The chief executive of the Association of British Healthcare Industries (ABHI) has called for increased transparency of information, improved post market surveillance, and better co-ordination around the regulation of medical implants.
Speaking to the UK Parliament’s Science and Technology Select Committee last week, Peter Ellingworth said patient safety was of ‘paramount importance’ when regulating medical devices.
He spoke out as ministers consider reforming the regulatory system in the wake of a number of scares, including the PIP breast implant scandal and concerns over metal-on-metal hip implants.
Ellingworth stressed to the committee the importance that industry places upon regulatory compliance, telling the hearing: “The companies we represent take patient safety incredibly seriously. Finding a quick or easier route is not in their long-term interest.”
On the importance of the relationship between industry and the NHS, he added: “There’s a unique relationship here where the clinicians and the companies are focused on the patient at the centre of this exercise and how they work together. Nothing is developed purely on a bench.”
"The medical technology industry is of a significant scale in the UK, so it is crucial we maintain an appropriate regulatory regime in order to support industry’s continued growth
His comments come amid calls for a major shake-up of the current regulatory system, which is overseen by the Medicines and Healthcare products Regulatory Agency (MHRA). They follow comments made last year by a number of leading industry experts, including Brian Toft, professor of patient safety at Coventry University, who said of the existing authorisation process: “In the UK, devices reach patients without the reassurance of adequate clinical trials to demonstrate their safety and efficacy.”
However, while MedTech firms support improvements, they warn against changes that will make it harder to get innovative devices and equipment onto the market, fearing it will have a negative effect on future research and development.
Speaking after giving his evidence, Ellingworth said: “I was delighted to be offered the opportunity to represent industry at this important Parliamentary inquiry. The issue of medical device regulation is fundamental to the future success of industry and to the ability of patients to get access to safe innovative medical devices.
”Patient safety is a key objective in medical device regulation and has to be constantly borne in mind when evolving the system. Industry has set out a number of changes which we believe will help improve the system and I was happy to discuss these with the committee."
Among the recommendations put forward by the ABHI are improvements to the designation and control of Notified Bodies; the organisations that making the final decisions on whether or not to grant CE Mark regulatory approval for specific technologies. Ellingworth also called for transparency of information, better central co-ordination, and improvements to the post-market surveillance, which would have helped in the case of the PIP implants, where the manufacturer switched to non medical-grade silicon some time after the original permission was given.
Medical device manufacturers work closely with frontline clinicians to develop the technologies that patients need. This relationship is crucial and must be supported by appropriate regulation which, in turn, will assure the availability of safe, innovative products for patients
And he said the relationship between manufacturers and the NHS and other healthcare providers would be crucial, adding: “Medical device manufacturers work closely with frontline clinicians to develop the technologies that patients need. This relationship is crucial and must be supported by appropriate regulation which, in turn, will assure the availability of safe, innovative products for patients.
"The medical technology industry is of a significant scale in the UK, with around 3,000 companies employing 64,000 people, and the Government has picked out the MedTech sector as being a cornerstone of life sciences, so it is crucial we maintain an appropriate regulatory regime in order to support industry’s continued growth.”
He was joined at the inquiry by ABHI’s executive director of technical and regulatory affairs, Mike Kreuzer, who called for better co-ordination between Competent Authorities on how they approve Notified Bodies. He also indicated that Unique Device Identifications, such as RFID and barcoding, could help with the setting up of registries.”