Go with the Flow: Insights into Complex Infusion Delivery...
Transcript of Go with the Flow: Insights into Complex Infusion Delivery...
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The AAMI Foundation’s National Coalition to Promote the Safe Use of Complex Healthcare Technology
Presents:
Go with the Flow:
Insights into Complex Infusion Delivery Systems
July 20, 2018
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CurrentNationalPatientSafetyCoalitions:
NationalCoalitiontoPromotetheSafeUseofComplexHealthcareTechnology
NationalCoalitiontoPromoteContinuousMonitoringofPatientsonOpioids
NationalCoalitionforAlarmManagementSafety
NationalCoalitionforInfusionTherapySafety
PatientSafetyInitiativeLibrary:o Seminarso Paperso +More
Vision:Healthtechnologyenhanceshealthcareproviders’abilitiestoimprovepatientoutcomes.
Mission:TheAAMIFoundationdrivesreductionsinpreventablepatientharmandimprovementsinoutcomeswithcomplexhealthtechnology.
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ASpecialThanks
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Thankyoutoourindustrypartners!Withouttheirfinancialsupport,wewouldnotbeabletoundertakethevariousinitiativesundertheNationalCoalitionToPromotetheSafeUseofComplexHealthcareTechnology.TheAAMIFoundationanditsco-conveningorganizationsappreciatetheirgenerosity.TheAAMIFoundationismanagingallcostsfortheseries.Thisseminardoesnotcontaincommercialcontent.
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Questions?PostaquestionattheAAMIFoundationLinkedInpage:https://www.linkedin.com/grou
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Speaker Introduction
Bob Butterfield Becton-Dickinson Engineering Fellow (retired) Principal - RDB Medical Instrument Consulting
Nathaniel Sims, MD Cardiac Anesthesiologist & Physician Advisor to Biomedical Engineering,
Massachusetts General Hospital (MGH) Assistant Professor of Anesthesiology,
Harvard Medical School
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Go with the Flow: Insights into Complex Infusion Delivery Systems Bob Butterfield
Becton-Dickinson Engineering Fellow (retired) Principal - RDB Medical Instrument Consulting
Nathaniel Sims, MD Cardiac Anesthesiologist & Physician Advisor to Biomedical Engineering, Massachusetts General Hospital (MGH) Assistant Professor of Anesthesiology, Harvard Medical School
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Bob Butterfield • Serves as expert on Standards Committees
• AAMI Infusion Devices • IEC 60601-2-24 Infusion Devices • ISO 7886 Disposable Syringes
• Serves as advisor/invited lecturer and industry liaison • Harvey Mudd College • University of San Diego • UC San Diego
• Serves currently as a consultant to Ivenix, Inc.
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Disclosures
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Nathaniel Sims, MD
• Cardiac Anesthesiologist at Mass General Hospital
• “Smart Infusion Pump” inventor - patent in public domain
• AAMI - Standards Organization - Board of Directors
• ASHP & ASA Initiatives on “Standardized Concentrations”
• “Micro-Infusion” Syringe Pumps in Surgery & Critical Care
• Closed Loop Control of Anesthesia - EEG signal
• Education: Infusion Pump Basic Principles & Best Practices
• No financial disclosures
AAMI Infusion Seminar ver 2018.07.02 C 9
Disclosures
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Learning Objectives • Understand large volume pump (LVP) technology and its use
in typical clinical environments
• Identify external conditions that impact LVP flow accuracy
• Examine the impact to patient safety when flow variations occur
• Describe how hospitals teach about infusion safety, basic principles, and best practices
Overview
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• Oncology Unit • 1,000 mL infusion to be delivered over 24 hours
• Infusion Complete
• 100 mL remains in the bag • ~2.4 hours over expected infusion time
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Case 1: The Long Long Infusion Long-term Mean Flow
What’s going on?
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What IS a "Large Volume Pump (LVP)?"
• LVP's act like a conveyor belt to transport fluid from a container to the patient continuously
• LVP's do not apply 'pressure' to the fluid, rather they 'displace' the fluid
• Most LVP's do not sense flow or volume but depend on accuracy of tube and mechanism
*graphics courtesy Dr. Nat Sims & Chris Colvin "Drug Administration & Mixing Decisions"
Massachusetts General Hospital 2018
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Effect of Intake Pressure (Head Height) on Flow
The human heart and most IV pumps behave remarkably similarly. In general, the greater the intake pressure, the greater the flow.
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“pump chamber” under-filled
Filling Phase: Fluid (Head Height) Too Low
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actual level
optimum fluid elevation over pump
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“pump chamber” under-filled
Delivery Phase: Fluid (Head Height) Too Low
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actual level
optimum fluid elevation over pump
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“pump chamber” OVER-filled
Filling Phase: Fluid (Head Height) Too High
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actual level
optimum fluid elevation over pump
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“pump chamber” OVER-filled
Delivery Phase: Fluid (Head Height) Too High
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actual level
optimum fluid elevation over pump
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“pump chamber” OPTIMALLY-filled
Filling Phase: Fluid (Head Height) Level Correct
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optimum fluid elevation over pump
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“pump chamber” OPTIMALLY-filled
Delivery Phase: Fluid Level Correct
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optimum fluid elevation over pump
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Effect of Output Pressure on Pump Flow
The heart regulates its flow automatically. IV pumps are much simpler - their flow is often reduced by
output pressure.
