我国人工耳蜗系统安全性和有效性评价的初步探讨

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入性医疗器械产品.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...

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

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.