Analysis and suggestion on adverse events of active medical devices in Shandong province / 中华医院管理杂志

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.

Bidding evaluation method of active medical device based on clinical requirements / 医疗卫生装备

Objective To explore the bidding evaluation method of the active medical device to meet clinical requirements. Methods The present situation of bidding purchase and bidding evaluation methods were analyzed for the active medical device, and a new evaluation method was put forward with considerations on the device's characteristics as well as its advantages in technology and commerce. Results The method contributed to purchasing the device with the highest cost-performance ratio, which showed the technical advantages of medical engineering department. Conclusion The method ensures that the purchased medical device meets clinical requirements,and enhances the social and economic benefits of the hospital.