Mar 22 2024 71 mins 1
Join us in our latest episode of Safe and Effective, where we welcome back our good friend Dr. Albert Boquet to talk about using an existing framework, such as HFACS, to develop a unified use error classification system and database to add as a tool to the human factors engineering process in the medical device and combination product (development) industry.
In our discussion we shed light on the nuances between not only use errors and their identification and classification, but also how such is a data driven system that requires building on. We get into the complexities of how humans are not engineered, but instead bio-psycho-social systems, and how therefore, their behaviors and actions can not be evaluated using methods and thinking originally derived and intended for engineered systems. We end our discussion with exploring the idea of implementing such a use error classification system, where to start, and how ultimately it could enable an elevated capacity of prioritization and mitigation of risks associated with such and increase device safety and effectiveness overall.
Additionally, we provide a sneak preview of what all we have in store for you during the upcoming Safe and Effective Instagram Live events streamed directly from the HFES 2024 International Symposium on Human Factors and Ergonomics in Health Care in Chicago, Illinois, from March 24-26th, 2024.
Instagram: safeeffectivepodcast
- Guest: Albert Boquet
- The Human Factors Analysis and Classification System (HFACS) Framework
- HFES HCS Poster, March 26th, 2024: Determining When and How to Include Multiple Users in Human Factors Testing - Case Study Examples
- HFES 2024 International Symposium on Human Factors and Ergonomics in Health Care, March 24 - 27, 2024 at the Hilton Chicago Hotel
- Host: Heidi Mehrzad
- HFUX Research | Medical Human Factors
- Applying Human Factors and Usability Engineering to Medical Devices | FDA
- Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry
- FDA Draft Guidance (December, 2022): Content of Human Factors Information in Medical Device Marketing Submissions
