Data from: 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, 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 The authors wrote to 192 manufacturers of withdrawn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.