Alarm Fatigue - American Association of Critical

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AACN Advanced Critical Care
Volume 24, Number 4, pp.378-386
© 2013 AACN
Alarm Fatigue
A Patient Safety Concern
Sue Sendelbach, RN, PhD, CCNS
Marjorie Funk, RN, PhD
ABSTRACT
Research has demonstrated that 72% to 99%
of clinical alarms are false. The high number
of false alarms has led to alarm fatigue.
Alarm fatigue is sensory overload when clinicians are exposed to an excessive number
of alarms, which can result in desensitization
to alarms and missed alarms. Patient deaths
have been attributed to alarm fatigue. Patient
safety and regulatory agencies have focused
on the issue of alarm fatigue, and it is a 2014
Joint Commission National Patient Safety
Goal. Quality improvement projects have
O
ne needs only to step into any busy hospital unit to hear a cacophony of alarm
sounds. Alarms are found on most medical
devices used at the bedside. These alarms
sound every hour of every day. An analysis of
alarms at The John Hopkins Hospital,
Baltimore, Maryland, revealed a total of more
than 59 000 alarm conditions over a 12-day
period—or 350 alarms per patient per day.1,2
The purpose of clinical alarms is to enhance
safety by alerting clinicians to deviations from a
predetermined normal status. The alarms alert
clinicians when a patient’s condition is deteriorating and when a device is not functioning as it
should. Device or system problems include loose
connections or an intravenous medication having run out. Although nothing may be wrong
with the patient, these conditions must be corrected immediately. In a well-publicized case,3
no one responded to a monitor alarm that
sounded softly for about 75 minutes, signaling
demonstrated that strategies such as daily
electrocardiogram electrode changes, proper
skin preparation, education, and customization of alarm parameters have been able to
decrease the number of false alarms. These
and other strategies need to be tested in rigorous clinical trials to determine whether
they reduce alarm burden without compromising patient safety.
Keywords: alarm fatigue, patient safety,
regulatory agencies
that the patient’s telemetry battery needed to be
replaced. The battery eventually died, and when
the patient went into cardiac arrest, no loud crisis alarm sounded. The patient was found unresponsive and could not be resuscitated.
Sue Sendelbach is Director of Nursing Research, Abbott
Northwestern Hospital, 800 E 28th St, Minneapolis, MN
55407 (sue.sendelbach@allina.com).
Marjorie Funk is Professor, Yale School of Nursing, Yale University West Campus, West Haven, Connecticut.
Sue Sendelbach serves on the Healthcare Technology Safety
Institute (HTSI) Alarm Systems Steering Committee and the
HTSI Alarm Best Practices Group. Marjorie Funk serves on the
AAMI/AL Medical Device Alarms Committee, the HTSI Alarm
Systems Steering Committee, and the HTSI Alarm Best Practices Working Group, and she is a developer of the HTSI Alarm
Webinar Series. Both authors presented a webinar for the
American Association of Critical-Care Nurses on alarm fatigue
on June 20 (http://www.aacn.org/DM/Webinar/WebinarDetail
.aspx?Category=WEBINAR-SERIES&ProductCode=WB0004).
Otherwise, the authors declare no conflicts of interest.
DOI: 10.1097/NCI.0b013e3182a903f9
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A perfect alarm system would never miss a
clinically important event—the sensitivity
would be 100%. Also, the alarm would not go
off when there is no clinically important
event—the specificity would be 100%. By
design, alarms are highly sensitive so that they
do not miss an important event. However, this
high sensitivity is achieved at the expense of
specificity. False alarms are very common,
which can lead to alarm fatigue.
Alarm fatigue occurs when nurses become
overwhelmed by the sheer number of alarm
signals, which can result in alarm desensitization and, in turn, can lead to missed alarms or
a delayed response to alarms. The desensitization to alarms occurs largely because the
devices have “cried wolf” too often—as the
boy in Aesop’s fable did. Studies have shown
that in some hospital units, more than 85% of
alarms are false.4–7 The large number of false
alarms has caused nurses to turn down the volume of audible alarm signals, adjust the alarm
settings outside limits that are safe and appropriate for the patient, ignore alarm signals, or
even deactivate alarms, which has resulted in
sentinel events and patient deaths.
