Research on the Status of Medical Device Adverse Event Monitoring in China
WANG Dongjing1, WU Weimin2
1. School of Information and Management, Guangxi Medical University, Nanning Guangxi 530021, China;
2. Guangxi Zhuang Autonomous Region Medical Device Testing Center, Nanning Guangxi 530031, China
Abstract：Objective To analyze the monitoring data of medical device adverse events in China in recent years to provide references
for the monitoring and prevention of medical device adverse events. Methods The compound annual growth rate and growth rate
were used to conduct descriptive analysis on the data of 5 “National Medical Device Adverse Event Monitoring Annual Report”
from 2016 to 2020 published by the National Medical Products Administration. Results From 2016 to 2020, the number of medical
device adverse events reported in China showed an increasing trend, with a compound annual growth rate of 11.09%. The initiative
of different monitoring subjects in reporting adverse events was different. The number and proportion of adverse events caused by
medical devices of unknown categories were increasing rapidly. Medical institution were the actual places of use where adverse
events are primarily involved. Conclusion The overall situation of medical device adverse event monitoring in China in recent
years is relatively good. It is suggested to improve the ability of medical device adverse event monitoring from the following
aspects: improving the awareness of medical device adverse event monitoring, improving the quality of medical device adverse
event reporting, strengthening scientific management of medical device life cycle and urging all monitoring subjects to actively and
truthfully report medical device adverse event monitoring.
王东京1，吴维民2. 我国医疗器械不良事件监测现状研究[J]. 中国医疗设备, 2022, 37(3): 127-130.
WANG Dongjing1, WU Weimin2. Research on the Status of Medical Device Adverse Event Monitoring in China. China Medical Devices, 2022, 37(3): 127-130.
