摘要
目的研发一种在用医疗设备故障及不良事件监管系统,提高医疗设备不良事件的上报数量及效率,帮助医疗设备监管部门了解在用医疗设备的使用情况。方法该系统需要通过好医工APP登录,共涉及五大模块,分别为设备信息管理模块、设备故障维修模块、设备日常巡检模块、不良事件上报模块和医疗设备运行数据统计模块。使用者需先将所在医疗机构的设备基本信息录入该系统,再根据日常巡检工作的周期,定期将设备的巡检结果以及发生故障、不良事件的真实信息填入系统。最后可以通过数据统计模块将数据导出。结果使用者可通过本系统随时随地查看所在医疗机构的所有设备信息,包括设备的工作状态、维保记录、巡检记录等,方便设备负责人及管理者对本医疗机构在用医疗设备的管理。结论在用医疗设备故障及不良事件监管系统使用方便,操作简洁。解决了原先纸质记录方式的耗时、存储不便以及不能实时查看等弊端。同时,医疗设备的利益相关者,包括设备管理人员、设备使用人员、受益的病患及其家属都能够通过使用该系统参与到医疗器械不良事件的上报工作中来。
Objective To develop a monitoring system for the malfunction and adverse events management of in-service medical device,improve the reporting quantity and efficiency of medical device adverse events,and assist the medical equipment supervision department in mastering the use of medical equipment.Methods The system needed to log in through Outstanding CE app.The system involved five modules,including equipment information management module,equipment fault maintenance module,equipment daily inspection module,adverse event reporting module and medical equipment operation data statistics module.The user needed to input the basic information of the equipment in the medical institution into the system first,and then,according to the cycle of daily inspection work,filled in the system with the inspection results of the equipment and the real information of the faults and adverse events regularly.Finally,the data could be exported through the data statistics module.Results Through this system,users could view all the equipment information of the medical institution at anytime and anywhere,including the working status,maintenance records,inspection records,so as to facilitate the management of the medical equipment in use of the medical institution by the person who was in charge.Conclusion This system is easy to use and simple to operate.It solves the problems of the original paper record method,such as time-consuming,inconvenient storage and unable to view in real time.At the same time,the stakeholders of medical device,including equipment managers,equipment users,benefited patients and their families,can participate in the reporting of medical device adverse events by using this system.
作者
赵观宇
ZHAO Guanyu(Department of Product Operation,Wanglaitianxia Medical Technology Co.Ltd,Beijing 101312,China)
出处
《中国医疗设备》
2021年第1期119-122,126,共5页
China Medical Devices
关键词
医疗设备
不良事件
设备故障
监管
维修保养
medical devices
adverse event
equipment faults
supervision
maintenance
