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

该项目是NSF-FDA驻校学者（SIR）计划下的合作项目。 随着预期寿命的增加导致人口老龄化，人们越来越需要随时随地提供医疗保健服务。此外，当疾病在较晚阶段被发现时，医疗保健费用会大幅上升。因此，疾病的早期检测可能会以更低的成本带来更好的医疗保健。实现广泛的医疗保健和确保早期发现疾病需要复杂的医疗控制系统来监测人体的状况。 然而，这些医疗设备控制系统的不安全操作和医疗设备控制的故障可能导致有害的生理状况，甚至生命和安全危害。在医疗设备中部署的操作控制下的患者安全至关重要。 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时空混合自动机（STHA）形式化建模和分析技术，用于医疗器械控制操作，以验证患者安全性。 具体而言，该项目侧重于三个主要的科学挑战：控制操作的正式建模，可以响应时变生理过程和生理参数的时空变化;表征多个医疗设备同时运行的综合效应;和医疗设备的正式安全分析。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提供技术，并提高公众对其使用的信心，同时实现更安全，更便宜的医疗保健。项目结果可在IMPACT实验室网站（http：//www.example.com）上查阅。impact.asu.edu

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).