How to Identify the Most Important Alarm Signals to Manage October 30, 2013 10/30/2013 1 Co-Conveners 10/30/2013 Alarm Systems Management Webinar Series 2 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. 10/30/2013 3 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) 10/30/2013 Alarm Systems Management Webinar Series 4 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 10/30/2013 5 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 10/30/2013 Alarm Systems Management Webinar Series 6 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 10/30/2013 7 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 10/30/2013 Alarm Systems Management Webinar Series 8 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 10/30/2013 9 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 10/30/2013 Alarm Systems Management Webinar Series 12 11 9 8 10 Initial Steps to Meet the Goal of Reducing Alarm Fatigue Shashi Avadhani, CBET, CCE, MBA Resident Regional Manager Crothall Clinical Equipment Solutions 10/30/2013 11 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 10/30/2013 Alarm Systems Management Webinar Series 12 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 10/30/2013 13 Devices With Alarms Feeding Pump Ventilator Monitor Infusion Pump Bed Exit Pulse Oximeter Sequential Compression Device 10/30/2013 Alarm Systems Management Webinar Series IABP 14 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) 10/30/2013 15 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 10/30/2013 Alarm Systems Management Webinar Series 16 Level of Oversight Needed Based on Priority • A = High • To prevent harm to the patient • B = Moderate • C = Low 10/30/2013 17 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 10/30/2013 Alarm Systems Management Webinar Series 18 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) 10/30/2013 19 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 10/30/2013 Alarm Systems Management Webinar Series B *B patient specific B *clinical judgment to determine oversight 20 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 10/30/2013 21 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 10/30/2013 Alarm Systems Management Webinar Series 22 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 10/30/2013 23 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 10/30/2013 Alarm Systems Management Webinar Series 24 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? 10/30/2013 25 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 10/30/2013 Alarm Systems Management Webinar Series 26 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. 10/30/2013 27 Dashboards – Enterprise View 10/30/2013 Alarm Systems Management Webinar Series 28 Dashboards – Enterprise View 10/30/2013 29 Dashboards – Enterprise View 10/30/2013 Alarm Systems Management Webinar Series 30 Dashboards – Individual Medical Center View 10/30/2013 31 Dashboards – Set a Baseline, Look for Outliers 10/30/2013 Alarm Systems Management Webinar Series 32 Dashboards – Set a Baseline, Look for Outliers 10/30/2013 33 Dashboards – Make It Simple to Understand 10/30/2013 Alarm Systems Management Webinar Series 34 Create Reports List 10/30/2013 35 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. 10/30/2013 Alarm Systems Management Webinar Series 36 Charts – Number of Alerts in 24hrs Based on Criticality 10/30/2013 37 Charts – Type of Alerts Received by the Nurse, by Unit Type 10/30/2013 Alarm Systems Management Webinar Series 38 Charts – Number of Alerts and Dispatches per Occupied Bed 10/30/2013 39 Charts – Number of Heart Rate Alerts and Dispatches 10/30/2013 Alarm Systems Management Webinar Series 40 Reports – % Heart Rate Alerts and Dispatches 10/30/2013 41 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 10/30/2013 Alarm Systems Management Webinar Series 42 What You Can Do With the Data 10/30/2013 43 Alarm Management Assessment Lisa A. Pahl, RN, BSN, MSN Sr. Manager, Enterprise Consulting Philips Healthcare Americas 10/30/2013 Alarm Systems Management Webinar Series 44 Alarm Management Assessment Interviews and Observation, Review, and Data CULTURE People Processes Technology DATA 10/30/2013 45 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 10/30/2013 Alarm Systems Management Webinar Series 46 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 10/30/2013 47 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 10/30/2013 Alarm Systems Management Webinar Series 48 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’? 10/30/2013 49 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 10/30/2013 Alarm Systems Management Webinar Series 50 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 10/30/2013 51 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 10/30/2013 Alarm Systems Management Webinar Series 52 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 10/30/2013 53 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 10/30/2013 Alarm Systems Management Webinar Series 54 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 10/30/2013 55 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 10/30/2013 Alarm Systems Management Webinar Series 56 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 10/30/2013 57 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 10/30/2013 Alarm Systems Management Webinar Series 58 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 10/30/2013 59 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 10/30/2013 Alarm Systems Management Webinar Series 60 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 10/30/2013 61 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 10/30/2013 Alarm Systems Management Webinar Series 62 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 10/30/2013 63 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. 10/30/2013 Alarm Systems Management Webinar Series 64 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 10/30/2013 65 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. 10/30/2013 Alarm Systems Management Webinar Series 66 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 10/30/2013 Alarm Systems Management Webinar Series 67
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