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Medical Audible Alarms and IEC 60601-1-8

Article  in  Proceedings of the Human Factors and Ergonomics Society Annual Meeting · September 2016
DOI: 10.1177/1541931213601145

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 Proceedings of the Human Factors and Ergonomics Society 2016 Annual Meeting 634

MEDICAL AUDIBLE ALARMS AND IEC 60601-1-8

Judy Edworthy, Cognition Institute, Plymouth University, UK
Carryl Baldwin, Department of Psychology, George Mason University, Fairfax, VA

It is well acknowledged in the literature that the set of audible alarms supporting a global standard for
medical devices (IEC 60601-1-8) is in need of updating. Developments in sound design, computer
technology and sound reproduction now make it possible to develop a wider range of possible alarm sounds
producing both new challenges and opportunities. In this symposium we discuss and present progress in
developing both new audible alarms for IEC 60601-1-8 and a framework for evaluation, covering the
processes of design, usability in middleware, testing sounds in realistic work environment, and masking.

INTRODUCTION IEC 60601-1-8 contains detailed information about

It is almost universally acknowledged in the clinical
world that there are problems surrounding the use of alarms.
For several years ‘alarm hazards’ have been top of the
Emergency Care Research Institute’s (ECRI) list of top
medical hazards; in 2011 a joint summit event between the
Joint Commission, the FDA, ECRI and the Association for the
Advancement of Medical Instrumentation (AAMI) on alarms
took place in Washington; and subsequent to this alarm
committees have been formed in many hospitals, with the
remit of reviewing alarm settings, the reduction of false
alarms, the adoption and sharing of good practice, and other
aspects of better alarm management. Resources and national
groups such as AAMI’s Alarm Coalition have been
instrumental in helping to reduce the alarm problem.
The focus of these efforts is largely on the reduction
of the number of alarms, rather than on the alarms themselves,
and the topic of appropriate alarm setting (for example) is by
necessity a clinical problem. In the case of audible alarms,
these are often referred to as ‘beeps’ or even ‘noise’. So, even
if the number of alarms is reduced, the ‘beeps’ and ‘noise’ will
Copyright 2016 by Human Factors and Ergonomics Society. DOI 10.1177/1541931213601145
the categories that should be alarmed: these are Oxygen,
Ventilation, Cardiovascular, Temperature, Drug
administration, Artificial perfusion, Power down, and a
General sound. There are unique alarm sounds for each of
these categories, differentiated into High priority (5 pulses of
sound, repeated) and Medium priority (three pulses of sound,
not repeated). The alarms themselves are tonal in nature and
sound like short melodies (Block, Rouse, Hakala &
Thompson, 2000). These alarms have been demonstrated to be
difficult to learn and retain by clinical staff, and to be easier
for nurses with musical training to learn than those without
(Sanderson, Wee & Lacherez, 2006; Wee & Sanderson, 2008).
It is acknowledged that the alarms should be updated (Block,
2008). Many, including the authors of those alarms and the
various technical committees in a position to update these
alarms, are of the view that the audible alarms require
updating.
Little testing and evaluation was done on the current
alarms but this should not and will not be the case for any new
alarms developed in support of IEC 60601-1-8 in the future.
Improving the learnability and meaningfulness of the alarms

