【摘要】 世界卫生组织指出医疗器械对许多国家的卫生系统是一种经济和技术挑战,主要问题有引进的医疗器械不符合临床优先需求、与现有基础设施不匹配、使用不合理或不正确、不能有效运行等,造成了卫生资源的浪费,需要用卫生技术评估(Health Technology Assessment,HTA)方法对医疗器械实行评估、计划、购置和管理。医疗器械卫生技术评估可以分为为政府决策服务的宏观HTA和为医院决策服务的微观HTA。本文建立一种适应于医疗器械采购前评估的微观HTA框架,该框架包括了临床需求评估、技术性能评估、采购评估和服务评估四个方面。临床需求评估可以用列表提问方式,识别出引进新技术或新医疗器械与现有水平的差距,获得医疗器械引进计划的优先级。采购评估应遵循5R原则,即合适的质量、合理的价格、适当的数量、适当的时间和地点、合适的售后服务。采用供需均衡理论评估影响价格的因素。采用效用理论评估采购数量。消费者均衡理论,合理地评估出价格、数量、预算之间的关系,获得最大效益。更多还原

【Abstract】 World Health Organization points out that the medical devices represent an economic as well as technical challenge to the health systems of many countries. The issues include that the imported medical devices do not meet the clinical high-priority needs, do not match with the existing infrastructure, are not used rationally or correctly application, and cannot operate effectively, resulting in the waste of health resources. Therefore, it is necessary to implement the evaluation, planning, acquisition and management of medical devices using the health technology assessment(HTA). Medical device HTA(MD-HTA) can be divided into the macro-HTA for government decision-making service and the micro-HTA for hospital decision. In this paper, a framework of micro-HTA was established for the procurement of medical devices in hospital, including the evaluations of clinical needs, technical performance, procurement and service. The clinical needs assessment can use a list of questions to identify the gap between the new technologies or medical devices and the current level, and obtain the priority of the plan of medical device. Procurement evaluation shall follow the 5 R principle, that is, right quality, right price, right quantity, right time and place, and right service. The equilibrium theory of supply and demand was used to evaluate the factors affecting the prices of medical device. The utility theory was used to evaluate purchase quantity. The consumer equilibrium theory can reasonably evaluate the relationship among price, quantity and budget to obtain the maximum benefit.更多还原