探讨如何加强医疗器械临床试验的质量控制

Exploring how to Improve the Quality Control of Medical Instrument Clinical Trials

目的 提高医疗器械临床试验的质量.方法 分析2006-2010年医院承担医疗器械临床试验的情况,提出临床试验机构加强医疗器械临床试验管理的措施.结果 医院承担的医疗器械多为Ⅲ类医疗器械的临床验证试验,多数是外科专业承担的试验.至2013年7月共完成49项,仅占承担项目的56％,已完成的试验项目96％获得医疗器械注册证.结论 医疗器械临床试验的质量有待提高,需加强医疗器械临床试验实施过程的质量控制.

Objective To improve the quality of medical device clinical trial.Methods To analyze medical device clinical trials conducted in our hospital from 2006 to 2010,and proposed the strategy to strengthen medical device clinical trial management.Results Most of the medical devices clinical trials were class Ⅲ medical devices clinical validation in our hospital,Surgical departments undertook most of the clinical trials.Until July 2013,49 trials were done only 56% of undertake the project.96% of completed trials were approved for medical device registration certificate.Conclusions The quality of clinical trials must be improved,andthe quality control process in medical device clinical trial should be reinforced.