Research Article
Early identification of software causes of use-related hazards in medical devices
@INPROCEEDINGS{10.4108/eai.14-10-2015.2261754, author={Paul Curzon and Harold Thimbleby and Paolo Masci}, title={Early identification of software causes of use-related hazards in medical devices}, proceedings={5th EAI International Conference on Wireless Mobile Communication and Healthcare - "Transforming healthcare through innovations in mobile and wireless technologies"}, publisher={ACM}, proceedings_a={MOBIHEALTH}, year={2015}, month={12}, keywords={medical systems hazard analysis use error}, doi={10.4108/eai.14-10-2015.2261754} }- Paul Curzon
Harold Thimbleby
Paolo Masci
Year: 2015
Early identification of software causes of use-related hazards in medical devices
MOBIHEALTH
ICST
DOI: 10.4108/eai.14-10-2015.2261754
Abstract
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.