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

Arizona State University, Scottsdale AZ

Investigators

Abstract

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).