IFan Yen, Kynan Taylor, Xianshan Qi, Steve Martinuzzo, Chiahao Hsu, Michael Neidlin, Jamshid H Karimov, Po-Lin Hsu
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引用次数: 0
Abstract
Background: In a critical care setting, a plethora of life-saving devices, including mechanical circulatory support (MCS) systems, with their powering sources, wiring, and user interfaces, create significant challenges for operational efficiency and patient safety. We report a study of an integrated, user-friendly, modular life support platform (LSP) designed to be suitable for complex clinical and emergency use scenarios.
Methods: Surveys were conducted (21 centers of excellence), involving clinical and nursing staff (n = 39), focusing on functional requirements, environmental adaptability, alert systems, and user interfaces. In total, 77 user requirements specifications (URS), 272 product requirements specifications (PRS), and 30 KANO model parameters were analyzed by the cross-functional development team, complemented by industrial design analysis, usability engineering, and iterative validation of device features to produce a coherent modular architecture. We hypothesized that the integrated architecture would support task completion within predefined operational acceptance criteria and minimize potential use errors under simulated-use conditions.
Results: The LSP architecture incorporated three configurations: (1) an extracorporeal ventricular assist device (VAD) and adjustable support arm, (2) an extracorporeal membrane oxygenation (ECMO) system with a modular oxygenator and pump, and (3) an investigational percutaneous ventricular assist devices (pVADs) featuring a flushing pump system, a drive motor, and a catheter pump head. Usability testing confirmed its intended adaptability and effectiveness across ICU, ER, and cardiac intensive care units (CICU), operating rooms (OR), and cardiac catheterization laboratories.
Conclusions: Demonstrated task completion within predefined operational acceptance criteria, whereas user failure modes and effects analysis (UFMEA) reassessment reduced the numbers of NAC and ALARP risk items.
期刊介绍：
Artificial Organs is the official peer reviewed journal of The International Federation for Artificial Organs (Members of the Federation are: The American Society for Artificial Internal Organs, The European Society for Artificial Organs, and The Japanese Society for Artificial Organs), The International Faculty for Artificial Organs, the International Society for Rotary Blood Pumps, The International Society for Pediatric Mechanical Cardiopulmonary Support, and the Vienna International Workshop on Functional Electrical Stimulation. Artificial Organs publishes original research articles dealing with developments in artificial organs applications and treatment modalities and their clinical applications worldwide. Membership in the Societies listed above is not a prerequisite for publication. Articles are published without charge to the author except for color figures and excess page charges as noted.
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