Date of this Version
A 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.
Formal methods, Model-based development, Medical devices, User interface prototyping
Paolo Masci, Anaheed Ayoub, Paul Curzon, Insup Lee, Oleg Sokolsky, and Harold Thimbleby, "Model-based development of the Generic PCA infusion pump user interface prototype in PVS", . September 2013.
Date Posted: 06 September 2013
This document has been peer reviewed.