Edworthy Judy Reed, Schlesinger Joseph J, McNeer Richard R, Kristensen Michael Sonne, Bennett Christopher L
Biomed Instrum Technol. 2017 Feb;51(s2):50-57. doi: 10.2345/0899-8205-51.s2.50.
Alongside the development and testing of new audible alarms intended to support International Electrotechnical Commission 60601-1-8, a global standard concerned with alarm safety, the categories of risk that the standard denotes require further thought and possible updating. In this article, we revisit the origins of the categories covered by the standard. These categories were based on the ways that tissue damage can be caused. We consider these categories from the varied professional perspectives of the authors: human factors, semiotics, clinical practice, and the patient or family (layperson). We conclude that while the categories possess many clinically applicable and defensible features from our range of perspectives, the advances in alarm design now available may allow a more flexible approach. We present a three-tier system with superordinate, basic, and subordinate levels that fit both within the thinking embodied in the current standard and possible new developments.
在开发和测试旨在支持国际电工委员会60601-1-8(一项与警报安全相关的全球标准)的新型听觉警报的过程中,该标准所涵盖的风险类别需要进一步思考并可能进行更新。在本文中,我们重新审视该标准所涵盖类别的起源。这些类别基于组织损伤可能产生的方式。我们从作者不同的专业视角来考量这些类别:人为因素、符号学、临床实践以及患者或家属(外行人)。我们得出结论,虽然从我们的一系列视角来看,这些类别具有许多临床适用性和合理性特征,但目前警报设计的进展可能允许采用更灵活的方法。我们提出一个具有上级、基本和下级层级的三层系统,该系统既符合当前标准所体现的思路,也适应可能的新发展。