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Multi-institutional application of Failure Mode and Effects Analysis (FMEA) to CyberKnife Stereotactic Body Radiation Therapy (SBRT)

机译:失效模式和效果分析(FMEA)在射波刀立体定向放射治疗(SBRT)中的多机构应用

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Background A multidisciplinary and multi-institutional working group applied the Failure Mode and Effects Analysis (FMEA) approach to assess the risks for patients undergoing Stereotactic Body Radiation Therapy (SBRT) treatments for lesions located in spine and liver in two CyberKnife? Centres. Methods The various sub-processes characterizing the SBRT treatment were identified to generate the process trees of both the treatment planning and delivery phases. This analysis drove to the identification and subsequent scoring of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system. Novel solutions aimed to increase patient safety were accordingly considered. Results The process-tree characterising the SBRT treatment planning stage was composed with a total of 48 sub-processes. Similarly, 42 sub-processes were identified in the stage of delivery to liver tumours and 30 in the stage of delivery to spine lesions. All the sub-processes were judged to be potentially prone to one or more failure modes. Nineteen failures (i.e. 5 in treatment planning stage, 5 in the delivery to liver lesions and 9 in the delivery to spine lesions) were considered of high concern in view of the high RPN and/or severity index value. Conclusions The analysis of the potential failures, their causes and effects allowed to improve the safety strategies already adopted in the clinical practice with additional measures for optimizing quality management workflow and increasing patient safety.
机译:背景技术一个多学科,多机构的工作组应用了失效模式和效果分析(FMEA)方法来评估接受立体定向放射疗法(SBRT)治疗的患者的风险,该方法用于治疗两个射波刀中位于脊柱和肝脏的病变。中心。方法确定了表征SBRT治疗的各个子过程,以生成治疗计划和交付阶段的过程树。该分析使用风险概率数(RPN)评分系统,对潜在故障模式及其原因和后果进行识别和后续评分。因此考虑了旨在提高患者安全性的新颖解决方案。结果表征SBRT治疗计划阶段的过程树由总共48个子过程组成。同样地,在肝肿瘤的分娩阶段中确定了42个子过程,而在脊柱病变的分娩阶段中确定了30个子过程。所有子过程都被判断为潜在地倾向于一种或多种故障模式。考虑到RPN和/或严重性指数值高,十九个失败(即在治疗计划阶段为5个,在肝脏病变中为5个,在脊柱病变中为9个)。结论通过对潜在故障及其原因进行分析,可以改善临床实践中已经采用的安全策略,并采取其他措施来优化质量管理工作流程并提高患者安全性。

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