blood reflux: backflow, biofilm, and slime—oh my!s. blood reflux: backflow, biofilm, and...

Blood Reflux: Backflow, Biofilm, andSlime—Oh My!

Wednesday, April 2 7:00 8:45 AMRosen Shingle Creek Panzacola F 1/2

Thriving Thriving Amid TheAmid The Turbulent RideTurbulent Ride

2014 NHIA Annual Conference & Exposition

Thriving Amid The Turbulent Ride

A Symposium Held in Conjunction with the 2014 NHIA Annual Conference & Exposition

Supported by an educational grant fromSmiths Medical

Blood Reflux: Backflow, Biofilm, and Slime—Oh My!

2014 NHIA Annual Conference & Exposition 1

03S. Blood Reflux: Backflow, Biofilm, and Slime—Oh My!Wednesday, April 2 7:00 8:45 AMRosen Shingle Creek Panzacola F 1/2Supported by an educational grant from Smiths Medical

Pharmacist, Pharmacy Technician and Nurse Continuing Education Contact Hours: 1.5

ACPE Pharmacist and Pharmacy Technician Program #:0761999914145L01P & TKnowledgeBased Learning Activity

Education Overview:For the homebased patient receiving infusion therapy, a patent vascular access device (VAD) represents a lifeline to treatment. Maintainingthat lifeline to allow uninterrupted delivery of the prescribed infusion therapy is a goal of every home infusion provider, and requires anunderstanding of the catheter complications that can arise and their potential impact on patient outcomes. This program will provide acomprehensive overview of VAD thrombotic occlusions, from the effect of vascular pressure, to the pathophysiology of thrombus formation,and the relationship between occlusions, bloodstream infection and biofilms. Walk through published clinical guidelines from groups suchas the Centers for Disease Control and Prevention (CDC), and Standards of Practice from the Infusion Nurses Society (INS), as you considerthe evidence behind best practices in the prevention of catheter occlusions.

Faculty: Connie Nadeau, MBA BSN RNCNIC, Manager, Clinical Education Services, and Karen A. Tomlin, BS, MT(ASCP), CIC, Infection Preventionist, Smiths Medical, Norwell, MA

Faculty Biographical Statement:Connie Nadeau, MBA BSN RNCNIC, has over 40 years of nursing experience covering emergency, transport, neonatal and education arenas.Connie moved into industry 12 years ago and is currently the Clinical Education Manager for Smiths Medical. She and her team of registerednurses are responsible for facilitating customer education and successful product adoption on multiple Smiths Medical product portfoliosacross the US. In her role, Connie also is involved in new product development, process improvement, marketing activities and is a continuingeducation nurse planner/presenter. Connie received her BSN and MBA from Wilmington University [DE] and maintains a certification inNeonatal Intensive Care Nursing.

Karen A. Tomlin, BS, MT(ASCP), CIC is an Infection Preventionist with Smiths Medical. Certified by the Board of Infection Control, Karen isa Medical Technologist with over 28 years of infection prevention expertise in both the hospital environment and industry. Karen has participated in biofilm studies on medical devices developed a sharp safety program that has been implemented both in the US and Europe.She has contributed to performance improvement projects for reducing infection rates for surgical site and central line blood stream infections. In addition, she facilitated the implementation of evidencebased best practice resulting in reduction in MRSA and ventilator associated pneumonia. She received her Bachelor of Science degree in Medical Technology for AldersonBroaddus College and the MyersClinic Broaddus Hospital School of Medical Technology. She worked as a Medical Technologist prior to being commissioned in the United StatesAir Force where she was the Assistant Chief of Laboratory Service, attaining the rank of Captain. She ensured the quality of over 540,000annual laboratory procedures. Karen speaks nationally on the subjects of sharp safety and blood reflux.

