摘要
目的介绍医院加强体外诊断试剂器械临床试验管理的特殊性及建立相应管理体系。方法结合管理实践,应用医疗设备质量管理体系方法,分析体外诊断试剂临床试验管理的重点,并提出解决办法。结果建立体外诊断试剂临床试验管理体系,形成具有可操作性的监督方法。结论该方法可有效控制体外诊断试剂在医院合理开展临床试验,保证试验的安全性和有效性,为医院医学工程及器械管理部门进行体外诊断试剂有效监督打下良好的基础。
Objective To introduce the specifiC characters of strengthening the hospital＇ s medical instruments＇ clinical trials management of in vitro diagnostic reagents,and establish corresponding management system. Methods Appiied medical instroments＇quality management system, analyzed the emphasis of in vitro diagnostic reagents management, and gave the solution to it. Results Fulfill the system management of in vitro diagnostic reagents and the methods of Supervising it. Conclusion This method can effectively manage the clinical trials of in vitro diagnostic reagents and insure its safety and efficiency, then make better basic of supervising it for medical Engineering and management.
出处
《中国医疗设备》
2009年第3期65-67,共3页
China Medical Devices
关键词
体外诊断试剂
器械临床试验管理
医学工程
in vitro diagnostic reagents
medical instruments＇clinical trials management
medical engineering
