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The Generic Infusion Pump User Interface Architecture (GIP-UI)

Key points

Working with the US regulator, the Food and Drug Administration (FDA), we have:

  • developed a reference architectural model for modern infusion pumps (the GIP-UI);
  • used it to carry out a preliminary hazard analysis for commercial infusion pump software, and
  • identified user interface design issues to explain common problems reported in infusion pump incidents.

Figure 1: Generic Infusion Pump Architecture

Background
US regulator, the Food and Drug Administration (FDA) set up the collaborative Generic Infusion Pump Project to improve the safety of medical devices.  Their aim is to develop safety models and reference specifications that can be both directly used, and adapted by, manufacturers to check the safety of the designs of their own infusion pumps. Whilst other partners have focussed on, for example, the control hardware and software, our role in the project has been to work on the user interface of the generic infusion pump.

Our Generic Infusion Pump User Interface (GIP-UI) is a reference architectural model that captures the common characteristics and functionalities of interactive software found in modern infusion pumps. It can be used to reason about hazards in the use of infusion pumps and the factors that contribute to them. In particular, it focuses on factors rooted in poor design of user interface software. This architecture is our first step towards establishing a model-based risk analysis methodology that helps manufacturers identify and mitigate use hazards in their products at early stages of the development life-cycle, when they are still both easy and cheap to fix.

Figure 2: Close-up view of the Generic Infusion Pump User Interface architecture (GIP-UI) [click here for full size image]

Achievements
In collaboration with the FDA, we have successfully used the GIP-UI to carry out a preliminary hazard analysis for the data entry software of commercial infusion pumps (see Figure 2). Using the GIP-UI, we were able to:

(i) formulate precise hypotheses about software defects that could lead to use error;
(ii) identify a substantial set of user interface design issues that could explain common use-related hazards reported in infusion pump incidents.

Publications
Masci, P., Zhang, Y., Jones, P., Thimbleby, H., & Curzon, P. (2014). A generic user interface architecture for analyzing use hazards in infusion pump software. Proceedings of the 5th Workshop on Medical Cyber-Physical Systems (MCPS 2014), 1–14. OASIcs: Open Access Series in Informatics, vol. 36.

Partnerships
We have worked with researchers both at the FDA and at the University of Pennsylvania on this project.

Disclaimer
The information provided on this web page is for academic research purposes only. We make no claims as to the completeness or correctness of this information. We encourage academics and others to experiment with this work and report their results to this web page so that everyone involved may benefit from the work.