Alarm fatigue is recognized as an increasingly critical safety issue in current clinical
practice. The Healthcare Technology Foundation, an organization promoting the development, application, and support of safe and
effective health care technologies, initiated a
clinical alarms improvement program in 2004.
The Healthcare Technology Foundation has
conducted 2 large national surveys on alarm
signals.1,8 The ECRI Institute, an independent
nonprofit organization that addresses patient
safety, named alarm hazards as number 1 of
the “Top 10 Health Technology Hazards” for
both 20129 and 2013.10 Recently, The Joint
Commission released a Sentinel Event Alert,11
addressing medical device alarm safety in hospitals. The Sentinel Event Alert warned that
alarm fatigue can jeopardize patients, and
urged hospitals “to take a focused look at this
serious patient safety issue.”
In recent years, the number of devices with
alarms at the bedside has grown exponentially.
Alarms from monitors, ventilators, infusion
pumps, feeding pumps, pulse oximeters, intraaortic balloon pumps, sequential compression
devices, beds, and many other devices beep
endlessly, demanding our attention. In a study
in a medical intensive care unit, Görges et al12
found that ventilators (46%) were the source
of the highest proportion of alarms, followed
by monitors (37%). In most other settings,
physiological monitors produce the most alarm
signals. In this article, we focus on physiological monitors, which include hard-wire
monitors in critical care areas, telemetry monitors, and pulse oximeters.
Patient Safety
Scope of Problem
In 1974, the ECRI Institute published its first
report of a sentinel event related to an alarm. An
ignored alarm signal on a hypothermia machine
resulted in serious patient burns.13,14 The report
identified that a minor drawback to the hypothermia machine was the alarm light that would
flash continuously until the patient’s temperature reached the desired value. Because of the
constant flashing of the alarm light during a
normal phase of the warming process, the alarm
could be ignored during a critical event.
By 1982, researchers recognized the increasing number of monitoring signals, with “no
end in sight.”15(p792) A year later, Kerr and
Hayes16 identified that each patient could have
6 or more alarms that could increase the risk of
caregiver confusion as to which alarm is going
off and would actually be contrary to the
patient’s best interest. Cropp et al17 examined
whether physicians, nurses, or respiratory therapists could differentiate alarm signals heard in
an intensive care unit and found that of the 33
different sounds, they correctly identified only
50% of the critical alarm signals and 40% of
the noncritical alarm signals. By 1999, 40 different alarms for the ventilator, electrocardiogram (ECG), arterial pressure, and pulse
oximetry were identified.18
Studies have demonstrated that most alarm
signals have no clinical relevance. The percentage of false alarms ranges from 72% to
99.4%,4–7,12,18 which creates a “cry wolf” situation in which staff will respond to the alarm
the percentage of time they deem it reliable.19–21
The dire consequences of this situation are
seen in patient deaths being attributed to alarm
fatigue. National attention was brought to this
issue of alarm fatigue after the death of a
patient in a Massachusetts hospital. When the
alarm on the heart monitor was inadvertently
left off, nurses and physicians had a delayed
response to providing emergency care (http://
bit.ly/c2cGF6).3,22 Three patient deaths from
277 reports related to alarm response caused
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the state of Pennsylvania to conduct a failure
mode and effects analysis to help prevent further occurrences.23 In a patient undergoing
abdominal surgery, the alarms were turned off
for an intraoperative radiograph and never
turned back on, causing respiratory distress to
go unnoticed and resulting in death 11 days
later.24 More recent was the tragic death of a
17-year-old who had respiratory decompensation after a tonsillectomy, and because the
monitoring system was muted, her distress was
missed by the nurses.25
Alarm-related events are underreported.26
Some estimates put the actual number of
alarm-related deaths 10-fold or higher than
what the data show.27 Clearly, the reporting of
alarm-related events is increasing. As awareness of the issue increases, recognition and
reporting will increase. The reporting of
alarm-related events is critical to not only
identify the magnitude of the problem but
also determine strategies and/or interventions
to eliminate it.
