Preliminary study on safety and effectiveness evaluation of cochlear implant system in China
10.3760/cma.j.issn.1673-4181.2011.05.009
- VernacularTitle:我国人工耳蜗系统安全性和有效性评价的初步探讨
- Author:
Yujing ZHANG
;
Zhicheng LIU
;
Qianjie FU
;
Zhiyong SUN
- Publication Type:Journal Article
- Keywords:
Cochlear implant;
Safety and effectiveness;
Evaluation standard
- From:
International Journal of Biomedical Engineering
2011;34(5):293-297,313
- CountryChina
- Language:Chinese
-
Abstract:
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.
