摘要
目的:定量评估血液透析机使用过程中的潜在风险。方法:利用失效模式和效应分析(failure modes and effect analysis,FMEA)方法对血液透析机的透析用水、血液回路和透析液回路3个方面开展风险分析,评价其严重度、发生概率和探测度,计算出风险顺序数(risk priority number,RPN),根据RPN值的高低确定改进措施,并进行改进后的效果评价。结果:改进前FMEA方法识别的血液透析机的12个主要功能、22个主要失效模式的平均RPN值为26.6,采取风险改进措施后平均RPN值为12.3,患者对血液透析机的满意度提高了11%。结论:基于FMEA的血液透析机风险分析能明显降低血液透析机的临床使用风险,减少其潜在失效模式的发生,提高患者满意度。
Objective To quantitatively assess the potential risk of the hemodialysis machine in use. Methods Hemodialysis machine risk analysis was executed with failure modes and effect analysis (FMEA) from the aspects of dialysis water, blood circuit and dialysate circuit;the severity, occurrence rate and detectivity were evaluated, and the risk priority number (RPN) was calculated, then improvement measures were determined based on the RPN;efficacy assessment was carried out after improvement. Results The mean RPN of the 12 main functions and 22 failure modes of the machine determined by FMEA changed from 26.6 to 12.3 after improvement, and the patient satisfaction over the hemodialysis machine was increased by 11%. Conclusion The FMEA-based risk analysis decreases the clinical risk and failure possibility of the hemodialysis machine, and enhances the patient satisfaction.
作者
周兴朝
刘丽茹
杨红飞
段文清
周和良
ZHOU Xing-chao;LIU Li-ru;YANG Hong-fei;DUAN Wen-qing;ZHOU He-liang(The First Affiliated Hospital of Dali University, Dali 671000, Yunnan Province, China)
出处
《医疗卫生装备》
CAS
2019年第10期74-78,共5页
Chinese Medical Equipment Journal
基金
云南省教育厅科学研究基金项目(2018JS419)
关键词
失效模式与效应分析
血液透析机
风险分析
风险顺序数
failure modes and effect analysis (FMEA)
hemodialysis machine
risk analysis
risk priority number
