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PublicationModel-Based Development of the Generic PCA Infusion Pump User Interface Prototype in PVS(2013-09-01) Masci, Paolo; Ayoub, Anaheed; Curzon, Paul; Lee, Insup; Sokolsky, Oleg; Thimbleby, Harold; Masci, Paolo; Ayoub, Anaheed; Curzon, Paul; Lee, Insup; Sokolsky, Oleg; Thimbleby, HaroldA realistic user interface is rigorously developed for the US Food and Drug Administration (FDA) Generic Patient Controlled Analgesia (GPCA) pump prototype. The GPCA pump prototype is intended as a realistic workbench for trialling development methods and techniques for improving the safety of such devices. A model-based approach based on the use of formal methods is illustrated and implemented within the Prototype Verification System (PVS) verification system. The user interface behaviour is formally specified as an executable PVS model. The specification is verified with the PVS theorem prover against relevant safety requirements provided by the FDA for the GPCA pump. The same specification is automatically translated into executable code through the PVS code generator, and hence a high fidelity prototype is then developed that incorporates the generated executable code. PublicationSafety-Assured Development of the GPCA Infusion Pump Software(2011-10-01) Kim, BaekGyu; Ayoub, Anaheed; Sokolsky, Oleg; Lee, Insup; Jones, Paul; Zhang, Yi; Jetley, Raoul; Kim, BaekGyu; Ayoub, Anaheed; Sokolsky, Oleg; Lee, Insup; Jones, Paul; Zhang, Yi; Jetley, RaoulThis paper presents our effort of using model-driven engineering to establish a safety-assured implementation of Patient-Controlled Analgesic (PCA) infusion pump software based on the generic PCA reference model provided by the U.S. Food and Drug Administration (FDA). The reference model was first translated into a network of timed automata using the UPPAAL tool. Its safety properties were then assured according to the set of generic safety requirements also provided by the FDA. Once the safety of the reference model was established, we applied the TIMES tool to automatically generate platform-independent code as its preliminary implementation. The code was then equipped with auxiliary facilities to interface with pump hardware and deployed onto a real PCA pump. Experiments show that the code worked correctly and effectively with the real pump. To assure that the code does not introduce any violation of the safety requirements, we also developed a testbed to check the consistency between the reference model and the code through conformance testing. Challenges encountered and lessons learned during our work are also discussed in this paper.