Go with the Flow : Insights into Complex Infusion Delivery Systems - - PowerPoint PPT Presentation

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Go with the Flow : Insights into Complex Infusion Delivery Systems - - PowerPoint PPT Presentation

Apr 09, 2023 365 likes •947 views

The AAMI Foundations 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 Vision : Health technology enhances healthcare

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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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Current National Patient Safety Coalitions:

National Coalition to Promote the Safe Use of Complex Healthcare Technology National Coalition to Promote Continuous Monitoring

  • f Patients
  • n Opioids

National Coalition for Alarm Management Safety National Coalition for Infusion Therapy Safety

Patient Safety Initiative Library:

  • Seminars
  • Papers
  • + More

Vision: Health technology enhances healthcare providers’ abilities to improve patient outcomes. Mission: The AAMI Foundation drives reductions in preventable patient harm and improvements in outcomes with complex health technology.

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SLIDE 3

A Special Thanks

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SLIDE 4

Thank you to our industry partners!

Without their financial support, we would not be able to undertake the various initiatives under the National Coalition To Promote the Safe Use of Complex Healthcare Technology. The AAMI Foundation and its co-convening organizations appreciate their generosity. The AAMI Foundation is managing all costs for the series. This seminar does not contain commercial content.

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SLIDE 5

Questions?

Post a question at the AAMI Foundation LinkedIn page: https://www.linkedin.com/grou Type your question in the “Question” box

  • n your webinar dashboard

Or you can email your question to: jpiepenbrink@aami.org

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SLIDE 6

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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SLIDE 7

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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SLIDE 8

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.

8

Disclosures

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SLIDE 9

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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SLIDE 10

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
  • ccur
  • Describe how hospitals teach about infusion safety, basic

principles, and best practices

Overview

10

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SLIDE 11
  • 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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SLIDE 12

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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

  • ptimum 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

  • ptimum 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

  • ptimum fluid

elevation over pump

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SLIDE 17

“pump chamber” OVER-filled

Delivery Phase: Fluid (Head Height) Too High

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actual level

  • ptimum fluid

elevation over pump

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“pump chamber” OPTIMALLY-filled

Filling Phase: Fluid (Head Height) Level Correct

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  • ptimum fluid

elevation over pump

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SLIDE 19

“pump chamber” OPTIMALLY-filled

Delivery Phase: Fluid Level Correct

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  • ptimum 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

  • utput pressure.

20

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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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SLIDE 22

Delivery Phase: High Backpressure (Resistance)

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Pressure = flow x resistance

  • f path

Back pressure causes the “pump chamber” to be slightly overfilled, resulting in some fluid NOT going to patient

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SLIDE 23

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

  • f 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%

25

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SLIDE 26

Impact of Mean Flow Error: Delivery Time and Volume

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2.4 hours LATE

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SLIDE 27
  • 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

27

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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SLIDE 28
  • 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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SLIDE 34

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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SLIDE 35
  • 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

35

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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SLIDE 36
  • 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

  • ne-way valve closed

pressure lost due to flow through Secondary / Primary connection

37

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
  • bserve the drip chambers to confirm equipment
  • MGH has created on-line, interactive educational modules
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SLIDE 43

510(k) pending. The Ivenix Infusion System is not commercially available in the U.S. 43

# #

  • 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

  • cclusion 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
  • f 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 robert.dwaine.butterfield@gmail.com Nathaniel Sims, MD - MGH nsims@mgh.harvard.edu

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Polling Questions

Select your answer in the “Polling Section” on

your webinar dashboard

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Coming Next!

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 Gold Platinum

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Questions?

Post a question at the AAMI Foundation LinkedIn page: https://www.linkedin.com/grou Type your question in the “Question” box

  • n your webinar dashboard

Or you can email your question to: jpiepenbrink@aami.org

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How to Support? It is easy! you

make a tax deductible donation two ways: Why Support? Adverse events continue to be a troubling issue in healthcare and technology is a contributing factor. With complex technology being introduced at the point of care at a rapid rate there is a need to identify solutions to help care givers navigate this environment and mitigate the risks that are present. Your support will create essential tools to help reduce the risk of technology related incidents.

The AAMI Foundation is a 501(C) (3) Charitable Organization

AAMI Foundation 4301 N Fairfax Drive Suite 301 Arlington, VA 22203-1633

  • r

We hope that you will support this important mission

http://my.aami.org/store/ donation.aspx

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Thank you for attending the AAMI Foundation Complex Technology Seminar Series! This concludes the presentation