Architecture Reconstruction and Analysis of Medical Device Software

New research is underway at the FDA to investigate the benefits of integrating architecture analysis into safety evaluations of medical-device software. Due to the complexity in setting up testing environments for such software, the FDA is unable to conduct large-scale safety testing, instead, it must rely on other techniques to build an argument for whether the software is safe or not. The architecture analysis approach, formalized using relational algebra, is based on reconstructing abstract, yet precise, architectural views from source code to help build such arguments about safety. This paper discusses the use of the formal approach to analyze the Computer-Assisted Resuscitation Algorithm (CARA) software, which controls an infusion pump designed to provide automated assistance for transfusing blood. The results suggest that a) architecture analysis offers many insights related to software quality in general and testability (i.e., the ease of testing) and its impact on safety in particular, and b) architectural analysis results can be used to help configure static analysis tools to improve their performance for verifying safety properties.