remain. Addressing what should be done about the remaining
alarms is a human factors and design issue and there is a
wealth of literature that can be brought to bear on this topic.
Reducing the number of alarms likely to be heard in
clinical environments is a huge and valuable task, but it does
not necessarily deal with those issues that are broadly within
the human factors domain. For example, there will likely be
acoustics issues such as masking. Even though there will be a
reduced likelihood of masking if there are fewer audible
alarms, there is still the prospect that alarms will mask one
another when an emergency occurs. There will be a raft of
human factors issues such as learnability and possible
confusion between alarms, potential lack of urgency mapping,
lack of meaningfulness of alarms even when they are true, and
other features which will mean that medical alarms will still
be less than optimal even when best practice in alarm
reduction has spread across the clinical spectrum.
In this symposium we will address a range of these
issues, using a specific and important context: that of global
standard IEC 60601-1-8 ‘Medical electrical equipment -- Part
1-8: General requirements for basic safety and essential
performance -- Collateral standard: General requirements,
tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems’.
might be a starting point because comparisons can be made
directly with the existing alarms. However, beyond this there
are acoustic, technological and performance issues which will
need to be considered, as well as simulation testing and
eventual clinical testing. This symposium presents a series of
studies that elucidate this broader context. In some cases the
studies directly address the development and evaluation of
candidate replacements for the current IEC 60601-1-8 alarms,
and in some cases the studies present data and techniques that
can be brought to bear in the development and evaluation of
new alarms for IEC 60601-1-8.
SYMPOSIUM PAPERS
Detection
There are two factors that make it difficult to
determine if masking will occur between medical alarms.
First, any given alarm can have several different sounds that
occur over the span of its sounding cycle. Second, multiple
sounds can interact with each other and mask another sound,
where none of the original sounds would cause masking on
their own. Thus, due to the combinatorics, determining if
alarms can be partially or totally masked is difficult to
impossible using conventional analysis approaches. In this
Proceedings of the Human Factors and Ergonomics Society 2016 Annual Meeting
symposium, a paper will be presented that shows how model-
checking, an analysis technique developed by computer
scientists to address issues in concurrent systems, can be
applied to the alarm masking problem. The presented paper
shows how model checking can be used to determine if and
how masking can occur in a modeled configuration of IEC
60601-1-8-like medical alarms. Specifically, the paper shows
that medical alarms can be modeled as a collection of
independent, concurrently executing, state machines.
The paper describes this method and demonstrates its
detection capabilities by analyzing the IEC 60601-1-8-
compliant alarms from an actual system (a GE Carescape
Telemetry Monitor). Results of this analysis are discussed
along with future research directions that would allow this
method to account for additional IEC 60601-8 and future
alarm standard features.
Understanding
Once an alarm is detected, it needs to be understood
in some way in order to be acted upon. Most alarms used in
the medical context, including IEC 60601-1-8, are abstract,
tonal alarms. Also, in the case of the IEC 60601-1-8 alarms,
each of the eight alarms specified is very similar to each other
– they differ only in their pitch patterns, and each have the
same rhythm and acoustic structure. This means that they are
very difficult to learn and retain. It is generally acknowledged
that the alarms currently specified in IEC 60601-1-8 require
updating.
A paper will be presented in the symposium that
describes the process of designing updated sounds for IEC
60601-1-8 and the results obtained thus far. This includes the
design of three sets of alternative alarms, and results for both
the ease of learning and the ease of localizing these new sets.
Evaluating and designing alarms in middleware
It is becoming increasingly possible to indicate patient
status through telemetry and middleware and not just the
bedside of the patient. Instead of alarm signals being emitted
from a variety of devices, they are aggregated and delivered
through a single device, often worn or carried by the clinician
(e.g., their mobile phone). This introduces a number of other
issues:
Alarms must be evaluated and designed in larger sets.
Because a wider array of clinical as well as technical alarms is
being transmitted by one device, it is even more critical that
the entire set be evaluated and designed together. This raises
questions that previously may have been minimized, such as
how alarm source and increased urgency must be
discriminable and identifiable for technical or clinical events,
and how alarms must be discriminated from other
environmental sounds such as reminders or incoming phone
calls.
Alarms cannot be localized. There is one speaker in one
location that is responsible for transmitting alarms from
multiple devices. The ability to localize can only be
transmitted indirectly through the semantic qualities of the
signal.
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Alarm signals must be discriminable at lower bit rates
and through clothing. Although this is not always true, the bit
rate of these aggregator devices is much lower than that of the
source device that triggers the alarm. It is often as low as 8
kHz. Also, the alarming device will often be stored in the
clinicians’ clothing. Sounds must be adapted to be
discriminable and identifiable at these lower bit rates and more
difficult conditions. A paper will be presented in the
symposium reporting the outcomes of studies that have
developed and evaluated alarms intended for use under such
circumstances.
Evaluating alarms under high workload
Alarm research often involves undergraduate students in a
laboratory setting to obtain quantifiable data, or clinicians in
the clinical environment to obtain qualifiable data. However, it
is also necessary to parse attributes of alarms in a laboratory
setting, to include clinician participants, and use tasks that
have real-life clinical relevance. The final paper in the
symposium presents results of studies where clinicians are
tested in a high-fidelity acoustic environment whilst
performing alarm-related tasks. Here, the experimental
paradigm includes a primary clinical task where the clinician
participant must respond with drug choices for different
clinical scenarios via a key-press selection, together with an
auditory and visual distracting task. The auditory distracting
task is a Coordinate Response Measure (CRM), which is a
validated speech paradigm consisting of 3 different male
talkers and 256 unique sentences per talker. Studies are
presented in this paper which consider performance efficiency
through an inverse efficiency score (IES = response time /
accuracy), the effects of signal-to-noise ratio, number of
alarms, true/false alarm ratios, and conventional versus novel
alarms on clinician performance and indices of decision
making.
REFERENCES
Block, F. E., Rouse, J. D., Hakala, M., & Thompson, C. L.
(2000). A proposed new set of alarm sounds which satisfy
standards and rationale to encode source information. Journal
of Clinical Monitoring and Computing, 16(7), 541-546.
Block Jr, F. E. (2008). “For if the trumpet give an uncertain
sound, who shall prepare himself to the battle?”(I Corinthians
14: 8, KJV). Anesthesia & Analgesia, 106(2), 357-359.
IEC 60601-1-8 (2006) Medical electrical equipment --
Part 1-8: General requirements for basic safety and essential
performance -- Collateral standard: General requirements,
tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems. International
Electrotechnical Commission
Sanderson, P. M., Wee, A., & Lacherez, P. (2006).
Learnability and discriminability of melodic medical
equipment alarms. Anaesthesia, 61(2), 142-147.
Wee, A. N., & Sanderson, P. M. (2008). Are melodic
medical equipment alarms easily learned?. Anesthesia &
Analgesia, 106(2), 501-508.