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Defective Medical Devices

Motion made, and Question proposed, That this House do now adjourn-- [Mr. Arbuthnot.]

10 pm

Mrs. Bridget Prentice (Lewisham, East) : This debate is about medical devices such as artificial heart valves and pacemakers, which are life saving and enhance and prolong the lives of thousands of our constituents. One would think, then, that the debate would be about how wonderful those devices are and how we should praise the manufacturers for producing such excellent instruments of health. But it is not, because, tragically, some of those devices go wrong and, as a result of their failure, people die.

The debate is about what we do when those devices fail and how we react to the inevitability that mechanical devices are not, and cannot be, perfect. How we stop them failing is for the technicians and scientists in the laboratories of the manufacturers, universities and research establishments. We should consider what we do when they fail and how we ensure that as little damage as possible is done. On 24 April last year, my constituent, Mrs. Marian Sheedy, died. The death certificate recorded that she died of cardiac failure, renal failure and mitral valve disease. It did not record that she wore a pacemaker, nor that a year earlier, according to medical notes that I have seen, the pacing wire of that pacemaker appeared to malfunction. At the time of her death, no reference seemed to be made to the role of the pacemaker. It was as if it could have played no part in determining whether she would live or die.

Although nothing can bring Mrs. Sheedy back, her husband, John, is determined that everyone who wears a pacemaker or other device to help him or her live a more active life should be absolutely confident that the devices are of the highest quality, and have been thoroughly checked and monitored, and that the Department of Health has a duty to ensure that that happens.

When Mr. Sheedy came to my surgery to raise his concerns about what was happening, I knew nothing about pacemakers or about the Medical Devices Directorate, which is supposed to monitor the use of pacemakers, artificial heart valves and the like. I was no more a medical or technical expert than I was an expert in Mandarin Chinese. However, Mr. Sheedy had looked after his wife for many years and learned a great deal about pacemakers and their development. Before long, he had explained to me the basis on which they worked. I also knew that a number of manufacturers sold their products to the national health service. The pacemaker lead implanted in Mrs. Sheedy in 1987 was a Siemens type 93.

Mr. Sheedy had written to Siemens after his wife's death, asking about the lead. He discovered that Siemens had issued a warning to the Department of Health in February 1993, some two months before his wife died. It had also warned all the pacing clinicians of which it was aware. I say, "of which it was aware", because, as a result of an answer that I received from the Minister, I believe that not all pacing clinics are listed with the Medical Devices Directorate, the organisation responsible for issuing warnings.

As a result of Mr. Sheedy's investigations, I followed up with questions in the House, which have led me to believe that there is a yawning gap in the communications


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system between the Department, hospitals and, most importantly, patients. I want that gap to be closed. I want to be assured that when things go wrong, patients are seen as quickly as possible and doctors know what they are looking for and how to fix it. There are a number of players in the debate. There are the patients and their families, who have been told little or nothing about the devices implanted in them. There are the manufacturers, whose aim must be profit and whose trials and warnings with regard to their products seem to be under little or no scrutiny. There are the national pacemaker database and the national pacemaker registry, which are supposed to be recording the patients, devices, deaths and other important data, but are of little or no use to us because their records are so inaccurate. There is the Department of Health, which, through the Medical Devices Directorate, is supposed to assess the effects of faults in medical devices, investigate incidents and issue warnings, but which, in reality, has little or no power to do anything about it. I want to discuss each in turn, but I shall leave the patients and their families to the end because, to me, they are the most important players of all.

According to the national pacemaker database, there are 12 manufacturers of pacemakers currently selling in Britain, and 10 such manufacturers of artificial heart valves. The House might be surprised to know that there is no guarantee whatsoever that those are the only manufacturers of such devices operating here. Indeed, we have no way of knowing whether other manufacturers are also selling to hospitals and clinics throughout the country.

That is frightening. That devices which have to be, by their very nature, extremely sensitive, costly and for life-saving purposes, can be sold to hospitals without any scrutiny by any organisation, especially the Department of Health, is, I believe, a scandal. Why is that the case ? The Minister tells me that it is because the Department will not make any rules about purchasing of medical implants, but simply says that it will

"strongly recommend purchasers to buy devices only from companies registered under the Department's Registration Scheme."

