This article is part of our special report Medical devices regulation.
SPECIAL REPORT / The scrutiny procedure on medical devices in the US is so strict that American doctors say the system works against the interest of patients, leaving some waiting years for treatment that could save their lives. European doctors now start to worry that a similar system envisaged in the EU could have the same impact.
American doctors are frustrated that the US approval requirements for cardiovascular devices, for example, are much more stringent than in Europe, due in part to the centralised approval system.
“There is a frustration among … US care providers around delayed access to certain interventions that appear to be a winner,” Dr Patrick O’Cara, a cardiologist with Brigham and Women’s Hospital in Boston, told the Reuters news agency.
A common example used by US doctors are heart valves made by Edwards Lifesciences. The US company says its transcatheter aortic valve replacement (TAVR) system is particularly well suited for elderly and frail patients since it can be put in place through an artery rather than by cracking open the chest for heart surgery.
“With this disease, if you wait two or three years, 60-80% of [patients] are dead,” said Dr Martin Leon, director of the Centre for Interventional Vascular Therapy at Columbia University Medical Centre in New York. “So not to have the most updated version of the device to treat more patients like this doesn’t seem to be a particularly good idea.”
Leon said some researchers are now calling the US “a Third World country” when it comes to availability of cutting-edge heart devices.
In Europe, EU institutions are currently looking at ways to tighten safety of medical devices after faulty breast implants placed the issue at the top of the political agenda in late 2011. The European Commission tabled a proposal which is now being examined by the European Parliament.
Some lawmakers in Parliament have said the EU system is too lax, calling for a model which resembles the US centralised approval model rather than the current decentralised one, where each country sets its own legal and safety requirements.
Dr David Holmes, a cardiologist at the Mayo Clinic and a past American College of Cardiology (ACC) president, said a middle ground was probably the best way forward. “I think we need to meet somewhere in between,” Holmes said, adding that Europe might need to tighten its regulations without necessarily adding delays to its nimble approval process.
US system or not?
In the European Parliament, German MEP Dagmar Roth-Behrendt (Socialists and Democrats) is responsible for steering the new medical devices legislation through the assembly.
She has proposed a pre-market approval procedure for high-risk devices (Class III) such as pacemakers and other implants, which are inserted inside people’s bodies.
Her draft report suggests establishing a Committee for the Authorisation of medical devices within the European Medicines Agency (EMA) to oversee the process, where patients would be represented.
Industry has warned that this approval system was as complex as the US one and might create the same kinds of delays. But Roth-Behrendt told EURACTIV that she thinks this comparison is particularly misleading as she does not refer to the US system in her draft report.
“The US system of approval also faces some problems and I have not used it as an example for the changes I propose,” she told EURACTIV.
“The system which I have proposed, for the authorisation of the highest potential risk class of medical devices, is based on the fact that, in the recent past, too many unsafe medical devices, such as hip prosthesis or breast implants for instance, have been inserted into the body of thousands of patients. Those devices had received an approval to be placed on the EU market,” Roth-Behrendt stated.
Dr Angelo Auricchio, who is member of the European Society of Cardiology and president of the European Heart Rhythm Association, said he was unsure whether the Parliament rapporteur has introduced something new.
However, he welcomed amendments to the proposal that he says has given patient groups the opportunity to be part of the preview process along with physicians and technologists, under the authority of the European Medicines Agency (EMA).
“But the fact having a pre-market approval and to have under the same large agency like the EMA… You have everything going there from devices to pharmaceutical components. This is not the right thing to do. You may not want to use the words ‘it’s a US-like system’, but it is a US-like system,” Auricchio said in an interview.
“De facto, it is like in the US. So even if you don’t name it that essentially this is what it is.”
US system described as ‘nonsense’
America’s bulky approval system is routinely used as a benchmark in Parliament debates.
At a Parliament conference on medical devices held in February, professor Werner Siebert, who is also medical director of the Vitos Orthopaedic Clinic in Kassel, said the current EU system is satisfying if everybody does the job correctly.
However, he suggested that the EU may have too many notified bodies at national level that are empowered to approve new devices.
Siebert does not see any added value in the European Commission’s proposed scrutiny procedure. But he says a pre-market approval system for the most risky categories of medical devices could be necessary.
