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Use Error – NOT User Error

Posted in Medical Devices and Technology

I attended this month’s San Diego’s Medical Device and Technology Network meetup. The always wonderful Dr. Joely Gardner, author, speaker, and industry leader human factors and usability testing expert in medical devices, software, and web-based applications, shared with us insightful, real-life stories from the field.

One of the things that Dr. Gardner shared is the FDA change from “User Error” to “Use Error.” The distinction was first coined by William A. Hyman in “The Issue Is ‘Use,’ Not ‘User,’ Error,” MD&DI, 17(5), May 1995). In IEC 62366, the industry standard, use error is defined as “an act or omission of an act that results in a different medical device response than intended by the manufacturer or expected by the user.”

“The term use error precludes the assignment of cause (i.e., user’s fault) by providing only the identification of what happened, not why it happened. Essentially, it takes the onus off the user; no longer is it the user’s fault if the device causes the user to commit an error. The intention is to minimize or eliminate the ability of the user to commit an error despite device design and instructions for use (including labeling and training).” – Sean Hägen, Industry Viewpoint: User error vs. use error: More than just semantics

This is a paradigm shift for technology solution providers from putting the blame on “the user” – their customers, instead of blaming the error-inducing design that fail to help their customers achieve their goal… let alone, delight them!

Do you want to attract, retain and grow your customer based? Do you want long-term sustainable revenue growth? Then you need to determine, develop and deliver a great experience that they love. It’s not User Error – it is Use Error.

I will be speaking at the San Diego Medical Device and Technology Network in May. We will be discussing journey maps and how they can help you to understand how your customers interactions with your products and services and identify opportunities for improving the experience you create for them.

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