摘要
目的探讨失效模式与影响分析(Failure Mode and Effects Analysis,FMEA)方法在植入性医用耗材管理中的应用价值,为植入性医用耗材持续性优化管理提供一种理论探讨依据。方法建立以FMEA方法为基础的植入性医用耗材管理体系,分析植入性医用耗材管理过程中存在的潜在失效模式,并观察FMEA实施前后我院植入性医用耗材风险顺序系数、工作质量及耗材管理效率等指标。结果植入性医用耗材管理中主要失效模式风险顺序系数均得到了显著性降低,差异具有统计学意义(P<0.05);植入性医用耗材各配送时间节点以及耗材管理日均花费时间均显著性减少,差异具有统计学意义(P<0.05);植入性医用耗材库存质量合格率、信息完整率、条形码完整率和耗材可追溯率均得到显著性改善,差异具有统计学意义(P<0.05)。结论FMEA管理方法在一定程度上可优化植入性医用耗材的管理,值得进一步研究和推广。
Objective To explore the application value of the failure mode and effects analysis(FMEA)method in the management of implantable medical consumables,and to provide a theoretical basis for continuous optimization of the management of implantable medical consumables.Methods This article established a management system for implantable medical consumables based on FMEA methods,analyzed the potential failure modes that existed in the management of implantable medical consumables,and observed indicators such as the risk sequence coefficient,work quality and consumable management efficiency of our hospital before and after the implementation of FMEA.Results The risk coefficients of the main failure modes in the management of implantable medical consumables were significantly reduced,and the difference was statistically significant(P<0.05).The delivery time nodes of implantable medical consumables and the average daily time spent in consumable management were significantly reduced,and the difference was statistically significant(P<0.05).Implantable medical consumables inventory quality qualification rate,information integrity rate,barcode integrity rate and consumable traceability rate have all been significantly improved,and the difference was statistically significant(P<0.05).Conclusion FMEA management method can optimize the management of implantable medical consumables to a certain extent,and it is worthy of further research and promotion.
作者
杨小娟
郭晏平
范琳
吴国荣
YANG Xiaojuan;GUO Yanping;FAN Lin;WU Guorong(Purchasing Center,Wuxi No.5 People’s Hospital,Wuxi Jiangsu 214004,China;Department of Laboratory Medicine,Wuxi People’s Hospital,Wuxi Jiangsu 214000,China)
出处
《中国医疗设备》
2021年第11期120-123,135,共5页
China Medical Devices
关键词
失效模式与影响分析
植入性医用耗材
管理体系
风险顺序系数
失效模式
追溯率
failure mode and effects analysis
implantable medical consumables
management system
risk priority number
failure mode
traceability rate
