Medical Device Design: Asthma Inhaler Leaves a Lot to be Desired

April 7, 2011

By Margaux Boyaval, Program Director

A recent article in Futurity quotes study findings that three out of four kids and teens with asthma have trouble using inhalers properly and only one in four gets it completely right.

Could inhalers benefit from earlier usability testing? The study’s leader, Betsy Sleath, included 296 patients aged eight to 16 using four different devices, three of which deliver medication, one of which is a need assessment device. The top scoring drug delivery device, Advair’s diskus, had the high score with just 21.9 percent of participants able to perform all steps correctly.

Food for thought - just one in four children uses their inhaler properly.

Sleath advises pediatric medical practices to not only show a child how to use a device, but also have the child demonstrate the device use in front of the doctor or pharmacist to enhance effective delivery and prevent hospitalizations that can result from poor control of the condition.

Who could argue with the need for that? No one. But one could certainly argue that such devices, even when placed in the hands of relatively young children, should be more intuitive, more user-friendly than they apparently are. Given the time that may elapse between that learning and demonstration session and the actual incident requiring the use of the device, it seems reasonable to presume that most kids (and many adults) will have forgotten some or maybe even all of the proper use protocols.

It is crucial then that in designing and engineering inhalers, turbuhalers and diskuses, medical device designers rely on sound human factors engineering and early and frequent usability testing. And it’s certainly easy to understand why the FDA enacted the new standard, HE-75, to point the way. With the new standard in place, human factors and usability are well integrated into the process required for regulatory approval helping to insure that companies put out products that reduce risk factors related to misuse. And that’s the good news.