Those of us who are worried about the national health service being finance -led can only speculate that purchasers might go for the cheapest option, rather than check that a manufacturer is registered with the Department, although being registered in itself is not a guarantee that the Department has checked the approved device. Surely it is not beyond the Department of Health's remit to say that such devices must be bought only from the manufacturers on the list. Of course, that would also mean that the onus would be on the Department to ensure that a manufacturer gets on the list only if he has a proven record of quality, expertise and response. I hope that when the Minister responds he can assure the House that the manufacturers about whom we know are all registered under his scheme.

In Mrs. Sheedy's case, Siemens issued a warning in January 1993, which reached the directorate in early February. It, in turn, informed pacing clinics later that month. I make no great issue of the delay in informing clinics, but I should have thought that when a company issues a warning about its own products there can be no reasonable excuse for hanging on, thinking about it and


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eventually deciding to do something. I hope that the Minister will ensure that in future there is no delay between the receipt of a warning and passing it on.

As it happened, Siemens also warned the purchasers of the devices themselves. One would think that that would have covered everyone, but it does not, because a patient may be fitted with a device in one hospital but may return to a different hospital for follow-up work. At the moment, there is simply no way for Siemens or any other manufacturer to know where patients are being seen. That problem must be tackled, especially as the responsibility is now on manufacturers to inform the Department of any deaths or injuries resulting from faults in their products.

Let me illustrate that with two examples. Mrs. Sheedy was fitted with her pacemaker at King's hospital. It was then suggested that she have her pacing follow-up at Lewisham hospital, our local hospital. When I asked the Minister for names of pacing and pacing follow-up centres, the reply did not include Lewisham hospital. Last week, I noticed that Victoria infirmary in Glasgow was not on the list, so I phoned it up. I asked whether it fitted pacemakers or did follow-up work. The coronary heart unit staff there informed me that they did do follow-up pacing work. They were not on the list. Did they know of Siemens' warning ? I doubt it.

The Minister will say that those hospitals are not on the list because informing the database is a voluntary exercise, but that is exactly my argument. That is the gap which I mentioned when I began this debate. Such information must be available to the database by compulsion if it is to be of any use at all. No one in the House or outside can say with absolute confidence that patients have not died as a result of follow-up clinics being unaware of warnings and thus not having acted on them.

In another reply, the Minister said that it was the responsibility of the manufacturers to advise users and purchasers when faults became apparent. Siemens certainly informed the purchasers, but it was impossible for the company to inform users. One of the main thrusts of my argument is that the users, the patients, have the right to know. I believe that some manufacturers might be disinclined to tell them ; even Siemens is unhappy that I should be raising the issue because it has said that a media scare campaign would cause stress and concern for others. But the matter is too important to the 80,000 people in Britain who are fitted with pacemakers, and to their families and friends, for them not be kept fully informed of developments.

I want to refer briefly to another device--the artificial heart valve--and in particular to the Bjork-Shiley valve and the case of Mrs. Pauline Judge from West Bromwich. She would be the same age as me, 41, if she were alive. She died in September last year. In 1982, she was fitted with a valve and recovered quite well from the operation, resuming an active life even to the point of going swimming and taking aquarobic classes. She had even begun a business administration class through employment training.

In April 1993, however, Mrs. Judge's health deteriorated--she became dizzy, and so on. On Wednesday 1 September, she was in terrible pain and was vomiting. Her husband Eddie listened for the valve, which gives off a particular sound, and realised it was not working. I shall not go into the details of the tragic minutes that followed,


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except to say that Mrs. Judge was in the most awful pain and distress, while her husband did all he could to care for her. What followed was one of the most tragic episodes I have ever had the misfortune to read. Mr. Judge pleaded with nurses, ambulance staff and doctors, explaining what was wrong with his wife, but to no avail. He knew what was wrong, but no one at the hospital appeared to understand the need to get his wife to a hospital with the facilities to care for her. She died at 1.15 am. Mr. Judge and his family believe that his wife's death was avoidable.

