Background Medical devices are used widely for virtually every disease and condition. Although devices are subject to regulation, the number of recalls, the clinical data requirements for regulation and the impact on patient safety are poorly understood.
Methods The authors defined a device using European directives and used publicly available information on the Medicines and Health Regulatory Authority website to determine the number of devices recalled from January 2006 to December 2010. Two reviewers independently assessed Field Safety Notices and Medical Device Alerts. The authors wrote to manufacturers to obtain further information and clinical data, and summarised data by year, Conformité Européenne classification, indication, and Food and Drug Administration recall system of severity.
Results In total, 2124 field safety notices were issued over the 5-year period, an increase of 1220% (62 in 2006 to 757 in 2010). 447 Medical Device Alerts were issued in the same period, and 44% were assessed as a reasonable probability of causing serious adverse health consequences or death. The authors wrote to 192 manufacturers of withdrawn devices and received 101 (53%) replies; only four (2.1%) provided the clinical data the authors requested. A lack of available transparent data prevented full analyses of the safety impact. Of the highest-risk recalled devices, more than half were related to the cardiovascular system (25%) or musculoskeletal system (33%), and 88% (95% CI 80% to 97%) were assessed as a reasonable probability of causing serious adverse health consequences or death. For low-risk devices, the figure was 34% (95% CI 26% to 42%).
Conclusion The number of medical devices subject to recalls or warnings in the UK has risen dramatically. A substantial number of these devices may have caused serious adverse effects in patients and contributed to healthcare costs. Significant problems exist in the UK with a lack of access to transparent data and a registry of the highest-risk devices.
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To cite: Heneghan C, Thompson M, Billingsley M, et al. Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts. BMJ Open 2011;1:e000155. doi:10.1136/bmjopen-2011-000155
Funding CH and MT have received payment for evidence-based training workshops.
Competing interests DC and MB are employees of the BMJ Group. MT is an editorial adviser who attends the BMJ's research manuscript committee from time to time, for which he receives an honorarium and, when in the UK and attending in person, travel expenses. CH and MT co-developed products with the BMJ Evidence Centre and run a joint conference with the BMJ Evidence 2011.
Contributors CH and DC devised the study. CH and MT extracted the data for the Field Safety Notices and Medical Device Alerts. MB wrote to manufacturers, Notifying Bodies and the Medicines and Health Regulatory Authority. CH and MT analysed the data, and all authors contributed to the writing of the paper and approved the final draft.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All data and files used in the manuscript are available upon request from the corresponding author.
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