How to Identify the Most
Important Alarm Signals
to Manage
October 30, 2013
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Co-Conveners
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Alarm Systems Management Webinar Series
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Thank You to Our Sponsors
This webinar series is offered at no charge
thanks to commercial grants from the
companies shown here. HTSI and its coconvening organizations appreciate their
generosity. AAMI and HTSI are managing
all costs for the series. None of the coconvening organizations participated in
seeking, discussing, or otherwise
facilitating the commercial grants. The
companies had no role in content
development, and the webinars do not
contain commercial content. Webinar
presenters were selected based on topic
expertise without regard to industry
affiliation by a multi-disciplinary HTSI
volunteer planning committee.
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Speaker Introductions
• Shawn Forrest, MS, Biomedical Engineering Reviewer, Cardiac
Diagnostic Devices Branch, Division of Cardiovascular Devices,
Office of Device Evaluation, CDRH, U.S. Food and Drug
Administration
• Shashi Avadhani, CBET, CCE, MBA, Resident Regional Manager,
Crothall Clinical Equipment Solutions
• Melanie E. Quinton, MS, Solution Consultant/Consultant Specialist,
CD BIO MDI, Kaiser Permanente
• Lisa A. Pahl, RN, BSN, MSN, Sr. Manager, Enterprise Consulting,
Philips Healthcare Americas
• Marjorie Funk, PhD, RN, FAHA, FAAN, Professor, Yale University
School of Nursing (Moderator)
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Alarm-Related Adverse Events
Shawn Forrest, MS
Biomedical Engineering Reviewer
Cardiac Diagnostic Devices Branch
Division of Cardiovascular Devices
Office of Device Evaluation, CDRH
U.S. Food and Drug Administration
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Adverse Event Reporting
• Manufacturer and User Facility Device
Experience (MAUDE) Database
• Reports of suspected device-associated:
• Deaths
• Serious injuries
• Malfunctions
• Mandatory reporting:
• Manufacturers, importers, user facilities
• Voluntary reporting:
• Healthcare professionals, patients, consumers
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MAUDE Limitations
• Passive Surveillance
• Submission of incomplete, inaccurate, or biased
reports
• Under-reporting of events
• Cannot establish rates of events
• Cannot compare event rates over time or between devices
• Often difficult to establish causality from event
descriptions
• Variations in trade, product, and company names
complicate searches
• Some information protected from public disclosure
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Alarm-Related Reports
• Each adverse event report is assigned one or
more:
• Device Product Code(s)
• Device Problem Code(s)
• Patient Problem Code(s)
• Codes are assigned by the reporter
• Alarm-related reports were identified by
searching by Device Problem Codes containing
the term “alarm” for 2010-2012
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Types of Alarm Problems
Medical Device Reports by Device Problem Code
with Alarm-Related Adverse Events
January 1, 2010 - December 31, 2012
n=393 Occurrences
(of the 383 Death Reports)
306
63
5
Device
Alarm
System
issue
Not
Audible
Alarm
5
Alarm,
Audible
4
Delayed
Alarm
Improper
Alarm
3
False
Alarm
3
2
Low
Audible
Alarm
Defective
Alarm
1
Alarm
Not
Visible
1
Alarm,
Failure of
Warning
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Devices With Reported
Alarm Problems
Medical Device Reports by Product Type
with Alarm-Related Adverse Events
January 1, 2010 - December 31, 2012
n=313 Occurrences
(of the total 383 Death Reports)
215
38
20
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Initial Steps to Meet the Goal of
Reducing Alarm Fatigue
Shashi Avadhani, CBET, CCE, MBA
Resident Regional Manager
Crothall Clinical Equipment Solutions
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National Patient Safety Goal
06.01.01 EP1
Elements of Performance EP1
• Leaders establish alarm system safety as a
hospital priority
• Formation of a multidisciplinary team
• Representation from administration, nursing, medical
staff, clinical engineering
• Identification of alarms in the clinical patient care
setting
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National Patient Safety Goal
06.01.01 EP2
Elements of Performance EP2
• Identification of alarms
• Risk assessment to patient care if alarms
unattended
• Input from medical staff and clinical departments
• Assessment of potential for patient harm based
on history
