New report on "Engineering evidence for safer medical devices"
This report, which is part of the Royal Academy of Engineering and the Academy of Medical Sciences' response to the European Commission's current revision of the EU legislation on medical devices, was based on a roundtable forum held on 16 January 2013 which brought together clinicians and engineers from healthcare, industry and academia along with funders and regulators.
Medical devices play an important role in enhancing patients' quality of life and supporting the healthcare system. However, there is a need for improved methods of demonstrating their safety, performance and efficacy according to this report.
A major theme is the potential to adopt methods from the engineering sector for assessing medical devices. The engineering framework for assessing safety has been built by dialogue between industry and regulators, and the development of a regulatory framework for medical devices would potentially benefit from a similar level of dialogue to establish hazards, safety functional requirements and thresholds. Dialogue between clinicians, device manufacturers and the 'end user' is also important to ensure that devices are designed to meet real clinical need.
The report discusses the value of observational studies where randomised controlled trials are not possible or appropriate. Devices, unlike medicines, are increasingly part of complex interventions where it is difficult to create a control group. However, these complex interventions are have a major impact on healthcare delivery and have the potential to offer considerable patient benefit. With appropriate design and guidance, meaningful trials for medical devices can and should be undertaken. Given its strong research base and with the NHS at the core of its healthcare system, the UK is well placed to generate the necessary high quality evidence for such devices.
Professor Lionel Tarassenko, who jointly Chaired the January roundtable, alongside Professor Sir Alasdair Breckenridge CBE FRSE FMedSci and Professor Gus McGrouther FMedSci, outlined the themes of the report in the event's keynote speech. He said: "The design and testing of medical devices is a collaborative process between engineers and clinicians. Proper evaluation of safety, performance and efficacy is an essential part of this process, and the roundtable forum organised by the two academies provided an ideal opportunity for engineers and clinicians to learn from each other with a view to promoting best practice."
Sir Alasdair Breckenridge, Chair of the Medicines and Healthcare products Regulatory Agency, said: "As medical devices become more complex, their regulation needs to keep up with the underlying science. The current devolved European regulatory system requires a drastic overhaul to reflect these changes and collaboration between engineers, clinicians and regulators will become even more important".
- The report is available at http://www.raeng.org.uk/news/publications/list/reports/Medical_devices_and_systems.pdf