Leading the Call for Reform of Medical Device Safety Surveillance

December 20, 2019 – JAMA Internal Medicine – Article
Authors: James W. Salazar, MD, MAS1; Rita F. Redberg, MD, MSc1,2
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.

Acknowledgements: We thank Madris Tomes, MBA, chief executive officer of Device Events, for her information on the history of unique identifiers and data on the number of adverse events entered in the US Food and Drug Administrations Manufacturer and User Facility Device Experience database. She was not compensated for is contribution.


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