Pharmacist, Pharmacy Technician and Nurse Education Objectives:1. Describe how blood reflux in vascular access catheters contributes to thrombotic catheter occlusions and bloodstream infections. 2. List two quality initiatives to prevent blood reflux complications.3. Identify two strategies for preventing complications created by blood reflux in the vascular access catheter.


2014 NHIA Annual Conference & Exposition2

Learning Assessment Questions:

1. Preventing blood reflux into a catheter can reduce occlusions.a. Trueb. False

2. Biofilms are a survival mechanism for bacteria and yeast.a. Trueb. False

3. There is a relationship between thrombosis and infection.a. Trueb. False

4. Factors that influence hemodynamics include:a. Syringe connection/disconnectionb. IV bag running dryc. Patient movement d. All of the above

5. The flushclamp sequence, flushing volume and disinfection is the same for all connectors approved by the FDA.a. Trueb. False

Answers can be found on the last page of this booklet.



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Objectives

Describe how blood reflux in vascular access catheters contributes to thrombotic catheter occlusions and bloodstream infections.

List two quality initiatives to prevent blood reflux complications.

Identify two strategies for preventing complications created by blood reflux in the vascular access catheter.

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Reflux & Bloodstream Infections

heoretically, blood reflux into either the IV catheter or needleless connector increases both the risk of occlusion and

biofilm formation. Both also increase the risk of Health Care Associated Blood Stream Infections.”

Infection Control Today August 2010 Vol. 14 No 8, “Choosing the Best Design for Intravenous Needleless Connector to Prevent HA-BSI” By: William R. Jarvis, MD

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Catheter placement and size

Catheter composition

Stabilization • Preserve integrity of access device • Minimize catheter movement at insertion site • Prevent catheter dislodgement

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Science of Fluid Dynamics

In Physics, “Fluid Dynamics” deals with fluid flow. Fluid is a substance that flows under pressure, which includes liquids and gases. Water is a fluid, air is a fluid, the sun is a fluid, even honey is a viscous fluid.

Science of Fluid Mechanics

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Human Physiology

The circulatory system is a closed pressure system • The pathway taken by blood

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• The pathway taken by blood from the heart to the lungs and back is called pulmonary circulation.

• The pathway taken by blood from the heart to the rest of the body and back is called systemic circulation.

Science of Fluid Pressure

Fluid Pressure Is caused by gravity, acceleration, or forces in a closed container Pressure changes are constant during IV therapy Blood reflux occurs promptly when venous pressure is greater than external infusion pressure Fluid will equalize atmospheric pressure in an open system creating back flow

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Hemodynamics: Influencing Factors

Syringe connection/ disconnection Syringe plunger rebound IV bag running dry Low infusion rates External pressure

Ventilators/other hospital equipment

Patient Movement Coughing Crying Sneezing Respiration Vomiting

Mechanical Physiological

Dynamics of Vascular Pressure

Pressure mm Hg

Example (rounded pressure values)

Pressure psi

2 - 20mm Hg Central Venous pressure range 0 - 0.4 psi 10 - 30mm Hg Peripheral Venous pressure range 0.2 - 0.6 psi 80-100mm Hg Extravasation risk > 2 psi

75mm Hg Gravity pressure of fluid 100cm (39 inches) above cannulation site

1.5 psi

36” height above the heart = 1.33 psi overcomes the patient’s vascular pressure with gravity infusion



Type of Thrombotic Occlusions:

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Bacteria Yeast Algae Fungi Dynamic ecosystem of microorganisms embedded in a matrix of extracellular polymeric substances (Slimy Matrix)

Biofilm bacteria are 1000X more resistant to antibiotics than free-floating bacteria Share and transfer resistance to other organisms

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1. Initial reversible attachment of free swimming microorganisms to surface 2. Permanent chemical attachment, single layer, bugs begin making slime 3. Early vertical development 4. Multiple towers with channels between, maturing biofilm 5. Mature biofilm with seeding / dispersal of more free swimming microorganisms

Graphic by Peg Dirckx and David Davies © 2003 Center for Biofilm Engineering Montana State University.

