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Hartchirurg Tjark Ebels © Fenna Jensma

Heart valve manufacturers deceive surgeons and patients

Companies that manufacture heart valves are widely mislabelling their products, which can have major consequences for patients. When a cardiac surgeon from Groningen exposed the problem, he sparked a battle that has raged for years.

What is this about?
  • Mislabelled heart valves

Dutch heart surgeon Tjark Ebels discovered in 2014 that many manufacturers were overstating the sizes of heart valves on their packaging, thereby misleading surgeons. Using the wrong size valve can have disastrous consequences for patients, who may continue to have symptoms, sometimes need further surgery, or may even die.

In September 2020, after a six-year tug-of-war, Ebels received support from the Food and Drug Administration (FDA), which ordered manufacturers to display the correct information on boxes. The FDA will now enforce this requirement, but it is not clear whether regulators in the Netherlands and elsewhere in Europe will pick up the gauntlet.

  • Why is this relevant?

Ebels' story shows how manufacturers’ shrewd opposition to new guidelines on the sizing of valve prostheses is affecting patients worldwide. In the Netherlands, regulators and professional associations still believe that they do not need to intervene.

  • How did we investigate this?

Ilona Dahl scoured numerous guidelines, and spoke with cardiologists, surgeons, and professional associations. She wrote this article in cooperation with Argos, Small Stream Media, and Follow the Money.

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Tjark Ebels, a heart surgeon at the University Medical Center Groningen, has a collection of heart valves at home. He has taken them apart piece by piece, and measured them accurately. At the end of 2014, he discovered something very wrong with several manufacturers’ valves: they were not the size they claimed to be.

About 1,500 heart valves are implanted each year in the Netherlands alone. In January 2019, the Universities of Quebec, Canada and Pernambuco, Brazil published a study showing that out of 100,000 patients, more than half received an incorrectly sized valve. The risk of mortality rises from 1 per cent to 1.5 per cent when a heart valve is too small, an additional 500 deaths per 100,000 operations. Other patients continue to suffer, and may need further surgery. The researchers conclude that it is essential for patients to be fitted with the correct valve.

'The most important dimension, the inner diameter, is regularly many millimetres different from what’s stated on the packaging,’ Ebels explains. ‘This applies to all the major players in the market, although some are more inaccurate than others. But no manufacturer uses the correct size.’ This affects valves from Medtronic, LivaNova, Edwards Lifesciences and Abbott, amongst others.

When a heart valve is too small, the risk of mortality rises from 1 per cent to 1.5 per cent: an additional 500 deaths per 100,000 operations

George Schut, director of Schut Geometric Measurement Technology, meticulously measured the valves together with Ebels in October 2019. 'I was dumbfounded,’ he says. ‘That can't be true, can it?'

Follow the Money has presented these findings to cardiologists in recent weeks, and they have also been surprised. One, Jobst Winter, said: 'I had no idea this was happening. Why on earth are the manufacturers doing this?’

Cardiac surgeons sometimes know about the problem. Robert Klautz, cardiac surgeon at Leiden University Medical Center and Amsterdam UMC, told us: ‘My teachers warned me decades ago: you should never presume that if it says 25 millimetres on the package, it's true. That says it all. I was warned about this even then.’

Manufacturers’ stated dimensions are also inconsistent: company A’s 23-millimetre valve may be the same size as company B’s 25-millimetre one. 'That’s very confusing for surgeons,’ Klautz says. ‘The manufacturers want us to believe that we can buy a larger valve from them than from their competitors. As a doctor, you want to place as large a valve as possible in patients. The bigger the valve, the less resistance and the easier it is for the blood to flow through the body.’ The crux of the matter is that the valves often turn out to be smaller than manufacturers claim.

Harmful effects for the patient

And that is risky, says Mohamed Soliman Hamad, a heart surgeon at the Catharina Hospital in Eindhoven. ‘The size determines whether the valve will function properly or not. If you place a valve that’s too small, it will cause a narrowing, making it more difficult for the blood to flow through the aorta. It's as simple as that.’

