摘要
目的本文旨在通过分析近5年FDA公开数据库MAUDE中电外科的不良事件,归纳不良事件的原因,来探讨避免不良事件的对策。方法将检索结果中标记为死亡的事件逐一阅读分类,将标记为伤害的事件和产品召回数据进行统计分类。结果在死亡事件中占29.27%的是使用和管理问题,可以通过医疗单位加强管理、制造厂商加强培训降低发生概率;在死亡事件中占9.76%是设备故障问题,可以通过加强高频电外科设备维保检测降低发生概率。结论医疗单位应当加强高频电外科设备维保检测管理,设备制造商应当加强使用者、使用单位的培训。
Objective This paper aimed to explore the countermeasures to avoid adverse events by analyzing the adverse events of electrosurgical,cutting&coagulation&accessories equipment in the MAUDE public database of FDA in recent five years and describing the causes of adverse events.Methods The events marked as DEAD in the retrieval result were read and identified one by one,and the events marked as Injury and product recall data were statistically classified.Results The use and management problems accounted for 29.27%of the deaths,which could be reduced by strengthening management of medical institutions and training by manufacturers.Equipment broke accounted for 9.76%in death events,which could be reduced by strengthening the maintenance and testing of electrosurgical equipment.Conclusion Medical institutions should strengthen the maintenance and testing management of electrosurgical equipment,and equipment manufacturers should strengthen the operation training of users.
作者
陆晓华
宋海峰
LU Xiaohua;SONG Haifeng(Erbe China Ltd.,Shanghai 200336,China)
出处
《中国医疗设备》
2020年第5期154-160,共7页
China Medical Devices
关键词
高频电外科设备
不良事件
使用和管理
维护保养
设备检测
high frequency electrosurgical device
adverse events
use and management
maintenance
device testing