• Identification of possible steps based on
published best practices
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Devices With Alarms
Feeding Pump
Ventilator
Monitor
Infusion Pump
Bed Exit
Pulse Oximeter
Sequential Compression Device
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Risk Assessment
PRIORITY
RISK
Level of
Clinical Equipment
Alarms
Central Monitor
A=Highest; could
Oversight
result in death if
needed
unattended
B=High priority; may
A-High
lead to unintended
consequence if
unattended
B-Moderate
C- Low priority; little
risk if unattended
Level of
oversight
typically
available
C-Low
Telemetry monitors
ICU, PICU, NICU, ED
(both), PEDS, 3G
A
A
A (enhancement ongoing)
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Priority of Alarm
• A = Highest; could result in death if unattended
• B = High priority; could lead to unintended
consequence if unattended
• C = Low priority; little risk if unattended
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Level of Oversight Needed Based
on Priority
• A = High
• To prevent harm to the patient
• B = Moderate
• C = Low
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Current Status
• Level of oversight available, based on risk
• e.g. monitor tech in case of central monitoring may
reduce risk, level of oversight available would be A
• Input from all areas of patient care
• Based on multidisciplinary team’s input
• Identify alarms that are high priority, that
currently do not possess the level of oversight
required
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Telemetry Monitors
Clinical Equipment
Alarms
Central Mon.
PRIORITY
RISK
A=Highest; could
result in death if
unattended
B=High priority;
may lead to
unintended
consequence if
unattended
C- Low priority;
little risk if
unattended
Level of
Oversight
needed
ICU, PICU, NICU, ED (both),
PEDS, 3G
Telemetry monitors
A
A-High
Level of
oversight
typically
available
B-Moderate
C-Low
A
A
(enhancement
on-going)
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IV Infusion Pump/Syringe Pump
RISK
PRIORITY
Level of
Clinical Equipment
Alarms
Central Monitor
A=Highest; could result in Oversight
Level of
death if unattended
needed
oversight
B=High priority; may lead
typically
to unintended
A-High
consequence if
available
unattended
C- Low priority; little risk B-Moderate
if unattended
C-Low
IV Infusion pump/syringe
pump
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*B patient
specific
B *clinical
judgment
to
determine
oversight
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PCA Pump
RISK
PRIORITY
Level of
Clinical Equipment
Alarms
Central Monitor
A=Highest; could result Oversight
Level of
in death if unattended
needed
oversight
B=High priority; may lead
typically
to unintended
A-High
consequence if
available
unattended
C- Low priority; little risk B-Moderate
if unattended
C-Low
PCA Pump
C
C
C
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Other Steps and Best Practices
• Rounding to identify areas that have high noise
levels due to alarms
• Follow published best practices, such as
• Skin prep for ECG monitoring
• Periodic electrode replacements
• Regular battery changes on telemetry transmitters
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Methods of Collection of
Alarm Data
• Manual
• Continuous observation
• Periodic rounding to assess most common alarms not
silenced and adding to background noise
• Automated
• Manufacturer-provided tools
• Middleware/secondary notification systems
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How Do We Get the Data and
What Do We Do With It?
It’s All About the Data
Melanie Quinton, MS
Solution Consultant/Consultant Specialist
CD BIO MDI
Kaiser Permanente
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How Do We Get the Data and What
Do We Do With It?
• To ensure quality clinical decision support making we
need to look at the data
• You do not need to be a clinician or understand medical
terminology to retrieve data. You simply need to take
ownership
• Where is the alarm data stored? – in primary system or in
secondary system
• Who has access to the data? – work with your vendor and
business partner to access
• How can the data be retrieved?
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How Do We Get the Data and What
Do We Do With It?
• How will the data be presented?
• Reports
• Dashboards
• Begin with a baseline that is simple, and build from there
• How many alerts are the nurses receiving per day?
• Compare day-to-day, month-to-month, and even season-to-season
• What are the top 3 alerts the nurses are receiving?
• Are the top 3 alerts actionable?
• Who will analyze the data?