When a patient needs a new valve, the cardiologist refers them to the surgeon, who carries out the operation and then sends them back to the cardiologist. Cardiologist Winter says: ‘Some of my patients don’t recover after valve surgery, and continue to have shortness of breath and chest pain.’ He says it is often impossible to find out whether these complaints are due to a heart valve that is too small. ‘Although the type and size are listed in the operative report, its size may not correspond to reality. This is alarming, because it is commonly known that if the valve is too small, it can cause short- and long-term problems.’

 Follow the Money’s questions to suppliers received little response. LivaNova said it was following the rules, and Medtronic did not reply. Edwards Lifesciences denied there was a problem, saying: ‘It is incorrect to suggest that our valves are incorrectly labelled. We provide doctors with measurement devices that fit the valves, so we can guarantee accurate sizing for each patient.' And Abbott responded with a platitude: ‘[We have] made recommendations regarding the correct valve sizes and treatment to ensure optimal results.’

But Ebels and Schut, who measured all the valves in detail, came to a different conclusion. Says Ebels: 'Manufacturers may fear that patients will sue if they know that a valve that’s too small may have caused their injury'.

The international task force on valve label sizes

In 2014, Ebels submitted a proposal to the International Organization for Standardization (ISO), calling for changes in the sizes stated on packaging. The ISO is a federation of 165 national standardisation bodies that considers proposals to improve standards; each country has one vote.

The ISO working group on heart valves, representing a few cardiac surgeons (including Ebels) and manufacturers, meets to discuss new guidelines. Its membership is confidential, but documents seen by Follow the Money show that Medtronic, Boston Scientific, Abbott, LivaNova, and Edwards Lifesciences are represented.

‘Initially I was under the naive impression that manufacturers would actually adjust the size labels,’ says Ebels. ‘But after the new ISO standard was published in 2015, clearly stating that they had to change the packaging information, nothing changed.’

In October 2017, three medical organisations set up a valve labelling task force to deal with the issue

Ebels then tried to put the label problem on the international agenda by publications and giving lectures. In 2016, for example, he gave a presentation in Venice explaining the problem to colleagues. There, he found an ally in Duke Cameron, a heart surgeon at Massachusetts General Hospital and former head of cardiac surgery at Johns Hopkins University School of Medicine.

Cameron presented Ebels’ findings to his professional body, the American Association for Thoracic Surgery (AATS). In October 2017, along with the European Association for Cardio-Thoracic Surgery (EACTS) and the Society of Thoracic Surgeons (STS), it set up a valve labelling task force to deal with the issue and that would exert pressure by publishing recommendations from the surgeons. The task force consists of cardiac surgeons, cardiologists, the chairman of the ISO working group, and representatives of the manufacturers.

This trajectory runs parallel to the ISO working group on heart valves, which also concerns itself with labelling. Ebels is a member of both groups at that point in time.

‘We’ve been fooled’

Ebels is optimistic. At the task force’s first meeting, in Paris in February 2018, he is one of the speakers. He even thinks that he can get manufacturers onside. They seem to be aware of the damage patients can suffer if they are implanted with the wrong valve. Now I have to press ahead, Ebels thought, and emailed Domenico Pagano, the secretary general of EACTS, to ask if he could give a presentation in England about valve labelling. He gets no response.

In the spring of 2018, Ebels emails Pagano again, asking to speak on behalf of EACTS at the ISO working group’s semi-annual meeting in San Diego. 'It would give me great pleasure if I could voice the opinion of a substantial proportion of the worlds’ cardiac surgeons,’ he wrote. ‘It would strengthen my position within the working group, and with that the position of EACTS.’

Pagano rejects the request, describing it as ‘complicated’. In September 2018, the San Diego meeting takes place. Despite not being able to speak on EACT’s behalf, Ebels manages to gain a lot of support from colleagues. And then there’s an important breakthrough: the manufacturers agree to adjust the size labels on the packaging.

The outcome of the meeting was disastrous: the new labelling scheme was torpedoed

In January 2019, there is another meeting in San Diego, this time of the task force. Ebels could not physically attend, but participated via a poor internet connection. When he later receives the minutes, he notes with disbelief that the valve relabelling has suddenly been dropped.

In May 2019, Ebels organises a three-day ISO working group meeting at the Amsterdam UMC to discuss the issue once again. The forty participants included only a few scientists and two surgeons, Ebels being one of them.

