About FDA

Laboratory of Functional Performance and Device Use

Laboratory leader: Eugene Civillico 301-796-0577 Eugene.Civillico@fda.hhs.gov

The Human-Device Performance Laboratory is a new facility for research in the human factors of medical device use. Based upon an evaluation of CDRH data, a significant fraction of adverse event reports and device recalls are related to human factors. Additionally, the Affordable Care Act Section 4203 requires FDA to work with the Architectural and Transportation Barriers Compliance Board to develop standards to ensure accessibility to medical diagnostic equipment for people with disabilities. This requirement together with a Memorandum of Understanding with the National Institute on Disability and Rehabilitation Research, informs research on medical device accessibility.

The Human-Device Performance Laboratory was designed as a flexible facility to study topics such as task analysis associated with medical device use, impacts of universal design, accessibility for the disabled to medical devices, and use of medical devices under austere conditions and mass casualty events. Under all these situations, the characteristics of patients and their providers (users), medical devices, and the environment are all measured and can be manipulated. This research shall improve our understanding our how environmental conditions, user characteristics (including physical abilities and prior training or experience) and device features can contribute to medical device use errors and patient outcomes. Current laboratory capabilities include video-based motion capture, electromyography and force measurement with plans to expand testing capacity in the future.

This is a new laboratory initiated in 2011. Research projects and outputs will be added as they become available.

Page Last Updated: 11/03/2014
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