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Infusion Pumps: a hazard analysis for infusion pump user interface software

Key points

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

  • identified a substantial set of hazards related to the use of the data entry systems of infusion pumps.
  • determined how poor design could lead to these hazards and identified marketed devices where they occur, and
  • explored systematic analysis techniques for identifying use-related hazards.

Background

A hazard is a potential source of physical injury or damage to people or environment, and a hazard analysis is the process of identifying all known and foreseeable hazards and their causes in a system. As indicated in reference standards such as ISO:14971 and FDA guidance documents, a rigorous hazard analysis is the first step required to implement a systematic risk management process for medical devices.

Figure 1: Sample of the developed hazard analysis table. The full table is in our technical report [1].

Achievements

In collaboration with the FDA, we carried out a preliminary hazard analysis focusing on the number entry software of infusion pumps. A substantial set of root causes of use-related hazards in software design was identified that can be used by manufacturers as an independent reference to challenge the safety of their own user interface design. Ongoing work includes the definition of a hazard analysis technique that integrates human cognitive process models and general interaction design principles. The technique is designed to support a more comprehensive and systematic identification of design flaws in user interfaces at the early stages of device design. Preliminary experiments suggest that this hazard analysis technique can help developers to identify 3 times more use-related hazards in user interface software designs compared to standard hazard analysis techniques.

 


"A study of problems with current interface technology in infusion pumps, basically manifesting itself in data entry scenarios, showed us numerous examples of infusion pump interfaces that came up with the wrong number or did the wrong thing. ..that was a big shock to us. … So we discovered this big hole in user interface design, not only for medical devices but other systems as well, like calculators. [CHI-MED work] has provided the means for the medical device industry to check their user interface design for errors; once they know where errors are, they can correct them, rerun the test and check. This reduces risk of harm to patients." - US government stakeholder


 

Publications
[1] Masci, P. (2014). A preliminary hazard analysis for the GIP number entry software. Technical report.

[2] 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.

Key people
Paolo Masci, Paul Curzon, Harold Thimbleby

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.

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. pdf (1.2 MB) doi bibtex abstract