The outcome of the meeting was disastrous: the new labelling scheme was torpedoed. Ebels says he cannot go into detail, for confidentiality reasons, but found the arguments 'improper' and unscientific to say the least. The ISO’s rules specify that any change must be adopted by consensus.

How is the ISO structured?

The International Organization for Standardization (ISO) is the federation of national standards bodies, founded in 1947 and based in Geneva, where it employs 150 people. Its Dutch member body is the Royal Netherlands Standardization Institute (NEN). It operates alongside in European institutions such as the European Committee for Standardization (CEN).

ISO issues standards that national bodies adopt either partially or fully. Each participating country has one vote per new or amended guideline. Much of ISO’s work is carried out by the national standards bodies and other organisations.

The organisation currently has 334 technical committees. TC150 focuses on surgical implants, and is listed after TC148 (sewing machines) and TC149 (bicycles). The secretariat for TC150 is provided by the DIN, the German standards organisation. It has six subcommittees, including SC2, which deals with cardiovascular implants and extracorporeal systems. The subcommittee’s secretariat is the responsibility of the USA’s national standard body: ANSI, which has delegated it to the AAMI.

Cliff Bernier of the AAMI is the committee manager of SC2, and acts as its liaison with the ISO. SC2 is divided into seven working groups, of which WG1 deals with heart valves. WG1 used to be chaired by Ajit Yoganathan, and is recently headed by Ulrich Steinseifer. Its members represent three different groups: governmental regulators, manufacturers and other experts such as surgeons and cardiologists.

The SC2 subcommittee (officially TC150/SC2) currently consists of 21 participating countries, all of which have one vote when accepting documents or plans. There are also observer countries; they are not allowed to vote. This rule means that the Dutch vote has the same weight as that of the largest country, the United States. Of these twenty-one countries, fifteen are represented by one or more members in the ISO heart valve working group (TC150/SC2/WG1). The number of members varies from country to country, and also over time. The national standards bodies are free to appoint or withdraw members, so the number of members and composition is constantly changing.

The surgical implants committee had only one member from the Netherlands. Later it turned out that this member was the company Medtronic

Currently, WG1 has eighty-six members, of whom twenty-eight are from the US. Germany has twelve, the UK eight, Japan and Korea seven each, Canada six, Ireland, Israel and Italy three, Denmark, the Netherlands and Switzerland two, and China, Russia, and Sweden one.

Membership of a working group is obtained via the national standards body; in the Netherlands this is NEN, which has been appointed by the government to supervise all standardisation processes. An annual membership fee of €763.87 is payable to the NEN; in Ebels’ case, this is paid by his employer, the University Medical Center Groningen.

When Ebels contacted the NEN in 2014/15 to become a member of TC150/SC2, he was told that the surgical implants committee had only one member from the Netherlands. Later it turned out that this member was the company Medtronic.

Cardiologists and cardiac surgeons are always in the minority at meetings of the working group; sometimes Ebels is the only one, sometimes there are two or three. Representatives of the various authorities are sparsely present. Furthermore, the status quo is assumed: all changes proposed require consensus amongst members.

An overview of the ISO’s work can be found here.

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'The bottom line is that the relabelling has been sidetracked,’ Ebels says. ‘I was incensed that there was no consensus on this essential improvement in the care of these heart patients.’ He emailed Ruggero De Paulis, then president of EACTS, but to no avail.

Wearing two hats at once

EACTS relies heavily on the industry. During its three-day annual conference, manufacturers can promote and show their products, and pay large sums for stands, auditorium sessions, and other facilities. The 2019 conference earned it almost €5 million, and according to its annual report, the event is its main source of income. EACTS uses the money to provide grants and scholarships, give advice, sponsor studies, run courses, and publish scientific journals.

Most of the surgeons and cardiologists on the task force also act as consultants for one or more manufacturers. They participate in advisory committees, provide training for manufacturers, and carry out research sponsored by them. De Paulis is no different: he is a consultant for Medtronic and Edwards Lifesciences.

