中国医疗设备2025，Vol.40Issue(11)：110-116,7.DOI:10.3969/j.issn.1674-1633.20241990
基于AHP的导尿类医疗器械不良事件监测研究
Research on Adverse Event Monitoring of Urinary Catheter Medical Devices Based on AHP
摘要
Abstract
Objective To provide a regulatory basis for medical device supervision and administration departments,adopt effective mechanisms to conduct risk control and prevention of adverse events,reduce the risks of medical device use for patients and medical staff,and ensure the safety of people's medical device use as well as life and property.Methods Based on the Shandong Provincial Medical Device Adverse Event Monitoring Special Research Platform,data analysis of adverse events was conducted to determine the research category of medical devices.The analytic hierarchy process(AHP)was used to determine the index weight of causes for adverse events of medical devices in the research category,and consistency test analysis was performed on the weights.Targeted measures were formulated and implemented from different perspectives of device supervision,production and use,followed by continuous tracking and monitoring.Results The research category was determined as urinary catheterization-related medical devices.The AHP results showed that product quality issues were the primary cause of adverse events of urinary catheterization-related medical devices.The consistency test results of the two dimensions(CR=0)all met the requirements,which were consistent with the statistical results of the provincial platform.Usage management and personnel management were key influencing factors leading to adverse events of urinary catheterization-related medical devices.After the implementation of targeted measures,the incidence of adverse events of urinary catheterization-related medical devices in medical institutions decreased significantly.Conclusion Data analysis using AHP can effectively identify the root cause indicators of medical device adverse events.Implementing targeted measures for risk control of medical device adverse events can not only promote medical institutions to improve the requirements for the performance and function of the products used,but also drive enterprises to enhance product quality,thereby effectively reducing or even avoiding the recurrence of similar adverse events.关键词
医用耗材/医疗器械不良事件/层次分析法(AHP)/导尿类医疗器械/产品质量/一致性检验Key words
medical consumables/medical device adverse events/analytic hierarchy process(AHP)/urinary catheterization-related medical devices/product quality/consistency test分类
预防医学引用本文复制引用
孟华阳,赵玉娟,潘恩,徐滨,杨建卫,马宝荣,徐可苓..基于AHP的导尿类医疗器械不良事件监测研究[J].中国医疗设备,2025,40(11):110-116,7.基金项目
山东省医疗器械专项研究平台(2024SDADR024). （2024SDADR024）
