植入性医疗器械的电子监管  

Electronic Regulation Mode on Implantable Medical Device

作　　者：吴云红[1] 朱亮[2] 初炜[1] 孔祥金[1] 

机构地区：[1]大连医科大学社会科学与管理科学学院 [2]大连医科大学基础医学院,大连市116044

出　　处：《中国医疗器械杂志》2009年第2期124-127,共4页Chinese Journal of Medical Instrumentation

基　　金：国家自然科学基金(NO.30801127);辽宁省社科规划基金题(NO.L07DJY069);辽宁省社科联课题(NO.2006lnsklktjjx-254-73);大连市社科联课题(NO.06DLSK144).

摘　　要：目的:探讨我国植入性医疗器械监管改革的有效方法。方法:采取文献检索、比较研究、状况研究、发展性研究和个案分析的方法进行分析。结果:植入性医疗器械领域发生问题的根本原因是相关信息的严重不真实、不对称。结论:建立植入性医疗器械电子监管系统,即建立各种既独立又相互联系实时更新的动态数据库,保证信息公开、透明,杜绝虚假信息的传递,维护植入性医疗器械行业的良好秩序,保障广大公众的切身利益。OBJECTIVE： To discuss the methods of implantable medical device supervision reform. METHODS： Methods of literature review, comparative study, the research of situation, developmental study and case study were adopted. RESULTS：It is the untrue and asymmetric information of Jmplantable medical device that results in Jmproper behavior in the implantable medical device industry. CONCLUSIONS： A implantable medical device electronic monitoring system, namely establishing the independent but interrelated real-time dynamic updating of the databases, which would guarantee the information of implantable medical device is open and transparent, eliminate false food information transmission, vindicate the good order of domestic implantable medical device industry and protect the vital interests of the public.

关 键 词：植入性医疗器械 电子监管 互联网 不正当行为 

分 类 号：TH772[机械工程—仪器科学与技术]