Guided by the Plan-Do-Check-Action (PDCA) cycle theory, our hospital conducted the activity of special rectiifcation of clinical trial of medical instrument. According to the operation quality inspection record of the clinical trial of each department’s medical instrument taken by the agency ofifce, the research conducted statistical analysis of the scores of operation quality of medical equipment in each department in the clinical trial, as well as of the score rate of each elements of the PDCA cycle theory before, during, and after the rectiifcation by comparing the result to the quality assessment index. After the PDCA special rectiifcation activities, the quality scores of clinical trial increased signiifcantly; the score rate of each elements increased signiifcantly. The application of PDCA theory established a long-term mechanism for steady management of medical instrument clinical trial.%我院以PDCA循环理论为指导，展开医疗器械临床试验专项整改活动。具体根据机构办对科室医疗器械临床试验运行质量检查记录，对照科室临床试验运行质量评分标准，对整改前、整改期间和整改后的科室医疗器械临床试验运行质量得分以及各要素的得分情况进行统计分析。经过PDCA整改后，科室医疗器械临床试验质量得分、各要素的得分及得分率均显著提高，初步建立了医疗器械临床试验运行管理稳态的长效机制。
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