Abstract:Objective To improve the reporting quality of suspicious adverse events of medical devices in the hospital and improve
the ability of medical staff to find risks of medical devices in work, so as to control potential risks of medical devices. Methods The
management methods of suspected adverse events of medical devices in our hospital were analyzed, and the quantity and quality of
reported adverse events of suspected medical devices from January 2016 to April 2018 were analyzed and compared. Results The
quantity and quality of suspicious medical device adverse event reporting in all department of my hospital had been greatly improved.
Medical personnel had a more profound understanding of medical device adverse event, and the risk of medical devices was well
monitored, which effectively protected the patient’s safety. Conclusion As an important measure to control the potential risks of
medical devices, the monitoring of medical device adverse event reporting can effectively monitor the risk of risk of medical device
after listing. As an important part of the monitoring of medical device adverse events, hospitals should raise awareness in the process
of monitoring adverse events, collect the basic data and improve the quality of suspicious medical device adverse event reporting, so
as to improve the level of risk management in hospitals.
宋来全,王鑫. 我院可疑医疗器械不良事件上报情况分析及思考[J]. 中国医疗设备, 2019, 34(3): 149-151.
SONG Laiquan, WANG Xin. Analysis and Reflection on the Report of Suspicious Adverse Events
of Medical Devices in Our Hospital. China Medical Devices, 2019, 34(3): 149-151.