A Human Factors Analysis of Cardiopulmonary Bypass Machines and Associated Components and Procedures

Abstract

Cardiopulmonary bypass machines (CBM's), first developed in 1953, are commonly used during heart surgery to oxygenate blood and circulate it throughout the body while the heart is stopped. Although several advances have occurred in the engineering of perfusion pumps, the interface design of CBM's has not changed appreciably for several decades. The growing awareness of human error in medicine has highlighted the role that poorly designed medical devices can play in producing errors that cause patient harm. The purpose of this study, therefore, was to identify issues related to CBM design that may predispose surgical teams to make errors. The study utilized multiple research methods including observations, heuristic evaluations, structured interviews and usability assessments. Results revealed several fundamental design problems associated CBM displays, controls, alarms, and component integration, as well as communication and procedural issues. These data provide valuable information for redesigning CBM's to reduce errors and improve patient safety.