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RECORDED WEBINAR: Medical Device Use Error - Root Cause Analysis

July 4, 2017

About this webinar:

In this 60+ minute webinar, Michael Wiklund, Andrea Dwyer and Erin Davis, senior members of the UL Human Factors Engineering (HFE) practice described the regulatory and commercial imperative to identify the most likely root causes of medical device use errors. In this recording, they reflect on the harm that arises from use errors involving perse medical devices, such as infusion pumps, insulin pen-injectors, and dialysis machines. As covered in their book due out early 2016, they outline the steps necessary to progress from the observation of use errors, such as those that might occur during a usability test (i.e., simulated device use) to reasonable hypotheses about the root causes.


Michael Wiklund, MS, P.E., CHFP, General Manager, UL Human Factors Engineering (HFE);
Andrea Dwyer, Managing Human Factors Specialist;
Erin Davis, Managing Human Factors Specialist

Please note this webinar was delivered September 10, 2015.

Register to view the recording:

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Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Read more about this.

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