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Lauren Dubinsky, Senior Reporter | December 04, 2014
From the December 2014 issue of HealthCare Business News magazine
For example, we all associate green with go and red with stop. Buttons on devices should follow this stereotype. However, end-users have accidentally powered down a charged defibrillator by pressing the green “go” button when they mean to press a red button to deliver a shock.
Beyond button coding, a user-centered defibrillator design would confirm that the user really wanted to power down the charged defibrillator. After all, if a non-safety critical device like a projector can ask if you meant to power down, a medical device can.
HCBN: What questions regarding usability problems should an end-user ask a manufacturer before purchasing their product?
VL: Before purchasing any product it’s very important to find out from the vendor if usability testing has been conducted with representative end users. If the end-user of the device is an ICU nurse in a hospital for example, it’s important that usability testing be done with ICU nurses in an environment that is similar to the one in which they work.
The testing should be done with at least 15 people who are representative end-users, according to the FDA.
If a medical device manufacturer hasn’t done testing that meets the recommended guidelines from the FDA for usability evaluation, then the buyer can look at their purchasing options. Also, the end-user or their organization may decide to have independent usability testing conducted before making a purchase.
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