Earlier this month our team had the opportunity to attend the 10th Annual International Symposium on Human Factors and Ergonomics in Health Care and our company was pleased to be the Silver Sponsor of this notable event.
The virtual event took place between April 12th – 16th and featured content in five educational tracks:
- Medical and Drug Delivery Devices
- Hospital Environments
- Patient Safety Research and Initiatives
- Digital Health
- Education and Simulation
Besides the daily track sessions, staff from the FDA Center for Devices and Radiological Health (CDRH) presented their annual workshop “Human Factors Validation of Medical Devices and Services.” Moreover, staff from the CDRH and the Center for Drug Evaluation and Research (CDER) were on an FDA panel.
This year’s symposium brought a lot of great content, and we enjoyed hearing from some of the most seasoned human factors veterans about the state of our practice. We were also excited to hear from some new presenters who challenged the status quo and sought innovative ways to turn tough problems on their head. We especially enjoyed presentations on how we as human factors professionals can be more inclusive in our research and the reality of interpreting participant-reported root causes.
As we reflect on our experience, we thought it would make sense to share a few key takeaways:
- Remote testing. The FDA acknowledged the challenges of performing in-person testing during 2020 and a few presenters discussed their experience with remote testing as a viable alternative. Several ideas were suggested to minimize the methodological differences between remote and in-person testing. The FDA recommended that manufacturers submit validation protocols for review to determine the acceptability of remote testing for the product under investigation.
- Critical and Non-Critical Tasks. FDA/CDRH asked that tasks be classified as either critical or non-critical. There was no need for “essential” to be used, as both critical and non-critical tasks are necessary for product use. Non-critical tasks should be included and reported on in validation testing if they occur in the process of completing critical tasks.
- Risk Analysis Quality. A poor quality risk analysis remains the #1 topic the FDA provides feedback on human factors validation test protocol.
- URRA vs uFMEA. The FDA stated they are seeing companies using a uFMEA as their primary method for understanding the potential hazards associated with their products. The FDA made it clear that the preferred approach is a URRA (Use-Related Risk Analysis).
- Acceptance Criteria. Regardless of usability expectations for CE marking, FDA does not accept setting “acceptance criteria” for validation tests.
- User Groups. Manufacturers should make sure they understand their user groups thoroughly. A missing user group or inappropriate definition of a user group is a common piece of feedback in validation protocols.
We are so thankful to the organizers, track chairs, and reviewers who worked so diligently to provide a great forum for us to hear the latest and greatest. Here’s hoping that we will be able to gather in person in 2022!