中国标准化Issue(12)：245-248,4.DOI:10.3969/j.issn.1002-5944.2024.12.047
规范化医疗器械不良事件管理对医疗器械使用质量控制的影响
Influence of Standardized Medical Device Adverse Event Management on Quality Control of Medical Device Use
摘要
Abstract
Objective:To analyze the effect of standardized medical device adverse event management in the quality control of medical devices.Methods:In this study,100 medical devices with routine quality control management in 2022 were selected as the control group,and 100 medical devices receiving standardized adverse event analysis and targeted management in 2023 were selected as the observation group.The incidence of adverse device events,types of adverse events,medical device management quality score and medical service satisfaction were compared between the two groups.Results:Combined with the data analysis results compared with the control group,the observation group had a significantly lower incidence of medical device adverse events,decreased types of adverse events,and higher medical device management quality score and medical service satisfaction.The results of this data study were significant(P<0.05).Conclusion:Using the management of standardized medical device adverse events in the quality control of medical devices can obtain significant management effect,which can not only reduce the incidence of adverse events,but also effectively reduce the performance of adverse events,improve the quality of medical device management,and lay the foundation for improving the management system of medical devices.关键词
规范化医疗器械不良事件管理/医疗器械使用质量控制/不良事件发生率Key words
standardized management of medical device adverse events/quality control of medical device use/incidence of adverse events引用本文复制引用
何鑫,张高坤,吴璇,赵宇飞..规范化医疗器械不良事件管理对医疗器械使用质量控制的影响[J].中国标准化,2024,(12):245-248,4.
