UK regulation of total hip replacement devices

03/12/2015
Photo: The ball segment of a hip replacement device

The implantation of hip replacement devices needs to be revised for various reasons, for example infections, bone abrasion or implant displacement; ©panthermedia.net/ edwardolive

A new study from the University of Warwick is calling for more UK compulsory regulation of devices used in hip replacements to reduce the need for further traumatic and expensive surgery.

In a paper published today in the British Medical Journal, a team from Warwick Medical School looked at ten year revision rates for five of the most commonly used hip replacement devices. This means the number of devices that had to be replaced within 10 years of the original surgery.

The team found the revision rates for these devices were less than 5% but warned many other devices still in active use had higher revision rates than 5%. As a result of the Warwick research, the National Institute for Health and Care Excellence (NICE) has now recommended a reduction in the benchmark for hip replacement revision rates from 10% at 10 years to 5% at 10 years.

One of the authors of the study, Prof 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 NHS. "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, but the fact remains that the regulation process is not good enough."

"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."

Prof Clarke said that ODEP needed to be strengthened and that randomized controlled trials should be compulsory for devices, in the same way that they are for new drugs.

Fellow author Dr Ngianga-Bakwin Kandala 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."

COMPAMED.de; Source: University of Warwick