Abstract: Objective To introduce FDA sentinel initiative operation action to provide a reference for our medical product safety monitoring. Methods By analyzing the background, characteristics of sentinel initiative, the organizational framework, the specific operation, and safety assessment process of Mini-sentinel which is a pilot of sentinel initiative, put forwarda security monitoring method suited to our national conditions. Results & Conclusion Based on passive monitoring of existing medical products, actively carry out an active surveillance. Through a combination of medicare data systems and electronic medical records system, integrate existing electronic data resources for query and analysis of the safety monitoring data, at the same time develop new data management Methods to improve the data processing and analysis capabilities.

Key words: FDA, sentinel initiative, active surveillance, enlightenment