Design of Automatic Analysis Software for Medical Device Adverse Event Reports
LING Qingqing1, WANG Haowen1, XIA Jingtao1, ZHANG Bohan2, LI Zihao1, SUN Yao1, CHEN Hongwen1
1. Department of Medical Engineering, Nanfang Hospital Southern Medical University, Guangzhou Guangdong 510515, China;
2. Guangdong ADR Monitoring Center, Guangzhou Guangdong 510515, China
Abstract：Objective In order to realize the automatic screening and early warning of adverse event reports and improve the
efficiency and accuracy of adverse event analysis, to develop an automatic analysis software of medical device adverse event reports.
Methods The software was developed based on Visual Studio 2013 and QT 5.9.5, including five functional modules: reports import,
reports display, reports analysis, analysis results and keyword library management. The keyword library was created and continuously
updated by using the previous adverse event report. A number of analysis rules were formulated according to the requirements, the
imported report to be checked was automatically analyzed after the rules were selected, and the analysis results were exported to
realize the screening and risk early warning of the report. Results A keyword library was extracted and created from 5399 medical
monitor adverse event data, and the software was tested with 695 monitor adverse event reports. The results showed that the accuracy
of automatic analysis was about 85%, and the analysis time was shortened to within 5 s, and the difference was statistically significant
compared with manual analysis (P<0.05). Conclusion The software can screen and analyze a large number of reports and export the
analysis results at the same time, realize the automatic screening and early warning of adverse event reports, and greatly reduce the
burden of analysts in monitoring institutions.
凌庆庆1，王浩文1，夏景涛1，张博涵2，李子好1，孙遥1，陈宏文1. 医疗器械不良事件报告自动分析软件的设计[J]. 中国医疗设备, 2024, 39(2): 90-94.
LING Qingqing1, WANG Haowen1, XIA Jingtao1, ZHANG Bohan2, LI Zihao1, SUN Yao1, CHEN Hongwen1. Design of Automatic Analysis Software for Medical Device Adverse Event Reports. China Medical Devices, 2024, 39(2): 90-94.