The Joint Commission
In 2003, The Joint Commission set a National
Patient Safety Goal to improve the overall
effectiveness of clinical alarms,8,28 which was
in response to a review of 23 incidents of
death or injury related to ventilators in which
the root cause analysis revealed that contributing factors included (1) alarm off or set
incorrectly (22%), (2) no alarms for certain
disconnects (22%), and (3) alarm not audible
in all areas (22%).26 After 2004, the effectiveness of alarms was removed as a National
Patient Safety Goal and became one of The
Joint Commission’s accreditation requirements.8 The value of The Joint Commission’s
identification of alarm fatigue as a patient
safety issue can be demonstrated in a survey of
hospitals’ chief executive officers and senior
quality executives that revealed that 87% of
respondents said that government and regulatory agencies exerted a high level of influence
over institutional quality priorities.29
In April 2013, The Joint Commission published a Sentinel Event Alert11 on medical
device alarm safety in hospitals. The alert cited
the 2010 case of a 60-year-old patient in Massachusetts who had died not because of the
condition that originally brought him to the
hospital but from the delayed response to an
alarm.22 The alert identified the absence of or
inadequacy of an alarm system, improper
alarm settings, inaudibility of alarm signals,
and alarms being turned off as contributing
factors to deaths. Also cited was alarm fatigue.
The most common contributing factors, along
with alarm settings not being customized to
the patient, were inadequate staff education
and inadequate staffing to respond to alarms.
Recommendations and potential strategies for
improvement included leadership ensuring a
process for safe alarm management, inventory
of alarm-equipped medical devices, guidelines
for alarm settings and tailoring of alarms,
maintenance of alarm-equipped devices, training and education for the clinical care team,
and leadership and organizational planning.
Recognizing that patients can be compromised if clinical alarm signals are not properly
managed, The Joint Commission released its
2014 National Patient Safety Goal on Alarm
Management in June 2013.30 By July 1, 2014,
leaders need to establish alarm system safety as
a hospital priority and identify the most
important alarms to manage. In addition, by
January 1, 2016, hospitals will be expected to
develop and implement policies and procedures for managing alarms and to educate staff
about the purpose and proper operation of
alarms systems for which they are responsible.
ECRI Institute
The ECRI Institute is an independent, nonprofit organization that examines the best
approaches to improving the safety, quality,
and cost-effectiveness of patient care. Every
year, the ECRI Institute identifies the “Top 10
Health Technology Hazards,” which focuses
on those technologies that need special attention in the coming year.10 Selections are based
on potential for harm, frequency, breadth,
insidiousness, and profile by a group of engineers, scientists, and patient safety analysts
from the ECRI Institute.10 The final decision on
the top hazard is based on health care- and
technology-related problem reports, a critical
review of the literature, and conversations with
persons from practice including clinicians,
engineers, administrators, and manufacturers
who supply the devices. For both 20129 and
2013,10 alarm fatigue was the number 1 identified hazard. The ECRI Institute’s recommendations in approaching this issue included
examination of the organization as a whole
about alarms, in addition to more targeted
assessments. The ECRI Institute also recommended an evaluation of the manner in which
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alarms are handled by devices and systems, the
overall alarm load, the number of parameters
being monitored, staffing levels and patterns,
the physical layout of the unit, and protocols
and policies for alarm system management.
The ECRI Institute also stressed the importance
of soliciting input from clinical staff, especially
nurses.
