基于层次分析的医疗器械不良事件主动报告影响因素分析

Study on the influencing factors of proactive reporting of medical device adverse events based on analytic hierarchical analysis

目的:分析医院以护理人员为主体基于层次分析法(AHD)的主动上报医疗器械不良事件影响因素并提出相应改进措施。方法:选取医院2021年度上报医疗器械不良事件例数为0的22个临床科室,自制调研问卷调研临床科室护士长主导的上报主体,采用AHP分析影响医疗器械不良事件主动上报的主要因子并制定相关改进对策。结果:2021年医院共上报医疗器械不良事件99例,其中医疗设备类不良事件22例,医用耗材类不良事件77例。影响医疗器械主动上报因素的7项指标权重占比由高到低依次为产品信息不易查找(占17.317%)、故障过程等分析复杂上报流程繁琐(占17.073%)、不影响日常工作忽略上报(占15.854%)、可疑不良事件发生后无上报意识(占14.878%)、上报后担忧产生医疗纠纷(占13.902%)、不知晓上报途径或范围(占10.732%)和奖励机制不知晓或不具吸引力(占10.244%)。结论:医疗器械不良事件主动有效上报可以为医疗器械监督管理提供监管依据,减少或避免同类医疗器械不良事件重复发生;应加强医院设备管理工程师对医疗器械不良事件的日常管理,提高临床科室护士长医疗器械不良事件上报思想认识,降低患者、医务人员和其他人员使用医疗器械风险,保障临床用械安全。

Objective:To study the factors influencing factors of proactive reporting medical device adverse events in hospitals with nursing staff as the main body and corresponding improvement measures.Methods:22 clinical areas in which the number of reported medical device adverse events in the hospital in 2021 was zero were selected.A self-made questionnaires was used to investigate the reporting main body led by the head nurses of the 22 clinical areas.The main factors influencing the proactive reporting of adverse events of medical devices were analyzed by using on analytic hierarchical analysis(AHP)and the relevant improvement countermeasures were formulated.Results:In 2021,the hospitals reported a total of 99 cases of adverse events related to medical device,including 22 cases of medical equipment adverse events and 77 cases of medical consumable adverse events.The weight proportion of the seven indicators that affected the proactive reporting of medical devices were,in descending order,the product information was not easy to find(accounting for 17.317%);complicated analysis of fault process,etc.,and cumbersome reporting procedures(accounting for 17.073%);neglecting to report without affecting daily work(accounting for 15.854%);lack of awareness of reporting suspicious adverse events after its occurrence(accounting for 14.878%);worried about medical disputes after reporting(accounting for 13.902%);unaware of the means or scope of the submission(accounting for 10.732%);unknown or unattractive incentive mechanism(accounting for 10.244%).Conclusion:The active and effective reporting of adverse events on medical devices can provide a regulatory basis for medical device supervision and management,and reduce or avoid the recurrence of similar medical device adverse events.It is imperative to strengthen the daily management of medical device adverse events by hospital equipment management engineers,improve the awareness of clinical area head nurses in reporting medical device adverse events,and reduce the risk of patients,medical personnel,and other personnel using medical devices to ensure the safety use of equipment.