What does this all mean?

Microbes colonize intravascular catheters and connectors and form biofilms Organisms shown to cause healthcare-associated infections (HAIs) may be present in these biofilm communities Microbial communities on these devices are highly diverse, may contain organisms from skin and gastrointestinal mircobiomes or from the environment, and will likely contain substantial numbers of organisms that cannot or have not been cultured

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What does this all mean?

The presence of a device-associated biofilm does not necessarily result in a device-associated infection Biofilm organisms may be pathogens or opportunistic pathogens, and multi-drug resistant Biofilm –associated organisms do not respond to therapeutically achievable concentration and may elicit disease processes by detachment of cells or aggregates or by production of endotoxins or other pyrogenic substances

“Biofilms, Medical Devices and Anti-Biofilm Technology – Challenges and Opportunities” FDA Public Workshop (February 20, 2014) Dr. Rodney Donlan, Director, CDC Biofilms Laboratory

Relationship between Thrombosis and Infection

“Shortly after insertion, intravascular catheters are coated with a conditioning film, consisting of fibrin, plasma proteins, and cellular elements, such as platelets and red blood cells. Microbes interact with the conditioning film, resulting in colonization of the catheter. There is a close association between thrombosis of central venous catheters and infection.” CDC Guidelines for the Prevention of Intravascular Catheter-Related Infection, 2011 O’Grady NP, Alexander, M, Burns LA, et al.

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Relationship Between Thrombosis and Sepsis

“The presence of CRS (catheter-related sepsis) or significant catheter colonization was more frequent in patients whose catheter-related central vein thrombosis was diagnosed.”

Chest 1998; 114;207-213 Central Vein Catheter-Related Thrombosis in Intensive Care Patients: Incidence, Risk Factors, and Relationship with Catheter-Related Sepsis. By: Jean-Francois Timset, MD, PhD

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Predictors of Occlusions/Infiltration

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Risk Factors for PIV Catheter Failure: A multivariate analysis of data from a randomized controlled study. Wallis M, McGrail M, Webster J, Marsh N, Gowardman J, Playford G, Rickard CM. Infection Control and Hospital Epidemiology.

P<0.001

Implications of Occlusion

Patient discomfort High risk of DVT (deep vein thrombosis) Increased risk of embolism Delay in treatment Increased length of stay Nursing time Increase in medication and supply cost Increased risk of infection



Impact of Central Line-Associated Bloodstream Infections (CLABSI)

In the United States, 15 million central vascular catheter (CVC) days occur in intensive care units (ICUs) each year

Outcomes associated with hospital-acquired CLABSI • Mortality rate of 12%-25% • Increased length of hospital stay 6-10 days • Excess health care cost of $16,550

Morbidity and Mortality Weekly Report, Vital Signs: Central Line–Associated Blood Stream Infections — United States, March 1, 2011, Vol. 60

Bloodstream Infections: By Device

No. of Prospective Studies

Pooled Mean per/1000 catheter days

Arterial catheters 6 2.9

Short-term non-medicated CVC 61 2.3

Long-term tunneled and cuffed CVC 138 1.2

Peripheral venous catheters 13 0.6

Peripherally inserted CVC (PICC) 8 0.4

Subcutaneous central venous port 13 0.2

Crnich, CJ, Maki DG, The Promise of Novel Technology for the Prevention of Intravascular Device-Related Bloodstream Infections. I Pathogenesis and Short-Term Devices. CID 2002



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Association for Professionals in Infection Control and Epidemiology, Inc. 3/31/10.

