医疗器械故障类不良事件一键上报系统功能与对接维修管理探讨  

Study on the function of one key reporting system about adverse events of the failure of medical device

作　　者：张博[1] 李旭[1] 古凯[1] 孙雪梅[1] ZHANG Bo;LI Xu;GU Kai(Department of Equipment, Taian City Central Hospital, Taian 271000, China)

机构地区：[1]泰安市中心医院设备科,山东泰安271000

出　　处：《中国医学装备》2018年第3期120-123,共4页China Medical Equipment

摘　　要：目的:通过分析历年医疗器械不良事件监测数据,研究医疗器械故障类不良事件一键上报功能,避免医疗器械不良事件上报过程中重耗材应用、轻设备故障管理的现象,为患者安全就医提供保障。方法:以医疗器械不良事件重点监测为依托,探索研究在医疗机构固定资产管理软件中增加自动提取医疗设备故障维修信息、一键生成不良事件报告并上报国家监测系统的功能。结果:一键上报医疗器械不良事件项目提高了医疗器械故障类不良事件的上报数量和上报效率,确保了不良事件信息的及时、完整和准确,提升了医疗器械不良事件报告质量,有效对接医疗器械故障维修管理。结论:医疗器械故障类不良事件一键上报系统功能与维修管理对接,为不良事件上报提供了便利途径,实现监管、生产、使用和患者四方受益,具有推广价值。Objective:To study the function of one key reporting system about adverse events in failure of medical device through analyzed the monitoring data of adverse events of medical devices over the years,so as to avoid a kind of phenomenon that pay more attention to application of consumables but not consider of failure of equipment in the reporting process for adverse event of medical equipment,and to provide guarantee for patients.Methods:Based on the monitoring for adverse events of medical device,this paper explored to add three functions in the fixed-assets management software of medical organization included of automatically extracting maintenance information of medical equipment,one key creating report for adverse event and reporting national monitoring system.Results:The project of one key reporting has increased reporting amount of adverse event of medical device and reporting efficiency,and it ensured timeliness,integrity and accuracy of adverse events,and enhanced reporting quality of adverse events of medical devices.Conclusion:This project conforms to the current situation,and it has provided a shortcut for reporting adverse event,and has produced benefits for4aspects included of supervision,production,usage and patient.Therefore,it is worthy to be popularized.

关 键 词：医疗器械 不良事件报告 一键上报 故障维修 

分 类 号：R-058[医药卫生]