Establishment and Consideration of Monitoring System for Regional Medical Device
Adverse Events with Risk Consultation as the Core
LIU Wen1
, YANG Kai2
1. Taian Center for Adverse Drug Reaction Monitoring, Taian Shandong 271000, China;
2. Department of Equipment, Taian Chinese Medicine Hospital, Taian Shandong 271000, China
Abstract:Objective To establish a regional medical device adverse event monitoring system with risk consultation as the core to
improve the monitoring level of medical device adverse event in the whole city. Methods By regular meetings, PDCA analysis and
other forms, the risk signals in a period of time were analyzed, and the disposal opinions were put forward. Results After practice,
the signals analyzed by the monitoring system had high quality and analytical value, which could promote the monitoring level of
adverse events of medical devices. Conclusion The system is practical and operational, and is suitable for popularization.
柳文1
,杨凯2. 以风险会商为核心的区域医疗器械不良事件监测体系的建立与思考[J]. 中国医疗设备, 2020, 35(8): 137-139.
LIU Wen1
, YANG Kai2. Establishment and Consideration of Monitoring System for Regional Medical Device
Adverse Events with Risk Consultation as the Core. China Medical Devices, 2020, 35(8): 137-139.