Undercover probe reveals continuing failures in medical device regulations

Concern over EU regulatory system compounded as investigation reveals firms are putting cash before patient safety

Recent scares have led to renewed criticism of the UK and European medical device approval systems

Medical product regulators insisted they would be overseeing a major shake-up of UK legislation after an undercover probe revealed patients are being ‘failed’ as companies take advantage of flaws in the system to make money at the expense of safety.

A joint investigation by the Daily Telegraph and the British Medical Journal this week disclosed that the current regulation of European medical products is in certain circumstances being sub contracted to questionable firms in Asia.

When asked by undercover journalists why the European Union certification system - CE marking - was so attractive, an executive at one firm based in Seoul rubbed his fingers together and answered ‘money’. Another representative of the Slovakian regulatory body in Hong Kong boasted that he had never had an application for a medical device rejected.

Your investigation into the regulation of medical devices is a stark reminder that the governance of these medical implants continues to fail patients

The discovery had led to an open letter from the Royal College of Surgeons and the British Orthopaedic Association warning that the revelations are a ‘stark reminder’ of the ‘urgent need to address regulatory flaws’.

The statement, published in the Daily Telegraph adds: “Your investigation into the regulation of medical devices is a stark reminder that the governance of these medical implants continues to fail patients. New surgical devices, and the techniques required to implant them, must be regulated so that they can be safely introduced into our healthcare system and monitored in the long term.”

The institutions said that ‘as a minimum’ a mandatory database showing which surgical implants have been licensed for use, and on what basis, should be introduced. Currently, it is impossible to find out which regulatory body has licensed a particular medical device for use.

The comments come exactly a month after the European Commission published plans to overhaul the current system. This followed the widely-publicised PiP breast implant scandal and concerns over metal-on-metal hip replacement products.

The proposed changes affect both the current directive on active implantable medical devices and the directive on medical devices, which cover a huge spectrum of products.

The current system divides products into four classes of risk: Class I is low-risk things such as sticking plasters and corrective glasses; Class IIa covers medium to low-risk items such as dental filling material and tracheal tubes; Class IIb is for medium to high-risk devices such as X-ray machines and bone plates and screws; and Class III is for high-risk instruments such as pacemakers and implantable defibrillators.

New surgical devices, and the techniques required to implant them, must be regulated so that they can be safely introduced into our healthcare system and monitored in the long term

At present devices are subjected to a conformity assessment, which for medium and high-risk items involves an independent third party, known as a Notified Body. In the wake of the PiP scandal, the spotlight fell on these organisations, with criticism that they were operating to different standards across Europe and that their decisions and actions were not being properly scrutinised.

The EU proposal stated: “In an internal market with 32 participating countries and subject to constant technological and scientific progress, substantial divergences in the interpretation and application of the rules have emerged, thus undermining the main objectives of the directives, i.e. the safety of medical devices and their free movement within the internal market. Moreover, regulatory gaps or uncertainties exist with regard to certain products (e.g. products manufactured utilising non-viable human tissues or cells; implantable or other invasive products for cosmetic purposes.

“This revision aims to overcome these flaws and gaps and to further strengthen patient safety. A robust, transparent and sustainable regulatory framework should be put in place that is ‘fit for purpose’. This framework should be supportive of innovation and the competitiveness of the medical device industry and should allow rapid and cost-efficient market access for innovative medical devices to the benefit of patients and healthcare professionals.”

But this action will take time, the Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulatory body, has admitted.

Responding to this week’s revelations, a spokesman for the MHRA said: “We recognise that improvements to the regulation of medical devices need to be made, and that’s why we fed into the European Commission’s review, specifically recommending improving the oversight of Notified Bodies, the improved surveillance of post-market events, and the better collaboration between national regulatory bodies.

We will shortly be consulting on the approach that the UK should take for negotiating the proposed legislation

“The European Commission published its proposals on 26 September and that includes many of the areas of improvement that the UK has been pushing for. We will shortly be consulting on the approach that the UK should take for negotiating the proposed legislation.”

The new evidence has led to a call from the new Health Secretary, Jeremy Hunt, for officials to introduce safeguards to ensure British patients are protected whatever happens elsewhere in Europe.

He said: “There is a worrying and completely unacceptable weakness in the regulatory system.”

The joint investigation was launched amid growing evidence that the procedure for regulating medical products is open to abuse.

Official regulatory bodies in Slovakia and the Czevch Republc were prepared to approve a ‘toxic’ hop replacement, which means it could be sold to the NHS and legally used on unsuspecting British patients, the undercover team found.

The commission recognises that there are some weaknesses in the current regulatory framework and, of course, anything which jeopardises patients’ health or safety is unacceptable

In Hungary, officials were found to be offering advice on how to re-label potentially-dangerous devices made in China so that patients would think they were manufactured in the EU. And the South Korean office of a Czech regulator was discovered to be offering expensive ‘consultancy’ services while also assessing whether products were safe to be licensed. EU rules ban regulators from doing this.

These findings have led to fears that regulators are putting the commercial needs of manufacturers ahead of patient safety.

Commenting in response to the findings, a spokesman for the European Commission said: “The commission recognises that there are some weaknesses in the current regulatory framework and, of course, anything which jeopardises patients’ health or safety is unacceptable.”

Details of any UK-specific regulatory interventions are due to be revealed early next year, but implementation could take several years, campaigners fear.

To read the Daily Telegraph article, click here

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