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Delivery Phase: High Backpressure (Elevation)
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Back pressure causes the “pump chamber” to be slightly overfilled,
resulting in some fluid NOT going to patient
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Delivery Phase: High Backpressure (Resistance)
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Pressure = flow x resistance
of path Back pressure causes the “pump chamber”
to be slightly overfilled, resulting in some fluid NOT going to patient
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Delivery Phase: High Backpressure - Fluid Lost
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When the intake 'valve' opens, the “pump chamber” expels excess fluid UPSTREAM into the drip chamber
Pressure = flow x resistance
of path
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Summary: Effects of Intake and Output Pressure on Mean Flow Rate
pressure
flow
INTAKE OUTLET Lowering inlet pressure DEcreases pump flow
Raising outlet pressure DEcreases pump flow
User manuals offer some data- but it’s not interpreted
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±5% is the typical mean accuracy variation of set & pump under laboratory test conditions - 0 backpressure, nominal head height of source fluid
• Low fluid elevation • Restricted vent • Kinked tubing • Viscous fluid • Fluid filter
Low intake pressure -3% to -6%
Combined Effects of Flow Error Sources
0%
- 5%
-10%
-15% -20%
-25%
+ 5%
• High flows • Viscous fluids • Small bore - long catheters • Manifolds • Anti-siphon valves • Needle-free valves
High back pressure -10% to -25%
-30%
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Impact of Mean Flow Error: Delivery Time and Volume
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2.4 hours LATE
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• Oncology Unit • 1,000 mL infusion to be delivered over 24 hours
• Infusion Complete
• 100 mL remains in the bag • ~2.4 hours over expected infusion time
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Case 1: The Long Long Infusion Long-term Mean Flow
• Today’s LVPs don’t actually measure flow • Real world conditions are always different • Head height, catheter size, and other factors impact flow • Standardize on practices that optimize YOUR hospital’s
equipment
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• PICU • Post open-heart surgery patient
• Vasopressor & Inotrope infusions
• Epinephrine concentration changed in order to decrease flow rate of pump
• Patient’s blood pressure becomes more varied
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Case 2: An Unstable Blood Pressure Short-term Flow
What’s going on?
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Short-Term Flow Behavior
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Flow from Pumps – Discrete “Shots”
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Most pumps use "stepper” motors. This may result in non-continuous delivery - especially at low flow rates!
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Importance of Continuity & Uniformity
Continuity
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Device Standards describe the discrete flows produced by pumps as “SHOTS”
… so we will also..
Lack of interruption of flow
Consistency of individual units of flow delivered (aliquots or 'shots')
Uniformity
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Flow Continuity & Uniformity
Poor Continuity Good Uniformity
One shot cycle
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Drug level
in body
low rate
high rate minutes seconds
time
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One pump cycle
Flow Continuity & Uniformity
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low rate
high rate
Drug level
in body minutes
seconds
time
Good Continuity Poor Uniformity
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Flow Continuity & Uniformity
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low rate high rate
Drug level
in body minutes
seconds
time
Good Continuity (small shots) Good Uniformity (equal shots)
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• PICU • Post-heart surgery
• Vasopressor & Inotrope infusions
• Epinephrine concentration changed in order to decrease flow rate of pump
• Patient’s blood pressure becomes more varied
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Case 2: An Unstable Blood Pressure Short-term Flow
• Due to the nature of LVP & syringe technology, there can be various types of irregularities in flow
• Depending on flow rate and infusion site, this variability can be more pronounced – carrier solutions may help resolve
• Mix drugs thoughtfully for best balance between fluid restriction and pump capabilities
• MGH has created on-line, interactive educational modules
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• Oncology unit • Frequent Secondary mode gravity infusions
• Common occurrence of medication remaining in Secondary container although pump indicates infusion is complete
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Case 3: The Piggyback that stayed home.. The challenges of Secondary infusions using check-valve sets and elevation
What’s going on?
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Beginning Secondary Flow
Primary Secondary Primary
gravity pressure keeps one-way valve closed
pressure lost due to flow through Secondary / Primary connection
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PRI. SEC.
ZZ
PRI.
←Sec. Flow Rate ←Sec. Volume
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Completing Normal Secondary
Primary Secondary Primary
gravity pressure is now too small to keep valve closed
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PRI.
PRI.
SEC.
ZZ ZZ
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Slow Secondary
Primary Secondary Primary
gravity pressure is now too small to keep valve closed
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PRI.
PRI.
High rate
SEC.
ZZ ZZ
pressure lost due to high flow
through connection
pressure lost
Primary and Secondary run simultaneously (sympathetic flow)
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No Secondary at ALL
Primary Secondary Primary
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PRI.
PRI.
SEC.
