Presentation
MDD3 - A Review and Critical Analysis of Use Error Classification Schemes
DescriptionApplying human factors throughout the product development lifecycle is imperative, so much so that in 2016, the U.S. Food & Drug Administration (FDA) released Guidance Applying Human Factors and Usability Engineering to Medical Devices. The guidance provides information for medical device manufacturers to consider during the development process, include the identification of critical tasks and potential use errors. Not currently included in the guidance, however, is an overview of error classification schemes or taxonomies, which are often applied during any human factors evaluation examining use errors.
The current presentation will provide an overview of the most common error classification schemes, particularly those that are applied during medical device usability evaluations. Furthermore, we will identify key strengths and weaknesses of these schemes, and discuss how the application of these methods may, or may not, help identify how use errors may occur and be mitigated in the real world.
We will address the challenges and intricacies involved in identifying what defines a use error, and how to classify it, during medical device development, where accurate error identification and categorization are paramount for design improvements and risk mitigation. We will further explore the impact of error classification findings in real-world applications. This bridge between usability testing and practical use is vital for ensuring the efficacy and safety of medical devices.
In summary, the current presentation will provide a comprehensive examination of error classification schemes, their applications in usability testing, and their implications for real-world medical device use. This discussion will be relevant for professionals involved in medical device design, development, and regulatory compliance, contributing to safer and more effective healthcare devices.
The current presentation will provide an overview of the most common error classification schemes, particularly those that are applied during medical device usability evaluations. Furthermore, we will identify key strengths and weaknesses of these schemes, and discuss how the application of these methods may, or may not, help identify how use errors may occur and be mitigated in the real world.
We will address the challenges and intricacies involved in identifying what defines a use error, and how to classify it, during medical device development, where accurate error identification and categorization are paramount for design improvements and risk mitigation. We will further explore the impact of error classification findings in real-world applications. This bridge between usability testing and practical use is vital for ensuring the efficacy and safety of medical devices.
In summary, the current presentation will provide a comprehensive examination of error classification schemes, their applications in usability testing, and their implications for real-world medical device use. This discussion will be relevant for professionals involved in medical device design, development, and regulatory compliance, contributing to safer and more effective healthcare devices.
Event Type
Poster Presentation
TimeTuesday, March 264:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives