Abstract:Objective To carry out risk assessment and continuously improve the operation mechanism of consumables
management by using the failure mode and effect analysis (FMEA) method and focusing on the consumables management
process. Methods FMEA quality improvement team was established to sort out the key links of each sub process in the
consumables management process, and to evaluate high-risk factors and formulate a cluster improvement plan. The risk priority
number (RPN) value, qualification rate of consumables management related indicators, and clinical satisfaction before and after
the improvement of this process were compared. Results After the application of FMEA to consumables management, the
RPN value of failure modes such as introduction and notification of consumables was significantly decreased (P<0.001). After
management, the qualified rates of consumables access compliance rate, quality management index information record integrity
rate, inventory consumables quality qualification rate, bar code pasting specification rate, charging accuracy rate, on-time return
visit and recording rate, consumables traceability rate and patient satisfaction were 99.0%, 95.9%, 98.0%, 95.4%, 96.4%, 96.9% ,
99.5%, and 98.0% respectively, higher than 91.1%, 82.1%, 93.4%, 87.3%, 84.9%, 88.2%, 87.7%, 92.0% before management
(P<0.05). Conclusion As a forward-looking tool for risk management, FMEA method can timely help consumables managers
intervene and control the identified risk in advance, reduce the loopholes in their business process management.
陈湘a,习梦华a,钟志蓉a,林波a,刘红梅a,刘睿a,何梅b. 失效模式与效应分析在耗材管理中的应用探讨[J]. 中国医疗设备, 2022, 37(3): 123-126.
CHEN Xiang华a, XI Menghua华a, ZHONG Zhirong华a, LIN Bo华a, LIU Hongmei华a, LIU Rui华a, HE Meib. Application of Failure Mode and Effect Analysis in Consumables Management. China Medical Devices, 2022, 37(3): 123-126.