Healthcare Technology Foundation
“The American College of Clinical Engineers
formed the Healthcare Technology Foundation
on the principle that achieving improvement in
the safe use of healthcare technology requires
diverse stakeholders to come together in order
to utilize their collective knowledge on the
design, use, integration, and servicing of healthcare technology, systems, and devices” (http://
www.thehtf.org/). One of their first initiatives
was an effort to improve the effectiveness of
clinical alarms.14 Included in their assessment of
alarms were forums and meetings. A culmination of the work was the development of a survey of more than 1300 clinicians, engineers,
technical staff, and managers on the topic. The
survey revealed that effective alarm management relied on equipment design that promoted
appropriate use, clinicians taking an active role
in learning how to use the equipment, and hospitals devoting the necessary resources to
develop effective management schemes.8 The
Healthcare Technology Foundation’s final recommendations were 3-fold: (1) the medical
device industry should design alarm systems
that are operationally intuitive; (2) health care
organizations need to recognize the limitations
of alarm systems and use them only as a tool in
the overall assessment; and (3) education for clinicians is a critical aspect of the management of
the monitoring and needs to start during the
purchasing process.14 The survey was repeated
in 2011 with 4278 responders, with publications in submission.1
Association for the Advancement
of Medical Instrumentation (AAMI)
The AAMI is a nonprofit organization with the
mission of supporting the health care community in the development, management, and use
of safe and effective medical technology. Recognizing that “medical alarm systems are out
of control,”27(p8) an interprofessional summit
was convened in collaboration with the Food
and Drug Administration, The Joint Commission, the American College of Clinical Engi-
neers, and the ECRI Institute to address the
challenging issue of alarm system safety.27 The
resulting document, Clinical Alarms: 2011
Summit, contained the 7 identified clarion
themes. Within each theme, challenges, priority
actions, and accountability were identified.
Reflecting its interprofessional approach,
accountable parties included manufacturers,
researchers, responsible organizations, standards-setting organizations, regulatory and
patient safety organizations, nursing organizations, and clinicians. A “Top 10 Actions You
Can Take Now” was developed, with gaining
interprofessional leadership support being
number 1. Other steps identified included interprofessional teams that would address alarm
fatigue across all environments of care, continuous improvement processes, optimization of
alarm limits and delays, alarm system configuration policy based on evidence, changing single-use sensors more frequently to reduce
nuisance alarm conditions, education for all
clinical operators, and sharing experiences with
AAMI, the Food and Drug Administration,
The Joint Commission, and the ECRI Institute.
Also recognized was the opportunity to learn
from other industries where safety is intensely
important, such as the nuclear power industry.
American Association of
Critical-Care Nurses
The issue of alarm fatigue is a priority of the
American Association of Critical-Care Nurses.
At the 2013 National Teaching Institute, alarm
fatigue was 1 of 4 topics at the Patient Safety
Summit, and the 2013 National Teaching Institute ActionPak was focused on this topic. An
ActionPak is an online toolbox of evidencebased nursing resources that the American
Association of Critical-Care Nurses produces
annually in conjunction with National Teaching Institute. In addition, a Practice Alert on
alarm management31 and a webinar devoted to
the topic were a part of the approach in
addressing the issue. Included in the recommendations of how to address alarm fatigue
were proper skin preparation for ECG electrodes, changing ECG electrodes daily, customizing alarm parameters and levels on ECG
monitors (eg, life-threatening vs advisory
alarms), customizing delay and threshold settings on oxygen saturation (Spo2) monitors,
initial and ongoing education, and monitoring
only those patients with clinical indications for
monitoring.
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Summary
Common themes in addressing the issue of
alarm fatigue include education,11,13,27,31 customization and/or optimization of alarms,11,13,27,31
and addressing the issue from a systems
perspective10,27 (see Table 1). Adequate staffing
also has been identified in managing patient
alarms.10,11 However, Bitan and colleagues32
state that if a nurse responded to each alarm,
“…it would be almost impossible to perform
any activity that requires more than a few
seconds.”(p242) Although adequate nurse staffing
is clearly a need, just addressing the staffing
issue without identifying the underlying causes
of alarm fatigue does not solve the problem.
