By Carl Heneghan The Telegraph (FiDA highlight added.
6:55AM BST 23 Oct 2012
Carl Heneghan is director of the Centre for Evidence-Based Medicine, University of Oxford
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.
http://www.telegraph.co.uk/health/9626921/Faulty-medical-implants-investigation-A-system-in-disarray-that-favours-manufacturers-at-the-expense-of-safety.html
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