Between 1980 and 1983, the Bjork-Shiley valve was recalled three times in the United States because of fractures. In 1985, large valves were withdrawn, and in 1986 finally removed from the market. When the Food and Drug Administration in the United States became aware of the fractures, it first suspended and then revoked export approval for the 70 deg. valve. There is, however, every reason to believe that Bjork-Shiley aggressively marketed the valve abroad, in places such as Britain, during the suspension period. The FDA withdrew export approval in May 1983, yet the Minister tells me that the first departmental record indicating the suspension and subsequent withdrawal of the export permission is dated 15 January 1985, two years after the first suspension.

The phraseology of the Minister's reply leads me to suspect a lack of effort by the Department to find out exactly what was going on with the device in question. That is why I think it is time the Department's relationship with the FDA was put on a more formal footing. There must be more direct and detailed discussions about medical devices and their impact. Then, people such as Pauline Judge might have the opportunity to be seen by a specialist and have a fatal valve replaced.

The last thing I want to say on behalf of the Judge family is that they are still awaiting the coroner's verdict on Pauline's death. I understand the delay is due to waiting for reports of evidence. I feel that the Minister should use his offices, if appropriate, to ensure that the inquest goes ahead as speedily as possible for the sake of the Judge family.

The national pacemaker database and registry are purely voluntary institutions. It is entirely up to hospitals and pacing follow-up clinics to let them know who has a pacemaker and how it is functioning. I believe that the figures that the Department has given me are woeful underestimates of the number of pacemakers in use. How, then, can the Department feel sure that it knows what is going on, or that it can seriously monitor the effectiveness of the devices ? I draw a comparison here with the system set up to approve and monitor new drugs. A study by Social Audit in 1992 suggested that the level of serious injury for newly prescribed drugs was seriously underestimated. Among the reasons for that were the excessive secrecy of manufacturers and the voluntary nature of reporting of side- effects by doctors. The comparison is apt. It is absolutely essential that the use and effectiveness of those devices is carefully and properly monitored and that when anything goes wrong, as it inevitably will, there is no delay between warning and caring for the patient concerned.

It has been suggested to me that the debate and the raising of these issues will scare patients and their families unnecessarily. I think that that is a cop-out put forward by those who do not want patients to know what is going on, or who are not prepared to take responsibility for what is


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happening. In the course of my learning about medical devices, I have been contacted by a number of families of patients from around the country. Every one of them says, "We have the right to know." I do not for one moment think that this will scare patients. We are talking about people who have had serious heart conditions which have been controlled by such devices. They are all too well aware of their conditions, and their families monitor and care for them, sometimes for many years. They are not people who do not know and understand what is wrong with them. They are entitled to know how the device that is implanted in them is functioning. If it stops functioning, they are entitled to be assured that it will be dealt with as speedily as possible, so that they may go on enjoying their lives. That is not a lot to ask for.

Let me touch briefly on the views of Mrs. Delonnette of Hastings, whose husband's had a Bjork-Shiley implant. She says :

"I myself feel that if I had known about it, I may have been able to have something done about it sooner, and maybe he would have been saved from such a tragic death."

Then there is Mrs. McGregor of Bradford, whose husband had a Siemens lead, which rusted inside him, and who now can no longer speak or care for himself and needs to be nursed by Mrs. McGregor 24 hours a day. She says :

"On behalf of those involved in this issue may I offer my husband's and my support in bringing this matter to the full glare of the media."

Then there is Mr. Edghill from Maidstone, who, by happy chance, discovered from my constituent, Mr. Sheedy, that he had problems on his electrocardiogram and that he should have his pacemaker checked. As a result of that check, it was replaced two weeks later. He said :

"I consider that this situation should never have occurred, and it is plain to me that the explanations given to date need to be brought to the notice of the public."

Or there is Mrs. Earle, another of my constituents, who had a pacemaker fitted six years ago, and who recently found that she was getting breathless. Her GP arranged for her to go into hospital and have it replaced, where she was asked by the cardiologist why she had not been in before. She had to inform him that she had never had her pacemaker monitored in the six years since it was implanted. Surely that is an indication of the terrible lapse in the proper recall of patients in such situations.

Only today, I received a letter from Mr. Bates, also from Hastings, whose pacemaker was fitted in October 1992. It was also a Siemens. It punctured his lung, and he was hospitalised again. Until August last year, he continued to have problems with it. It was not until October 1993 that the matter was finally sorted out. He said :

"At the time of my pacemaker implant, I was not warned . . . of any risk involved with either the implantation process itself . . . or the device itself."

