Abstract：Objective To strengthen the monitoring and management of adverse events of medical devices in our hospital, to detect
product risks as early as possible, reduce the recurrence of similar adverse events, eliminate safety risks, and protect public health and
safety. Methods The study analyzed the problems existing in the monitoring of adverse events of medical devices in our hospital,
and put forward a series of targeted improvement measures and methods to further improve the monitoring and management of
adverse events of medical devices in our hospital. Results Medical staff and clinical engineers’ awareness of the safety of medical
devices was continuously improved, and the number of adverse events reported on medical devices was increasing year by year. The
management and quality system of medical devices in hospitals was further improved. Conclusion Through the establishment of a
leading group for adverse event monitoring, the establishment of a three-level monitoring system, the optimization and improvement
of the reporting process, the organization of publicity and training and other management measures, the level of adverse event
monitoring and management of medical devices in our hospital has been improved, the use risk of medical devices has been reduced,
and the safety and effectiveness of public devices has been guaranteed.
鄂恒，刘禹，李丹，胡海泉，沈岚. 我院医疗器械不良事件的监测与管理[J]. 中国医疗设备, 2019, 34(10): 152-154.
E Heng, LIU Yu, LI Dan, HU Haiquan, SHEN Lan. Monitoring and Management of Medical Device Adverse Events in Our Hospital. China Medical Devices, 2019, 34(10): 152-154.
