心脏除颤器三级质量控制管理办法的研究

Research and practice of management method with three-level quality control for cardiac defibrillator

为加强心脏除颤器的运行质量管理,提高急危重症疾病引发的心室、心房颤动和心脏骤停等症状的救治成功率,研究制订“科室自检+工程师定期巡检保养+工程师定期质控检测”的心脏除颤器三级质量控制管理办法,其中质量控制检测包括仪器外观和日常管理检查、开机检测、释放能量检测、充电时间、同步触发延迟时间、心率示值检测、声光报警测试、电源部分电气安全测试和应用部分电气安全测试9个维度。通过实施心脏除颤器三级质量控制管理办法,心脏除颤器的运行质量得到有效保障,质量控制检测不合格率呈递减趋势,能切实保障心脏除颤器安全有效运行,为提高急危重症疾病救治成功率提供支持,并可避免心脏除颤器有关的医疗器械不良事件的发生。

In order to strengthen the management of operation quality of cardiac defibrillators and improve the success rate of treatment in ventricular,atrial fibrillation and cardiac arrest caused by acute,critical and severe diseases,this paper studied and formulated the management method with three-level quality control for cardiac defibrillator,which included"department self-inspection+regular patrol maintenance of engineers+regular quality control detection of engineers",in which quality control detection included"Instrument appearance and daily management inspection,startup detection,released energy detection,charging time,synchronous trigger delay time,heart rate indication detection,audible and visual alarm test,electrical safety tests of power supply part and application part".Through the implementation of the management method with three-level quality control of cardiac defibrillator,the operation quality of cardiac defibrillator is effectively guaranteed,and the unqualified rate of quality control detection shows a decreasing trend,which can effectively ensure the safe and effective operation of cardiac defibrillator,and provide support for improving the success rate of treatment of acute,critical and severe diseases,and avoid the occurrence of adverse events of medical devices related to cardiac defibrillator.