Faulty medical implants investigation: ‘A system in disarray that favours manufacturers at the expense of safety’
The role of medical devices in health care is essential. Yet a number of recent high-profile failings have prompted serious concerns about the current system of regulatory approval, says Carl Heneghan.
By Carl Heneghan
6:55AM BST 23 Oct 2012
In terms of regulation, the role of the European Union is to ensure the highest level of patient safety. But what has been found out by the Telegraph and the BMJ’s investigation now puts this claim in serious doubt.
To put it bluntly, device regulation is in disarray: the evidence requirements at the time of approval are woeful, the conduct of notified bodies is sub-standard, and individuals supposedly representing the regulatory system are conflicted and in many cases under-qualified.
This all means that the system now heavily favours manufacturers at the expense of patient safety.
Notified bodies are organisations authorised to grant a CE mark in the EU. A company is free to select any notified body it sees fit to undertake certification of a new device.
An application for a metal hip should raise significant alarm bells, particularly given the worldwide alerts that exist to its problems. A Google search immediately retrieves “compensation”, “implant failure” and “could cause cancer”. But, in this case it did not raise concerns among eight of the contacted notified bodies.
It gets worse. In the evidence document submitted for application, the device was based on two previous recalled devices and a number of deliberate errors were inserted into the document: tests for corrosion didn’t add up, the hip data showed it wore at a very high rate and the data implied the hip would literally “fall out”.
Basically, it couldn’t be any worse for the device. But some notified bodies seem to want a device to get through at any cost. One said that they would provide a “solution for certification, somehow”.
European regulations state that companies should submit clinical data at the time of device approval, yet this can be as little as an evaluation of the scientific literature. This data is supposed to relate to the “safety, performance, design characteristics and intended purpose of the device”.
The investigation informs us that submitted data can be wrong, refer to previous recalled devices and not demonstrate safety at all. To date, no one adequately knows the make-up of notified bodies, their qualification or their skills.
But in this investigation they were certainly not equipped to deal with this case. Indeed, they had never dealt with a hip implant.
There have been many unsubstantiated reports that companies shop around for the best deal. As the Telegraph/BMJ investigation shows, the notified body does not need to see the device, clinical data can be sub-standard and wrong, the organisation with oversight of the device approval process does not need to reside in Europe, and they certainly do not need relevant skills. And despite all this you can access the European market, for an implantable device, without a single patient ever having received it.
The current situation needs urgent remediable action. At a minimum, and as a quick fix, there should be a requirement for new devices to have published clinical data.
The investigation has revealed appalling loopholes in the current system that could allow defective devices onto the European market. What is needed is transparency.
None of the regulators has a register of approved devices and none of them get to see the submitted data for the device. This can’t be right.
Carl Heneghan is director of the Centre for Evidence-Based Medicine, University of Oxford
- Faulty medical implants investigation: Surgeons’ letter to the Telegraph – Telegraph (earlsview.com)
- Faulty medical implants investigation: ‘We can help you label it European so China is not on packaging’ – Telegraph (earlsview.com)
- Faulty medical implants investigation: Patients at risk from flaws in medical device rules, admit EU chiefs – Telegraph (earlsview.com)
- Dodgy medical implants getting approved – EasyBlog (earlsview.com)
- Video: Faulty hip implants have ruined lives says Orthopaedic Professor – Telegraph (earlsview.com)
- Faulty medical implants investigation: Patients at risk from flaws in medical device rules, admit EU chiefs (telegraph.co.uk)
- Faulty medical implants investigation: Patients’ health put at risk by unscrupulous EU regulators (telegraph.co.uk)
- Faulty medical implants investigation: Patients failed by poor implant regulation, say surgeons (telegraph.co.uk)
- UK – Jeremy Hunt: I will not tolerate British patients being put at risk – Telegraph (earlsview.com)
- Hip implant probe sparks call for better NZ system (radionz.co.nz)