Monitoring and Report Analysis of Adverse Events of Medical Devices in a Comprehensive Hospital from 2021 to 2023
Objective To provide guidance in the safety use and adverse event monitoring of medical devices by analyzing the medical device adverse event(MDAE)reports of a comprehensive hospital from 2021 to 2023.Methods Retrospective analysis method was used to statistically analyze the reporting year,reporting days,audit results,medical device name,origin,management category,product category,product classification and correlation evaluation of 1082 cases of MDAE reports in the hospital.Results In the past three years,the total number of MDAE reported and the passing rate increased year by year,and the average reporting days showed a downward trend(P＜0.001).Among the 990 valid reports,the numbers of MDAE reports in domestic,Class Ⅱ and passive medical devices were higher than those in imported,Class Ⅰ and Ⅲ,active medical devices and in vitro diagnostic reagents(P＜0.05).The most MDAE reports were observed in 14-infusion,nursing,and protective equipment(P＜0.001),the main MDAE symptoms included the breakage,deformation and contamination of disposable instruments,and the malfunction of infusion pumps and injection pumps.The highest number of serious injuries was 03-neurological and cardiovascular surgical instruments(P＜0.001),mainly due to the breakage and deformation of the guide wire and balloon,resulting in intraoperative implantation failure.Conclusion By conducting full traceability from procurement,storage to clinical use,and adding MDAE reports into the departmental target assessment,the linkage between clinical departments and medical device management can be strengthened,thereby enhanced the effectiveness of MDAE monitoring efficiency in medical institutions.
medical devicesadverse eventserious injurymonitorwhole process traceabilitymedical device breakdown
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