ZZ ZZ
All the Secondary infusion has drawn from the Primary
Roller clamp accidentally left closed
Will the un-delivered Secondary be noticed ?
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Over Delivery of Secondary
Primary
Secondary 500 mL
Primary Secondary Primary
Programmed Secondary
125 mL
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ALL the Secondary volume will be
delivered…but at different flow rates!
"...the order is for 125 mL, why can't I just set
the Secondary VTBI to 125 mL ?.."
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• Oncology unit • Frequent Secondary mode gravity infusions
• Common occurrence of medication remaining in Secondary container although pump indicates infusion is complete
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Case 3: The Piggyback that stayed home.. The challenges of Secondary infusions using check-valve sets and elevation
• Secondary infusions are complicated and require careful attention to set-up and manage
• Caregivers need to thoroughly understand basic principles of secondary infusions--
• -- particularly back-check valves, setting the VTBI, and how to observe the drip chambers to confirm equipment
• MGH has created on-line, interactive educational modules
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510(k) pending. The Ivenix Infusion System is not commercially available in the U.S.
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# #
• Under real-life operating conditions, LVP flow/volume error can be as much as negative 20-30%
• The way medications are mixed should take into account the pump’s performance characteristics (continuity & uniformity)
• Secondary infusions are complex to set up and assure intended delivery
• Choice of materials including secondary sets, needle-free valves, and vents all impact performance
• Risks of both over and under delivery of medication exist with each application
Summary
Clinical impacts range from inconvenience to serious under-medication
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Education Resources
https://druginfusionsafety.massgeneral.org
Series of online modules aimed at teaching key concept for understanding safe drug infusion practices.
Modules use:
Graphic and animated content
Interactive questions to practice applying the concepts
Professional audio narration
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Education Resources
https://druginfusionsafety.massgeneral.org
Syringe Infusion Pumps – Operation & Safety Considerations
2-part series. Topics include:
Ø Mitigating startup delays due to slack
Ø Limiting delays in occlusion detection and avoiding a post occlusion bolus
Ø The impact of changes in pump height on medication delivery
Ø What to think about when selecting the syringe volume and tubing set
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Education Resources
https://druginfusionsafety.massgeneral.org
Dead Volume
2-part series. Topics include:
Ø What is dead volume?
Ø Explaining the implication of dead volume on drug delivery
Ø How to minimize the impact of dead volume
Delivery of Life Supporting Drugs: Dead Volume
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Education Resources
https://druginfusionsafety.massgeneral.org
Drug Administration
Topics include: Ø Selecting the optimal standardized concentration and flow rate based on pump
limitations and a patient’s fluid tolerance.
Drug Administration & Mixing Decisions
Ø Key considerations when selecting between a large volume pump and syringe pump.
Ø Thinking about the container/mix volume.
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Education Resources
https://druginfusionsafety.massgeneral.org
Secondary Infusions
Topics include:
Ø Key setup elements of secondary infusions
• Height difference • Back-check valve • Secondary roller clamp
Ø Back priming
Basic Principle of Secondary Infusions
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Conclusion & Call to Action
• Going with the flow.. requires significant insight into the design and behavior of your pump
• Determine how your LVP will meet the clinical needs of all the patients in your hospital
• Work with your pump vendor to understand how your LVP behaves under real-life operating conditions
• Participate in improving the design and performance of medical devices you use
• AAMI is developing new methods of evaluating flow performance of pumps
• Get involved: AAMI National Coalition to Promote the Safe Use of Complex Healthcare Technology
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Thank you! Bob Butterfield - RDB Consulting [email protected] Nathaniel Sims, MD - MGH [email protected]
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PollingQuestions
Selectyouranswerinthe“PollingSection”onyourwebinardashboard
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ComingNext!
The challenges of ensuring a safe and competent workforce in the use of medical devices in
healthcare
David Williams RGN Medical Devices - Clinical Lead
Clinical Engineering Medical Physics & Clinical Engineering
NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST QMC Campus
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Diamond GoldPlatinum
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Questions?PostaquestionattheAAMIFoundationLinkedInpage:https://www.linkedin.com/grou
Typeyourquestioninthe“Question”box onyourwebinardashboard
Oryoucanemailyourquestionto:[email protected]
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HowtoSupport?Itiseasy!youmakeataxdeductibledonationtwoways:
WhySupport?Adverseeventscontinuetobeatroublingissueinhealthcareandtechnologyisacontributingfactor.Withcomplextechnologybeingintroducedatthepointofcareatarapidratethereisaneedtoidentifysolutionstohelpcaregiversnavigatethisenvironmentandmitigatetherisksthatarepresent.Yoursupportwillcreateessentialtoolstohelpreducetheriskoftechnologyrelatedincidents.
TheAAMIFoundationisa501(C)(3)CharitableOrganization
AAMIFoundation4301NFairfaxDriveSuite301Arlington,VA22203-1633
or
Wehopethatyouwillsupportthisimportantmission
http://my.aami.org/store/donation.aspx
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ThankyouforattendingtheAAMIFoundation
ComplexTechnologySeminarSeries!
This concludes the presentation