失效模式与效应分析在低能X线术中放疗的应用

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，...

Application of failure mode and effect analysis in low-energy X-ray radiotherapy

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.