Arie Pieter Kappetein, a cardiac surgeon at Erasmus University Medical Center (Erasmus MC), was EACTS’ secretary general for 9 years until August 2017, and then became vice president of Medtronic and leader of the task force. His assistant Stuart Head was involved in writing treatment guidelines on behalf of EACTS until 2018. In February 2019, he too joined Medtronic. Both Kappetein and Head remained on the task force after their career switch, but now as industry representatives. Andras Durko has been a member of the task force since its inception, and was listed there as a cardiac surgeon, but was a physician-researcher for Kappetein, and in that capacity conducted studies sponsored by Medtronic.

Ebels protested against this state of affairs, saying that it made the official Medtronic delegation ‘too dominant’.

Hidden Medtronic contracts at Erasmus MC

Medtronic has long maintained strong links with doctors at Erasmus MC. Follow the Money has seen three consultancy contracts between Medtronic Vascular Inc. and one or more surgeons from that hospital, signed in 2014, 2015 and 2016. The consultant is required to perform a variety of work for Medtronic, listed in the contract. They provide training at sites using the company’s products, and teach colleagues in the operating room how to insert them. They do this in hospitals selected by Medtronic.

The company also requires them to be ready to provide feedback on scientific studies, present research data to the most appropriate audience (such as peers at sponsored conferences), and publish clinical trials in line with the company’s publishing strategy. They participate in Medtronic's advisory boards and publication committee, and are responsible for analysing new products brought to market by other manufacturers.

Contrary to the rules, the three contracts in Follow the Money’s possession were not reported to the Dutch Healthcare Transparency Register.

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In the United States, doctors are required to report outside interests, and manufacturers of medicines and medical devices must enter all payments larger than $10 in the federal Open Payments Data Register. This shows that members of the task force also received fees from manufacturers (see box), and were also regularly paid for their hotels and dinners. In the Netherlands, doctors are required to report their financial relationships to the healthcare transparency register, but compliance is not monitored.

Task Force members: not devoid of interests

The following surgeons and cardiologists are members of the valve labelling task force. Follow the Money investigated their possible links to the device industry. For doctors in America, we used the Open Payments Data Register.

Ruggero De Paulis, cardiac surgeon at the European Hospital in Rome, Italy and senior lecturer at Weill Cornell University in New York. De Paulis was president of EACTS from October 2018 to October 2019. He is chair of the task force and a consultant for Edwards Lifesciences and Medtronic.

Pavan Atluri, senior lecturer in cardiac surgery at the University of Pennsylvania, in Philadelphia. Atluri is a consultant for Medtronic, Abbott, Atricure and Edwards. In 2019, these companies paid him $12,525 in consulting fees, $3,570 for travel expenses, $2,207 for lodging and food, and $118,709 in research fees [see Open Payments Data].

Vinayak Bapat, professor of cardiac surgery at Columbia University Medical Center and cardiac surgeon at Presbyterian Hospital, both in New York. Bapat is a consultant for Edwards Lifesciences and Medtronic. In 2019, he received $78,588 in consulting fees from these manufacturers [see Open Payments Data].

Duke E. Cameron, cardiac surgeon at Massachusetts General Hospital; previously chief of cardiac surgery at Johns Hopkins University School. President of the American Association for Thoracic Surgery. In 2019, he received $10,850 in travel and accommodation expenses and $10,917 in research funding from Edwards Lifesciences and Medtronic, among others [see Open Payment Data].

Filip P.A. Casselman, heart surgeon at OLV Hospital in Aalst, Belgium. Casselman is a consultant for Medtronic and Edwards Lifesciences. In 2018, he received an honorarium of €3,237 from Medtronic, and Edwards Lifescience paid him €2,015 for access to conferences, plus travel and accommodation expenses of €888. In 2019, he received €4,071 for travel and accommodation from St Jude Medical, plus €1,953 for participation in scientific meetings.

Edward P. Chen, heart surgeon at Duke University Medical Center in Durham, NC. Chen is a consultant and proctor for Medtronic and CryoLife. In 2019, he received $8,300 from Medtronic and others in consulting fees, travel, accommodation, and food and drink, and $2,730 in research funding [see Open Payment Data].

Gry Dahle, cardiac surgeon at Rikshospitalet (Oslo University Hospital) in Norway. Dahle participates in the speakers’ bureau for Abbott Vascular.

