Formal Specifications and Analysis of the Computer Assisted Resuscitation Algorithm (CARA) Infusion Pump Control System

Reliability of medical devices such as the CARA Infusion Pump Control System is of extreme importance given that these devices are being used on patients in critical condition. The Infusion Pump Control System includes embedded processors and accompanying embedded software for monitoring as well as controlling sensors and actuators that allow the embedded systems to interact with their environments. This nature of the Infusion Pump Control System adds to the complexity of assuring the reliability of the total system. The traditional methods of developing embedded systems are inadequate for such safety-critical devices. In this paper, we study the application of formal methods to the requirements capture and analysis for the Infusion Pump Control System. Our approach consists of two phases. The first phase is to convert the informal design requirements into a set of reference specifications using a formal system, in this case EFSMs (Extended Finite State Machines). The second phase is to translate the reference specifications to the tools supporting formal analysis, such as SCR and Hermes. This allows us to conclude properties of the reference specifications. Our research goal is to develop a framework and methodology for the integrated use of formal methods in the development of embedded medical systems that require high assurance and confidence.