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.

Full Text
Paper version not known

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call

Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.