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Media type:
E-Article
Title:
How much does a Medical and Healthcare Products Regulatory Agency medical device alert for metal-on-metal hip arthroplasty patients really cost?
Contributor:
Nandra, Rajpal S;
Ahmed, Usman;
Berryman, Fiona;
Brash, Lesley;
Dunlop, David J;
Matharu, Gulraj S
Description:
<jats:sec><jats:title>Background:</jats:title><jats:p> Many worldwide regulatory authorities recommend regular surveillance of metal-on-metal hip arthroplasty patients given high failure rates. However, concerns have been raised about whether such regular surveillance, which includes asymptomatic patients, is evidence-based and cost-effective. We determined: (1) the cost of implementing the 2015 MHRA surveillance in “at-risk” Birmingham Hip Resurfacing (BHR) patients; and (2) how many asymptomatic hips with adverse reactions to metal debris (ARMD) would have been missed without patient recall. </jats:p></jats:sec><jats:sec><jats:title>Methods:</jats:title><jats:p> All BHR patients eligible for the 2015 MHRA recall (all females, and males with head sizes ⩽46 mm, regardless of symptoms) at one centre were invited for review (hips = 707; patients = 593). All patients were investigated (Oxford Hip Score, radiographs, blood metal ions, and targeted cross-sectional imaging) and managed accordingly. Surveillance costs were calculated using finance department data. </jats:p></jats:sec><jats:sec><jats:title>Results:</jats:title><jats:p> The surveillance cost £105,921.79 (range £147.76–£257.50/patient). Radiographs (£39,598) and nurse practitioner time/assistance (£23,618) accounted for 60% of overall costs. 31 hips had ARMD on imaging (12 revised; 19 under surveillance). All revisions were symptomatic. 7 hips with ARMD under surveillance were asymptomatic and remain under regular review. The number needed to treat to avoid missing one asymptomatic ARMD case was 101 patients, representing a cost of £18,041 to avoid one asymptomatic case. </jats:p></jats:sec><jats:sec><jats:title>Conclusions:</jats:title><jats:p> Implementing MHRA surveillance for “at-risk” BHR patients was extremely costly. The risk of asymptomatic ARMD was low with the BHR (1%), suggesting recommended follow-up in asymptomatic patients is not cost efficient. This raises concerns about the increasingly intensive surveillance recommended in the 2017 MHRA guidance for metal-on-metal hip patients. </jats:p></jats:sec>