Tjark Ebels, professor of cardiac surgery at UMC Groningen. In 2018 and 2019, he worked as a cardiac surgeon at the AMC hospital in Amsterdam. The task force was established partly on his initiative, and he sat on it as a representative of EACTS, but was removed in June 2019.

Andras P. Durko, ANIOS (physician in training) at Amsterdam UMC since April 2020. Previously, he performed PhD research under Arie Pieter Kappetein (see below) at Erasmus MC. He conducts scientific studies sponsored by Medtronic.

John A. Elefteriades, professor of cardiac surgery at Yale University School of Medicine in New Haven, CT. In 2019, he received $1,055 in travel and accommodation expenses from Cryolife, WL Gore, Bolton, Medtronic, and GE Healthcare [see Open Payment Data].

Stuart Head was involved in drafting treatment guidelines on behalf of EACTS until 2018. He joined Medtronic in February 2019, and transferred to GATT Technologies in October 2020. Head received a $205 stipend from Medtronic for food and drink in 2019 [see Open Payment Data].

Arie Pieter Kappetein, heart surgeon at Erasmus MC, secretary general of EACTS until August 2017; then joined Medtronic as medical director. Although he was still shown as a cardiac surgeon on the task force membership list in 2019, he was described as a 'consultant' in 2021.

Patrizio Lancellotti, professor of cardiology at the University of Liège, Belgium. In 2019, he received €900 from St Jude Medical for participation in conferences and €2,109 in travel and accommodation expenses. He also received honoraria of €1,500 euros from Edwards, €750 from Bayer, and €300 from Servier Benelux. In 2017, he received €10,000 from the latter manufacturer.

Philippe Pibarot, professor at Laval University, Quebec, and leader of the research group in valvular heart diseases at the Quebec Heart and Lung Institute. In 2017, he had a contract with Edwards Lifesciences (without pay); in 2019, he was a paid consultant for Medtronic (amount unknown). In 2020, he received research funding from Edwards Lifesciences and Medtronic.

Richard L. Prager, professor of cardiac surgery at the University of Michigan Hospital in Ann Arbor. He has not reported any conflicts of interest. Prager  received $64 from Medtronic and Maquet in 2018 [see Open Payment Data].

Raphael Rosenhek, cardiologist and clinical director at the Medizinische Universität in Vienna, Austria. He is listed on the Medtronic website as a speaker.

Alan M. Speir, cardiac surgeon and medical director of the Inova Heart and Vascular Institute, Falls Church, VA. Speir is a consultant for Medtronic, where he sits on an advisory board, and for Articure. In 2019 he received $36,593 from Medtronic and Articure in consulting fees, travel, lodging, food, and beverages [see Open Payment Data].

Giordano Tasca, cardiac surgeon at King Saud Medical City, Riyadh, Saudi Arabia. He received speaker fees from St. Jude Medical in 2019.

Thomas Walther, heart surgeon at the University Hospital of Frankfurt and Goethe University, Frankfurt, Germany. He has not reported any conflict of interests.

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Dismissed from the task force

In May 2019, Ebels receives a call from Kappetein, now medical director of Medtronic. Shortly before, the task force had published a scientific article on the sizing of heart valves, and Ebels, its co-author, subsequently spoke with the Dutch newspaper De Telegraaf about the problem. His employer at the time, the AMC hospital, fully supported his statements in the article, but Kappetein turns out to be very angry about the publicity. ‘Medtronic felt that its interests were being harmed,’ Ebels recalls.

In the following days, an email exchange ensues between Ebels and Pagano, the secretary general of EACTS. Pagano claims that the article undermines confidence in the organisation, and is worried that it might be held liable as a result of the revelation about the valve labels. He tells Ebels that the board has decided to remove him from the task force, and demands that he refrains from interviews or statements about valve sizes in the future.

Ebels does not bow down. On 13 October 2019 he flies to Lund, Sweden for a meeting of the ISO working group, where he presents another proposal to get the box labelling corrected. He meets with resistance – again.

Eventually, the meeting reaches a meagre compromise, deciding once again to print the actual size on the packaging, but only for new or altered valves. This was a relaxation of the 2015 and 2005 editions of the standard, which, however, had never been enforced nor complied to by the same manufacturers that voluntarily agreed to the standard. The meeting also decided to set up a sub-working group to investigate methods for determining the exact size, and publish these after the release of the new standard.

