Demonstrating that medical devices satisfy user related safety requirements

M.D. Harrison and P. Masci and J.C. Campos and P. Curzon
In Software Engineering in Healthcare (FHIES/SEHC 2014), volume 9062 of Lecture Notes in Computer Science, pages 113-128. Springer. 2017.

Abstract

One way of contributing to a demonstration that a medical device is acceptably safe is to show that the device satisfies a set of requirements known to mitigate hazards. This paper describes experience using formal techniques to model an IV infusion device and to prove that the modelled device captures a set of requirements. The requirements chosen for the study are based on a draft proposal developed by the US Food and Drug Administration (FDA). A major contributor to device related errors are (user) interaction errors. For this reason the chosen models and requirements focus on user interface related issues.

download PDF