建立医疗设备风险管理体系的探讨

目的:提高医疗设备应用质量,降低临床使用风险,探索医疗设备风险管理体系。方法:从临床工程技术角度出发,结合医疗设备具体特性,使用风险分析、风险评价和风险控制等方法降低医疗设备风险。结果:通过拒绝不可接受风险和降低可接受风险达到降低医疗设备风险的目的。结论:医疗设备风险管理体系能够完善诸如医学计量、质控等医疗设备管理方法,促进医疗设备的安全性和有效性。

Research on the establishment of risk management system of medical equipment

Objective：To improve the application quality,reduce the risks of clinic application and explore the risk management system of medical equipment.Methods：From a clinical engineering technological standpoint,risk analysis,risk assessment and control that combined with clinic speciality were adopted for decreasing the risks of medical equipment.Results：The object what decrease clinic risks were achieved though refusing no-acceptable risks and decreasing acceptable risks.Conclusion：Medical equipment risk management system can improve medical equipment management means,such as medicinal measure and quality-control etc.It can also promote the safety and validity of medical equipment.