Abstract: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.
张莉,康长清,舒鹤,郭晋敏. 我院医疗器械临床试验PDCA专项整改[J]. 中国医疗设备, 2016, 31(4): 149-151.
ZHANG Li, KANG Chang-qing,
SHU He, GUO Jin-min. Clinical Trial of PDCA Special Rectification of Medical Instrument in
Our Hospital. China Medical Devices, 2016, 31(4): 149-151.