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. Work is underway to update the audible alarms associated with an important global medical device standard, International Electrotechnical Commission (IEC) 60601-1-8, General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.1 The standard, which is concerned with the safety of medical devices, specifies the audible alarms that should accompany the risk categories described. The audible alarms themselves were demonstrated to be less than optimal.2-5 Four sets of prototype updates were developed and are in the process of being benchmarked.6 The alarms then will be made available for further testing. An important issue emerging from this work is that the categories of risk specified in the standard may require updating in addition to the audible alarms. In this article, we revisit the categories from our multidisciplinary perspective in an attempt to open up a discussion of the categories and suggest how updating them might be approached. The writing team consisted of a human factors and auditory alarms specialist, a semiotician, two anesthesiologists, and a layperson who might be a patient or a member of a patient's family. This article is not a systematic or a narrative review. It is a collection of viewpoints aimed at stimulating debate. We also provide an updated proposal in an attempt to stimulate the debate further.
ASJC Scopus subject areas
- Biomedical Engineering
- Computer Networks and Communications