Medical Equipment Human Factors Evaluation for FDA Emergency Use Authorization
Client's innovation presented as a testable physical prototype was evaluated in multiple simulated scenarios for FDA Human Factors compliance per emergency use protocol.
[2021]
"AerVent" is a scalable, mobile negative pressure solution designed to increase hospital isolation capacity and reduce risk to persons who come in contact with airborne infectious disease patients.
Team
Ryan Ahmed, Sarah Colletta, Jeanne Carroll, Tammy Toscos (Parkview Research Center), Charlotte Gabet, Adam Fischer, Matt Stieber (Parkview Advanced Simulation Lab).
Objective
Test and report AerVent device use related risks and impact on operational performance in the following scenarios: patient transport, assessment, intubation, extubation, nursing care and emergency procedures such as cardiopulmonary resuscitation (CPR).
How much domain knowledge is needed to design an effective research? A lot. Long hours of reviewing recorded medical procedures, clinical training content and consultation with clinical professionals (external to the study) went into planning the research project.
Process
Research Protocol Development
Study protocol was developed per Federal Drug Administration (FDA) guidelines for Emergency Use Authorization (EUA) of hospital equipment, including research design, recruitment criteria, usability goals and performance goals.
Usability Testing
Multiple usability testing sessions were conducted for each scripted scenario. Participants per appropriate roles were recruited to play each scenario to support patient care in the Advanced Simulation Lab on a patient mannequin.
Measures collected include time on task, task completion and task success with and without AerVent in randomized sequence to reduce ordering effect. Qualitative data was collected on potential usability issue or risk to humans in the study.
User Feedback Questionnaire
User feedback was collected as Likert rating and open-ended responses following each test session.
Outcome
Data was analyzed using Microsoft Excel and reported as deidentified aggregated findings categorized in three (high, medium, low) severity scales per FDA guidelines. Final report was delivered to client for inclusion in the EUA application to FDA.