• What will be accomplished with the analyzed data?
• Always continue to improve your alarm management program by
analyzing the numbers and through Key Performance Indicators
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Examples of How You Can Present
the Data
• Dashboards
• Reports/Charts
The following data is for illustration purposes only
and is not real data. Some items are blurred
intentionally.
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Dashboards – Enterprise View
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Dashboards – Enterprise View
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Dashboards – Enterprise View
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Dashboards – Individual Medical
Center View
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Dashboards – Set a Baseline,
Look for Outliers
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Dashboards – Set a Baseline,
Look for Outliers
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Dashboards – Make It
Simple to Understand
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Create Reports List
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Filtering Reports
Our reports can be run by date range, criticality, and/or unit type, and we can drill
all the way down to the actual patient bed. There is no PHI.
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Charts – Number of Alerts in 24hrs
Based on Criticality
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Charts – Type of Alerts Received
by the Nurse, by Unit Type
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Charts – Number of Alerts and
Dispatches per Occupied Bed
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Charts – Number of Heart Rate
Alerts and Dispatches
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Reports – % Heart Rate Alerts and Dispatches
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What the Data Can Tell You
• We have confirmed (by analyzing the number of alerts at Kaiser
Permanente Medical Centers) that the industry-leading physiological
alerts are consistent with our results
1. High Heart Rate = 24%
2. Low Heart Rate = 12%
3. Sp02 = 12%
• A majority of our heart rates
1. 44% >120, but <125
2. 33% >45, but <50
• We have also discovered that electrode replacement/hygiene has
decreased our alerts by 22%* at our first pilot medical center
• 60 alerts per patient, per day (2.5 alerts per hour)
* There may be other factors that account for the decrease, i.e. increased awareness and attention to the issue
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What You Can Do With the Data
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Alarm Management Assessment
Lisa A. Pahl, RN, BSN, MSN
Sr. Manager, Enterprise Consulting
Philips Healthcare Americas
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Alarm Management Assessment
Interviews and Observation, Review, and Data
CULTURE
People
Processes
Technology
DATA
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Frequent Alarm Signals
One patient’s alarms in 24 hours
633 Alarms*
A disruption every 2 minutes for
the nurse and for the patient!
Impacts work flow, patient care, and healing
*Does not include technical alarms
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One Patient’s Pages in 2.5 Hours
Just for irregular heart rate
10:02
9:41
10:04
9:43
10:06
9:45
10:08
9:47
10:10
9:49
10:12
9:51
9:53
9:55
9:57
9:59
8:08
8:10
8:18
8:20
8:28
8:30
8:40
8:50
9:00
9:10
9:13
9:15
9:17
9:19
9:21
9:23
9:25
9:27
9:29
9:31
9:33
9:35
10:22
10:24
10:26
10:28
10 irregular heart rate alarm
signals translated into 43 alerts
because of delays in
acknowledging the alarms signals
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What Alarm Signal Data Can
You Capture?
Potential Categories of Monitoring Alarm Signals – Priority level may vary
Life-Threatening
Arrhythmia Alarm
Signals
•
•
•
•
•
Asystole
Vfib/Tach
Extreme Tachy
Extreme Brady
Vtach
Other Arrhythmia
Alarm Signals
• Ventricular
• Beat Detection
• Rate/ Rhythm
Detection
• HR Limit
Violations
Bed/NonArrhythmia Alarm
Signals
• Apnea
• SpO2 Desat
• Invasive
Pressure Line
Disconnect
• High or Low
Limit Violations:
Technical Alarm
Signals
• Multiple Types
• Sensor
disconnect
• Cannot analyze
ECG
• Leads Off
• Etc.—refer to IFU
• SpO2
• Resp
• NBP
• Invasive Pressure
• Temp
• CO2
• Other
You can select which alarm signals to route to a secondary notification system
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Data: What Stands Out?
• Understand the difference between alarm signal data
and secondary notification alert data—what stands out
for each may vary
• Look at the big picture first and then drill down—total
numbers of alarm signals compared to individual alarm
signal occurrences
• Which unit(s) have the most alarm signals per patient
bed?
