How to Identify the Most Important Alarm Signals to...

Alarm Systems Management Webinar Series

How to Identify the Most Important Alarm Signals

to ManageOctober 30, 2013

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Co-Conveners

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Thank You to Our SponsorsThis webinar series is offered at no charge thanks to commercial grants from the companies shown here. HTSI and its co-convening organizations appreciate their generosity. AAMI and HTSI are managing all costs for the series. None of the co-convening 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, MSBiomedical Engineering Reviewer

Cardiac Diagnostic Devices BranchDivision of Cardiovascular DevicesOffice 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

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DeviceAlarm

Systemissue

NotAudibleAlarm

Alarm,Audible

DelayedAlarm

ImproperAlarm

FalseAlarm

LowAudibleAlarm

DefectiveAlarm

AlarmNot

Visible

Alarm,Failure ofWarning

306

63

5 5 4 3 3 2 1 1

Medical Device Reports by Device Problem Codewith Alarm-Related Adverse Events

January 1, 2010 - December 31, 2012n=393 Occurrences

(of the 383 Death Reports)

Devices With Reported Alarm Problems

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215

3820 12 11 9 8

Medical Device Reports by Product Typewith Alarm-Related Adverse Events

January 1, 2010 - December 31, 2012n=313 Occurrences

(of the total 383 Death Reports)


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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Monitor

Ventilator

Infusion Pump

Bed Exit

Feeding Pump

Sequential Compression Device IABP

Devices With Alarms

Pulse Oximeter

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Risk Assessment

Clinical Equipment Alarms Central Monitor

PRIORITY

A=Highest; could result in death if

unattendedB=High priority; may lead to unintended

consequence if unattended

C- Low priority; little risk if unattended

RISK

Level of Oversight

needed

A-High

B-Moderate

C-Low

Level of oversight typically available

Telemetry monitors ICU, PICU, NICU, ED (both), PEDS, 3G A A

A (enhance-ment on-

going)

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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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Clinical Equipment Alarms Central Mon.

PRIORITY

A=Highest; could result in death if unattendedB=High priority; may lead to unintended consequence if unattendedC- Low priority; little risk if unattended

RISK

Level of Oversight needed

A-High

B-Moderate

C-Low


Telemetry monitors ICU, PICU, NICU, ED (both), PEDS, 3G A A

A (enhancement

on-going)

Telemetry Monitors

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PRIORITY

A=Highest; could result in death if unattended

B=High priority; may lead to unintended



RISK

Level of Oversight

needed

A-High

B-Moderate

C-Low


IV Infusion pump/syringe pump B *B patient

specific

B *clinical judgment

to determine oversight

IV Infusion Pump/Syringe Pump

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PRIORITY

A=Highest; could result in death if unattended

B=High priority; may lead to unintended



RISK

Level of Oversight

needed

A-High

B-Moderate

C-Low


PCA Pump C C C

PCA Pump

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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 DataMelanie Quinton, MS

Solution Consultant/Consultant SpecialistCD BIO MDI

Kaiser Permanente

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• 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 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 – 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 ReportsOur 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

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 results1. High Heart Rate = 24%2. Low Heart Rate = 12%3. Sp02 = 12%

• A majority of our heart rates1. 44% >120, but <1252. 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, MSNSr. Manager, Enterprise Consulting

Philips Healthcare Americas

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TechnologyProcessesPeople

Alarm Management AssessmentInterviews and Observation, Review, and Data

DATA

CULTURE

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Frequent Alarm SignalsOne patient’s alarms in 24 hours

46

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 HoursJust for irregular heart rate

8:088:10

8:188:20

8:288:30

8:408:50

9:009:10

9:139:15

9:179:19

9:219:23

9:259:27

9:299:31

9:339:35

9:419:43

9:459:47

9:499:51

9:539:55

9:579:59

10:0210:04

10:0610:08

10:1010:12

10:2210:24

10:2610:28

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

48

You can select which alarm signals to route to a secondary notification system

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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/Non-Arrhythmia Alarm

Signals

• Apnea• SpO2 Desat• Invasive

Pressure Line Disconnect

• High or Low Limit Violations:

• SpO2• Resp• NBP• Invasive Pressure• Temp• CO2• Other

Technical Alarm Signals

• Multiple Types• Sensor

disconnect• Cannot analyze

ECG• Leads Off• Etc.—refer to IFU


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 ComparisonPatient outliers

0 50 100 150 200 250 300 350 400 450

1

2

3

4

5

6

7

8

9

10

11

Number of Alarm Signals

Patie

nt Id

entif

ier

24 Hour Alarm Signal Totals Per Patient

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Numbers Alone Don’t Tell the Whole Story

3842

2617

1681

0

500

1000

1500

2000

2500

3000

3500

4000

4500

Alarm Signal TotalsICU PCU STEP DOWN

119112

94

0

20

40

60

80

100

120

140

Alarm Signals Per Patient BedPCU 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 BasicsElectrode 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 BasicsArtifact 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

0%10%20%30%40%50%60%70%80%90%

100%

DAY 1 DAY 2

TRUEFALSE

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TechnologyReview 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 non-actionable 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

0%10%20%30%40%50%60%70%80%90%

100%

Arrhythmia Alarms

One ICU Patient: 242 Alarm Signals in 24 Hours

AfibMultiform PVCsPVC Rate>10/minR-On-T PVCPair PVCs

112

92

2

333

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Eliminate Non-Actionable Alarm Signals

0%10%20%30%40%50%60%70%80%90%

100%

Arrhythmia Alarms

One ICU patient: 130 Alarms in 24 Hours?


92

2

333

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Eliminate Non-Actionable Alarm Signals

0%10%20%30%40%50%60%70%80%90%

100%

Arrhythmia Alarms

One ICU patient: 5 Alarms in 24 Hours?


2

3

A decrease of 98%

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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., high-

priority 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, 20131:00-2:00 pm Eastern

www.aami.org/htsi/events.html

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Continuing Nursing Education1.0 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=1025&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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