我院医疗器械临床试验PDCA专项整改  

Clinical Trial of PDCA Special Rectification of Medical Instrument in Our Hospital

作　　者：张莉[1] 康长清[1] 舒鹤[1] 郭晋敏[1] 

机构地区：[1]济南军区总医院药剂科,山东济南250031

出　　处：《中国医疗设备》2016年第4期149-151,121,共4页China Medical Devices

摘　　要：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。Guided by the Plan-Do-Check-Action（PDCA） cycle theory, our hospital conducted the activity of special rectification 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 office, 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 rectification by comparing the result to the quality assessment index. After the PDCA special rectification activities, the quality scores of clinical trial increased significantly; the score rate of each elements increased significantly. The application of PDCA theory established a longterm mechanism for steady management of medical instrument clinical trial.

关 键 词：医疗器械 临床试验 PDCA循环 临床试验质量 质量评分标准 

分 类 号：R197.3[医药卫生—卫生事业管理]