Computer-automated monitoring system may help identify medical devices with potential safety risks

Implementation in Massachusetts of a computer-automated safety surveillance system of clinical outcomes registries for cardiovascular devices resulted in the identification of a drug-releasing stent that had significantly higher rates of major adverse cardiac events than similar stents, according to a study in the November 10 issue of JAMA. The findings indicate that this type of system appears feasible and useful in identifying new cardiovascular devices with early low-frequency potential safety issues that are not observed in premarket approval studies.

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