Verification of closed loop feedback/feed-forward control actions for safe medical devices

该项目是NSF-FDA常驻学者(SIR)计划下的一项合作。随着预期寿命的增加导致更多的老龄化人口，随时随地提供医疗服务的需求越来越大。此外，当在较晚阶段发现疾病时，医疗成本会大幅上升。因此，及早发现疾病可能会以更低的成本带来更好的医疗保健。要实现广泛可用的医疗保健并确保及早发现疾病，需要复杂的医疗控制系统来监测人体状况。然而，这些医疗器械控制系统的不安全运行和医疗器械控制的失败会导致有害的生理条件，甚至生命安全危险。在医疗设备中部署的操作控制下验证患者安全至关重要。例如，输液泵控制系统必须防止药物过量。本项目的目标是开发用于医疗器械控制操作的时空混合自动机(STHA)形式化建模和分析技术，以验证患者的安全性。具体地说，这个项目集中在三个主要的科学挑战上：能够对时变的生理过程和生理参数的时空变化做出反应的控制操作的形式化建模；表征同时运行的多个医疗设备的综合影响；以及医疗设备的形式化安全分析。该项目涉及美国食品和药物管理局和亚利桑那州立大学的研究人员之间的合作。研究结果将为保证患者使用医疗器械时的安全提供理论依据。该项目将为开发高度可靠的医疗设备贡献技术，并增加公众对其使用的信心，同时使医疗保健更安全、更便宜。项目结果可在Impact实验室的网站(http://impact.asu.edu).)上获得

This project is a collaboration under the NSF-FDA Scholar-In-Residence (SIR) program. With increases in life expectancy leading to larger aging populations, there is growing need to make healthcare services available anywhere and anytime. In addition, healthcare costs rise significantly when diseases are identified at a later stage. Thus, early detection of diseases can potentially lead to better healthcare at lower costs. Achieving widely available healthcare and ensuring early detection of diseases require complex medical control systems to monitor the condition of the human body. However, unsafe operation of these medical device control systems and failures of medical device control can cause harmful physiological conditions and even life and safety hazards. Verifying patient safety under the operational control deployed in medical devices is critical. For example, infusion-pump control systems must prevent drug overdose. The goal of this project is to develop spatio-temporal hybrid automata (STHA) formal modeling and analysis techniques for medical device control operations to verify patient safety. Specifically, this project focuses on three principal scientific challenges: formal modeling of control operations that can respond to time-varying physiological processes and to spatio-temporal variation of physiological parameters; characterizing aggregate effects of multiple medical devices operating simultaneously; and formal safety analysis of medical devices. This project involves collaboration between researchers at U.S. Food and Drug Administration and Arizona State University. The research results will contribute theoretical foundations for assurance of patient safety when using medical devices. The project will contribute technology for developing highly reliable medical devices and increase public confidence in their use, while enabling safer and cheaper healthcare. Project findings are available at IMPACT lab's website (http://impact.asu.edu).