What is it about?

One source of human error in medical device operation occurs when users switch from one device to another. These switches occur when transferring between units (paramedic services to ICU, ICU to OR) where different equipment models may be used. When manufacturers have different mode definitions and descriptions it increases the chance of these errors. This protocol is to show how to conduct a test for this specific situation. We have used ventilators because that is a project we have right now, but the protocol is generic to any device switching context where human error may be a concern.

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Why is it important?

Switching devices is a potential context for human error. Understanding this situation requires a specific test construction. A standard usability test or performance test is not an adequate experiment design for this situation.

Perspectives

This problem situation was presented to us by Dr. Dain, who made us aware of this unique error context. It was a challenge to determine a reasonable test protocol for this situation, which is why, when we did, we felt the protocol was worth sharing. We are currently still getting the actual study going.

Dr Catherine M Burns
University of Waterloo

Read the Original

This page is a summary of: Protocol for Usability Testing and Validation of the ISO Draft International Standard 19223 for Lung Ventilators, JMIR Research Protocols, September 2017, JMIR Publications Inc.,
DOI: 10.2196/resprot.7298.
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