PDCA Applied in Special Rectiifcation of Medical Instrument Clinical Trial

VernacularTitle:医疗器械临床试验PDCA专项整治
Author: Lei WANG ¹ ; Xintao QU ; Xiuchun YU
Author Information

1. 济南军区总医院骨病科
Keywords: medical instrument; clinical trial; PDCA
From: Chinese Journal of Medical Instrumentation 2015;(5):376-379
CountryChina
Language:Chinese
Abstract: PDCA cycle was applied in special rectification activities for medical instrument clinical trial, with quality criteria of implementation made. Completed medical instrument clinical trial from January 2011 to December 2012 was believed as control group, from January 2013 to December2014 as PDCA group, the scores of clinical trial and the score rate of items were compared and analyzed. Results show quality scores of clinical trial in PDCA group are higher than that in control group (51 vs. 81,P<0.001), score rate of items increased except adverse events (P<0.001). The special rectification activities with PDCA applied in our department are feasible and effective. It significantly improves implement quality of medical instrument clinical trial.