mine the data as well.
That is the first half of my answer. The second half of my answer is this: In my view, electronic health records will not provide us with comprehensive warning on poor outcomes with medical devices. Some of the information will be there as patients are followed by their treating physicians and their health care teams. Some information will be aggregated, again, typically in the form of medical notes that are difficult to search afterwards. That is a very poor way of trying to catch early warnings that problems are occurring with a device.
I am sounding a bit like a broken record here. I keep coming back to the importance of early warning systems that really flag the issues that are coming up with devices. Again, if this were to be done through an electronic health records system, there would need to be a separate component of that health records system that would specifically flag those and make them searchable and mineable for data in ways that are efficient.
The Chair: I agree entirely with you on the state of our current electronic health records systems and all of the difficulties that you have identified. I will simply make the personal observation that it is my opinion that we should have been a lot further ahead with a number of those issues, with the billions we have spent in this area, and indeed all the issues that you have identified have to be collected electronically in some form in any event and that it should be possible to integrate that in an electronic health record. However, your points are exceedingly well made in terms of the reality. Here we are looking down the road to what might be possible.
Ms. Velji: I would tend to agree and I think CNA would tend to agree with you wholeheartedly that electronic patient records in their most ideal forms are critical enablers of patient safety and patient centeredness. Therefore we support those comments wholeheartedly.
We also support Dr. Easty's comments that the majority of our records are not electronic in the health care system. We have a long ways to move to that state, let alone the ideal state. Even where we have electronic patient records, and in my organization we do, there are deficiencies that do not meet the requirements of this registry that we are formulating in our minds.
There is an additional point that I wanted to make about electronic patient records as an issue about nursing workload. We foresee that if such a registry were to exist in the future, the data entry into that registry, the information that has to be registered about the patient, the device and so on, most likely will fall to health care providers, most likely nurses within organizations. We do perceive that there will be a workload issue in the future and electronic patient records would enable that data to be entered in more seamless ways.
The Chair: I want to point out that the difficulties you are raising with the existing systems need to be dealt with in a registry that we are talking about. The issue I am trying to get to here is why are we not thinking about having true electronic health records that achieve not only what Senator Harb is looking for in this specific area, but all of the other issues that we are trying to get to?
I do not intend to debate this. I am just throwing this out from my point of view as chair.
Ms. Sabourin, is there anything you would like to bring into this aspect or anything further to say?
Ms. Sabourin: No, thank you.
The Chair: Thank you. I want to thank our witnesses who have joined us here today on this very interesting discussion. I want to thank Dr. Easty and Dr. Urbach for joining us by teleconferencing. It seems to have been very effective. Certainly you have been able to make very clearly and very importantly the issues that you wanted to address in response to the questions.
To our witnesses here with us, I also want to thank you very much for the clarity of your responses, and to my colleagues for their questions. With that, I declare the meeting adjourned.
(The committee adjourned.)