Presentation
Identifying Use Related Risk Factors and Usability for an EBUS TBNA Through Iterative Formative Evaluations
SessionWednesday Poster Session
DescriptionEndobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a standard minimally invasive procedure for mediastinal staging in lung cancer. As device complexity increases, identifying use-related risk factors and evaluating usability from a human factors perspective becomes critical to minimizing use errors and ensuring procedural safety. This study aimed to identify use-related risk factors and assess the usability of the ClearTip EBUS-TBNA biopsy device (FINEMEDIX, South Korea) through iterative formative evaluations conducted in accordance with IEC 62366-1 and FDA Human Factors guidance. Five pulmonologists participated in each of two formative evaluations. The first used a survey-based method assessing user manual clarity and device handling, yielding satisfaction scores ranging from 3.95 to 4.5 out of 5. The second employed scenario-based task performance testing across 28 subtasks in a simulated clinical environment, achieving a 96% task success rate with a mean satisfaction score of 4.8/5. Key strengths included the button-based catheter adjuster, lightweight design, and stable connector. Recurring use-related risk factors centered on insufficient visual illustrations in the user manual and the lock button's size and smoothness. These findings informed targeted design refinements prior to summative evaluation. Iterative formative evaluations showed effectiveness in proactively identifying use-related risks and enhancing usability in complex bronchoscopic devices.
Event Type
Poster
TimeWednesday, October 21st5:30pm - 6:30pm PDT
Location