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。随着预期寿命的延长导致人口老龄化，越来越需要随时随地提供医疗保健服务。此外，在较晚阶段发现疾病时，医疗保健费用会大幅上升。因此，疾病的早期发现有可能以更低的成本带来更好的医疗保健。实现广泛提供卫生保健和确保疾病的早期发现，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操作和医疗器械控制的失效会造成有害的生理状况甚至生命和安全隐患。在医疗设备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。该项目的目标是开发用于医疗设备控制操作的时空混合自动机（STHA）形式化建模和分析技术，以验证患者安全。具体而言，该项目侧重于三个主要的科学挑战：控制操作的形式化建模，可以响应时变的生理过程和生理参数的时空变化；表征多个医疗器械同时运行的综合效应；以及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。研究结果将为保障患者在使用医疗器械时的安全提供理论基础。该项目将为开发高度可靠的医疗设备提供技术，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).