我国人工耳蜗系统安全性和有效性评价的初步探讨  

Preliminary study on safety and effectiveness evaluation of cochlear implant system in China

作　　者：张宇晶[1] 刘志成[2] 付前杰 孙志勇[4] 

机构地区：[1]国家食品药品监督管理局医疗器械技术审评中心,北京100044 [2]首都医科大学生物医学工程学院,北京100069 [3]美国House Ear Institute [4]国家食品药品监督管理局沈阳医疗器械质量监督检验中心,沈阳110179

出　　处：《国际生物医学工程杂志》2011年第5期293-297,313,共6页International Journal of Biomedical Engineering

摘　　要：目的由于科技的发展与社会进步，我国企业已经开始生产人工耳蜗系统这种长期植入人体的有源植人性医疗器械产品。由于该种类产品有较高的安装和使用风险，而目前国内尚没有相应的国家或行业标准，也没有转化论证的国际标准，各公司提交的安全性和有效性证据差异很大，与现有的技术审评要求有较大差异。旨在对人工耳蜗系统安全性和有效性的评价进行初步探讨，为建立国家及行业标准从而客观地评价人工耳蜗的安全性和有效性提供理论基础。方法系统地分析国外人工耳蜗的安全性和有效性评价的历史及现状，同时指出目前国内人工耳蜗安全性和有效性评价中存在的问题，参比同类可借鉴的产品标准。结果提出了人工耳蜗系统安全性和有效性标准制定的系统性建议。结论从医疗器械监管角度来说，制定人工耳蜗系统安全性和有效性标准势在必行，组织专家、企业和用户共同研究，从而制定科学、合理并切实可行的评价标准。Objective As China＇s technological development and social progress, China＇s enterprises have begun to produce cochlear implant which has high risk in installation and application. While, currently there is not yet the corresponding state or industry level standards, nor is the international conversion demonstrate standard. The evidence of safety and effectiveness submitted by companies vary widely, and they are quite different from the existing requirements of the technical review. This article aims to do preliminary study on safety and efficacy evaluation in order to establish national and industrial standards to objectively evaluate the cochlear implant safety and efficacy. Methods Systematic analysis of the foreign history and status of safety and efficacy evaluation of cochlear implant were performed, with the indication of the current problems in safety and efficacy evaluation and the reference standard of similar products. Results The systemic recommendations of the safety and efficacy standards of cochlear implant system werw provided. Conclusion From the perspective of medical device regulation, it is imperative and possible to develop the reasonable and scientific safety and effectiveness evaluation for cochlear implant with the effort of experts, enterprises and users.

关 键 词：人工耳蜗 安全性和有效性 评价标准 

分 类 号：TH7[机械工程—仪器科学与技术] R76[机械工程—精密仪器及机械]