By 2004, the US Food and Drug Administration (FDA) had received a number of reports of serious complications associated with the use of vascular closure devices during cardiac catheterization procedures. In response, the FDA contracted with the National Cardiovascular Data Registry to conduct a prospective comparative safety study of approved devices.1 One device was found to pose an increased risk for vascular complications, and the device was subsequently removed from the market. While this was a victory for patient safety and demonstrated the potential for clinical registries to support device surveillance, the study raised questions: Should this safety signal have been detected earlier? What other undetected device safety issues exist?
Rumsfeld JS, Peterson ED. Achieving Meaningful Device Surveillance: From Reaction to Proaction. JAMA. 2010;304(18):2065–2066. doi:10.1001/jama.2010.1648
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