PDCA cycle in quality control of medical device adverse event report forms
Objective This paper aims to evaluate the effectiveness of the Plan Do Check Act(PDCA)cycle in the quality improvement of medical device adverse event report forms to provide references for developing improvement strategies.Methods This study randomly selected 271 report forms from hospitals in Guangdong Province from January 1,2022,to March 31,2022 as the pre-implementation group.Another 462 report forms from January 1,2023,to March 31,2023 were randomly selected after implementing the PDCA cycle as the post-implementation group.The effect evaluation was concluded by comparing the average score on quality assessment of report forms between the two groups from 21 cities in Guangdong Province.Results The post-implementation group showed significantly higher overall average score on quality assessment as compared to the pre-im-plementation group(P＜0.05).After the implementation,the form completions on medical devices,adverse events,and usage,were significantly improved(P＜0.05).Conclusion The PDCA cycle can effectively improve the quality of medical device ad-verse event report forms,which is significant for standardizing the monitoring of medical device adverse events and subsequent in-vestigation and resolution of risk.
万方数据
维普
