The third day of HFES 2013 was given over to the FDA.

Ron Kaye at HFES 2013

Anthony Watson, the Director of the Division of Anesthesiology, etc. in the Office of Device Evaluation (ODE) of CDRH, started off by giving a historical talk about human factors at the agency. He mentioned the first HF Guidance, which was developed by Ron Kaye and Jay Crowley. But, as he said, HF was considered to be “advisory;” it was not in ODE.

However in 2004, there was a fatality associated with an infusion pump that was clearly related to use error. This event was the trigger for a series of actions that led to the HF group moving to ODE in 2006. That, in turn, changed the role of human factors to that of a requirement. As Anthony said, the key difference is that devices are now, at times, rejected solely for HF shortcomings, something that didn’t happen in the past.

He was followed by Molly Story, one of the members of the HF Premarket Team at ODE. Molly talked about the new FDA guidance document for home-use devices. She pointed out some of the variability one has to consider with home healthcare devices—variability in the environment of use and variability in who the users are, for example. She also mentioned various other home-use initiatives, including the development of a labeling library and the creation of video instructions for devices.

The final presentation of the session was by Ron Kaye, Molly’s colleague, who’s the Human Factors Premarket Review Team Leader. He began by acknowledging that finalizing the HF Draft Guidance will take some time; he didn’t commit to a date. His talk was about what they see at FDA that they don’t want to see. Some examples of things that “aren’t helpful”:

• Quantitative “usability objectives” ala IEC 62366.

They’ve made it clear for some time that setting a criterion of, say 90% correct performance, and showing evidence of meeting such a made-up criterion is not acceptable.

• A statement of “compliance with IEC 62366” rather than a HF report.
• Participant rating scales for validation testing.
• Validation that doesn’t clearly describe or focus on use-related risk.
• Use of non-US participants in validation testing (although there are a few exceptions, if adequate justification is given that the data are generalizable to the US).
• Changes to devices to mitigate problems that are then not validated or even mentioned in a HF report.
• The absence of formative (exploratory) testing, so discovering new problems in summative (validation) testing.
• The absence of summative testing on the grounds that formative testing has shown no problems.
• “Partial validation tests” that only addresses some of the functions of a device because formative testing has “demonstrated” that other functions don’t pose problems.
• Obscure reports with complicated protocols that are impossible to interpret—where the relevance to use-related risk is not clear.
• HF reports that are cluttered up with discussion of “usability” issues that are not safety-related.

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Stephen B. Wilcox, is a principal and the founder of Design Science (Philadelphia), a 25-person firm that specializes in optimizing the human interface of products—particularly medical devices. Wilcox is a member of the Industrial Designers Society of America’s (IDSA) Academy of Fellows. He has served as a vice president and member of the IDSA Board of Directors, and for several years was chair of the IDSA Human Factors Professional Interest Section. He also serves on the human engineering committee of the Association for the Advancement of Medical Instrumentation (AAMI), which has produced the HE 74 and HE 75 Human Factors standards for medical devices.

More Adventures in Medical Device Usability

HFES 2013 and Regulated vs. Unregulated Components of Human Factors Work

HFES 2013 and Rewriting IEC 62366: Adventures in Medical Device Usability