广东省妇幼保健院 a. 院办丨b. 生殖健康与不孕症科丨c. 人事科丨d. 设备科，广东 广州 511442
Practice and Thought on the Monitoring of Medical Device Adverse Events
SHI Xianfenga，WANG Yaqinb，XIE Shuc，DONG Chongd，LI Lingd
a. General Office丨 b. Department of Reproductive Health & Infertility丨 c. Department of Human Resource丨 d. Department of
Equipment, Guangdong Maternal & Children Health Care Hospital, Guangzhou Guangdong 511442, China
Abstract：Objective To discusses how to effectively control the potential usage risks of medical devices and ensure the safety of
the public. Methods The number and quality of medical device adverse events actively reported by a hospital from 2014 to 2019
were statistically described and the root causes were analyzed. Results In the recent 6 years, medical adverse events in the hospital
were reported more than 50 cases/year, and the proportion of nursing staff reports accounted for 78.89%. A total of 15 categories of
products were involved, and the top 5 categories accounted for 84.16%. The quality of the reporting of adverse events needs to be
further improved. Conclusion To improve the level of hospital risk management, we should build a safety culture atmosphere and
improve the quality of information reporting, use management tools to improve the ability of analyzing the causes of incidents, and
strengthen the functions of supervisory departments to carry out continuous monitoring and feedback control.
时先锋a，汪雅琴b，谢舒c，董冲d，李玲d. 医疗器械不良事件监测的实践与思考[J]. 中国医疗设备, 2021, 36(6): 120-123.
SHI Xianfenga，WANG Yaqinb，XIE Shuc，DONG Chongd，LI Lingd. Practice and Thought on the Monitoring of Medical Device Adverse Events. China Medical Devices, 2021, 36(6): 120-123.
