Medical devices are indispensable in the diagnosis, treatment and management of disease. To enhance the usability of medical devices, human factors engineering (HFE) has been widely applied. While it takes into account human capabilities and limitations, the use of HFE in the design of medical devices has challenges that render its implementation incomplete, resulting in its potential not being fully exploited. This study examines the literature on HFE to identify gaps and review recommendations with regard to its application in the design of medical devices. The literature reveals that HFE tends to place emphasis on the reduction of errors at the expense of medical device usability, that it has challenges in drawing on multiple perspectives, that it provides limited space for creativity and innovation, that it does not give adequate attention to contextual factors, and that communication barriers interfere with its implementation. The literature suggests that the shortcomings of HFE are methodological. To fill the gap, we propose the use of design thinking in HFE, not as a substitute but as a complementary approach, for enhancing usability. Design thinking, by virtue of being a human-centered approach, has the potential to add value to HFE by incorporating the subjective components of usability.

医疗设备是疾病诊断，治疗和管理必不可少的。为了提高医疗设备的可用性，人为因素工程（HFE）已被广泛应用。尽管考虑了人类的能力和局限性，但在医疗设备设计中使用HFE面临着一些挑战，使其无法完全实施，导致其潜力没有得到充分利用。这项研究检查了有关HFE的文献，以发现差距并审查有关其在医疗器械设计中的应用的建议。文献表明，HFE倾向于以减少医疗设备的使用性为代价来减少错误，它在多种角度上都面临挑战，它为创造和创新提供了有限的空间，它没有充分重视上下文因素，并且沟通障碍妨碍了它的实施。文献表明，HFE的缺点是方法论上的。为了填补空白，我们建议在HFE中使用设计思想，而不是作为替代，而是作为补充方法，以提高可用性。通过以人为中心的方法，设计思想有可能通过合并可用性的主观要素来为HFE增加价值。