I am aged 44, quite a young age to have a pacemaker inserted, and may need to rely on it for another 40 years or more. If some of the problems mentioned on the programme begin to happen, will I necessarily know about them ?"

What technical information is available to patients like myself about the pacemaker and leads which I have inside me ?"

I fully support your call for adequate information, research and monitoring of pacemaker implants".

The database is inaccurate. It needs to be made accurate. The registry is not up to date ; it needs to be. The Department of Health, through the Medical Devices Directorate, is supposed to monitor the effects of devices.


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It cannot do so properly in the present circumstances. It simply does not know what is going on and, even if it did, it has no power to do anything about it.

I put it to the Minister that here is an opportunity to fulfil the principles of the patients charter. It is an opportunity to ensure that no one suffers the pain and loss suffered by my constituents and the others whom I have mentioned, without full knowledge of the effect that artificial devices have, their safety record, the manufacturers' commitment to the highest quality, and with the most detailed monitoring of the effectiveness of such devices. Tonight, the Minister can begin to give hope and reassurance to the 80,000 people with pacemakers in this country, and to the 5,000-plus with artificial heart valves and other devices. He can say that the Medical Devices Directorate will scrutinise every manufacturer of devices for safety, quality and history follow-up and response. He can say that it will work in a formal and productive programme with the FDA, exchanging information as soon as it is known and acting on it. He can say that the directorate will issue warnings to hospitals, follow-up clinics and GPs when that is necessary, and will check that every hospital has acted on those warnings. He can say that he will ensure that the database is up to date, because pacing centres will be obliged to forward information identifying each patient with his or her unique pacemaker number. He can warn patients, as well as hospitals and GPs, so that they know what is going on.

By so doing, the Minister will ensure that he enhances the quality and length of thousands of people's lives. I plead with him to do so.

10.20 pm

The Parliamentary Under-Secretary of State for Health (Mr. Tom Sackville) : I can accede to nearly all the requests and recommendations of the hon. Member for Lewisham, East (Mrs. Prentice). We do precisely what she suggested. Although she has criticised the way in which we do it, we are on the same side in trying to ensure that devices are monitored and any problems are brought to the attention of the right people.

The hon. Lady has engaged in a good deal of correspondence with the Department of Health by means of parliamentary questions. I applaud the methodical way in which she has gone into the matter, on behalf of her constituent and the constituents of other hon. Members. I certainly would not characterise what she has done as alarmist ; it is very proper to discuss how we can perfect a system of trying to monitor the complicated network of devices that the health service currently uses.

Let me say how sorry I am about what has happened to the Sheedy and Judge families. These are great tragedies. I accept what the hon. Lady said about holding an inquest ; I shall look into the matter, and get back to her.

On the whole, people pay little attention to the safety of medical devices until something goes wrong. The hon. Lady was honest enough to say that she did not know much about the Medical Devices Directorate, which is probably one of the foremost such organisations in the world and which we are lucky enough to have in our health service. For example, a pacemaker registry has existed since 1972, funded by the Department since 1977 ; a heart valve


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registry has existed since 1985, a breast implant registry since 1993 and a hydrocephalus shunt registry since earlier this year. The expectation of both health service staff and patients is that medical devices are safe, and the Department of Health puts a great deal of effort into ensuring that they are. Every year, new medical devices and equipment become available that offer improvements in the treatment and care of patients ; but new technology brings with it potential hazards that need to be carefully assessed.

The Medical Devices Directorate, within the Department, comprises a wide range of professional and technical experts with extensive experience in medical devices. It is responsible for ensuring that medical devices used by the health service are safe and effective. It discharges that responsibility in four main ways--by being closely involved in the drafting of legislation and safety standards that will form a framework for the control of devices into the 2lst century, particularly in a European context ; by operating a registration scheme ; by managing a programme to evaluate the technical and clinical performance of medical devices ; and by assessing adverse incidents associated with those devices, reported by manufacturers and health care users.

The last of those is the most important in the context of the issue raised by the hon. Lady. The investigation of adverse incidents is critical in ensuring the safety of medical devices. We have issued a number of guidance notes to health service chief executives to encourage the reporting of such incidents, and we shall continue to press for it. The reporting of serious incidents by manufacturers is becoming mandatory under EC directives, as the hon. Lady probably knows.

