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Usability engineering standards for medical device design

Key points

  • We prepared a summary guidance document to signpost relevant standards for manufacturers on usability engineering.
  • This led to raised awareness of the need for usability engineering standards during the design of medical devices with manufacturers, regulators and advisory committees.
  • It led to our acting as expert reviewer on a white paper on Usability Engineering standards for the British Standards Institute.

Medical device manufacturers are required to design products that conform with regulations. Within the European Union, this typically involves the use of harmonised consensus standards. These are standards developed by a recognised European Standards Organisation with the cooperation of all interested parties so that all views considered.
With respect to ensuring that devices are easy to use and are not likely to lead to human error the relevant areas are Human Factors and Usability Engineering. However, many of the standards in these areas are relatively new and subject to frequent revision. For example, internationally recognised standards such as 62366 and 14971 serve a recognised purpose in putting in place a usability engineering process that aims to reduce the chance of errors happening during use. However feedback has suggested it can be challenging to realise this process in practice. For Usability Engineering it is difficult to know what standards apply and there are differences in the way that the standards are interpreted.

A guidance document summarising the standards
To make it easier to comply with the Human Factors standards for interactive medical devices, we prepared a summary guidance document to help people navigate through the relevant ones. Manufacturers, regulators and advisory committees are using some of our guidance and support are are consequently more aware of the usability engineering standards. We worked directly with manufacturers to share the guidance as well as highlighting it through trade shows. Most notably the Association for the Advancement of Medical Instrumentation (AAMI), who are the primary source of international consensus standards for the medical device industry, asked us to share it with them, as did the UK regulator the Medicines and Health Products Regulatory Agency (MHRA). It has also made available to those involved in procurement decisions for medical devices. As a result of this work we also acted as an expert reviewer of a white paper on Usability Engineering standards for the British Standards Institute.

Vincent, C., 2010, "Mind the gap: What interactive medical device manufacturers need," Interfaces, 84, pp. 14-15.

Vincent CJ, Blandford A (2014). Usability standards meet scenario-based design: Challenges and opportunities. Journal of Biomedical Informatics, published online.

Vincent CJ, Blandford A (2014). The challenges of delivering validated personas for medical equipment design. Applied Ergonomics, 45(4):1097-1105.

Vincent, C., & Blandford, A. (2014). Infusion pump standards guide. Technical report IP002.

North, B. "The growing role of human factors and usability engineering for medical devices What's required in the new regulatory landscape", White Paper, The British Standards Institute.
CHI+MED researcher Chris Vincent acted as an expert reviewer for this paper

Key People
Ann Blandford; Chris Vincent