Analysis and suggestion on adverse events of active medical devices in Shandong province
10.3760/cma.j.cn111325-20220430-00379
- VernacularTitle:山东省有源医疗器械不良事件分析
- Author:
Yina HE
1
;
Yuejie TIAN
;
Lin HUANG
;
Yujuan ZHAO
;
Jianwei YANG
;
Hongkai LI
;
Xia LI
;
Fuzhong XUE
Author Information
1. 山东大学齐鲁医学院公共卫生学院，济南 250012
- Keywords:
Equipment safety;
Active medical device;
Adverse event monitoring;
Status analysis
- From:
Chinese Journal of Hospital Administration
2022;38(8):617-621
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the characteristics of adverse events of active medical devices in Shandong province, as well as the impact of device use duration on the risk rate of adverse events, for reference in improving the monitoring system of active medical device adverse events in China and the level of hospital medical quality management.Methods:The data came from the adverse event reporting data of active medical devices collected by Shandong Adverse Drug Reaction Monitoring Center from January 2019 to October 2021. The R software was used to analyze the distribution, cause and severity of adverse events, and a linear regression model of adverse event risk rate(Y) and adverse event time point(X) was established.Results:A total of 35 254 adverse events of active devices were included, of which 3 059 were serious injuries. The province/municipality with the largest number of reported adverse events was Shanghai(8 006 cases), and the least was Hainan province(4 cases); The majority of adverse events were reported by hospitals, with 34 056(96.60%). The medical devices reporting a higher number of adverse events were ventilators(688 cases), monitors(4 623 cases), infusion pumps(1 079 cases), syringe infusion pumps(1 995 cases), medical electron accelerators(529 cases)and infant incubators(513 cases). In the linear regression model, the risk rate of adverse events increased with the useduration of the device when 0.00%≤ X<14.14%; the risk rate of adverse events decreased with the increase of service time when 14.14%≤ X<100.00%. Conclusions:The number of adverse events reported in each province is different, and hospitals are the main reporting units.The causes of adverse events of different medical devices indicate different correlation strengths with the product itself. The use duration of medical devices poses a great impact on the risk rate of adverse events.
