Medical errors, defined as unintended acts either of omission or commission that cause the failure of medical actions, are the third leading cause of death in the United States. The application of autonomy and robotics can alleviate some causes of medical errors by improving accuracy and providing means to follow planned procedures. However, for the robotic applications to improve safety, they must maintain constant operating conditions in the presence of disturbances, and provide reliable measurements, evaluation, and control for each state of the procedure. This article addresses the need for process control in medical robotic systems, and proposes a standardized design cycle toward its automation. Monitoring and controlling the changing conditions in a medical or surgical environment necessitates a clear definition of workflows and their procedural dependencies. We propose integrating process control into medical robotic workflows to identify change in states of the system and environment, possible operations, and transitions to new states. Therefore, the system translates clinician experiences and procedure workflows into machine-interpretable languages. The design cycle using hFSM formulation can be a deterministic process, which opens up possibilities for higher-level automation in medical robotics. Shown in our work, with a standardized design cycle and software paradigm, we pave the way toward controlled workflows that can be automatically generated. Additionally, a modular design for a robotic system architecture that integrates hFSM can provide easy software and hardware integration. This article discusses the system design, software implementation, and example application to Robot-Assisted Transcranial Magnetic Stimulation and robot-assisted femoroplasty. We provide assessments using performance in terms of robotic tool placement and response to failure injections.

翻译：医疗差错，定义为导致医疗行为失败的意外疏忽或过失行为，是美国第三大致死原因。自主性与机器人技术的应用可通过提升精准度并确保按计划流程执行，在一定程度上减少医疗差错的成因。然而，为使机器人应用提升安全性，必须在存在干扰的情况下维持恒定的操作条件，并对流程的每个状态提供可靠的测量、评估与控制。本文阐述了医疗机器人系统中过程控制的必要性，并提出一种实现其自动化的标准化设计周期。在医疗或手术环境中监测与控制变化的条件，需要明确定义工作流及其流程依赖性。我们提出将过程控制整合至医疗机器人工作流中，以识别系统与环境的状态变化、可能的操作动作以及向新状态的转换。由此，系统将临床经验与手术流程转换为机器可解读语言。采用hFSM建模的设计周期可作为确定性过程，为医疗机器人领域实现更高层级的自动化开辟可能性。本文研究表明，借助标准化设计周期与软件范式，我们为可自动生成的受控工作流奠定基础。此外，集成hFSM的机器人系统架构模块化设计可简化软硬件集成。本文讨论了系统设计、软件实现及其在机器人辅助经颅磁刺激与机器人辅助股骨成形术中的应用实例。我们通过机器人工具定位精度及故障注入响应性能指标进行评估。