Standards of Evidence-Based and Best Practice

Infusion Nurses Society – INS

Association for Vascular Access – AVA

Centers for Disease Control and Prevention - CDC

Society for Healthcare Epidemiology of America - SHEA

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Guidelines for Peripheral and CVCs

Needleless Connectors Add-On/ Administration Sets

Site and Dressing Changes

CDC 2011

Split septum valve preferred over mechanical valve

No more frequently than 96-hours intervals, but at least every 7 days

Peripheral catheters: 72-96 hours

SHEA 2008 (CVCs only)

Do not routinely use positive pressure needleless connectors

No longer than 96 hours

Non-tunneled CVCs, change transparent dressings every 5-7 days

INS 2011

Needleless connectors shall be Luer-lock design

Change with site rotation: up to 96 hours dependent on infusate

When clinically indicated

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Needleless Technology

Negative displacement: Upon syringe disconnection, blood refluxes into catheter tip

Action: clamp BEFORE syringe disconnection

Positive displacement: Upon syringe disconnection, small amount of fluid pushes out end of catheter tip

Action: clamp AFTER syringe disconnection

Neutral displacement: Designed to minimize blood reflux into catheter tip upon syringe disconnection

Action: clamp BEFORE syringe disconnection

Anti-reflux technology: Prevents blood reflux from occurring in IV therapy due to mechanical and physiological factors Action: NO dependency on clamping sequence, reflux protection is automatic

No ISO standard on fluid displacement

Clamping does NOT stop all blood reflux potentials

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Blood Reflux and Thrombosis

How much reflux is too much?

Blood Reflux associated with needleless connector into catheters between

8 – 139 L Total Incidence of Occlusion

15 L = 2.94% 30 L = 24.71%

Impact of blood reflux on the incidence of catheter occlusions – A controlled experimental trial. Hunter M. VonBriesen T, Faintuch S. 37th National Canadian Vascular Access Association Conference, 2012

Positive Needleless Connectors

SHEA – Do not routinely use positive-pressure needleless connectors with mechanical valves

FDA Alert – Initiated post market surveillance and supports SHEA’s recommendations

CDC – Split septum valve may be preferred over some mechanical valves

Risk Benefits Education



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Are you doing what it takes to decrease the occurrence of blood reflux?

Clinical Practice: Policy and Protocol

Policy must reflect facility-specific flush protocol:

Proper flush-clamp sequence according to connector being used Proper flush solution, technique, frequency of flush,

and volume of flush Treat partial and complete occlusion in central

catheters PROMPTLY

PR

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Clinical Practice: Needleless Connectors

Negative Fluid Displacement Needleless Connector

Flush Clamp Remove Syringe

Positive Fluid Displacement Needleless Connector

Flush Remove Syringe Clamp

Clinical Practice: Data

Number of PIV catheters placed Number of PIV catheter days Mean, median and average dwell time Complications:

Phlebitis Infiltration and extravasation Infection Air embolism Catheter embolism Thrombosis and occlusion



SUM

MIN

G IT

UP

Strategies to Prevent Blood Reflux

Standards of best practice

Education

Data collection– continuous quality improvement

Select new devices based on outcome evidence

Investigate new technology to reduce:

Biofilm formation, blood reflux, catheter occlusion and accidental needle stick

SUM

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DON’T FORGET!!

• Hand hygiene is king! • Site care and maintenance including a

meticulous “scrubbing the hub” routine is essential

• Assessment for complications • Catheter site dressing regimens per best

practice

Objectives

• Describe how blood reflux in vascular access catheters contributes to thrombotic catheter occlusions and bloodstream infections.

• List two quality initiatives to prevent blood reflux complications.

• Identify two strategies for preventing complications created by blood reflux in the vascular access catheter.

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QUESTIONS?



