Wiegmann Douglas, Suther Thomas, Neal James, Parker Sarah Henrickson, Sundt Thoralf M
Department of Industrial and Systems Engineering, University of Wisconsin-Madison, Madison, Wisconsin, USA.
J Extra Corpor Technol. 2009 Jun;41(2):57-63.
The practice of cardiovascular surgery demands daily interface with sophisticated technologies including most commonly the cardiopulmonary bypass (CPB) machine. Although other industries have recognized the importance of considering human factors in the design of machines to reduce operator error, the evolution of the CPB machine over the past half-century has been characterized by incremental modifications of component parts with attention principally to mechanical efficiency and biocompatibility, but with little awareness of the impact of design changes on the human user. As a first step in the redesign of a safer pump, systematic observations of perfusionists during 10 adult and pediatric cases were conducted by staff cardiac surgeons and by human factors experts. Observations were classified according to accepted ergonomics principles. Perfusionists also performed usability evaluations and provided feedback concerning the design and functionality of bypass machines. Problems identified clustered around several usability themes. Issues with displays (8% of total comments) included location, legibility, format, and integration. Multiple problems with controls (11% of total comments) including location, sensitivity, and shape were identified, as were issues with audible alarms (6% of total comments). Component integration (14% of comments) and work-space design (21% of comments) were suboptimal as well. Procedural and communication issues (21% of comments) related to pump utilization, rather than pump design, were also identified, which stemmed from a lack of standardized operating room practices. Clinical issues (14% of comments) surrounding care of the patient were also identified but were not further analyzed, because these comments did not pertain to the design of the perfusion pump. Our observations confirmed the hypothesis that opportunities exist to incorporate usability and ergonomics insights into CPB machine design to optimize the human/technology interface. Such fundamental design considerations may improve the safety of the conduct of CPB and, consequently, outcomes after cardiovascular surgery.
心血管外科手术的实践要求每天都要与复杂的技术进行交互，其中最常见的就是体外循环（CPB）机。尽管其他行业已经认识到在机器设计中考虑人为因素以减少操作员错误的重要性，但在过去的半个世纪里，CPB机的发展主要是对部件进行渐进式改进，主要关注机械效率和生物相容性，而很少意识到设计变更对用户的影响。作为重新设计更安全泵的第一步，心脏外科医生和人为因素专家对10例成人和儿科病例中的灌注师进行了系统观察。观察结果根据公认的人体工程学原理进行分类。灌注师还进行了可用性评估，并就体外循环机的设计和功能提供了反馈。发现的问题集中在几个可用性主题上。显示屏问题（占总评论的8%）包括位置、清晰度、格式和集成度。发现了与控件相关的多个问题（占总评论的11%），包括位置、灵敏度和形状，以及声音警报问题（占总评论的6%）。部件集成（占评论的14%）和工作空间设计（占评论的21%）也不尽如人意。还发现了与泵的使用相关而非泵的设计相关的程序和沟通问题（占评论的21%），这源于缺乏标准化的手术室操作规范。还发现了围绕患者护理的临床问题（占评论的14%），但未作进一步分析，因为这些评论与灌注泵的设计无关。我们的观察结果证实了这样一个假设，即有机会将可用性和人体工程学见解纳入CPB机设计，以优化人机界面。这些基本的设计考虑可能会提高CPB操作的安全性，从而改善心血管手术后的结果。