Professor Panos Vardas, the president the European Society of Cardiology (ESC) agreed, adding that the first priority should be to ensure the safety of patients fitted with high-risk implants.
“The ESC advises that high-risk medical devices should be evaluated only by notified bodies with proven expertise in evaluating the specific type of device under consideration. Regulation should give the Commission the authority to designate notified bodies for particular applications,” he said.
Auricchio said that instead of a pre-market approval, Europe should improve the synchronisation of the different national regulators.
“The problem is that we know very well that some competent authorities in Europe are extremely good and I would say even better than the American competent authorities. So it’s a matter of better coordination of knowledge among the competent authorities,” the doctor said.
He added that the FDA system in the US would have been unable to prevent the scandals recently seen in Europe.
“As a physician and possibly in the future as a patient, what I would like to have is certainly a safe therapy, but as soon as I’m exposed to any therapy, there’s always a risk of having a problem and unfortunately that is how it is, dealing with technology,” he said.
“It’s actually nonsense to have a pre-market approval as the FDA has. Patients in the US often wait 4-5 years longer for great therapies that we have in Europe. We have a great advantage. These advantages have to come with the knowledge of potential risk, but what you want to do is to limit the risk and to accurately monitor the effect of the therapy,” Auricchio stated.
He explained that in the US, some devices that are not characterised as high-risk (Class III) now undergo the same scrutiny process as because of safety concerns.
FDA ‘losing’ credibility
Auricchio said Europe was now also having “problems” with the FDA as the American authority wants to impose its rules on the rest of the world.
“They understand that because they have been heavily criticised by American doctors for increasing regulation without a significant benefit for the US system or for US doctors. They are losing now their credibility and now they are trying to blame someone else on the other side and they try to influence our good politicians,” Auricchio said.
But Europe should be happy with its system, with some exceptions, the doctor stressed.
“I do accept that there have been issues in the past and there continue to be issues, but these issues can be solved. Europe has to have a much different way of regulating things compared to what the US has,” Auricchio said.
The European Public Health Alliance (EPHA), a civil society organisation, said it does not want a system of pre-market approval by a state authority but was in favour of continuing the current system by improving the functioning and supervision of the notified bodies:
“There should be a stricter supervision of notified bodies by member states, as well as more control of notified bodies over manufacturers, including unannounced factory visits. The independence and quality of pre-market assessments must also be assured. Conducting conformity assessments prior to placing devices on the market should prevent problems such as those experienced during the PIP breast implant debacle.”
Dr Katrín Fjeldsted, president of the Standing Committee of European Doctors (CPME), told EURACTIV:
“Mandatory approval of the ethics committee for medical devices before the clinical investigation begins is crucial for patient safety. European doctors consider this essential to be taken on board in the Regulation and welcome the report of MEP Dagmar Roth-Behrendt (amendments 15 and 84) which upholds internationally recognised standards of protection (Declaration of Helsinki, Rev. 2008, paragraph 15). Notwithstanding the different ramifications of the proposal for patient safety and innovation, CPME reminds, just like clinical trials for medicinal products, that the start of clinical investigations should only be granted after positive approval of the ethics committee. CPME calls on members of the European Parliament to maintain the mandatory role of ethics committees and vote in favour of amendments 15 and 84 in September.”
Medical devices are defined broadly and can include anything from sticking plasters to contact lenses, pregnancy tests, dental filling materials, X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.
Following a huge health scandal involving faulty breast implants sold around Europe, the European Commission published proposals in late 2012 for a new regulatory regime for medical devices. The Parliament is currently debating the shape of new regulation.
The new regulations are scheduled for adoption later in 2013.
>> Read our LinksDossier: Medical Devices: A new regulatory landscape
- 22 Oct.: The Parliament’s Environment, Public Health and Food Safety (ENVI) Committee are scheduled to vote on its final report on the two proposed medical devices regulations (Roth-Behrendt report).
- Nov. 2013: Parliament is scheduled to vote on the report in a plenary session.
- Public health: Revision of the medical device directive
- Environment, Public Health and Food Safety (ENVI) Committee: Draft report on medical devices
- Environment, Public Health and Food Safety (ENVI) Committee: Website
NGOs and think tanks
- European Public Health Alliance: EPHA position on medical devices
- Standing Committee of European Doctors (CPME): CPME statement on medical and in vitro diagnostic medical devices