The MDD handles well over 3,000 reports each year, using its scientific, technical and clinical experts--who take advice, where necessary, from relevant specialists in academia, the health service and industry. Where a risk to the safety of patients or users has been identified, advice is issued, in the form of a safety warning, to health service staff. This advice will take into account the nature and use of the device, the likelihood and severity of patient injury and the consequences of any action taken. This may result in the modification of a device, or sometimes its withdrawal from use. Departmental safety warnings may take the form of hazards notices, safety action bulletins, pacemaker technical notes or direct correspondence from the Chief Medical Officer or other professionals in the Department. Since 1991, 85 hazard notices, 183 safety action bulletins and 18 pacemaker technical notes have been issued. I mention that because I should like to refute one of the hon. Lady's more exaggerated statements--that the Department does not know what is going on. We closely follow what is happening with medical devices. She has criticised our means of doing so, but we do much monitoring work and will continue to do so.

Responsibility for ensuring that action is taken in response to safety advice issued by the MDD rests with health services-- the specialists. It is the responsibility of chief executives to have a policy in place for the dissemination of information contained in advisory notices to the relevant health care professionals. The nature of the action taken in relation to patient management in the light of such information must, however, remain a matter for the judgment of doctors to whom that advice is issued. In all cases, clinical judgment must be exercised in weighing the


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risk of potential failure of a device against a patient's condition and the additional risks that may result should further surgical intervention be necessary. Such judgment must be made with a full knowledge of the individual circumstances of each patient. It is the clinician who takes responsibility for ensuring that patients receive suitable advice without generating needless anxiety.

Since the action to be taken as a result of safety warnings is a matter for the clinical judgment of a patient's doctor, advice from the Department of Health is issued only to clinicians. The advice is often rather complex and technical-- I do not think that it is patronising to patients to say that-- and the action taken invariably depends on the particular circumstances of the patient. It is therefore inappropriate for such advice to be given outside the context of a clinician-patient consultation.

I know that the hon. Lady's particular interest is in the reliability of certain pacemaker leads manufactured by Siemens. In the particular case of the Siemens leads, a thorough consideration of clinical and technical issues was undertaken by the Department in conjunction with clinical specialists and manufacturers. Once sufficient information and clarification had been provided, the directorate was able to draft a pacemaker technical note for issue to all pacemaker implanting centres and follow-up clinics in the United Kingdom.

I heard what the hon. Lady said about the adequacy of the registry and about whether the identity of all centres was known. We must keep that matter constantly under review and ensure that we are aware of all centres. The technical note brought to the attention of relevant clinicians important information previously issued by Siemens in an advisory note, which was appended to the pacemaker technical note. The hon. Lady mentioned delay. I am informed that 14 days, including weekends, elapsed from the moment the


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documentary evidence was received by the Medical Devices Directorate, following an informal advice some days earlier, to the moment that our pacemaker technical note was issued. I do not think that is undue delay. We are talking about some technical instructions that have to be interpreted by people who make decisions about patients. They are not something that can be rushed out, for fear that decisions will be taken based on the wrong information. I do not think that there was undue delay in the case that the hon. Lady mentioned from January or February 1993.

The document advised clinicians that patients implanted with particular leads should be evaluated as soon as possible. This evaluation would include a specific test to check the performance of the lead. Since the risk of lead failure was calculated by the manufacturer to be less than 1 per cent. after one year, patient evaluation would not necessarily result in lead replacement in all cases. As I have already said, it is for the individual patient's doctor to weigh the risk of lead failure against the risk resulting from further surgery. A clinical judgment must always be made in the best interests of the patient.

I am sorry that I am unable to say more, but I end by saying that the replacement of a pacemaker lead--a possible course of action--is not a simple procedure. The electrode of the lead may be embedded in the heart tissue and, when a lead is replaced, the original lead is usually left in place. There is thus a limit to the extent to which the new lead can be fitted without causing damage to the heart. It is a complicated matter that we must

The motion having been made after Ten o'clock, and the debate having continued for half an hour, Mr. Deputy Speaker-- adjourned the House without Question put, pursuant to the Standing Order. Adjourned accordingly at half-past Ten o'clock.


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