• Which alarm signals are the most frequently
occurring—across the institution and within a unit?
• Are there ‘patient outliers’?
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Unit Per Patient Comparison
Patient outliers
24 Hour Alarm Signal Totals Per Patient
11
Patient Identifier
10
9
8
7
6
5
4
3
2
1
0
50
100
150
200
250
300
350
400
450
Number of Alarm Signals
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Numbers Alone Don’t Tell the
Whole Story
4500
140
3842
4000
119
120
112
3500
94
100
3000
2617
80
2500
2000
1681
1500
60
40
1000
20
500
0
0
Alarm Signal Totals
ICU
PCU
STEP DOWN
Alarm Signals Per Patient Bed
PCU
STEP DOWN
ICU
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After the Data: Actionable Versus
Non-Actionable?
Actionable Alarm Signal – Requires clinical intervention or some type of
action
•
•
•
Life threatening, immediate response and action required
Change in patient status, requires action to reverse or prevent further deterioration
Requires action to correct a technical problem to assure proper patient monitoring,
e.g., leads off, SpO2 sensor disconnected
Non-Actionable Alarm Signal – Does not require a clinical intervention or
action
•
•
•
•
Short duration, self correcting, e.g., SpO2 alarm signal
Intentional, e.g., suctioning or positioning/moving a patient
Triggered due to tight limits rather than actionable ones
False alarm:
• System itself incorrectly identifies an alarm condition
• Something interferes with system causing it to detect an alarm, e.g., artifact or
low voltage-triggered asystole
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Start With the Basics
Electrode Selection
•
•
Select electrodes and lead sets that provide the best continuing signal and adherence
with the least irritation
Electrodes for specific patient populations, e.g., diaphoretic patients
ECG Signal Quality
•
•
•
•
Select the best lead for monitoring purposes:
• Signal quality (gain, waveform criteria, learned and labeled appropriately)
• Patient diagnosis, history, and reason for monitoring (e.g., ischemia or
arrhythmia detection)
Pacemaker identification
Single versus multi-lead monitoring
Assign “Leads Off” as a high-priority alarm
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Start With the Basics
Artifact Prevention
• Skin prep prior to electrode attachment
• Electrode storage
• Proactive electrode replacement and battery replacement (for telemetry
devices)
Patient and Family Education
• Basic but often overlooked or limited
• Explain why the patient is being monitored and what the patient can expect
• Need to notify staff if electrode becomes loose or electrode or lead set
becomes detached
• Importance of not ‘self’ disconnecting or silencing alarms
• Talk with nurse if perception that alarms are occurring frequently and/or
impacting sleep or stress level
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High-Priority Arrhythmia Alarms ICU
Impact of artifact
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
TRUE
FALSE
DAY 1
DAY 2
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Technology
Review and Revise Default Settings/Configurations
•
•
•
•
•
Use data to prioritize which settings to address first
Evaluate limits for all parameters—balance limits, not too tight, not too wide—Melanie’s
example of majority of alerts between 120-125, high of 125
Assess if some medium-priority arrhythmia alarms can be defaulted off
Identify redundant settings and determine when they should be utilized or eliminated
Additional settings to review: delay times before an alarm is triggered, e.g., SpO2 low
limit, Desat, Apnea
Optimization
•
•
•
•
•
Proactive use of alarm pause/suspend when you know you will trigger an alarm
Monitor standby use
Utilization of NBP alarm suppression for SpO2
Understand functionality and when to use and when not to, e.g., ST-segment
monitoring
Customization capabilities
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Protocols to Guide Customization Practice
and Decrease Non-Actionable Alarms
•
•
These are designed to reduce nonactionable alarms by focusing on when
and how to customize alarm settings
Others to consider:
• Monitoring admission criteria
• 24-hour monitoring renewal
• Transports
• Change-of-shift report/handoffs
• Daily huddles/rounding with
physician, nurse, and others to do
a quick review of current settings
and alarms in the past 24 hours
• New hire education and on-going
training and competency
assessments
Elements of Performance for NPSG.06.01.01
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Potential Impact of
Customizing Alarms
One ICU Patient: 242 Alarm Signals in 24 Hours
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
112
92
Afib
Multiform PVCs
PVC Rate>10/min
R-On-T PVC
Pair PVCs
2
3
33
Arrhythmia Alarms
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Eliminate Non-Actionable
Alarm Signals
One ICU patient: 130 Alarms in 24 Hours?
