Abstract: Objective: To reduce the risk of infant theft in hospital. Methods: Healthcare Failure Mode and Effects Analysis (HFMEA) was used in this study. The authors built a team to analyze and prioritize the potential failure modes, identify the root causes and redesign the process of infant safety management. Results: It reduced the risk of the infant theft; and the infant safety system was set up in the hospital. Conclusion: HFMEA was effective to reduce the infant theft risk and ensure infant safety system.