Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts

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, ...