Analysis of Adverse Events Monitoring Report and Management
Strategy of Medical Consumables in Our Hospital
DONG Guiqing, FAN Yilu
Department of Medical Engineering, The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial
Qianfoshan Hospital), Jinan Shandong 250014, China
Abstract：Objective To analyze the monitoring report and management status of adverse events of medical consumables in our hospital,
and to provide reference and ideas for the monitoring and prevention of adverse events of medical consumables. Methods The
measures were taken to strengthen supervision of adverse events including improving the management structure and system of
medical device adverse events, optimizing the reporting process, upgrading the reporting platform, adopting SPD device management
system and strengthening the management of monitors and monitoring teams. The distribution of medical device management
categories, the severity distribution of adverse events, the occupation distribution of the reporter and the absence of required items in
the adverse event report form before and after the strengthening of supervision in our hospital from 2020 to 2021 were compared and
analyzed. Results A total of 503 adverse events of medical consumables were reported from 2020 to 2021, including 273 in 2020
and 230 in 2021. The highest probability of adverse events was “14 infusion, nursing and protective devices”, accounting for 47.91%
of the total number of reports. The number of one-time infusion set with needle was the largest, 113 cases in total. After strengthening
management, the proportion of adverse events of Class Ⅲ medical consumables in 2021 was 63.04%, significantly lower than 2020
(P<0.05). The proportion of adverse events of mild, moderate and severe and above was 53.91%, significantly lower than 2020
(P<0.05). Among the occupations of the reporter, the proportion of doctors and technicians increased significantly compared with
2020 (P<0.05). In the adverse event report form, the missing rate of product batch number, production date, valid until, registration
certificate number, cause analysis, and device failure performance decreased significantly compared with 2020 (P<0.05).
Conclusion By developing and improving the management methods of adverse events of medical consumables, encouraging
personnel to report adverse events and establishing a regular supervision mechanism, the medical risks and occurrence of adverse
events can be reduced.
董桂青，范医鲁. 我院医用耗材不良事件监测
报告及管理策略分析[J]. 中国医疗设备, 2023, 38(10): 113-118.
DONG Guiqing, FAN Yilu. Analysis of Adverse Events Monitoring Report and Management
Strategy of Medical Consumables in Our Hospital. China Medical Devices, 2023, 38(10): 113-118.
