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）丨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）丨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.