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An ideal surveillance system for medical device safety would comprehensively collect data on adverse events across the life span of a device. Preferably, the system would be integrated into electronic health records to allow seamless identification, tracking, and real-time reporting of device-associated adverse events. Moreover, it would parse adverse events to detect substantial safety signals and underperforming devices. Such a system would also allow implementation of corrective actions in a swift and commensurate manner.
In this issue of JAMA Internal Medicine, 2 reports1,2 illustrate the importance of an improved surveillance system, particularly for life-sustaining medical devices. In one report, Davidsson et al1 present the nationwide experience of Iceland with the Riata defibrillator lead (St Jude Medical), which was recalled in 2011 because of the risk of serious injury or death. The study adds to prior experience about adverse events with the Riata lead.3 Davidsson et al1 used a proactive protocol to detect events, which ranged from externalization of the conductor to death, and compared these outcomes in patients with a control group of patients with other defibrillator leads. The report effectively illustrates the extent to which Riata leads underperformed; the lead failure rate was 37% (19 of 52), including 1 instance that resulted in death, compared with the 8% failure rate (4 of 50) for other defibrillator leads (hazard ratio, 4.67; 95% CI, 1.18-18.50). It is noteworthy that Iceland has exemplary record keeping; all adverse event data were captured and are available in a national registry.
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Salazar JW, Redberg RF. Leading the Call for Reform of Medical Device Safety Surveillance. JAMA Intern Med. 2020;180(2):179–180. doi:10.1001/jamainternmed.2019.5170
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