目的:探讨失效模式与效应分析(FMEA)在低能X线术中放疗(IORT)中的应用，分析其在IORT中的潜在风险，初步探讨FMEA优化IORT管理、减少潜在风险发生的可行性。方法:由IORT团队(1名放疗科医生、1名放疗科物理师、2名外科医生、2名护士)成立FMEA工作小组，应用FMEA方法开展系统风险评估。确立流程模块，对每项模块分析潜在失效模式和原因，对失效模式进行严重程度(SR)、发生频度(OR)和失效检验难度(DR)的评分，计算风险优先指数(RPN＝SR×OR×DR)。前瞻性地分析并理解放疗过程中的各个环节可能的错误及潜在临床影响，对每项失效模式均进行原因分析和现行措施分析，提出预防措施并采取相应的风险管理措施。结果:IORT流程分为8个模块，14项失效模式。OR值最高为靶区确认不满意(7分)，SR值最高为设备故障无法出束(10分)，DR值最高为剂量计算后按键输入错误(7分)，RPN值最高为靶区确认不满意(210分)和危及器官未有效保护(180分)。按照优先级对薄弱环节进行修正，优化工作流程和制定出更有效地管理方法。结论:FMEA是一种有效的IORT管理方法，有助于减少潜在风险发生。“,”Objective:To explore the application of failure mode and effects analysis (FMEA) in low-energy X-ray intraoperative radiotherapy (IORT), analyze its potential risks in IORT, and preliminarily explore the feasibility of FMEA in optimizing IORT management and reducing the occurrence of potential risks.Methods:An FMEA working group was established by the IORT team (1 radiologist, 1 radiology physicist, 2 surgeons, and 2 nurses) to apply the FMEA methodology to conduct a systematic risk assessment. The process modules were established, the potential failure modes and causes for each module were analyzed, the severity (SR), frequency of occurrence (OR) and likelihood of detection (DR) of failure modes were scored and the risk priority number (RPN) was calculated: RPN= SR × OR × DR. The possible errors and potential clinical impact of each part of the radiotherapy process were prospectively analyzed and understood, the causes and current measures were analyzed for each failure mode and preventive measures were proposed and risk management measures were taken accordingly.Results:The IORT process was divided into 8 modules with 14 failure modes. The highest OR value was unsatisfactory target area confirmation (7 points), the highest SR value was equipment failure to discharge the beam (10 points), the highest DR value was wrong key entry after dose calculation (7 points), the highest RPN values were unsatisfactory target area confirmation (210 points) and ineffective protection of endangered organs (180 points). Weaknesses were corrected according to priorities, workflows were optimized and more effective management methods were developed.Conclusion:FMEA is an effective method of IORT management and contributes to reducing the occurrence of potential risks.