Abstract: Objective: To analyze the application effect of Healthcare Failure Mode and Effect Analysis (HFMEA) in the management of high-value medical consumables in the interventional operating room, to provide a reference for medical institutions in the implementation of intelligent management of high-value medical consumables. Methods: An HFMEA working group was established on May 2023 to select the topic, map the consumables management process, identify failure modes in consumables management, analyze and confirm root causes, use a decision tree to determine improvement items, and formulate and implement action measures. Results: After the implementation of HFMEA, the pre-operative supply preparation time for emergency interventional surgeries was shorter (P<0.05). The completeness of pre-operative supply preparation improved, rising from 99.73% to 99.96% (P<0.05). The rate of abnormalities in high-value supply management decreased from 1.41% to 0.33% (P<0.05). The communication among medical staff regarding supplies and the unpacking process became more standardized, increased from 46.67% to 90.32% (P<0.05). The overall satisfaction of nurses increased, rising from 88.7% to 97.8% (P<0.05). Conclusion: The application of HFMEA to manage the high-value medical consumables in interventional operating rooms can effectively improve the quality of consumables management, and enhance the nursing quality.

Key words: Healthcare Failure Mode and Effect Analysis; interventional operating room; high-value medical consumable; process optimization