Thursday, September 10th; 11:00 am EDT, 60 mins.
During their 60-minute webinar presentation, senior members of UL’s human factors engineering practice will describe the regulatory and commercial imperative to identify the most likely root causes of medical device use errors. They will reflect on the harm that arises from use errors involving diverse medical devices, such as infusion pumps, insulin pen-injectors, and dialysis machines. As covered in their upcoming book, they will 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. The steps include careful observation and analysis of user-device interactions, interviewing the people who commit the use errors, assessing a medical device’s user interface quality based on human factors engineering design principles, working with collaborators toward a consensus on the root causes, and (in appropriate cases) developing recommendations on how to make a device’s user interface less vulnerable to use error. Audience members will take away from the webinar a good understanding of a productive root cause analysis process, which is central to use-related risk management.
The webinar presenters are co-authors of Medical Device Use Error – Root Cause Analysis (pending publication by CRC Press, 2016).