The right time to be in Human Factors: HFES Healthcare Symposium Recap 2023
It’s a great time to be in human factors – HFES Healthcare Symposium 2023 in Review
The Agilis team recently flew out to Orlando, Florida for the 2023 International Symposium on Human Factors and Ergonomics (HFES) in Health Care and wanted to share some of our insights.
From case studies presenting areas of need, to lectures on inspiring improvements, HFES had it all. The keynote speaker shared an emotional anecdote about the simulated environment and its ability to give a healthcare team the confidence to operate on a high-risk pediatric patient. Other sessions throughout the conference contained similarly inspiring stories, such as an example of applying human factors (HF) to cardiac visualization software, allowing both patients and surgical teams to be better educated and prepared for cardiac surgery. Through all these examples, we were reminded of all the potential that HF has to impact healthcare devices and systems.
One interesting aspect of the HF community is that we come from a wide variety of backgrounds. This year the Agilis team spoke to many professionals that came to the field of HF with backgrounds spanning medical, aerospace, design, and customer service. Other HFES attendees we spoke with had HF experience in different industries but were looking to explore new opportunities in healthcare. Whatever their background, HFES attendees all share the same drive that we have here at Agilis - to make products that are not only safe and effective but easy to use. This drive is what makes all the difference in our high-stakes environment.
There were several themes at the conference this year that we thought were notable.
Many sessions at the conference were led by HF professionals working full-time within hospital and clinical environments. It was extremely valuable to hear their firsthand accounts of the hectic hospital environments and their perspectives on the negative impact of cognitive load, communication gaps, and workflow interruptions that occur in real work environments and what might be overlooked during simulation testing.
A deep understanding of the clinical environment is critical not only to inform HF documentation, such as Context of Use, Task Analysis, and risk documentation, but also to ensure that your design team creates products that make sense to your users and fit into their existing workflow.
With this in mind, consider if your product team would benefit from more exposure to clinical work environments to inform the usability of your designs for actual users.
On the second day of the conference, there was a panel discussion of recent trends in FDA feedback, presented as a follow-up to a similar presentation from last year. This session contained a lot of information (too much to include all of it here), but here are some of the key takeaways and recommendations:
The use-related risk analysis template shown in the new Center for Devices and Radiological Health (CDRH) draft guidance issued in December of 2022 should not be considered a complete risk analysis and should only be used for submission purposes – the same is true for the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
Unless you are specifically testing instructions for use (IFU), be very careful about explicitly mentioning the IFU during HF validation studies, as this can be considered “too leading” in some circumstances. For example, say things like “You can make use of the materials that are available to you,” instead of mentioning any specific document or material.
Pre-clinical HF validation studies (conducted prior to clinical trial) are becoming more common to demonstrate the products have had enough use-risk mitigated to be used in a clinical trial.
FDA feedback on comparative use studies is inconsistent. If you need to perform one of these studies, consider working with a professional statistician who can assist you with sample size justifications.
One of the hot topics mentioned multiple times was the new draft guidance released by CDRH in December and how this might affect industry HF activities. The new guidance outlines three different categories of submission with corresponding HF requirements based on whether the submission is for a new product or an update to an existing product as well as the extent of UI design changes. See our newsletter post on this topic here.
Many sessions at the conference contained practical tips for HF submissions to the FDA.
One session used data from the Drugs@FDA1 database to point out that reviews of drug/biologic submissions tended to focus mainly on use errors for tasks related to dosing, such as placing the device at the correct site, gathering the medicine, and drawing dose into a syringe, as opposed to tasks which were not unique to the device, such as storage, washing hands, cleaning injection sites, and disposal. So, what should we do with this information? At the end of the day, all critical tasks have to be assessed, so keep categorizing critical tasks according to published guidance, and when creating a URRA, be realistic and honest in the assessment of potential risks.
Other practical tips were related to root cause analysis and the age-old answer: “I don’t know”. One session argued that this response may be enough information when probing for a root cause, as probing further or pressing after an “I don’t know” response could indicate to the study participant that this response is not acceptable and could cause them to make “best guesses” to fill in the blank. What was recommended instead was to remind participants in sessions that uncertainty is acceptable, to pause briefly after an “I don’t know” to allow the participant to expand on their answer naturally, and to be transparent with reporting uncertainty during study sessions.
Another session gave advice on opportunities to forego HF validation testing along with potential justifications. Foregoing HF validation testing may be justified if the submission is for an already existing device with no changes to the UI, a new device with no critical tasks, or a device that has a routine procedure for use. If the device is novel or has an unusual procedure for use, HF validation testing is likely required. This is not an exhaustive list of justifications – like other areas of HF, “it depends”.
Conclusion
In the ever-changing world of human factors, it’s important to keep up to date on practical applications of HF techniques. At Agilis, we cherish all opportunities to connect with our colleagues within the human factors community and discuss the ins and outs of this field as it relates to healthcare. If you’d like to connect with us at a future event, you can find our event schedule here or contact us through email at Kymanox-Agilis-Inquiries@kymanox.com.
References
[1] “Drugs@FDA: FDA-Approved Drugs.” Food and Drug Administration, Apr. 2023, https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm.
About the Author:
Alex Kruzer BS
Alexandria (Alex) Kruzer is the Engineering Manager and a Human Factors Engineering Consultant with Agilis Consulting Group, LLC. Alex has a B.S. in Biomedical Engineering and over 8 years of experience working on the design and testing of software as a medical device, primarily in the medical imaging space. Prior to joining Agilis Consulting Group, Alex gained extensive experience as a Clinical Scientist working with clinicians in the Radiology, Nuclear Medicine, and Radiation Oncology fields.
