CAJ | 학술논문

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.
목적 유우과기적발전여사회진보,아국기업이경개시생산인공이와계통저충장기식입인체적유원식입성의료기계산품.유우해충류산품유교고적안장화사용풍험,이목전국내상몰유상응적국가혹행업표준,야몰유전화론증적국제표준,각공사제교적안전성화유효성증거차이흔대,여현유적기술심평요구유교대차이.지재대인공이와계통안전성화유효성적평개진행초보탐토,위건입국가급행업표준종이객관지평개인공이와적안전성화유효성제공이론기출.방법계통지분석국외인공이와적안전성화유효성평개적역사급현상,동시지출목전국내인공이와안전성화유효성평개중존재적문제,삼비동류가차감적산품표준.결과 제출료인공이와계통안전성화유효성표준제정적계통성건의.결론 종의료기계감관각도래설,제정인공이와계통안전성화유효성표준세재필행,조직전가、기업화용호공동연구,종이제정과학、합리병절실가행적평개표준.
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.