Early identification of software causes of use-related hazards in medical devices

Masci P, Curzon P, Thimbleby H.  2015.  Early identification of software causes of use-related hazards in medical devices. 5th EAI International Conference on Wireless Mobile Communication and Healthcare - "Transforming healthcare through innovations , copy at www.tinyurl.com/hwnfswg


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. In this paper, we illustrate our ongoing work in collaboration with the FDA on defining a hazard analysis technique for early identification of the causes in user interface software design of use-related hazards. The technique integrates human cognitive process models and general interaction design principles, and uses a model-based approach for systematic exploration of potential hazards. Preliminary experiments suggest that this hazard analysis technique can substantially improve the identification of use-related hazards at the early stages of software design as compared to standard hazard analysis techniques.


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