除颤仪质量检测及不良事件产生原因分析

Quality Test of Defibrillator and Cause Analysis of Adverse Events

目的通过国家相关部门公布的除颤仪不良事件种类,了解其安全风险,结合定期检测医院在用除颤仪的质量控制及故障种类,得出减少不良事件发生的几点思考。方法参照GB9706.8-1995标准对除颤仪进行质量控制检测。结果2014年至2018年检测除颤仪183台次,参照国家食品药品监督管理总局药品评价中心发布的不良事件种类,对比分析了质量控制不合格项目的种类的检测项目和方法,发现质检中出现的故障。结论通过对不良事件和质量检测发现的问题分析,思索进一步完善急救生命支持类设备的管理体系,降低不良事件发生率,确保设备的使用质量,保障医疗的质量与安全。

Objective To understand the safety risk of defibrillator by analyzing the quality control and types of adverse events of defibrillators published by relevant national department,and to figure out some thought on reducing adverse events based on the quality control termly of defibrillators in our hospital.Methods The quality control test of defibrillator was carried out according to the GB9706.8-1995.Results From 2014 to 2018,a total of 183 defibrillators were tested.With reference to the types of adverse events released by the drug evaluation center of the state food and drug administration,we compared and analyzed the testing items and methods of the types of unqualified quality control items,and found faults in quality inspection.Conclusion Based on the analysis of problem found in adverse events and quality testing,we would further improve the management system of life support equipments for emergency,reduce the incidence of adverse events,ensure the quality of equipment,and guarantee the quality and safety of medical care.