Safety-assured development of the GPCA infusion pump software

TLDR

The study applies model‑driven engineering to create a safety‑assured PCA infusion pump software based on the FDA’s generic reference model. The reference model was translated into timed automata with UPPAAL, its safety properties verified against FDA requirements, platform‑independent code was generated with TIMES, then augmented for hardware interfacing, deployed on a real pump, and validated through a conformance‑testing testbed to ensure no safety violations. Experiments confirm the code functions correctly on the real pump, and the paper discusses challenges and lessons learned.

Abstract

This 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.