失效模式和效果分析用于术中放疗风险管理模式初探

Failure modes and effects analysis applied to the risk management of intraoperative radiotherapy

目的分析移动式直线加速器Mobetron实施术中放疗（IORT）中的潜在风险，初步探讨优化IORT各步骤的管理、减少潜在风险发生的可行性。方法由IORT团队（2名外科医生、2名放疗科医生、1名放疗物理师、1名放疗技术员、2名护士）应用失效模式和效果分析（FMEA）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，对失效模式行频度（OR）、严重度（SR）、探测度（DR）评分，计算风险优先指数（RPN）。结果IORT流程分为9个模块，15项失效模式。OR最高值为激光软对位时间明显延长（8分），SR最高为Mobetron设备故障无法出束（10分），DR最高值为是剂量计算中发生的数据查询误差（8分），RPN最高为靶区确认不满意（198分）和未有效保护正常组织（180分）。对每项失效模式均行原因和现行措施分析并提出预防措施。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 analysis of the various potential risks during the implementation of intraoperative radiotherapy （IORT） using a mobile linear accelerator Mobetron. Explore to optimize the management of IORT steps to reduce the occurrence of potential risks. Methods Selected the two surgeons, two of radiation oncologists, a radiation physicist, a radiation technician and two nurses who have been working for a long term in IORT team, applied failure modes and effects analysis （FMEA） to carry out systematic risk assessment. Established process modules, detected potential failure modes together with their causes and effects, scored to occurrence rating （ OR ）, severity rating （ SR ）, detection rating （ DR ）, calculated risk priority number （RPN）. Results IORT process is divided into 9 modules, 15 potential failure modes. The highest OR was the prol nged time of laser soft-docking （ 8 points）, the highest SR was the Mobetron equipment failed to output beams （ 10 points ） , the highest DR was the risk in the dose calculation （8 points）, the highest RPNs were recognized as the target not covered satisfyingly （198 points） and not adequately protected normal tissues （180 points）. For each failure mode, the existing measures were analysis, and preventive measures were proposed. Conclusions FMEA is an effective method of the management of intraoperative radiotherapy, to help reduce the occurrence of the potential risk in the IORT.