Statistic Analysis of 14660 Medical Device Administration Events Reports
ZENG Qian1, YE Yuehua2, YANG Cuilian3, HE Jichen4, TANG Zuqing2, OU Qiuqi1, PANG Ting1
1. School of Public Health, Guangxi Medical University, Nanning Guangxi 530021, China;
2. Department of Business, Guangxi Medical Device Testing Center, Nanning Guangxi 530021, China;
3. Department of Quality Control, Liuzhou General Hospital, Liuzhou Guangxi 545006, China;
4. Department of Orthopedic, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning Guangxi 530021, China
Abstract：Objective To understand the overall situation of medical device administration events monitoring in Guangxi by analyzing
the reports of medical device administration events collected in Guangxi in 2016, and provide reference for reasonable monitoring
and evaluation and further strengthening monitoring work. Methods A retrospective analysis method was used to analyze the
statistical results of 14660 cases of medical device administration events collected by the Guangxi Zhuang Autonomous Region
Adverse Drug Reaction Monitoring Center in 2016. Results In the survey, 86.40% of the sources of medical device administration
events reports were units of use. The occupation and use of reporters was mainly in medical institutions. Report quality needed to
be improved. High proportion of administration events caused by Class III medical device products such as intrauterine devices,
disposable infusion sets, and intravenous indwelling needles. Conclusion We need to improve awareness of risk monitoring of
medical device adverse events, carry out targeted publicity and training, improve the monitoring network and reporting system for
medical device administration events, further promote monitoring and ensure the safety of people's machinery.
曾茜1，叶月华2，杨翠连3，何基琛4，汤祖青2，欧秋琦1，庞婷1. 14660例可疑医疗器械不良事件报告分析[J]. 中国医疗设备, 2019, 34(9): 143-145.
ZENG Qian1, YE Yuehua2, YANG Cuilian3, HE Jichen4, TANG Zuqing2, OU Qiuqi1, PANG Ting1. Statistic Analysis of 14660 Medical Device Administration Events Reports. China Medical Devices, 2019, 34(9): 143-145.
