实时自适应螺旋式断片疗法的潜在危险分析
Jonathan Hindmarsh1, Scott Crowe2, Jemma Walsh2
1Image X Institute, Faculty of Medicine and Health, University of Sydney, Eveleigh, NSW, Australia.
Journal of applied clinical medical physics
|January 30, 2026
概括
系统理论过程分析 (STPA) 在Radixact Synchrony系统上的实时适应性辐射疗法中确定了潜在的风险. 建议采取缓解策略,以提高患者的安全性和改善治疗程序.
科学领域:
- 辐射瘤学 辐射瘤学
- 医学物理 医学物理
- 系统工程是系统工程.
背景情况:
- 在2016年后的放射治疗中对潜在危险分析的兴趣越来越大AAPM TG100报告.
- 系统理论过程分析 (STPA) 是一种用于复杂,时间敏感的过程的新兴技术.
- STPA非常适合分析涉及协作,决策和自动化的系统.
研究的目的:
- 在螺旋式断层疗法平台上评估现有实时自适应性放射治疗的流程.
- 确定与Radixact Synchrony系统相关的改进,缺口和不可预见的风险.
- 将STPA方法应用于特定的临床应用.
主要方法:
- 利用STPA进行Radixact Synchrony系统的潜在危险分析.
- 开发了整个患者旅程的控制结构模型,包括硬件,软件和人为因素.
- 确定了不安全的控制行动,并为风险评估生成了因果关系场景.
- 基于控制层次的建议减缓策略.
主要成果:
- 构建了一个全面的控制结构模型,包括12个子系统和21个控制行动.
- 确定了108个不安全的控制行动和595个因果场景.
- 选择了61种因果情景进行深入分析,并制定了有针对性的缓解策略.
- 拟议的缓解措施包括加强文档,参数灵敏度测试和程序指导.
结论:
- STPA有效评估了 Radixact Synchrony 实时自适应性放射治疗系统的安全性.
- 该研究提供了对整个患者治疗途径的潜在系统故障的见解.
- 该STPA应用框架可转移到放射治疗中的其他安全评估中.
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