The U.S. Food and Drug Administration's (FDA) Sentinel Initiative is a long-term effort to improve the FDA’s ability to identify and assess medical product safety issues. The Sentinel System is an active surveillance system that uses routine querying tools and pre-existing electronic healthcare data from multiple sources to monitor the safety of regulated medical products. FDA-Catalyst activities leverage the Sentinel Infrastructure by utilizing the data available through its Data Partners and supplementing it with data from interventions or interactions with members and/or providers.          


Diagram depicting the Sentinel Initiative and Sentinel Infrastructure relationship


The Sentinel System includes the Active Postmarket Risk Identification and Analysis (ARIA) system mandated by Congress in the U.S. Food and Drug Administration (FDA) Amendments Act (FDAAA) of 2007. In addition, the Sentinel Initiative created focused surveillance efforts around vaccine safety using the Postmarket Rapid Immunization Safety Monitoring (PRISMsystem, and supports regulatory review of blood and blood products with its Blood Safety Continuous Active Surveillance Network (BloodSCAN).