The findings of clinical research into the development of new medical devices will be made public for the first time as regulators announce changes to the rules following the hip replacement and PiP breast implant scandals.
The European Union is currently rewriting the regulations governing medical devices - the first update since the directives were first passed during the 1990s.
The original rules, written to protect the commercial interests of manufacturers, meant that all clinical evidence gathered in the development and testing of medical devices, and the details of adverse reactions linked to them, could be kept behind closed doors.
While suppliers were required to share some of this information with a ‘nominated body’ of their choice, which would authorise the product for use, it would not be seen by members of the public, clinicians or independent scientists.
In addition, a voluntary scheme through which UK surgeons can pass on concerns about medical devices does not have a reporting function whereby details of these issues are made public, unless the situation deteriorates to the point where a safety alert is issued.
Under the planned reforms, which are due to be published this autumn and are supported by the UK regulatory, the Medicines and Healthcare products Regulatory Agency (MHRA), clinicians and members of the public will be able to access information about the clinical research behind products and their safety record since being approved for sale.
The changes come after the high-profile cases involving metal-on-metal hip replacement implants and the PiP breast implant scandal. In the case of the hip implants, thousands of UK patients were given the devices, which were later found to poison the body, with failure rates of up to 50%. The PiP implants were found to have been made from industrial silicone instead of approved medical-grade materials, with the manufacturer altering the formula since the original regulatory approval was given.
The new rules will get rid of the duty of confidentiality currently placed on all organisations that handle clinical data on medical device testing.
It is believed this will help to strike a fairer balance between encouraging the continued development of new medical technologies and enabling clinicians and patients to make more informed choices. This is similar to the rules that already apply to the pharmaceutical market, where manufacturers have to make data from clinical trials public after drugs are licensed.
Professor Sir Kent Woods, chief executive of the MHRA, 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."
The regulatory changes may also tighten up the approval process so that ‘notified bodies’, the organisations charged with approving products for market across Europe, are working to the same standards.
