Cookies on this website
We use cookies to ensure that we give you the best experience on our website. If you click 'Continue' we'll assume that you are happy to receive all cookies and you won't see this message again. Click 'Find out more' for information on how to change your cookie settings.

Every medicine we take has been extensively trialled to prove it is safe and it works, but the same standards do not necessarily apply to medical devices like joint replacements, surgical mesh or pacemakers.

© IDEAL

Now, a group of researchers led by Oxford University and Weill Cornell Medicine have proposed a new framework to make sure that such devices get better scrutiny.

Writing in the June 9 issue of BMJ, the researchers compare the existing approaches to evaluation of medical devices in both the United States and the European Union — where manufacturers have to prove only that a device is safe to get approval to sell it — with an integrated evaluation pathway for demonstrating that devices are both safe and effective.

Regulators would get better, safer evidence faster while patients would get better, safer devices faster - Professor Peter McCulloch

'The current systems mean that a device is either unapproved – pre-market stage – or approved – post-market stage,' said Professor Peter McCulloch from the Nuffield Department of Surgical Sciences at Oxford University. 'Once approval is given, incentives for further study or evaluation become much weaker. Yet, with electronic or mechanical devices implanted in the body, long-term issues are possible and should be assessed.'

'An example is the failure of artificial metal-on-metal hip joints,' added Dr Art Sedrakyan, a professor of healthcare policy and research at Weill Cornell Medicine. 'Pre-clinical tests were enough to get these an approval by demonstrating technical performance, but were never likely to identify the issues of extensive wear, dislocations or pseudo-tumours as these devices were used by patients in the real world. That is why we are proposing a framework that tracks devices throughout the product life-cycle, from first design through long-term use.'

The two professors and their co-authors propose using a framework (IDEAL) developed initially for introducing new surgical techniques. IDEAL stands for Idea, Development, Exploration, Assessment and Long term study. Starting with the use of a new technique in just one patient, it can be used to build up evidence of how safe and effective the technique is as it is used by more surgeons with more patients.

Critical to the use of IDEAL for device regulation is the concept that, to get away from a yes-no system, regulators could gradually widen approval by linking it to participation in the appropriate IDEAL study type. This would encourage early stage clinical research, as well as support for registries of devices, allowing performance issues to be tracked. The writers say that this would make evaluation of new devices faster and better, allowing more learning from previous errors, and ultimately allowing products to be available sooner, with better scientific evidence.

'While medical devices need better regulation, wholesale adoption of the approval framework for medicines, including randomised controlled trials, is unlikely to be appropriate,' Dr Sedrakyan said. “The graduated approach of the IDEAL framework is better placed to support incremental improvements to existing devices.'

'Regulators would get better, safer evidence faster,' Professor McCulloch added, 'while patients would get better, safer devices faster, helping to improve health outcomes for a wide range of conditions.'

Similar stories

New reporting guidelines developed to improve AI in healthcare settings

New reporting guidelines, jointly published in Nature Medicine and the BMJ by Oxford researchers, will ensure that early studies on using Artificial Intelligence (AI) to treat real patients will give researchers the information needed to develop AI systems safely and effectively.

Results of the REF 2021: congratulations and thank you

Today, the UK funding bodies have published the results of the UK’s most recent national research assessment exercise, the Research Excellence Framework (REF) 2021.

NDS projects awarded CRUK Oxford Cancer Development Fund

Two research projects at the Nuffield Department of Surgical Sciences (NDS) have been awarded pump-prime funding from this year’s CRUK Oxford Centre Development Fund.

Blog posts

Lights, camera, action! My journey into video production

Dr Hannah McGivern provides a 'behind-the-scenes' account of her experience producing the video 'Journey of a QUOD Sample: Donating to Transplant Research', supported by the funds from the University of Oxford Public Engagement with Research (PER) Seed Fund.

Mentoring in practice

NDS has launched a new, interdepartmental mentoring scheme called RECOGNISE. In this podcast, Gemma Horbatowski (HR Advisor) interviews Monica Dolton (Programme Manager and Research Project Manager) about her experiences of mentor-mentee relationships.

Wrap up of 2021

After a brilliant year of hard work and dedication, the SITU team has done some reflection on 2021, focusing on key events, trial progression, and more. Read on to discover how the year 2021 went for the SITU team...