Automated Surveillance to Detect Postprocedure Safety Signals of Approved Cardiovascular Devices

Abstract

Monitoring the safety of approved medical products is of vital public health importance, given that in clinical practice such medical products are often used in numbers far greater and in patient populations more diverse than when studied in premarket evaluations and clinical trials.^1-6 Within the broad range of medical products, implantable medical devices represent high-risk products that are uniquely challenging to monitor because there is little consensus regarding the most appropriate methods to account for the complex interactions among devices, medications, patients, and implanting physicians. In addition, the lack of unique medical device identifiers challenges the effective use of administrative claims data and electronic health records as a primary data source to evaluate manufacturer-specific device safety.⁷