The UK National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending tightening standards for hip replacement devices. If adopted, the tougher standards could force the National Health Service (NHS) to stop using a significant number of existing devices, with obvious impacts on manufacturers of these products.
The proposed guidance follows concerns regarding “metal-on-metal” device failure rates that culminated in a series of regulatory alerts by the UK Medicines and Healthcare Products Regulatory Agency (MHRA), most recently in June 2012. NICE’s draft recommendations follow the publication in July earlier this year of the results of an in-depth NICE technology assessment into the devices.
Current standards recommend that the NHS should not use metal-on-metal hip replacement implants found to require revision surgery in more than 10% of cases at 10 years. The draft recommendations would see the tolerance levels reduced to 5% at 10 years. UK news reports suggest that at least 5 currently-available metal-on-metal implants would not meet the stricter threshold and would face exclusion from NHS use.
NICE will be inviting comments on its proposed recommendations until 8 November 2013. NICE is expected to issue final guidance in February 2014.