England Considers Tougher Device Regulations

A paper published in the British Medical Journal calls for more regulation of medical devices. The purpose—to reduce the need for further traumatic and expensive surgery.

The University of Warwick in the United Kingdom looked at ten year revision rates for five of the most commonly used hip replacement devices. They wanted to learn how many devices had to be replaced within ten years of the original surgery.

The team found that the five devices studied had a revision rate of less than 5%. But other devices that were still in general use had higher revision rates than 5%.

As a result of the Warwick research the National Institute for Health and Care Excellence (NICE) is now recommending a reduction in the benchmark for hip replacement revision rates from 10% at ten years to 5% at ten years.

One of the authors of the study, Professor Aileen Clarke, said more regulation was needed and that revision surgery to replace a total hip replacement device was traumatic for the patient and expensive for the National Health Service.

She said: “When we undertook this research for NICE we found that the revision rates for five of the most commonly used hip replacement devices were less than 5%, which gave NICE the confidence to suggest this lower benchmark figure. This new guideline will help to make sure only the most effective devices are used.”

She added, “Whether a total hip replacement device is assessed by the Orthopaedic Data Evaluation Panel (ODEP) or not depends on voluntary submission of evidence from the device manufacturers. The assumption is that these devices can be afforded a looser regulatory mechanism than drugs but we question whether this is wise because it has allowed a large number of different brands of device to slip into routine use although some have high rates of revision.”

Fellow author Ngianga-Bakwin Kandala, M.D. said: “Past use of poor devices has been bad for patients, bad for the reputation of orthopaedics and of clinicians, and has contributed to a waste of NHS resources. The NICE guidelines are very necessary, but a poor second best to more effective and compulsory regulation.”