Abstract
The reserved set of audible alarm signals embodied within the global medical device safety standard, IEC 60601-1-8, is known to be problematic and in need of updating. The current alarm signals are not only suboptimal, but there is also little evidence beyond learnability (which is known to be poor) that demonstrates their performance in realistic and representative clinical environments. In this article, we describe the process of first designing and then testing potential replacement audible alarm signals for IEC 60601-1-8, starting with the design of several sets of candidate sounds and initial tests on learnability and localizability, followed by testing in simulated clinical environments. We demonstrate that in all tests, the alarm signals selected for further development significantly outperform the current alarm signals. We describe the process of collecting considerably more data on the performance of the new sounds than exists for the current sounds, which ultimately will be of use to end users. We also reflect on the process and practice of working with the relevant committees and other practical issues beyond the science, which also need constant attention if the alarms we have developed are to be included successfully in an updated version of the standard.
