某院医疗器械ADE-ASAS的构建及其对不良事件上报情况的影响

Construction of ADE-ASAS for Medical Devices in a Hospital and Its Impact on the Reporting of Adverse Events

目的探讨某院医疗器械不良事件主动监测与智能评估警示系统(Adverse Drug Event-Active Safety Assessment System,ADE-ASAS)的构建及其对不良事件发生的影响。方法构建医疗器械ADE-ASAS,并选取某院2019—2022年全院上报的不良事件统计情况,数据来自早期手工填报以及医疗器械ADE-ASAS,统计分析系统实施效果及对不良事件发生的影响。结果2019—2022年4年间不良事件上报数逐年增长,医院在2021年上线医疗器械ADE-ASAS,2022年通过医疗器械ADE-ASAS不良事件上报数量较2021年显著增加,差异有统计学意义(P<0.001);2021年医患纠纷、医院投诉数量较2020年下降了14.00%,2022年较2021年下降了15.12%;不良事件报告整体质量评分逐年增高,差异有统计学意义(P<0.001)。结论医疗器械ADE-ASAS的构建提升了医院不良事件的上报数,并使报告整体质量得以提升,有助于相关部门采取有效措施进行干预,以减少医患纠纷和医院投诉,具有一定的临床应用和推广价值。

Objective To explore the construction of the Adverse Drug Event-Active Safety Assessment System(ADE-ASAS)for adverse events of medical devices in a hospital and its influence on the occurrence of adverse events.Methods ADE-ASAS of medical devices was constructed,and the statistics of adverse events reported by the whole hospital from 2019 to 2022 were selected.The data were collected from early manual reporting and ADE-ASAS of medical devices,and the implementation effect of the system and its impact on the occurrence of adverse events were statistically analyzed.Results The number of reported adverse events increased year by year from 2019 to 2022.After the hospital launched ADE-ASAS in 2021,the number of reported adverse events through ADE-ASAS in 2022 increased significantly compared with 2021(P<0.001).The number of doctor-patient disputes and hospital complaints in 2021 decreased by 14.00%compared with 2020,and the number in 2022 decreased by 15.12%compared with 2021.The overall quality scores of adverse event reports increased year by year,and the difference was statistically significant(P<0.001).Conclusion The construction of ADE-ASAS improves the number of reported adverse events in hospitals,improves the overall quality of reports,and helps relevant departments to take effective measures to intervene to reduce doctor-patient disputes and hospital complaints,which has certain clinical application and promotion value.