Scientists Propose a Framework for More Comprehensive Assessment of Medical Device Safety and Efficacy

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

Writing in the June 9 issue of the 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.

"The current systems mean that a device is either unapproved — pre-market stage — or approved — post-market stage," said Professor Peter McCulloch from 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-tumors 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," McCulloch added, "while patients would get better, safer devices faster, helping to improve health outcomes for a wide range of conditions."