Systems-Theoretic Safety Assessment of Robotic Telesurgical Systems
Systems-Theoretic Safety Assessment of Robotic Telesurgical Systems
复制标题
机器人远程手术系统的系统理论安全评估
DOI：
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发表时间：
2015
期刊：
影响因子：
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通讯作者：
R. Iyer
中科院分区：
文献类型：
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作者：
H. Alemzadeh;Daniel Chen;Andrew Lewis;Z. Kalbarczyk;J. Raman;N. Leveson;R. Iyer
机器人手术系统是市场上最复杂的医疗网络物理系统之一。尽管这些年来这些系统的设计有了显著的改进，但在手术过程中仍不断发生对患者产生负面影响的安全事件。本文提出了一种基于软件故障注入的机器人手术系统的系统理论安全评估方法。我们使用系统理论危害分析技术STPA来识别RAVEN II（一种开源远程机器人手术平台）中的潜在安全危害场景及其成因。我们将机器人控制软件与软件实现的故障注入引擎集成在一起，该引擎通过自动将故障插入软件的不同部分来测量系统对已识别危险场景的弹性。来自向美国食品药品监督管理局FDA MAUDE数据库报告的真实的机器人手术事件的代表性危害场景用于证明所提出的机器人手术系统安全设计方法的可行性。
Robotic surgical systems are among the most complex medical cyber-physical systems on the market. Despite significant improvements in design of those systems through the years, there have been ongoing occurrences of safety incidents that negatively impact patients during procedures. This paper presents an approach for systems-theoretic safety assessment of robotic telesurgical systems using software-implemented fault injection. We used a systems-theoretic hazard analysis technique STPA to identify the potential safety hazard scenarios and their contributing causes in RAVEN II, an open-source telerobotic surgical platform. We integrated the robot control software with a software-implemented fault injection engine that measures the resilience of system to the identified hazard scenarios by automatically inserting faults into different parts of the software. Representative hazard scenarios from real robotic surgery incidents reported to the U.S. Food and Drug Administration FDA MAUDE database were used to demonstrate the feasibility of the proposed approach for safety-based design of robotic telesurgical systems.