Report Status of Adverse Events of Medical Devices in Chinese
Hospitals and Demand Survey for Quick Report
ZHANG Jing1, ZHAO Yujuan2, HUANG Lin2, XUAN Yi2, NIU Huifang2
1. Department of Epidemiology, School of Public Health, Shandong University, Jinan Shandong 250012, China;
2. Department of Instrument Monitoring and Evaluation, Shandong Center for ADR Monitoring, Jinan Shandong 250012, China
Abstract：Objective To analyze the status quo and existing problems in the reports of equipment malfunctions in Chinese medical
institutions, as well as the demand for quick reports and information feedback. Methods By means of convenient sampling,
questionnaire survey was conducted for provincial monitoring center of adverse drug reactions and medical institutions, and
information was collected for collation and analysis. Results In total, 15.86% medical institutions in shandong province, and 13%
in other provinces were dissatisfied with the current reporting method of medical device adverse events. More than 80 percent of
monitoring centers and medical institutions believed that it was necessary to add the function of automatically extracting maintenance
records and generating adverse event reports in equipment management systems. Obtaining the instrument information and building
up the judgment standard for malfunctioning adverse events was the main factor affecting the report, and also the difficulty of
establishing automatic report mode. Conclusion The automatic reporting model of malfunctioning adverse events based on medical
device management system has theoretical basis and practical needs, and is also faced with difficulties, which needs further research.
张静1，赵玉娟2，黄琳2，玄怡2，牛惠芳2. 我国医院医疗器械不良事件报告现状及对快捷上报的需求调研[J]. 中国医疗设备, 2018, 33(11): 158-161.
ZHANG Jing1, ZHAO Yujuan2, HUANG Lin2, XUAN Yi2, NIU Huifang2. Report Status of Adverse Events of Medical Devices in Chinese
Hospitals and Demand Survey for Quick Report. China Medical Devices, 2018, 33(11): 158-161.
