Research on Auto-Reporting Mode of Adverse Events of Medical Device Failure
DONG Fang1, WU Shifu2, HUANG Lin2, WANG Gang1, TIAN Yuejie2, JU Yi3, LI Hongli4, LIU Songfeng5, ZHAO Yujuan2,
XUAN Yi2, NIU Huifang2
1.National Center for ADR Monitoring, Beijing 100045, China; 2.Shandong Center for ADR Monitoring, Jinan Shandong 250012,
China; 3.Weihai Municipal Hospital, Weihai Shandong 264200, China; 4.Binzhou Medical University Hospital, Binzhou Shandong
256603, China; 5.Yuhuangding Hospital, Yantai Shandong 264000, China
Abstract：Objective Based on the information management system of medical device, we studied a mode that adverse event reports
could automatically generate and report. Methods The mode of using information technology to monitor and report adverse events
in medical institutions at home and abroad was analyzed with the method of literature retrieval. Then the feasibility and demand of
the research were understood through questionnaire and field investigation. The model was tested in the pilot hospital and verified
and improved. Results The automatic reporting mode included five processes: the establishment of dictionary database, the report
of medical equipment failure, the maintenance and record of medical equipment, “one click generates” bad event report and “one
key report” adverse event report. The number of failure adverse events reported increased significantly, and the ability to detect
risk signals was improved after implementing automatic reporting mode. Conclusion The adverse event auto-reporting model and
parameter standards are adapted to the monitoring and reporting of medical device adverse events in Chinese medical institutions,
which can be popularized and implemented in the whole nation.
董放1，吴世福2，黄琳2，王刚1，田月洁2，鞠毅3，李洪利4，刘松峰5，赵玉娟2，玄怡2，牛惠芳2. 医疗器械故障类不良事件自动报告模式研究[J]. 中国医疗设备, 2018, 33(7): 142-146.
DONG Fang1, WU Shifu2, HUANG Lin2, WANG Gang1, TIAN Yuejie2, JU Yi3, LI Hongli4, LIU Songfeng5, ZHAO Yujuan2,
XUAN Yi2, NIU Huifang2. Research on Auto-Reporting Mode of Adverse Events of Medical Device Failure. China Medical Devices, 2018, 33(7): 142-146.
