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Don't Blame the User for Being Human, Says MD&M East Speaker

Human factors engineering expert encourages medical device designers to study all possible errors and develop designs that help prevent them. 
 
 
 
"It wasn't that a user forgot, but that the device depended upon the user to remember."
 
Michael Wiklund

Michael Wiklund spoke these words during his June 13 presentation on human factors engineering at MD&M East 2017 entitled "To Err Is Human, But How Do You Prevent It?" He offered tips on how to identify potential use errors and urged the use of human factors engineering to mitigate them.

 
Wiklund, who serves as general manager of the human factors engineering practice at UL (Underwriters Laboratories), said there is "no shortage of guidance," listing the following resources for medical device designers:
 
 
The medical device industry, however, "has historically been somewhat of a laggard at applying human factors engineering," he said.
 
Medical device designers seeking to prevent use errors "have to develop products that are sympathetic to user needs and limitations," he explained.
 
Wiklund encouraged attendees to "envision all of the use errors that can occur." To do so, he advised companies to observe and interview the intended users and perform a series of formative usability tests. "When you talk to them and watch them at work with medical devices, you can pick up on potential and actual mistakes," he said.
 
Wiklund also encouraged attendees to look at "known problems" by studying FDA's Manufacturer and User Facility Device Experience Database (MAUDE) and ECRI Institute's Medical Device Safety Reports (MDSR) database, both of which cite cases of use errors leading to harm.  
 
"Develop an inventory of all possible use errors no matter how unlikely," he said. 
 
Wiklund said that common use errors can occur when users do the following:
 
oSkip steps.
oMisconnect components.
oMisread a value.
oIncorrectly enter data.
oContaminate a component.
oOverlook an expiration date. 
 
Once a designer is aware of potential use errors, they can design user interfaces that could mitigate such risks. "Proactively ask what use errors could occur, and then develop user interface requirements leading to a design solution that can help prevent them" he said.
 
He concluded with this advice: 
 
oIdentify possible use errors.
oEmploy human factors engineering to mitigate them.
oConduct formative and summative usability tests.
oDon't blame the user for being human.
 
Plan now for MD&M East 2018, which will be held June 12-14, 2018, in New York City.
 
And don't miss this year's MD&M Minneapolis, held November 8-9, 2017.

Daphne Allen

Daphne Allen is editor-in-chief of MD+DI. She previously served as executive editor of Pharmaceutical & Medical Packaging News, which serves as the pharmaceutical and medical device channel of Packaging Digest. Daphne has covered medical device manufacturing, packaging, labeling, and regulatory issues as well as pharmaceutical packaging and labeling for more than 20 years. She is also a member of the Institute of Packaging Professionals's Medical Device Packaging Technical Committee. Follow her on Twitter at @daphneallen.

 

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