A Better Way to Track Safety of Medical Devices?

The lack of strong post-market surveillance of medical devices continues to vex clinicians and policymakers. Voluntary reporting of safety events has proven to be an inadequate means of monitoring the safety of approved devices. Another approach is prospective, active surveillance using national registries. To test such an approach, investigators used the American College of Cardiology CathPCI registry to obtain data on Mynx, a vascular-closure device that had safety concerns.

The investigators employed an analytic strategy called DELTA (Data Extraction and Longitudinal Trend Analysis), which is designed to conduct multiple risk-adjusted, prospective, safety surveillance analyses over time. The database included 1,822,575 patients who underw…