|Ed Israelski, Ph.D.|
As expected based on FDA’s priorities for 2016, the Agency recently released the final guidance document on human factors and usability engineering. The document, titled “Applying Human Factors and Usability Engineering to Medical Devices,” finalizes the draft guidance on the subject released in 2011 and officially overrides “Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management,” issued in 2000.
The update finalizes FDA’s stance that device manufacturers should consider human factors testing as part of a “robust design control subsystem.” When risk analysis for a device indicates that users performing tasks incorrectly or failing to perform tasks could result in serious harm, manufacturers should submit human factors data in their premarket submissions.
Two other documents were released with the final document. The first was a draft guidance, “List of Highest Priority Devices for Human Factors Review,” including over 15 types of devices that should include human factors data in premarket submissions. An exception exists when the submission does not involve any changes to users, user tasks, user interface or use environments from those of predicate devices.
Robotic surgery devices made the list – seemingly the only item pertinent for orthopaedic device manufacturers. However, if a type of device is not on the list, it doesn’t mean you’re off the hook for submitting data to FDA, says Ed Israelski, Ph.D., Private Consultant and Co-Convener of the IEC and ISO Joint Working Groups on Usability Engineering Standards.
“The fact that your device may be omitted from the current version of that list doesn’t mean you don’t have to do your human factors [in your premarket submission],” Israelski says. “You have to do a thorough risk analysis, looking at users and your tasks. You have to do historical analysis of use errors for some of the products, then risk analysis and iterative design with formative evaluations. In the validation final study, you have to rationalize user groups and say how many make sense. There are no statistical criteria – we didn’t expect FDA would change their mind on that – it’s qualitative.”
It’s highly likely that you’ll observe use errors in your validation study, says Israelski.
“Your job is to look at each one of those use errors that occur during the validation study and explain them,” he says. “Can you do more about them in design? If not, is the residual risk that remains acceptable compared to the benefit of the product?”
The Agency released the final guidance on considerations for human factors data in premarket submissions, as well as two draft guidances on the topic.