Beyond the VAD: Human Factors Engineering for Mechanically Assisted Circulation in the 21st Century.
Thousands of ventricular assist devices (VADs) currently provide circulatory support to patients worldwide, and dozens of heart pump designs for adults and pediatric patients are under various stages of development in preparation for translation to clinical use. The successful bench-to-bedside development of a VAD involves a structured evaluation of possible system states, including human interaction with the device and auxiliary component usage in the hospital or home environment. In this study, we review the literature and present the current landscape of preclinical design and assessment, decision support tools and procedures, and patient-centered therapy. Gaps of knowledge are identified. The study findings support the need for more attention to user-centered design approaches for medical devices, such as mechanical circulatory assist systems, that specifically involve detailed qualitative and quantitative assessments of human-device interaction to mitigate risk and failure.
BioCirc Research Laboratory, School of Biomedical Engineering, Science and Health Systems, Drexel University, Philadelphia, PA, USA.
Amy L
AL
Throckmorton
Independent Consultant, McLean, VA, USA.
Sonna M
SM
Patel-Raman
BioCirc Research Laboratory, School of Biomedical Engineering, Science and Health Systems, Drexel University, Philadelphia, PA, USA.
Carson S
CS
Fox
Department of Information Science, College of Computing and Informatics, Drexel University, Philadelphia, PA, USA.|Department of Health Systems and Services Research, College of Nursing and Health Professions, Drexel University, Philadelphia, PA, USA.
Ellen J
EJ
Bass
D000818:Animals; D000066491:Clinical Decision-Making / Q000379:methods; D018795:Device Approval; D006804:Ergonomics / Q000379:methods; D006353:Heart-Assist Devices / Q000009:adverse effects; D006801:Humans; D057285:Precision Medicine / Q000379:methods; D011474:Prosthesis Design
Artificial heart pump; Blood pump; Decision making; Human factors engineering; Mechanical circulatory support; Personalized medicine; Ventricular assist device