June 21, 2023
By Jenny Collinson and Yvonne Limpens
On May 25th 2023, our Human Factors Research & Design team’s Jenny Collinson and Yvonne Limpens delivered a webinar covering facts and opinions on incorporating Human Factors Engineering (HFE) into Post Market Surveillance (PMS) activities. They discussed the benefits of integrating HFE into PMS; the current approaches to HFE and PMS; and shared tips on how to successfully collect, handle and record HFE PMS data.
HFE in post market surveillance for medical devices
A key benefit of incorporating HFE data into PMS is addressing the shortcomings of pre-market usability data, where findings are often not based on actual use. Test artifacts cannot be completely eliminated during simulated use studies, and post-market monitoring allows you to identify any use-related risks that were not possible to recognize pre-market. Additionally, users can change over time due to experiences with other devices, shifting mental models and evolving performance shaping characteristics. PMS allows you to monitor the performance of the device as time goes on, something that cannot be achieved in the limited pre-market period. The insights gathered from HFE PMS data are highly valuable and can be used as inputs for the design of next-generation or similar devices, to update an on-market device or to proactively address safety issues and prevent product recalls.
Usability and human factors data in medical device PMS
Currently, HFE practices in PMS are often more reactive than proactive, and this approach has its shortcomings. Waiting for reactive data is a lengthy process, and usability and (use-)safety issues can be underreported. Additionally, you do not always have control over the reliability of reactive data. For example, consider MAUDE, the US Food and Drug Administration’s (FDA) database for medical device-related safety events and product complaints. The usefulness of any MAUDE report depends on how completely and accurately the reporter described the event, and the report might lack the details needed to determine a root cause for the event and make good use of the data.
So, how can manufacturers be proactive in collecting HFE-related usability data? The tips that Yvonne and Jenny shared during the webinar include:
Empowering users. Encourage users to report data by optimizing the usability and user experience of providing feedback. If a user wants to share an issue, how can they do this? Is there a website with a friendly user interface? Is there a QR code on the device that can help them get there quickly?
Identifying your goals: Identify the goals of your HFE PMS and choose appropriate activities. For example, if you are interested in detecting issues that might not have been picked up during simulated use, consider observing users operate the device in real-life (i.e., a contextual inquiry).
Asking the right questions: Identify the root causes of safety issues and clearly categorize data. Sources like IEC-62366 and AAMI TIR50 provide guidelines for which questions should be asked to accurately assign a root cause and determine if a device issue is use-related, and our team has previously shared our process for conducting root cause analysis.
Benefits of applying HFE to PMS
Moreover, incorporating HFE into post-market surveillance has a number of benefits. You can use it as input for the next generation of your device, to update an on-market device, and to proactively respond to issues and reduce the chances of a field-safety notice or a product recall. Contact our global team to learn more about conducting HFE PMS activities to benefit your organization. Or, sign up for a complimentary account with OPUS, our team’s software platform that provides HFE training, tools, and templates.
Jenny Collinson is Research Director and Yvonne Limpens is Managing Human Factors Specialist at Emergo by UL’s Human Factors Research & Design division.
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