Managing Infusion Pump Alarms

Kelcy Freeman, PharmD, BCPSNational Coalition for Infusion Therapy Safety

March 12, 2015

2 Proprietary & Confidential

Infusion Pump Alarm Management

3 Proprietary & Confidential

Syringe Pump Considerations

Rapid occlusion detection system for NICU

Constant pump monitoring by anesthesia

4 Proprietary & Confidential

Classifying Infusion Alarms

Alarms that summon a caregiver to the bedside, but do not result in clinical intervention once the situation has been assessed (Hyman)

Are false alarms non-actionable or a different category altogether?

Is an “Infusion Complete” alarm actionable or non-actionable?

5 Proprietary & Confidential

Alarms vs Alerts

2011 Medical Device Alarms Summit Priority Action (AAMI)Standards for alarms (IEC60601-1-8)are relatively new and have had mixed success

Need to standardize terminology of alarm conditions

R3 Report for NPSG.06.01.01 (TJC)NPSG addresses clinical alarms that can compromise patient safety if they are not properly managed…In general, this does not include items such as nurse call systems, alerts from CPOE, or other IT systems

6 Proprietary & Confidential

Medfusion® Syringe Pump AlarmsAlarm Type Definition and Examples

High PriorityAny condition that halts an ongoing infusion

OcclusionInvalid Syringe Size

Medium Priority

Any condition requiring intervention, but that does not halt an ongoing infusion

Pressure IncreasingOutside Range Limit (soft limit)

Low PriorityAny condition not requiring immediate intervention

Low Battery ReminderSet Time and Date

Limit PriorityProvides user feedback related to interaction with pump

Input Out of Range (hard limit)Syringe Does Not Match Entry

System FaultSystem fault conditions, fluid delivery stops

System Failure: Configuration RequiredSystem Failure: Force Sensor Test

7 Proprietary & Confidential

PharmGuard® Reports Alarm Categories

Alarm Category Examples

Operational Set Time and DateSyringe Does Not Match Entry

Routine Clinical OcclusionPressure Increasing

Non-Routine ClinicalOutside Range Limit (soft limit)Input Out of Range (hard limit)Invalid Syringe Size

Routine Hardware Low Battery Reminder

Non-Routine Hardware System Failure: Configuration RequiredSystem Failure: Force Sensor Test

8 Proprietary & Confidential

Alarm Summary

9 Proprietary & Confidential

Alarm Summary

10 Proprietary & Confidential

Different Perspectives: End-user

11 Proprietary & Confidential

Different Perspectives: End-user

12 Proprietary & Confidential

Directly Configurable AlarmsFeature Options

Alarm LoudnessDefines the loudness level of the pump’s alarms

Level 1 Level 4Level 2 Level 5Level 3

Alarm Silence TimeInterval for which an alarm waits before alarming again after user pressed the alarm silence button

1 minute2 minutes

Alarm StyleDefines the tone style a pump will use when sounding an alarm

Medfusion® DefinedInternational StandardMedfusion® Multi-Tone

Near Empty Alarm PriorityDefines the priority level at which the pump will generate the alarm

LowMedium

Near Empty TimeNumber of minutes remaining before a syringe is empty, at which time the pump will alert the clinician that the syringe is nearly empty

0 – 240 minutes

13 Proprietary & Confidential

Directly Configurable AlarmsFeature Options

Occlusion LimitDefines the pressure at which the pump will consider the line occluded

Very Low (~4 psi)Low (~8 psi)Normal (~12 psi)High (~16 psi)

FlowSentry™

Defines if the FlowSentry™ (Rapid Occlusion Detection) is enabled

EnabledDisabled

FlowSentry™ SensitivityDefines the sensitivity of the FlowSentry™ algorithm during normal infusion

LowNormalHighVery High

FlowSentry™ Startup SensitivityDefines the sensitivity of the FlowSentry™ algorithm during infusion startup

