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Regulating medical devices
Just before Christmas, on the 23rd December 2011, around 40,000 women with breast implants in the UK anxiously watched their television screens as the national news channels broadcast the news that the French government had recommended that 30,000 women in France should have their breast implants removed on a precautionary basis.
The implants, made by French company Poly Implant Prothese (PIP), had been banned in March 2010 after they were found to contain a non-medical grade silicone filler that was different to the filler that had been approved under the European system of regulation.
Testing of the unauthorised filler by scientists in the UK was quickly commissioned by the MHRA and the UK results, published in September 2010, showed there was no evidence of a cancer risk. This finding was later supported by Australian and French laboratories.
Further testing on additional samples of PIP breast implants by scientists in the UK, Europe and Australia has shown that there is no evidence of a long-term risk to human health. This has supported the UK Government’s position that it is not necessary to remove PIP breast implants from women in the UK on a precautionary basis. Instead, women are entitled to a free NHS scan and consultation to discuss any concerns they may have about their implants.
ALL EYES ON REGULATION
While the PIP company directors, including PIP founder Jean-Claude Mas, were charged with aggravated fraud and face up to five years jail if convicted, the episode has shone a bright spotlight on the regulation of medical devices.
Breast, hip and knee implants, pacemakers, inhalers, diabetes meters and hospital equipment are all examples of medical devices that are regulated under the European medical device regulations.
While many people are aware of how medicines are regulated through clinical trials public knowledge of how medical devices are regulated was little until the PIP episode.
Very few people understand that if a medical device such as a new hip implant is made by an Italian manufacturer and approved for use by a Norwegian-based Notified Body – an independent company that assesses the safety of a new medical device – then it can be implanted into patients in the UK or any other European country.
The lack of public knowledge about the European system of regulation for medical devices was demonstrated when the MHRA was blamed by the media and people affected by the PIP episode ‘for letting PIP breast implants into the UK’.
In reality, all the MHRA could do, like every other national regulator in Europe, was to monitor the safety of PIP breast implants once they were being used and then take action to remove them from the market if the evidence showed they were not safe. The MHRA immediately recommended that the PIP breast implants should no longer be used and the German Notified Body responsible supported this by withdrawing their CE marking so they were no longer used in Europe.
GETTING THE RIGHT BALANCE
The MHRA believes the current European system of regulation must be strengthened to protect patients from unsafe medical devices but a balance must be found in promoting innovative new medical devices. For example, if medical devices underwent clinical trials like medicines before being used, a new hip implant might need to undergo a clinical trial lasting at least 10 years to demonstrate its long term durability. Such an approach would deprive patients of access to treatment involving new medical devices which could have a significant impact upon their health and wellbeing.
Last year the MHRA held a public consultation about strengthening the European regulatory system and 116 responses were received in response. These were broadly supportive of our position that there must be tighter controls on notified bodies, better post-market surveillance of medical devices and better collaboration between regulators in different countries
We have fed these views into the negotiations that are currently taking place in Europe and we are optimistic that an improved European system of regulation for medical devices will emerge. A system based on what’s best for patients.
Improvements in Europe will take time but I believe the regulatory system in the UK can be strengthened more quickly and NHS staff can play a major part in this.
The MHRA needs nurses, doctors, pharmacists and other healthcare professionals to report any problems they encounter with any medical device; whether it is a hospital trolley, a dialysis machine or even an inhaler, the MHRA needs to know about it.
The quality and numbers of reports about problems with medical devices from healthcare professionals have a major influence on MHRA’s ability to assess whether a medical device is performing as it should be and whether it should continue to be used.
For example, if we aren’t aware that a specific model of defibrillator is unreliable then we can’t alert other users of potential problems and this could have serious consequences for patients.
At the same time, even if we receive an adverse incident report about a faulty medical device, we need a good quality report. We need to know the model of the defibrillator, when the problem occurred and in what circumstances.
We know that healthcare professionals are extremely busy but adverse incident reporting isn’t time consuming. It can be done quickly and easily on-line via the link on the front page of the MHRA website: www.mhra.gov.uk
The MHRA is also working closely with NHS England to improve levels of reporting of problems with medical devices in NHS trusts through enhanced Medical Device Liaison Officer roles. We will publish more information about how this will work in near future and hopefully this will help to raise awareness about the importance of reporting to the MHRA.
New technology is also being developed by the MHRA to help our surveillance of medical devices. We are working with a number of NHS trusts in piloting a new tracking system for high risk medical devices that will improve the monitoring of medical devices such as breast and hip implants, heart valves and pacemakers.
The new tracking system will ultimately incorporate unique device identifiers into hospital patient electronic records and national Hospital Episode Statistics databases. Analysis by the Clinical Practice Research Datalink (CPRD) – a secure e-health research service – will enable the MHRA to better assess the performance of high-risk medical devices and to trace patients in the event of a device recall or safety alert, without the need for multiple device registries.
This project is one of 11 projects that the MHRA has established to strengthen the regulation of medical devices. Many of these projects are still in early development but we need the help of surgeons, nurses, doctors, social workers, pharmacists and other healthcare professionals now so the MHRA can ensure that patients are protected from unsafe medical devices