B38-20 Safe for All Users? Validating Remote Auscultation Usability Across Patients, Caregivers, and Health Care Professionals

Rationale Remote auscultation enables virtual respiratory assessment, but its safety and effectiveness depend critically on whether diverse users, from patients of all ages to busy clinicians, can operate these devices correctly. Device failures or user errors during teleconsultation could result in misdiagnosis, delayed care, or patient harm. Despite this risk, human-factors validation of telehealth devices remains underutilized, and the applicability of standard usability tools like the System Usability Scale (SUS) for multi-user medical technologies is not well characterized. This study assessed the usability of a representative remote auscultation platform among lay users, caregivers, and healthcare professionals (HCPs), while examining the applicability of the SUS for telehealth device evaluations. Methods A human-factors validation study was conducted in the United States following IEC 62366 and U.S. FDA human-factors guidance. Participants included 17 adult lay users, 15 caregiver-child pairs (children aged 3-17 years), and 17 HCPs (nurses, respiratory therapists, physicians). Participants completed critical use tasks representative of real-world operation, including setup, chest sensor placement, recording, and data transmission within a teleconsult workflow. Observers documented task success, near errors, and critical errors. Participants completed the 10-item SUS questionnaire, which is a 0-100 scale where ≥68 indicates above-average usability. SUS response distributions and variance across user groups were analyzed to assess its discriminative value and applicability to remote clinical systems. Results All participants completed the evaluation successfully, with overall task completion rates exceeding 95% across all groups. No hazardous or critical errors occurred. Minor issues, such as temporary uncertainty during sensor placement or interface navigation, were self-corrected using the user guide without assistance. Mean SUS scores demonstrating good-to-excellent usability: 75.9 ± 9.2 (lay users), 77 ± 8 (caregiver-child pairs), and 88.8 ± 5.3 (HCPs). The SUS effectively differentiated performance between user groups and correlated with observed task success rates (i.e., participants with more observed difficulties produced lower SUS scores), supporting its applicability for telehealth usability testing. Conclusion Remote auscultation technology can be safely and effectively operated by clinical and non-clinical users across diverse age groups and experience levels, with no critical errors observed. The SUS provided a valid and practical measure of perceived usability, capturing meaningful differences across user groups and workflows. These findings support the use of SUS, in combination with observation-based task analysis, as a generalizable framework for evaluating usability of remote monitoring and telehealth technologies. Early integration of such assessments may enhance safety, reliability, and adoption in virtual respiratory care.