POCT产品在新政策下的质量控制需求  

Quality Control Requirements with the New Policy of POCT

作　　者：高阳[1,2] 张景春[3] 康熙雄[1] GAO Yang;ZHANG Jing-chun;KANG Xi-xiong(Capital Medical University Beijing Tiantan Hospital Laboratory Diagnosis Department,Beijing 100020;Hangzhou WastonBiotech. INC,Zhejiang Hangzhou 310051;Jilin Univercity China-Japan Fellowship Hospital,Jilin Changchun 130033)

机构地区：[1]首都医科大学附属北京天坛医院首都医科大学检验诊断学系,北京100020 [2]杭州华得森生物技术有限公司,浙江杭州310051 [3]吉林大学附属中日联谊医院,吉林长春130033

出　　处：《中国医疗器械信息》2017年第11期18-21,共4页China Medical Device Information

摘　　要：新政策对医疗改革内容提出了分级诊疗等的方向要求。为了满足不同层级医疗机构提供标准合格的诊断医疗服务,现场即时检测(POCT)产品需求量将会大幅度提升,这种前提下,使用单位及POCT生产供应者应分别建立完善质量体系文件,加强专业人员培训,有效执行预防纠正措施的实施,周期性进行质控分析,使质量体系进行有效。临床单位及生产企业专业人员应共同努力,为中国医疗市场的POCT产业,提供高质量、多功能、简单便捷的产品,使在新政策下要求的各级医疗机构能快速稳定地承担起分级诊疗的重任。New policies for medical reform content put forward the direction of the hierarchical diagnosis.In order to meet the different levels of medical institutions toprovide standard diagnostic medical services,the POCT product demand will be greatly improved.under the premise of the use of units and POCT productionsuppliers should be established to improve the quality system documents respectively,strengthen professional personnel training,effective implementation toprevent the implementation of the corrective actions,analysis of quality periodically,so that the quality system to be effective.Clinical units and productionenterprises professionals should work together for the Chinese medical market POCT industry,to provide high-quality,multi-functional,simple and convenientproducts,so that the new policy requirements at all levels of medical institutions can quickly and steadily assume the classification of medical treatment.

关 键 词：POCT 质量控制 分级诊疗制度 

分 类 号：R197.39[医药卫生—卫生事业管理]