Interventions to Reduce
Alarm Fatigue
Although the problem of alarm fatigue has
been well-documented in the literature, intervention studies to guide clinicians in an effort
to reduce and/or eliminate false and nonactionable alarms are lacking. In this section, we
review the evidence related to alarm fatigue
and recommend interventions in areas in which
the evidence is sufficiently strong.
ECG Electrodes
A relationship between electrode-skin contact
and electrical impedance measurement on signal
quality has been identified. Indeed, much of
the resistance with artifact is caused by dead
skin cells; proper skin preparation before
electrode placement can reduce artifact by
lowering skin impedance.33,34 In 2 separate
studies, mild abrasion with fine sandpaper
was demonstrated to decrease skin resistance
and to minimize artifact.33,35
Recognizing the relationship between
electrode-skin contact and electrical impedance on signal quality, Cvach and colleagues36
conducted a quality improvement project in
which ECG electrodes were changed every day
on patients in 2 adult acute care units. They
demonstrated a 46% reduction in the average
number of alarms per bed per day.
Individualizing Alarm Parameters
The AAMI’s 2011 Summit on Clinical Alarms2
recommended that alarm system configuration
policy should be based on clinical evidence as
opposed to accepting default alarm configurations. However, minimal research has been conducted on appropriate alarm parameters, and
no studies could be found from a critical care
setting. The lack of research on ECG monitoring was recognized by Drew et al,37 who developed ECG monitoring guidelines on the basis of
expert opinion, because there was little research
on which to make recommendations. Indeed,
Table 1: Resources for Alarm Safety
Organization
Web Site
Specific Resources
The Joint Commission
http://www.jointcommission.org
Sentinel Event Alert11 (http://www
.jointcommission.org/sea_
issue_50/)
ECRI Institute
https://www.ecri.org/
Top 10 Health Hazards for 20129
Top 10 Health Hazards for 201310
Healthcare Technology
Foundation
http://www.thehtf.org/
Association for the Advancement
of Medical Instrumentation
http://www.aami.org/
Clinical Alarms: 2011 Summit27
(http://www.aami.org/hottopics/
alarms/AAMI/2011_Alarms_
Summit_publication.pdf)
American Association of CriticalCare Nurses
http://www.aacn.org
2013 National Teaching Institute
Patient Safety Summit (http://
www.aacn.org/wd/nti/
content/patient-safety-summit
.pcms?menu= #alarm)
2013 National Teaching Institute
ActionPak (http://www.aacn.org/
dm/practice/actionpakdetail
.aspx?itemid=28337&learn=true)
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this lack of evidence has been cited as a patient
safety issue in configuring alarm settings.2 In
addition, as alarm limits become more sensitive
and less specific, more false alarms are generated.38 By relying on expert opinion and/or
quality improvement studies, the core intervention that influences the outcome may be hard to
distinguish from efforts to implement it.39
An attempt to identify appropriate alarm
settings and individualizing alarms has been
one approach to minimizing nuisance alarms.
Burgess38 examined a data set of continuous
heart rate and respiratory rate data from a
general ward population and found a high
heart rate limit of 130 to 135/min, a low heart
rate limit of 40 to 45/min, a high respiratory
rate limit of 30 to 35/min, and a low respiratory limit of 7 to 8/min optimized false alarm
rates. Graham and Cvach40 studied the impact
of nurse education and revising default settings for the unit’s monitor alarms, including
parameter limits and levels. In this quality
improvement project, they demonstrated a
43% reduction in critical monitor alarms. As
default limits are widened, we need to ensure
that critical events are not missed and patients
are not harmed.
In addition to individualizing the alarms
that are set, an understanding of potentially
overlapping or redundant alarms helps identify
possible opportunities for change. An assessment of the necessity of all the alarms should
be conducted.40 For example, many systems
have both a tachycardia and a high heart rate
alarm that are configured slightly differently
but provide clinicians with essentially the same
information from 2 different alarms. Thus,
audible alarms may not be required for both,
and a visual alarm may be appropriate. Some
systems have an alarm signal for a staff alert
that is available on a telemetry box but may
not be needed, as the assist button in the
patient’s room or communication for assistance is via wireless communication systems.
