Presentation
MDD13 - Determining When and How to Include Multiple Users in Human Factors Testing: Case Study Examples
DescriptionThis presentation will cover examples of usability testing for products in which one or more individuals, such as a parent, caregiver or surgical team, may be involved regularly or infrequently in managing a device or drug delivery system for its intended purpose. This presentation will cover examples of home and clinical use products by presenting case studies the presenters have experienced with actual products in which more than one user is present during use as an intended user. The presentation will cover what questions should be asked to ensure the overall human factors process and individual study designs will need to meet regulatory human factors requirements. This would include understanding who are the intended users of the device to be tested, whether they should be tested separately, tested in the presence of a confederate who would simulate the other user group, or be tested in pairs or teams. In addition, this presentation will cover how to address known or foreseeable use error scenarios when those scenarios predict that the presence of other users could impact safe and effective use. Each case study will walk through the considerations of the intended user group or groups, the use environment, discuss the impact the different testing options would yield in relation to performance objectives, and will walk through the resolution of how each choice meets regulatory requirements for FDA and ISO 62336-1 human factors guidance. Device case studies will examine at least 2 home use devices (e.g., a home drug delivery system, patient implanted device or infusion system requiring lay user management) as well operating room interactions, such as those related to sterile surgical kit labeling. This presentation will provide case studies of how to evaluate a device when more than one intended user may be involved in use at the same time or in sequence and how to make appropriate decisions about user group inclusion throughout the human factors process.
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