The Design of Safe Networked Supervisory Medical Systems Using Organ-Centric Hierarchical Control Architecture

There are growing demands to leverage network connectivity and interoperability of medical devices in order to improve patient safety and the effectiveness of medical services. However, if not properly designed, the integration of medical devices through networking could significantly increase the complexity of the system and make the system more vulnerable to potential errors, jeopardizing patient safety. The system must be designed and verified to guarantee the safety of patients and the effectiveness of medical services in the face of potential problems such as network failures. In this paper, we propose organ-centric hierarchical control architecture as a viable solution that reduces the complexity in system design and verification. In our approach, medical devices are grouped into clusters according to organ-specific human physiology. Each cluster captures common patterns arising out of medical device interactions and becomes a survivable semiautonomous unit during network failures. Further, safety verification and runtime enforcement can be modularized along organ-centric hierarchical control structure. We show the feasibility of the proposed approach under Simulink´s model-based development framework. A simplified scenario for airway laser surgery is used as a case study.