By Laura Donnelly,
Health Correspondent, The Telegraph
7:50AM BST 09 Sep 2012 (FiDA blog highlight added)
The
changes will mean that for the first time the public will be able to access
details of the clinical research behind the products, and their safety record
since coming on to the market.
The rules are being drawn up by the
European Commission in the
wake of the PIP breast implant fiasco and the scandal of metal-on-metal hips,
which were found to poison the body and suffer failure rates of up to 50 per
cent.
Under the current system, the
clinical evidence to support devices, and the records of adverse incidents
linked with them are kept behind closed doors.
Manufacturers must share some
information with a "nominated body" of their choice, which authorises
their products for use, yet it cannot be seen by the public, nor by independent
scientists because of draconian European Union regulations.
British
regulators run a voluntary system so surgeons can report concerns about medical
devices, yet the EU confidentiality rules mean their data is not published,
with patients and doctors told nothing - unless the situation deteriorates so
badly that a safety alert is issued.
Last December it emerged that more
than 40,000 British women received substandard breast implants, made by Poly
Implants Protheses (PIP), with some made from industrial silicone, instead of
the medical substance which had been authorised.
In January, The Sunday Telegraph
disclosed that thousands of Britons had been given metal-on-metal hip implants
which were found to poison the body,
with some devices having failure rates of up to 50 per cent.
Weeks later, regulators the Medicines
and Healthcare products Regulatory Agency (MHRA) issued a warning that 49,000
people with the implants should undergo checks throughout their lifetime and
undergo further operations to replace the devices if problems were found.
The new proposals from the European
Commission, due to be published within weeks, are expected to recommend that
three directives on medical devices, passed during the 1990s, are rewritten.
Under
the plans, a duty of confidentiality which is currently placed on all
organisations which handle clinical data would be erased, in a bid to make the
system more transparent.
The current rules were intended to protect the
commercial interests of manufacturing companies, but safety campaigners
and regulators believe they
have gone too far in putting the interests of business ahead of patient safety.
Professor Sir Kent Woods, chief
executive of the MHRA, which has called for the change, said: "The
evidence should be out there – so that scientists can look at it, so that
patients can look at it and so the public can look at it."
He said it had now become
"widely accepted" in the pharmaceutical industry that companies had
to make the data from their clinical trials public after drugs were licensed,
and that reports of adverse reactions to drugs were documented and published.
Medical devices and implants should
follow the same direction, he said.
Because of the single European
market, devices used in this country can be manufactured elsewhere, then
authorised by a "notified body" in any of the 27 EU member states.
That meant that in the case of the
PIP implants, a company in Germany was responsible for the quality of devices
produced in France and imported for use in 300,000 women around the world,
including Britain.
British regulators the MHRA accredit
the six notified bodies which operate in this country and can audit them to
check their processes – but have little control over the quality of checks done
abroad.
The MHRA has urged the European
Commission to change the system, so that accreditation is done by
representatives from several countries, in order to ensure that all countries
are working to the same standards.
Prof Woods said he felt confident
about the expertise of the organisations it inspects but said: "I can't be
confident that notified bodies in every one of the 27 countries are working the
same way".
He said the rules of a single market
in Europe meant it was not possible for British regulators to check all the
devices used in this country.
The MHRA is also calling for more
rigorous standards to ensure that the clinical evidence to support the
application for a licence is more consistently and robustly scrutinised.
The commission is considering how
information should be better shared across EU member states, which Prof Woods
said could have helped regulators to detect the PIP scandal sooner.
"If we had been able to easily
share adverse incident data across Europe I think we would have picked up an
increased signal about rupture rates – though not that the filler was
fraudulent," he said.
The
Commission is also considering whether an "implant card" should be
given to all patients who receive an implant, with details of the date, name of
device, batch, lot and serial number.
The MHRA said it became clear when
problems arose over breast implants and metal-on-metal hip replacements that most patients given implants
were not aware what type of device they had.
Sir Bruce Keogh, the Department of Health medical
director, is leading a review of cosmetic surgery which is considering whether
details of all operations should be held on a central register, to help detect
problems with particular types of implants.
FiDA blog comment:
Tomorrow 9/10/12 the US FDA is conducting a
webinar/public meeting on the issue of unique device identifiers UDI's for
implanted medical devices. The US government is liberating a substantial
amount of 'big data' from Medicare for research. Patient harm will be
reduced and safe and effective implanted medical devices will be identified so
that consumers can make informed decisions. "Proprietary"
information that endangers public health will be exposed.
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