构建医疗新技术准入院内协同审查机制的建议  

Suggestion on the Construction of Collaborative Review Mechanism for New Medical Technology Access

作　　者：邵辰杰[1] 孙卫斌[2] SHAO Chen-jie;SUN Wei-bin(Medical Affair Department,Nanjing Stomatological Hospital/Affiliated Hospital of Medical School,Nanjing University,Nanjing 210008,China)

机构地区：[1]南京大学医学院附属口腔医院/南京市口腔医院医务处,江苏南京210008 [2]南京大学医学院附属口腔医院/南京市口腔医院医院伦理委员会,江苏南京210008

出　　处：《医学与哲学》2023年第12期44-49,共6页Medicine and Philosophy

基　　金：2022年南京市卫生科技发展专项资金项目(GBX22302);2022年南京大学医学院附属口腔医院“3456”骨干人才资助项目(0222M503)。

摘　　要：医疗技术开展能力是医院高质量发展的重要评价指标。医疗技术的目录管理、条块化审查以及国家层面技术准入伦理审查操作规范的缺失让医疗新技术准入存在诸多隐患。院内协同审查机制的构建既是依法执业的要求,也是提高审查效率、整合院内专家资源并形成审查合力的有效途径。协同审查机制的构建需要建立三级审查责任体系、明确划分各审查部门职责、形成全过程的沟通机制以及相对统一的审查内容与标准,并通过医疗技术档案的建立、医疗产品全周期管理、新增收费项目的及时申报、信息化平台的应用提升风险防控的效果。The ability of medical technology application is an important indicator for high-quality development of hospitals.The lack of catalog management,compartmentalized review of medical technologies,and the lack of operating regulations for ethical review of technology access at the national level has made access to new medical technologies problematic.The collaborative review mechanism is not only a requirement for legal practice,but also a way to improve review efficiency,integrate expert resources and form a synergy of review.The mechanism needs the establishment of the three-level review responsibility system,clear division of responsibilities of each review department,the communication mechanism throughout the process,and relatively unified review content and standards.The establishment of medical technology archives,full cycle management of medical products,timely reporting of new chargs,and the application of information technology platforms to enhance the effectiveness of risk prevention and control.

关 键 词：医疗技术准入 协同审查 伦理审查 

分 类 号：R-05[医药卫生]