人因工程应用于药械组合产品开发中的启示  

Enlightment from the Application of Human Factors Engineering to Development of Drug-device Combination Products

作　　者：卢望丁 陈桂良 罗华菲[1] 王健[1] 葛渊源 张景辰 LU Wangding;CHEN Guiliang;LUO Huafei;WANG Jian;GE Yuanyuan;ZHANG Jingchen(National Advanced Medical Engineering Research Center,China State Institute of Pharmaceutical Industry,Shanghai 201203;Shanghai Center for Drug Evaluation and Inspection,Shanghai 201210)

机构地区：[1]中国医药工业研究总院医药先进制造国家工程研究中心,上海201203 [2]上海药品审评核查中心,上海201210

出　　处：《中国医药工业杂志》2023年第7期1034-1041,共8页Chinese Journal of Pharmaceuticals

摘　　要：随着现代科学技术的快速发展,药械组合产品成为医疗产品创新的热点。集合了药品与医疗器械功能的药械组合产品普遍具有风险高且技术性能复杂等特点。中国药械组合产品的研发还处于起步阶段,相对应的监管体系也需要逐渐完善。美国FDA发布的指导原则阐述了人为因素在药械组合产品开发中的关键作用,以及人因工程对产品安全性和有效性的重要意义。借鉴FDA相对成熟的审评思路,对增进中国药品监管部门在药械组合产品审评体系中关于人因工程的理解及对相关指标的评判有着积极的推进作用。Drug-device combination products have become a hot spot of innovation with the rapid development of modern science and technology.Drug-device combined products integrate the functions of medicines and medical devices,so they generally have the characteristics of high risk and complex technical performance.The development of drug-device combination products in China is still in its infancy and the regulatory system needs to be gradually improved.The guidances issued by U.S.FDA describe the key role of human factors engineering in the development of drug-device combination products,as well as the importance of human factors engineering to product safety and effectiveness.The relatively mature review thinkings of U.S.FDA might have a positive role in promoting the understanding of human factors engineering and evaluation of some related indicators for drug-device combination products of regulatory authorities in China.

关 键 词：药械组合产品 人因工程 研发 设计 

分 类 号：R95[医药卫生—药学]