LowNormalHighVery High

14 Proprietary & Confidential

Indirectly Configurable Alarms

Override Alarm Loudness

Override Occlusion Limit

Enable/disable FlowSentry™

Enable/disable Syringe Near Empty Tone

Enable/disable Syringe Vol Empty Tone

15 Proprietary & Confidential

Syringe Empty Process

Syringe Near Empty is designed to provide warning so there is time to prepare another syringe, if needed

Syringe Volume Near Empty occurs at a syringe position near the end of the syringe travel

Syringe Empty or Syringe Empty—Stop occur when the syringe is empty, the pump has calculated that the syringe should be at its forward-most travel point, or the pump’s syringe plunger driver has moved as far forward as possible

16 Proprietary & Confidential

Evolution of Syringe Empty ProcessPump + firmwareversion

Syringe NearEmpty Alarm

Syringe VolNear Empty Alarm

Syringe Empty Alarm

Syringe Empty - StopAlarm

Medfusion®

3500 v5 or earlier

Configurableby customer N/A High priority

High priority(Syringe Empty—Manual)

Medfusion®

4000 v1.1Configurableby customer

Medium priority,audible alarm

High priority High priority

Medfusion®

3500 v6Configurableby customer

Low priority,muted alarm High priority High priority

Medfusion®

4000 v1.5

Configurableby customer

Low priority,muted alarm High priority High priority

17 Proprietary & Confidential

Different Perspectives: Pharmacist

18 Proprietary & Confidential

ReferencesAAMI Foundation, Healthcare Technology Safety Institute. Clinical Alarms [website]. Arlington, Va.: Association for the Advancement of Medical Instrumentation, [no date, ca. 2013]. Available online at: http://www.aami.org/htsi/alarms/

AAMI Foundation, Healthcare Technology Safety Institute. Priority issues from the AAMI/FDA infusion device summit. Association for the Advancement of Medical Instrumentation, [no date, ca. 2010]. Available online at https://www.aami.org/meetings/summits/infusion.html

American Association of Critical-Care Nurses. NTI ActionPak: Strategies for managing alarm fatigue [website]. Philadelphia, Pa: May 2013. Available online at http://www.aacn.org/dm/practice/actionpakdetail.aspx?itemid=28337&learn=true

Hyman, W. Learning from nonactionable clinical alarms, October 6, 2014. AAMIBlog. Available online at http://aamiblog.org/2014/10/06/william-hyman-learning-from-non-actionable-clinical-alarms/

The Joint Commission. Alarm system safety. R3 Report: Requirement, rationale, reference, December 11, 2013; 5. Available online at http://www.jointcommission.org/assets/1/18/R3_Report_Issue_5_12_2_13_Final.pdf

The Joint Commission. The Joint Commission announces 2014 National Patient Safety Goal. Joint Commission Perspectives, July2013; 33(7).McAlpine, B. Alerts versus alarms—Not just semantics, January 15, 2014. HIStalk Readers Write. Available online at http://histalk2.com/category/readers-write/.

The National Association of Clinical Nurse Specialists Alarm Fatigue Task Force. (2014). Alarm fatigue: Strategies to safely manage clinical alarms and prevent alarm fatigue. Available online at http://www.nacns.org/html/alarm-fatigue.php

Philips Healthcare. Just a nuisance? 2013. Available online at http://ec.europa.eu/health/expert_panel/consultations/docs/2014_pubcons_qualityhealthcare_co59_en.pdf

Vanderveen, T. Don’t approach the challenges of pump alarms with a broad brush, May 5, 2014. AAMIBlog. Available online at http://aamiblog.org/2014/05/28/tim-vanderveen-dont-approach-the-challenges-of-pump-alarms-with-a-broad-brush/

Welch, J. Alarm fatigue hazards: The sirens are calling. Patient Safety & Quality Healthcare, May/June 2012. Available online at http://psqh.com/alarm-fatigue-hazards-the-sirens-are-calling

Thank you!