Last week I had the opportunity to attend the Human Factors & Ergonomics Society Health Care Symposium. Since I work on medical devices, I mainly went to the presentations in the medical devices track and found them to be very interesting and educational. The opening keynote speaker, Dr. Ross Ungerleider, talked about practices that foster an environment (particularly in an operating room) conducive to innovative thinking and learning from human error. There were a number of presenters from the medical device industry who shared case studies, lessons learned, and various models for applying usability in their individual companies and departments. We were also fortunate to learn about some changes coming for human factors standards and the latest FDA perspectives on best practices, which I thought I’d share with you this week.

Let’s take a look at the upcoming changes to human factors standards and industry guidance. For those that haven’t heard, a new draft FDA Human Factors Guidance was released in June, 2011. It’s still in draft form because the team is still addressing the approximately 600 comments they received during the review period, but it’s available on the FDA website and gives the current FDA expectations regarding human factors and usability engineering practices. IEC 62366 is also in the process of being updated, one of the goals being to make the standard more “user friendly.” An annex will be added for legacy devices, and the standard itself will be divided into two parts: IEC TR 62366-1, which will be the normative standard harmonized with the FDA Human Factors Guidance, and IEC TR 62366-2, which will be more of an informative/tutorial form of the standard. ANSI/AAMI HE 75 is also being updated with new sections of device design guidelines.

So I’m sure everyone wants to make their regulatory submissions easier for the FDA to review, right? Ron Kaye, the FDA Human Factors group leader, and several members of his team at the CDRH filled us in on some ineffective practices they’ve seen and what they look for in submissions. They said they often see an approach of testing usability objectives that are not based on risk, and they made a plug for clear traceability in documentation to show effectiveness of risk mitigations through testing. The reviewers frequently see no formative usability testing done to identify problems prior to doing summative testing, which can lead to unexpected risks surfacing in formal validation. Interestingly, they also said that formative testing is often mistakenly used as evidence that there are no new use-related risks, and therefore no formal validation testing is required. Another similar mistake is using formative testing as partial validation and not including all critical and essential tasks for device use in summative testing. Ron Kaye made a point of emphasizing the role of formative usability testing as a tool for device user interface development and validation planning, not as standalone evidence of use safety. He also stressed that for the purposes of FDA review, only evidence that the device can be used safely and effectively by the intended users in the intended environment of use needs to be submitted. He didn’t say it outright, but this statement made it seem that the review process would be easier for them if the safety and efficacy usability results were reported separately from results of ease of use and preference type testing. He also mentioned the need to include a summary of formative testing activities in the summative usability report, so that the dispositions of any issues that were found along the way are tied in with the final results, telling the whole story.

Those are just a few of the more salient points I thought would be interesting to share from a human factors standards and implementation standpoint. Do any of the FDA review observations surprise or concern you? Do you have any thoughts to share about the upcoming standards changes?


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