The FDA backs Ebels

In the summer of 2020, the revised ISO standard is ready to be voted on. It is designed to end the lack of clarity regarding valve sizes, and the sub-working group has been working on a technical report describing how to measure them correctly. Ebels’ battle finally seemed to be bearing fruit.

In September 2020, Ebels receives a further boost: the Food and Drug Administration supports his cause. ‘I convinced the FDA by submitting scientific literature showing that many people had died from valves that were too small,’ he says. Barely five months later, on 22 January 2021, the new ISO standard is published, requiring manufacturers to include essential information, such as the correct valve size, on their packaging.

But the rule applies only to new and modified valves, not those already on the market. ‘That means that mislabelling will continue for quite a while,’ Ebels says. ‘I would have preferred existing valves to be covered as well, but we couldn’t get the manufacturers to go that far.’

Dutch authorities turn a blind eye

The case is illustrative of the way in which medical devices are regulated: the rules are scarce and flexible, professional associations are reluctant to take action, manufacturers have a finger in every pie, and national and international watchdogs are lax.

As early as 22 December 2016, Ebels raised the valve problem with Koen van der Kroef, policy officer at the Dutch ministry of Health. ‘I explained the whole story to him,’ Ebels says. Initially the ministry saw no need to intervene in any way, but the conversation ended on a positive note. ‘Van der Kroef said at first that changing European rules was a lengthy process, but later he understood that this might not be necessary. That’s how the idea arose to put new stickers on the valve boxes, and to organise this nationally.’

Soon afterwards, Ebels wondered: why don’t I just make those stickers myself? He emailed Van der Kroef, asking if the department could make stickers available to all professional organisations, so that surgeons and hospitals could add the correct information to the packaging. Van der Kroef replied that he welcomed action by the medical profession, and if that did not help, to report the matter to the healthcare inspectorate. That’s the last thing Ebels heard of him.

Two years later, Ebels once again sat down with the ministry, again without results. He then sounded the alarm to the Health and Youth Care Inspectorate (IGJ), which in 2019 turned to the Dutch Association for Thoracic Surgery. Jerry Braun, the association’s chair, said: ‘We have no reason to believe that incorrect measurements are being quoted or used. There are differences in the sizing that manufacturers use. It’s like footwear: the same foot might need a size 42 from manufacturer A, or a size 43 from manufacturer B. The shoes are the same size, and fit the foot, but the exact fitting is different.’ Ebels thinks it’s quite inappropriate to compare heart valves with shoes: ‘Patients’ lives are at stake.’

Spokesperson at RIVM

"Dr Ebels can always report the valve problem himself"

The inspectorate declines to take action against manufacturers who use wrong sizes, saying: ‘Sizing should be indicated on the packaging and based on the standards. The inspectorate has no role in drawing up or enforcing these standards.’ It suggests that this task belongs to the so-called notified bodies –companies hired by manufacturers to obtain CE marks, that are necessary to admitting their products on the European market.

On 2 November 2020, almost four years after Ebels first sounded the alarm with the ministry, it asked the National Institute for Public Health and the Environment (RIVM) to bring up the valve problem, including the option of affixing stickers with the correct information, with the Dutch standards committee for implants. The RIVM has been a member of the committee since August 2020.

Why did the ministry of Health leave the problem unaddressed for so many years? ‘Professional medical groups can include regulations about the safe use of medical devices via field standards,’ a spokesperson said. ‘The healthcare Inspectorate is responsible for overseeing product safety, and we play no role in this process.’ The RIVM has, as it turns out, not raised the subject with the committee for implants. A spokesperson for the institute could not explain why, but remarked: ‘Dr Ebels can always report the valve problem himself.’

The registration system is inadequate

It is unclear how many patients in the Netherlands have developed complications, or even died, after the implantation of incorrectly sized valves. The Inspectorate says it does not have this information, and nor does the National Heart Registry (NHR), which told us: ‘The government has decided to oblige hospitals to report implant information to the registry. [..] The process of collecting this data is currently under way, so that the implants’ performance can eventually be monitored nationally. We cannot answer your questions with the data currently available in the registry.’

