An international team of scientists led by Oxford University in the UK and Weill Cornell Medicine in New York, NY, has proposed a new evaluation framework to make sure that medical devices receive better scrutiny. They compared existing approaches to medical device evaluation in the US 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. They explain that with electronic or mechanical devices implanted in the body, long-term issues are possible.
“An example is the failure of artificial metal-on-metal hip joints,” explained 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 team proposes 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.