More UK regulation of hip replacement devices needed to prevent unnecessary surgery
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 surgery.
In a paper published in the British Medical Journal, a team from Warwick Medical School looked at 10 year revision rates for five of the most commonly used hip replacement devices.
The team found the revision rates for these devices were less than 5 per cent but warned that many other devices still in active use had higher revision rates. The National Institute for Health and Care Excellence (NICE) has recommended a reduction in the benchmark for hip replacement revision rates from 10 per cent to 5 per cent at 10 years.
Study author 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 per cent, 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.”
Clarke added that ODEP needed to be strengthened and that randomised controlled trials should be compulsory for devices, in the same way that they are for new drugs.
The research team used data from the National Joint Registry containing records of primary surgery for hip resurfacing and total hip replacement between April 2003 and March 2012.
‘Total hip replacement: Setting a benchmark revision rate – analysis of registry evidence’ is published in the British Medical Journal and is available at www.bmj.com/content/350/bmj.h756