Exploration of a Bayesian Updating Tool to Provide Real-Time Safety Monitoringfor New Medical Devices

摘要

Data Extraction and Longitudinal Time Analysis (DELTA) was developed to provide real-time safety monitoring of new devices in the domain of interventional cardiology. This field provides the necessary infrastructure for this type of endeavor. The American College of Cardiology National Cardiovascular Data Repository (ACC-NCDR) provides a national standardized data dictionary, and there is point of care data collection in many centers. The tool utilizes both Bayesian statistical updating and classical frequentist methods for automated event rate monitoring.