How much does a Medical and Healthcare Products Regulatory Agency medical device alert for metal-on-metal hip arthroplasty patients really cost?
| Autor: | DJ Dunlop, Fiona Berryman, Usman Ahmed, Lesley Brash, Gulraj S. Matharu, Rajpal Nandra |
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| Rok vydání: | 2021 |
| Předmět: |
Male
Reoperation Medical device business.industry Arthroplasty Replacement Hip medicine.disease Prosthesis Design Prosthesis Failure Hip arthroplasty Metals Health care medicine Metal-on-Metal Joint Prostheses Humans Orthopedics and Sports Medicine Surgery Female Medical emergency Regulatory agency Hip Prosthesis business Delivery of Health Care |
| Zdroj: | Hip international : the journal of clinical and experimental research on hip pathology and therapy. 32(4) |
| ISSN: | 1724-6067 |
| Popis: | Background: 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. Methods: 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. Results: 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. Conclusions: 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. |
| Databáze: | OpenAIRE |
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