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
92
Afib
Multiform PVCs
PVC Rate>10/min
R-On-T PVC
Pair PVCs
2
3
33
Arrhythmia Alarms
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Eliminate Non-Actionable
Alarm Signals
One ICU patient: 5 Alarms in 24 Hours?
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
A decrease of 98%
Afib
Multiform PVCs
PVC Rate>10/min
R-On-T PVC
Pair PVCs
2
3
Arrhythmia Alarms
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Partnering Within Your Facility:
Default Settings
• Compare units to assess what/if any variations currently
• Use your Alarm Management Committee to evaluate and revise unit
defaults based on patient populations, care models, and data, and to
determine which units should have the same defaults
• Test changes incrementally on a pilot unit to assess impact and
outcomes
• Establish unit-based Alarm/Technology Champions to assist in
implementing final changes, to function as a resource for the staff, to
provide a feedback loop for the committee, and to share best
practices across units
• Include the nurse managers, and physician and staff representatives
from each unit in the decision-making process and to ensure
definitions of actionable/clinically relevant are aligned
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Partnering Within Your Facility: Who
Needs to Hear the Alarm Signals?
•
•
•
TJC expectation that alarm signals are audible and recognizable above
other unit noise
All staff (clinical, ancillary, physicians, etc.) accountable to ensure alarm
signals are acknowledged and responded to – role responsibilities and
escalation processes clearly outlined
With primary alarm systems and notification:
•
•
•
Do walk-throughs to validate that alarm signals can be heard and recognized
anywhere within the unit
If not, explore options (additional audible displays/clients, bedside monitor
capabilities that may allow other patient’s alarm signals to be observed in other
rooms, monitor watchers, secondary notification systems)
With monitor watchers:
•
•
•
What do the units still need to hear?
What alarm signals should the monitor watchers notify staff directly of and how
do they notify them (unit phone, ‘red phone’, overhead page, etc.)?
Escalation pathway for techs if no staff response
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Partnering Within Your Facility: Who
Needs to Hear the Alarm Signals?
• With secondary notification systems:
• Well-thought-out process as to which alerts staff receive (e.g., highpriority only)? Charge nurse to receive alerts for patients who are
inadvertently not assigned in the secondary notification system?
• Decide who receives the alerts (nursing assistant receives leads off and
replace battery alerts, respiratory therapy receives ventilator alerts, etc.)
• Does your system allow programmable delays before alerts are
received or escalations to others if an alert is not addressed within a
certain time frame?
• Use your Alarm Management Committee and other internal experts
and resources to assist in evaluating and determining who needs to
hear which alarm signals
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In Conclusion
Any Alarm Management
Strategy must be carefully
thought out, tested, and
continuously evaluated to
ensure achieving the right
balance of patient safety
and quality of care with the
reduction/elimination of
nuisance alarms and alarm
fatigue.
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Closing Reminders
Thank you for your time and attention!
Mark Your Calendars!
How to Manage Alarms at the Bedside
Tuesday, December 3, 2013
1:00-2:00 pm Eastern
www.aami.org/htsi/events.html
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Continuing Nursing Education
1.0 contact hour
For those desiring CNE, please visit the link below
for the test, evaluation form, and certificate:
http://www.aacn.org/DM/CETests/Overview.aspx?TestID=1
025&mid=2864&ItemID=1017&menu=CETests
The American Association of Critical-Care Nurses (AACN) is accredited as a
provider of continuing nursing education by the American Nurses Credentialing
Center’s Commission on Accreditation.
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Evaluation Form and Certificate of
Attendance (Non-CNE)
Please let us know how we did!
http://aami.confedge.com/ap/survey/s.cfm?s=Signals
After you fill out the evaluation form and enter your
email address, you will receive a certificate of
attendance by email
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