Individualizing alarms also includes examining Spo2 parameters. Welch41 demonstrated
that increasing alarm delays in Spo2 monitors
from 5 to 15 seconds decreased alarms by
70%. In addition, by decreasing alarm thresholds from 90% to 88%, alarms decreased by
45%. However, clinicians will need to work
with the medical device industry to address
this issue. Currently, manufacturers primarily
establish alarm settings. For example, at one of
the author’s (S.S.) hospitals, the Spo2 delay
setting was at 4 seconds, and the hospital personnel are unable to change the parameter.
Interprofessional Teams
When Boston Medical Center began to address
the problem of alarm fatigue, they formed an
interprofessional team that was headed by the
chief medical officer.2 Indeed, including senior
management in addressing the issue of alarm
fatigue is crucial. The role of senior leadership
and their commitment to patient safety have
been demonstrated to be critical in health care
organizations.2,29,42,43 Better quality outcomes
have been associated with hospital boards of
directors who spend 25% of their time on
quality issues and receive a formal quality performance measurement report.28 In turn, leaders must recognize that the system needs to
change, not the employees.42
The problem of alarm fatigue also includes
opportunities for partnerships that include the
medical device industry. The industry needs to
broaden its role in solving the problem.2
Indeed, the industry should be brought in to be
a part of the alarm management work group,
so that all parties understand the complexity of
the work and what is needed to promote
patient safety by designing safer systems.
Human Factors
Human factors engineering focuses on the
design of tools, machines, and systems while
taking into account human capabilities, limitations, and characteristics, with the goal of safe
human use.44 The importance of human factors
in the development of alarm systems and their
potential to help provide a solution has been
identified.2,45 Alarm systems have been shown
to be configured incorrectly, reflexively inactivated, and overridden, misinterpreted, and
simply not heard.2 In the development of alarm
systems, engineers should follow health care
providers in the clinical setting to understand
how we work. In addition, usability testing in
health care settings is rarely done.
Measurement
Unless we are able to measure the outcome,
we are unable to fix the problem.46 Feedback
is important, as it helps maintain momentum
and build trust in management’s ability to
solve patient safety problems.47 Measurement
is critical to understanding the scope of the
problem and to assessing whether interventions are leading to improvements. However,
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measurement is very complex. The Johns
Hopkins Hospital took 2 years to determine
how to access and measure the data on the
number and type of alarms.40 Involvement of
the information technology department and
biomedical engineering is essential, as they
need to identify how to examine data from
the monitor.
Future Work
What do we still not know related to improving the safety related to alarms? The fundamental unanswered question is: What is the
best way to increase specificity of alarms without a significant loss of sensitivity? Although
work has begun, interventions to reduce false
or nonactionable alarms still have not been rigorously tested.
The focus of future clinical research related
to alarms on monitors can be classified into 4
areas: (1) false alarms, (2) nonactionable
alarms, (3) appropriateness of monitoring, and
(4) processes of care. We propose possible topics for research in each of these areas. They all
need to be tested in rigorously designed studies.
Alarm fatigue occurs when nurses are barraged
by so many false or nonactionable alarms that
they become desensitized. False alarms occur
when no valid triggering event occurs, whereas
nonactionable alarms correctly sound but for
an event that has no clinical relevance. These 2
types of nuisance alarm signals should be distinguished, because possible approaches to
reducing their occurrence differ.
smart alarm system can determine a more
robust hypothesis of an alarm’s cause and
suppress false alarms.
Nonactionable Alarms
Possible ways to reduce nonactionable alarms
also need to be studied. As discussed earlier,
changing default settings for the particular
patient population and customizing alarm settings to the individual patient have been tried.
Quality improvement initiatives have demonstrated reductions in the number of alarm signals, with no apparent harm to patients.