Ebels’ couldn’t investigate the consequences of patients having received incorrectly sized valves: the registration was inadequate

Since 1 January 2019, healthcare providers are required to record with the National Implant Registry which implants are used when, and in which patients, but relevant data is often absent. Ebels has tried to investigate how many repair surgeries have had to be performed because of incorrect valve sizes, and how many patients have died as a result. ‘That study didn’t get off the ground, because the register of implanted valves didn’t contain the necessary data,’ he says.

Ebels continues: ‘Doctors and patient associations should be able to participate more in the ISO working groups: that’s where the standards are set. Government agencies must learn to enforce rather than wait to see what comes their way. And if the EU’s new medical device regulation doesn’t get the notified bodies in line soon, we’d better set up an implants department within the European Medicines Agency.’

Look-away culture

Two members of parliament who have previously spoken out against the lack of regulation regarding medical devices, are affronted upon hearing Ebels’ story. Labour Party leader Liliane Ploumen: ‘When a manufacturer knowingly provides wrong information and thus increases the risk of patient harm, the Inspectorate must act immediately. It’s incomprehensible that the ministry and the Inspectorate think it’s not their role to take action against this. They can’t shift responsibility for devices to the notified bodies – it is known that they cannot guarantee the safety of implants, and don’t have safety as their primary objective.’

Socialist Party MP Henk van Gerven agrees. ‘The Inspectorate can’t just point to the notified bodies. Its own task is absolutely clear: to supervise the quality and safety of healthcare. If these are at stake, it must act and not look away. Such laxity constitutes a risk to our public health.’ Both he and Ploumen plan to question the minister Health about the matter.

Comments and responses

Follow the Money has repeatedly asked EACTS questions about valve sizes, the independence of task force members, and their financial links to the medical device industry. EACTS replied that these are ‘commercially sensitive’ issues, which it is not willing to address.

The association’s former president, Ruggero De Paulis, said through a spokesperson: ‘I am afraid we are unable to address all of your points and certainly not in the very short time frame you provide. Some of the information you seek will be subject to legal agreements which neither Professor De Paulis individually, nor EACTS as an organisation, is allowed to unilaterally declare. We can assure you that EACTS subscribes to all relevant international and national regulations and guidance on matters of industry partnerships and conflicts of interest.’

We repeatedly asked Arie Pieter Kappetein to comment, and he finally told us that Medtronic, his employer, had asked him not to respond. Nevertheless, he said his main objection was that Ebels had blown the whistle by speaking to De Telegraaf about the heart valve problem while the task force publication was still in draft form. However, the article had already been published earlier that month.

The ministry of Healthcare, Welfare and Sports informed us: ‘Standards are developed and adapted by standards committees in which professional groups and other stakeholders can participate. ISO standards provide a way for manufacturers to demonstrate compliance with legislative requirements. In other words, you can see them as concrete implementations of legal provisions. Notified bodies check whether manufacturers comply with the legislation, and are supervised by the competent authorities, which in the Netherlands is the Inspectorate (IGJ). Manufacturers may also use means other than standards to demonstrate that their products comply with the law. The use of standards is therefore voluntary, but widespread.’

The RIVM told us: ‘[We know] that the new version of this ISO standard has been published. It is important that standards are adapted to current insights and state-of-the art science.’ For the oversight of these standards, the RIVM refers to the healthcare Inspectorate.

The healthcare Inspectorate told us:

‘The guideline was drawn up by the medical field; the Inspectorate has no role in this. See also our earlier answer regarding guidelines. [..]

Valve sizes must be indicated on the packaging on the basis of these standards. The notified body checks whether the packaging complies with the standards before medical devices are put on the market. Manufacturers may deviate from the norms if necessary, and the notified body is responsible for assessing whether the reasons for such deviations are justified.

Enforcement is relevant only if:

  1. A manufacturer clearly is not complying with the standards, and
  2. The manufacturer has not made clear to the notified body why it is not doing so, and
  3. The notified body has subsequently done nothing to ensure that the manufacturer complies with the standard.

We are only able to enforce the law when the notified body or manufacturer is established in the Netherlands. Otherwise, we will approach the supervisory authorities of the country concerned, if appropriate.’

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