1 DOC /21/2016 Clinical Alarm Management

Growing issue… “One needs only to step onto any busy hospital unit to hear a cacophony of alarms. Alarms that are deactivated or ignored are a serious concern and have resulted in patient deaths. We need an interdisciplinary approach that addresses both false and non-actionable alarms to restore a safe care environment.” - Marjorie Funk, PhD, RN, FAHA, FAAN Professor, Yale University School of Nursing

Alarm definitions “Alarms are intended to call the attention of caregivers to patient or device conditions that deviate from a predetermined ‘normal’ status.” Reference 1 “Alarm fatigue may occur when the sheer number of monitor alarms overwhelms clinicians, possibly leading to alarms being disabled, silenced, or ignored.” Reference 2

4 DOC /21/2016 Poor perfusion Weak pulse Small variation around limit setting Motion Poor accessories: dried out inferior brand/quality heavy snaps fluid ingress disconnects whip Poor quality skin prep Catheter whip/interference Transducer malfunction Zeroing, sampling, flushing Cable disconnection Arterial disconnection Specificity < 100% Sensitivity < 100% Lack of cross- parameter signal analysis Lack of parameters trending Inappropriate monitor settings Disabled alarms Patient manipulation Sample alarm causations User Interface PhysiologicalPhysiological ECG prep & accessories accessoriesCaregiver set-up & actionsCaregiver actions IP prep & accessories Process/logic algorithm

5 DOC /21/2016 Affects everyone Patient and family Approximately 200 alarms in 24hrs Causes anxiety and constant room interruptions ICU Nurses Approximately 1,000 alarms in a week Disrupts patient care, can reduce trust in alarms, delay in reaction time or reduce probability of responding Reference 3

6 DOC /21/2016 Major sources of alarms Types of clinical devices that alarm Types of patient monitor alarms SPO 2 33% BP 43% ECG 24% Ventilators 46% Pulse Oximeter/ Patient Monitor 36% Infusion Pumps 12% Feeding Pump 3% Other 3% Notes: 1) Normalized to ECG, BP and SpO2 parameters (others ignored). 2) Assumed ECG and BP technical alarms distributed proportionally to limit physiological alarms in this study. Reference 4

7 DOC /21/2016 GE solutions for alarm management Clinical excellence - GE EK-Pro - Multiparameter - IntelliRate* Relevant - User-configurable alarm settings - Adjustable alarm limits Assurance - Absolute limits (guard limits) - Locking limits - Smart alarms - Audio and visual alarms - Minimum volume lockout Workflow - Alarm escalation - Bedside alarms at the central station

8 DOC /21/2016 GE EK-Pro Multi-lead ECG algorithm reliably detects arrhythmias while delivering clinically relevant alarms Beat detection and recognition in the presence of noise or artifact Incremental template updating to track subtle, progressive changes in beat shapes Contextual analysis, which uses information gained from neighboring beats in identifying arrhythmia events

9 DOC /21/2016 Multi-lead monitoring Reliably detects arrhythmias while delivering clinically relevant alarms Reliable detection of cardiac events that might otherwise go unnoticed Discrimination of noise and artifact from true beats Assurance of uninterrupted monitoring, even in case of an electrode contact failure Multi-lead ST Segment analysis for assessment of myocardial ischemia Example: American Heart Association (AHA) Leadwire Labeling

10 DOC /21/ GE Title or job number 6/21/2016 Alarms Analysis Phases Phase 1 Review Default Settings Define settings for Alarm Committee Champions Obtain log files/create report for analysis Review report with stakeholders Increase Alarm Fatigue Awareness with Alarm Champions Phase 2 Review Alarm Analysis Report with Customer Guide customer in decision making process Drive next steps with changing defaults and creating staff incentive for alarm management Conduct (3) Alarm Mtg. WebEx Training Sessions Phase 3 Review Final Alarm Analysis Report with Customer post changes Deliver Final Metrics from Alarm Study Conduct (1) Alarm Training Session Onsite

11 DOC /21/ GE Title or job number 6/21/2016 Sample Alarms Report

12 DOC /21/2016 Partnership Effective alarm management initiatives are built on coordinated strategies that combine staff training, evidence-based procedures and protocols, and appropriate monitoring and alarming technologies, tailorable to specific patient conditions. Standard clinical guidelines, practices & protocols Hospital procedures, protocols & education GE monitoring technologies Effective alarm management Effective alarm management

13 DOC /21/2016

14 DOC /21/2016 References 1 Impact on Clinical Alarms on Patient Safety. ACCE Healthcare Technology Foundation (2006). 2 Graham, Kelly and Cvach, Maria. Monitor Alarm Fatigue: Standardizing Use of Physiological Monitors and Decreasing Nuisance Alarms. AJCC. 19 (1), (2010). 3 Lipton, JA. van Ettinger, MJB., Barendse, RJ. TB van Dam, van der Putten, NHJJ. and Nelwan, SP. Alarms on the Intensive Center Cardiac Care Unit. Computers in Cardiology. 36, (2009). 4 Gorges, Matthias. Markewitz, Boaz A., Westenskow, Dwayne R. Improving Alarm Performance in the Medical Intensive Care Unit Using Delays and Clinical Context. Technology, Computing, and Simulation. 108 (5) (May 2009); Siebig, S, Kuhls, S, Gather, U, Imhoff, M, Müller, T, Bein, T, Trabold, B, Bele, S, Wrede, C.E., Noise in intensive care units. Do the alarms for subspecialties differ?. Anesthetist. 58, 240–246, (2009). Lipton, JA., van Ettinger, MJB., Barendse, RJ., TB van Dam, van der Putten, NHJJ. and Nelwan, SP. Alarms on the Intensive Center Cardiac Care Unit. Computers in Cardiology. 36, (2009). Chambrin, M.C., Ravaux, P., Calvelo-Aros, D., Jaborska, A., Chopin, C., Boniface, B. Multicentric study of monitoring alarms in the adult intensive care unit (ICU): a descriptive analysis. Intensive Care Med. 25, (1999); Lawless, Stephen. Crying Wolf: False alarms in a pediatric intensive care unit. Critical Care Medicine. 22 (6), (1994). Biot, L., Carry, P.Y., Perdrix, J.P., Eberhard, A., Baconnier, P. Évaluation clinique de la pertinence des alarmes en réanimation. Ann Fr Anesth Réanim. 19, 459–66 (2000).