Abstract：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.
杨小娟1，郭晏平1，范琳1，吴国荣2. 基于FMEA的植入性医用耗材管理的应用[J]. 中国医疗设备, 2021, 36(11): 120-123.
YANG Xiaojuan1，GUO Yanping1，FAN Lin1，WU Guorong2. Application of Implantable Medical Consumables Management Based on FMEA. China Medical Devices, 2021, 36(11): 120-123.