References:• Bagot, CN, Arya, R. Virchow and his triad: a question of attribution British Journal of Haematology. Oct2008, Vol. 143 Issue 2, p180190.• Baskin JL, ChingHon P, Reiss U, et al. Management of Occlusion and Thrombosis Associated With LongTerm Indwelling Central Venous

Catheters. Lancet. 2009 July 11; 373 (9684): 159.• Crnich, CJ, Maki DG. The Promise of Novel Technology for the Prevention of Intravascular DeviceRelated Bloodstream Infections. I

Pathogenesis and ShortTerm Devices. CID 2002• Deficit Reduction Act of 2005, Public Law 109171Feb.8, 2006, Retrieved 7/15/2013 at www.gpo.gov/fdsys/pkg/PLAW

109publ171/pdf/PLAW109publ171.pdf• FDA Memorandum, Dear Infection Control Professionals. Available at: www.fda.gov/MedicalDevices/Safety/AlertsandNotices/

ucm220459.htm Accessed July1, 2013• Hadaway L. Technology of flushing vascular access devices. J Infus Nurs. 2006; 2913745• Infusion Nursing Standards of Practice, Journal of Infusion Nursing, Volume 34, Number 1S ISSN 15331458. Revised 2011.• Jarvis W, Choosing the Best Design for Intravenous Needleless Connector to Prevent HABSI. Infection Control Today. August 2010 Vol.

14 No 8• Macklin D, What’s Physics Got to Do With It? J Vasc Access Devices. 1999;4(2): 713.• Marschall J, Mermel LA, Strategies to Prevent Central Line – Associated Bloodstream Infections in Acute Care, Infection Control and

Hospital Epidemiology, vol. 29, Supplement 1, October 2008.• McKnight S Nurse’s Guide to Understanding and Treating Thrombotic Occlusions of Central Venous Access Devices. Medsurg Nurs.

2004; 13:37782• Morbidity and Mortality Weekly Report, Vital Signs: Central Line–Associated Blood Stream Infections — United States, March 1, 2011,

Vol. 60• National Patient Safety Goals, Joint Commission, 2013. Accessed 5/10/2013 at: www.jointcommission.org/assets/1/18/NPSG_Chapter_

Jan2013_HAP.pdf• O’Grady NP, Alexander, M, Burns LA, et a. Guidelines for the Prevention of Intravascular CatheterRelated Infection, Centers for Disease

Control and Prevention, 2011 • Poole S. Central Line Infection: Improving our Surveillance, Treatment and Prevention in the Home Setting. Infusion Mar/Apr 2009. • Potera C, Biofilm Dispersing Agent Rejuvenates Older Antibiotics. Environmental Health Perspectives 2010; 118; A288• Premier Advisor Live® Hospital valuebased purchasing program: What’s in the new CMS proposed rule? 2011, Accessed 7/1/2013 at:

www.premierinc.com/advisorlive/Presentations/vbp011911.pdf• Ryder M. Needleless Connectors…minimizing the risk of bacterial transfer. Accessed 2/28/14 at: www.ncqualitycenter.org/wp

content/uploads/2013/01/Tenn_web.pdf• Sinno M, Alam M, Echocardiographically Detected Fibrinous Sheaths Associated with Central Venous Catheters. Echocardiography.

Mar2012, Vol. 29 Issue 3, pE56E59. • Timsit JF, Misset B, CarletJ, Central Vein CatheterRelated Thrombosis in Intensive Care Patients: Incidence, Risk Factors, and Relationship

with CatheterRelated Sepsis. Chest 1998; 114;207213.• Wallis M, McGrail M, Webster J. et. al. Risk factors for PIV catheter failure: a multivariate analysis of data from a randomized controlled

trial. Infection Control & Hospital Epidemiology. Under review. • Hunter M. VonBriesen T, Faintuch S. Impact of blood reflux on the incidence of catheter occlusions – A controlled experimental trial.

37th National Canadian Vascular Access Association Conference, 2012



NOTES:

Answers:1. a. True2. a. True3. a. True4. d. All of the above5. b. False

32 2014 NHIA Annual Conference & Exposition


blood reflux: backflow, biofilm, and slime—oh my!s. blood reflux: backflow, biofilm, and...

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