医疗设备准入评估模型设计与实践

Design and Practice of Admittance Evaluation Model for Medical Devices

按照世界卫生组织医疗器械技术序列《采购流程与资源指南》中医疗器械标准购置流程,以微型卫生技术评估(Mini-HTA)、VAC价值分析评估以及项目评估模型为依据,建立了标准且完整的医疗设备医院层级准入评估模型。该模型主要包括技术评估、效益评估、安全评估以及附件因素评估等四项指标,以实际证据为依据,采用定性、定量相结合的方式对医疗设备进行评估。应用该模型,对医院2019年50万元以上医疗设备进行准入评估,认为可有效优化医院资源配置,为医疗设备购置决策提供依据。

According to the standard purchasing procedure of medical devices in the WHO medical device technical series"Procurement Procedures and Resources Guidance",a standard and complete medical device hospital-level admittance evaluation model was established based on the Mini Health Technology Assessment(Mini-HTA),VAC value analysis and evaluation,and project evaluation model.The model mainly included four indexes,namely,technology evaluation,benefit evaluation,safety evaluation and accessory factor evaluation.Based on actual evidence,qualitative and quantitative methods were adopted to evaluate the medical devices.The model was applied to evaluate the admittance of medical devices with a value of over 500000 yuan in 2019.The results showed that the model can effectively optimize the allocation of hospital resources and provide a basis for the purchase decision of medical devices.