Testing and Validation Framework for Closed-Loop Physiology Management Systems for Critical and Perioperative Care

The research aims at developing a framework for testing systems such as closed-loop physiology management systems to ensure that they are safe and effective for use with patients. Building medical devices that are both robust and safe is a challenge. There has been a tremendous increase in modernization and innovation of various medical systems but many of these systems either fail trials or are recalled due to safety issues. Medical operation rooms require care teams responsible for monitoring the patients and other technical surgical devices. The care process requires a balancing administration that takes care of the drugs and fluids administered to patients. However, the safety and efficacy of these devices have been a concern to many medical practitioners and patients. Due to the complexity of surgical procedures, more fluids are required leading to a necessity of multiple pumps. To help the team in such circumstances, systems called closed loop assistants (CLAs) have been proposed. These systems help by monitoring the patient and possibly adjust infusions while clinicians maintain supervisory control. This thesis provides a framework for testing and validating CLAs through the use of computer simulations of human physiology called in silico patients. A simulated case study based on low blood pressure management in ICU is used to show how the framework can be used in software-only fast simulations or in real-time simulations. The results show that not only can the framework show what a CLA may do in terms of managing physiology but can also give insight as to why. The hope is that this framework will be useful to researchers and practitioners as they develop CLAs since they can test ideas early and often