Masking Between Reserved Alarm Sounds of the IEC 60601-1-8 International Medical Alarm Standard: A Systematic, Formal Analysis

Hum Factors. 2022 Aug;64(5):835-851. doi: 10.1177/0018720820967596. Epub 2020 Dec 22.

Abstract

Objective: In this work, we systematically evaluated the reserved alarm sounds of the IEC 60601-1-8 international medical alarm standard to determine when and how they can be totally and partially masked.

Background: IEC 60601-1-8 gives engineers instruction for creating human-perceivable auditory medical alarms. This includes reserved alarm sounds: common types of alarms where each is a tonal melody. Even when this standard is honored, practitioners still fail to hear alarms, causing practitioner nonresponse and, thus, potential patient harm. Simultaneous masking, a condition where one or more alarms is imperceptible in the presence of other concurrently sounding alarms due to limitations of the human sensory system, is partially responsible for this.

Methods: In this research, we use automated proof techniques to determine if masking can occur in a modeled configuration of medical alarms. This allows us to determine when and how reserved alarm sound can mask other reserved alarms and to explore parameters to address discovered problems.

Results: We report the minimum number of other alarm sounds it takes to both totally and partially mask each of the high-, medium-, and low-priority alarm sounds from the standard.

Conclusions: Significant masking problems were found for both the total and partial masking of high-, medium-, and low-priority reserved alarm sounds.

Application: We show that discovered problems can be mitigated by setting alarm volumes to standard values based on priority level and by randomizing the timing of alarm tones.

Keywords: audition; computational modeling; medical devices and technologies; patient safety; psychophysical methods.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Clinical Alarms*
  • Humans
  • Monitoring, Physiologic
  • Sound