However, these interventions have not been
tested in rigorously designed clinical trials to
determine whether they can be implemented
without compromising patient safety. We also
need to evaluate the safety of deactivating
default alarms for conditions we no longer
treat, such as premature ventricular contractions (PVCs). Premature ventricular contractions have not been treated for more than
20 years, since the Cardiac Arrhythmia Suppression Trial48 was stopped for excess mortality rate related to the use of antiarrhythmics for
asymptomatic ventricular arrhythmias. However, PVC alarms are rarely deactivated. One of
the primary causes of nonactionable alarms is
an outdated algorithm for PVCs that does not
reflect current evidence-based practice. However, PVCs in patients at risk for torsades de
pointe should be monitored, because PVCs are
known precursors for torsades de pointe.
Appropriateness of Monitoring
False Alarms
Possible ways to reduce false alarm signals
from cardiac monitors need to be studied.
First, a protocol to ensure good signal quality
from ECG electrodes needs to be tested. The
protocol should include good preparation of
the skin to ensure that electrodes adhere well,
which will help prevent electrodes from
becoming loose and falling off and help avoid
artifact that could mimic a tachycardia and
set off an alarm. The protocol also may
include changing electrodes daily. Second, a
protocol that promotes context awareness,
such as temporarily silencing alarms when
doing patient care, should be evaluated.
Third, the use of “smart” alarms that consider
other parameters before sounding, such as
considering blood pressure before alarming
for asystole, needs to be tested. By incorporating information from other parameters, a
Additional research related to indications for
monitoring is needed. Perhaps the most effective way to reduce both false and nonactionable alarms is to avoid unnecessary monitoring
and discontinue monitoring when it is no
longer clinically indicated. The more patients
who are being monitored, the more alarm signals will sound. The availability of sophisticated monitors does not mean we should use
them for all patients. The American Heart
Association Practice Standards for ECG Monitoring37 specify who should be monitored and
for how long. Litigation-wary physicians may
order cardiac monitoring for patients who
have no clinical indication for it. In an era of
inadequate staffing, alarms from monitors may
substitute for direct human surveillance.
Because monitoring is noninvasive, it seems
harmless. However, unintended consequences
occur, such as deaths related to alarm fatigue.
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Processes of Care
Future research also should address processes
of care related to alarm signals. Various
approaches to alarm notification need to be
evaluated, including the effectiveness of wireless technology, such as phones and pagers,
split bedside monitor screens in critical care
areas, and hallway waveform screens. The use
of central monitoring with monitor watchers is
urgently in need of careful research. In a study
conducted almost 20 years ago, the use of
monitor watchers was not associated with
lower rates of most adverse outcomes, including death and transfer to a critical care unit.49,50
The use of monitor watchers needs to be compared with other alarm notification modalities.
Also, we do not know how many patients a
monitor watcher can effectively watch, or the
best location (eg, on unit vs in a remote location). A cost-benefit analysis needs to be done
to determine whether better patient outcomes
justify the increased cost of monitor watchers.
Last, will the use of monitor watchers result in
a reduction in nurses’ knowledge of ECGs and
ECG monitoring? We need to determine the
most effective way to educate clinicians about
the full capability of the devices they are using.
ficity. The goal is to eliminate alarm fatigue
and provide a safer health care environment.
REFERENCES
Study Design
Consideration of the study design of future
research is critical. Randomized controlled trials, which generate the highest level of evidence,
are needed. Studies must be interdisciplinary,
specifically with collaboration among the medical device industry, biomedical engineers, and
clinicians. In addition, biostatisticians and academic researchers should be included. Multisite
studies are essential, and the studies must have
meaningful outcomes. The focus needs to be on
patient outcomes rather than only on reduction
of the number of alarm signals. Statistical
power may be lacking for mortality and sentinel events. We need large multicenter studies
and/or appropriate surrogates for outcomes.
Potential funders of such research (eg, the
National Institutes of Health, foundations,
industry) must make testing of alarm management strategies a funding priority.
Conclusion
Ironically, the very alarm systems that were
created to enhance patient safety have themselves become an urgent patient safety concern.
We need to fix our alarm systems to achieve
the highest levels of both sensitivity and speci-
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