Application of failure mode and effect analysis in low-energy X-ray radiotherapy
Yang Yining1, Wang Song2, Liu Qingfeng3, Gong Xinyuan1, Li Mu2, Li Nana1, Jiang Bo4, Peng Yuna1, Shen Ping1, Zhu Yu1, Yuan Guangjie1, Shen Wen1
1Department of Radiation Oncology, Tianjin First Central Hospital, Tianjin 300192, China; 2Department of Neurosurgery, Tianjin First Central Hospital, Tianjin 300192, China; 3Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China; 4Department of Radiation Oncology, Cancer Hospital of Tianjin Medical University, Tianjin 300060, China
Abstract：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.
Yang Yining,Wang Song,Liu Qingfeng et al. Application of failure mode and effect analysis in low-energy X-ray radiotherapy[J]. Chinese Journal of Radiation Oncology, 2021, 30(3): 266-271.
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2021, Vol. 30 
