听小骨假体应用现状及产品审评关注点探讨  

Discussion of Application Status and Key Attentions

作　　者：吴静 张家振 阿茹罕 翟豹 金乐 史新立 WU Jing;ZHANG Jiazhen;A Ruhan;ZHAI Bao;JIN Le;SHI Xinli(Center for Medical Device Evaluation,NMPA,Beijing,100081)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京市100081

出　　处：《中国医疗器械杂志》2023年第6期684-689,共6页Chinese Journal of Medical Instrumentation

摘　　要：听小骨假体应具有良好的生物相容性和稳定性,易于安装,且具有优异的声音传导能力。该研究通过检索目前临床中使用的听小骨假体相关信息,对不同材料、各类型产品的优势和不足进行对比分析,阐述理想的听小骨假体制造材料所应具备的特点。同时结合现行审评要求及审评经验对听小骨假体产品注册审评过程中的性能研究项目关注点进行论述,如产品的力学性能、固定稳定性、传音特性、生物学特性及磁共振兼容性等方面,通过进一步明晰该类产品的性能评价要求,以期为生产企业及监管机构未来的工作提供借鉴。The ossicular replacement prosthesis should have good biocompatibility,stability,easy to install,and excellent sound transmission capacity.In this study,the characteristics of ideal materials for the ossicular replacement prosthesis were analyzed by searching the types of materials used in clinical practice and comparing the advantages and disadvantages of various materials and structures.At the same time,in combination with the current evaluation requirements and evaluation experience,the focus of the performance research project of ossicular replacement prosthesis in the process of registration is discussed to clarify the performance evaluation requirements of these products,so as to provide reference for the future work of manufacturers and regulators.The performance evaluation of ossicular replacement prosthesis focuses on its mechanical properties,fixation stability,sound transmission characteristics,biological characteristics,and magnetic resonance compatibility.

关 键 词：听骨链重建 听小骨假体 传音特性 医疗器械注册 

分 类 号：R339.16[医药卫生—人体生理学] F203[医药卫生—基础医学]