Medical device rules need 'drastic change' to protect patients

Urgent and drastic changes to the rules around medical devices, such as pacemakers, are needed to protect patients, according to the Royal College of Surgeons.

It wants a register of every device in every patient set up so doctors know if new innovations are causing harm.

An investigation by 58 media organisations has uncovered patients being given implants that were unsafe.

The government said it would look at what changes may be required.

Medical devices range from implanted contraceptives to hip replacements to pacemakers in the heart.

BBC Panorama has been investigating the industry with the International Consortium of Investigative Journalists and organisations around the world including The Guardian newspaper and the British Medical Journal.

They found implants being put into people after failing in trials, some involving baboons or after tests only on pigs and dead bodies.

Prof Derek Alderson, president of the Royal College of Surgeons, called for “drastic” changes which it urged the government to “urgently” address.

“There needs to be compulsory registration of every new device and implant that goes into a patient in the United Kingdom,” he said.

He said doctors were “not sure” about the harms of some devices and the risks could grow as technology was advancing so rapidly.

Boz Michalowska, a medical devices lawyer at the firm Leigh Day, said: “It should be a source of shame for the UK government and its regulatory bodies that patients continue to suffer from such avoidable harm.”

A Department of Health and Social Care spokesperson said the UK regulator, the MHRA, had a “robust process” in place to support the regulation of new medical devices, and it “expected them to follow up any safety concerns swiftly and with patient care in mind”.

“We will work with the regulator to see what future changes may be required,” they said.

The MHRA said the regulatory system for medical devices had been in place for 25 years and medical technology had “improved and transformed countless lives”.

“The need to protect public health, whilst not stifling innovation, must be carefully balanced. The MHRA welcomes innovative medical devices that can bring huge health benefits to people as long as this doesn’t compromise patient safety,” it said.

Maureen ‘the good guinea pig’?

Maureen McCleave, 82 from Essex, was the first person in the UK to be fitted with the “Nanostim” pacemaker because of an irregular heartbeat.

Pacemakers are life-saving implants that deliver electrical pulses to the heart to keep them beating regularly.

Traditional ones have leads from a battery to the heart that deliver the electrical pulse, but the cables can break.

The Nanostim was the first leadless pacemaker that sat inside the heart.

Maureen said she was “over the moon” to be the first and felt like a “good guinea pig” when she was implanted with the device at Bart’s hospital in London.

“I was so grateful that I’d been chosen, because it sounded too good to be true.”

But three years after it was fitted, the battery in Maureen’s Nanostim failed and surgeons could not get it out.

She now has a traditional pacemaker keeping her alive. The Nanostim is still sitting inside her heart.

She says: “I don’t like the thought I’ve got a piece of metal or whatever in my heart that’s doing nothing and it’s just laying there.”

Maureen was not alone – a number of batteries failed and parts fell off inside patients.

The pacemaker was withdrawn for safety reasons. At least two people died and 90 events were recorded in which patients were seriously harmed by the device.

The Nanostim heart pacemaker was turned down by safety bodies in Germany because of a lack of evidence. Yet it was approved by the British Standards Institution in the UK.

How big a problem is this?

Not all medical devices are dangerous. Many save lives or dramatically improve quality of life.

But the investigation has found that some devices are failing patients including:

  • implants that cracked inside people’s backs and had failed in baboon tests
  • birth control implants that caused internal damage and bleeding
  • misfiring implantable defibrillators
  • mesh implants for incontinence that caused abdominal pain

The BBC also uncovered a treatment for children with a severely curved spine, or scoliosis, which was allowed on to the market following tests only on pigs and dead bodies.

Yet, due to a lack of transparency and data collection, the scale of any problem across the medical device industry remains a mystery to both patients and doctors.

I have an implant, what should I do?

If you are worried, a panel of experts put together by the International Consortium of Investigative Journalists has put together some advice.

It recommends: “Your first point of call should be the medical team that performed the operation.

“If you cannot go back to them for whatever reason, you should consult your primary care doctor.

“The doctor should be able to refer you to a specialist who is familiar with the device and the surgery you had.”

Patients in the UK can also report problems to the regulator.

How is all this allowed to happen?

Europe does not have a governmental body that checks medical devices before they are put onto the market.

Instead a series of companies called notified bodies issue CE marks – the same mark of approval given to devices like toasters and kettles.

There are 58 of them in Europe and approval by one means a product can be used anywhere in the European Economic Area (the EU plus Iceland, Liechtenstein, and Norway).

But if one body says no, a company can shop around and ask another.

But surely you need evidence?

Less than patients might think.

And there is so much secrecy that even surgeons implanting these devices do not always see the evidence upon which a device has been approved for its safety and effectiveness.

The British Standards Institution said it could not discuss the evidence for Nanostim due to “confidentiality requirements”.

Even the UK’s regulator, the Medicines and Healthcare Products Regulatory Agency, says it is “bound by confidentiality when it comes to some of the actions that we’ve taken around individual devices”.

But the investigation discovered there was only one clinical study before Nanostim was approved for use on the public.

It followed just 33 patients for 90 days.

Prof Rita Redberg, one of the world’s leading cardiologists and from the University of California, San Francisco, said: “We’re talking about a permanently implanted pacemaker, so I think that’s a very tiny study.

“They’re supposed to last 10, 20 years. A 90-day follow up is not enough to learn much about the pacemaker.”

What does the industry say?

MedTech Europe, the body that represents the medical devices industry, said: “Millions of people have safely benefited from medical devices and can now live healthier, more productive and more independent lives.

“Life is unimaginable today without the hundreds of thousands of medical devices in our hospitals and in our homes.”

And it defended the system of notified bodies which were “selected for the expertise, impartiality, transparency and independence of their staff”.

Abbott, which manufactured Nanostim, says that many patients have been helped by leadless pacemakers and many more will benefit from this technology in the future.

It said: “In accordance with the European CE Mark approval process, the Nanostim leadless pacing system was approved based on strong performance and safety data.

“In addition, upon CE Mark approval Nanostim was further assessed through a European post market clinical follow-up study.”

What is the solution?

The UK’s Royal College of Surgeons has called for “drastic regulatory changes”.

Prof Derek Alderson, president of the Royal College of Surgeons, said: “All implantable devices should be registered and tracked to monitor efficacy and patient safety in the long-term.”

But when the European Union suggested tightening the rules, the industry ran a campaign called “Don’t lose the 3”.

It referred to the fact that manufacturers can get new products to patients three years quicker in Europe then they can in the United States.

New medical device regulation will come into force in Europe in 2020, but campaigners say the new rules do not go far enough.

German MEP Dagmar Roth Behrendt told Panorama that an intensive lobbying campaign by the industry undermined the proposed reforms.

“It’s a success for them and a failure for the European parliament and for European patients, I have no doubt about it.

“It is like an open wound for me, that we could not do more for European patients and for the safety of European patients hurts.”

Let’s block ads! (Why?)

BBC News – Health