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NICE raise the standard for all hip replacements

The National Institute for Clinical Excellence raises the standards acceptable for all hip replacements in the UK

14 February 2014

The National Institute for Clinical Excellence (NICE), which approves medical devices and medicines, has published new guidance to protect people from faulty hip replacements otherwise known as protheses.

On 28 January 2014 NICE announced their ‘Final Determination' on hip prostheses, that only those which failed only 5% or less after 10 years will be permitted to enter the NHS Supply Chain.

NICE have also set a long term, 20 year survivorship ‘benchmark’, for all prostheses, of 12.9%.

Boz Michalowska a Partner in the product liability team at law firm Leigh Day which represents hundreds of people with failed hip devices, explained:

"The lowering of the NICE benchmark is significant in providing better protection for all UK patients undergoing a hip arthroplasty, better known as a hip replacement.

“The purpose of the original NICE benchmark was to guide surgeons as to which prostheses were the most clinically effective. However the benchmark was left for a long time at a level that permitted substandard products into the NHS supply chain.

“The revised benchmark more accurately reflects the current performance of the gold standard conventional components, which new devices should improve upon”.

It is likely that the new guidance will come into force during Spring 2014 with all clinical commissioning groups and NHS England, required to ensure that they are acting in compliance with the new NICE benchmark when purchasing products for the NHS Supply Chain.

This announcement updates original guidance issued in 2000, and has the effect of halving the existing 'benchmark' against which the clinical effectiveness of all hip prostheses implanted in the UK are measured.

A review of the 2000 NICE benchmark was initiated in 2011 in the wake of the widely publicized recall of the ASR devices manufactured by Depuy.

The ASR recall also alerted patients and regulators to wider problems with metal-on-metal hip devices and patient advocates expressed concern that UK regulators had permitted products with weak clinical evidence to enter the NHS Supply Chain.

As a result there were widespread calls for an overhaul of the way in which medical devices generally, and prosthetic hips in particular, are cleared by regulators for the UK market.

The new NICE benchmark reflects the fact that many prostheses are demonstrating improved survivorship, with fewer patients requiring revisions at up to 20 years post implantation. Based upon the data published by the National Joint Registry Report for 2013, none of the metal-on-metal products that currently remain on the UK market will meet the new performance standard introduced by NICE.

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