A Key To CR-BSI Reduction:

Practice/Product Partnership

Disclosure Speaker Bureauu

– RyMed Technologies Consultant Clinical Education Issues

– Baxter Healthcare– Hospira – RyMed Technologies – Catheter Connection

Investor– RyMed Technologies

Author– Elsevier

CR-BSIICU Data

684/day

28/hour

http://www.mcclatchydc.com/2010/12/09/105047/hospitals-will-report-patient.html

The Problem… Care & Maintenance

1. Mermel L, Farr B, Sheretz R. Guidelines for the management of intravascular catheter-related infections. Clinical Infectious

Diseases. 2001;32:1249-1272.

Non-ICU Patients

ICU Patients

The Problem… Biofilm Formation

Rate of adhesion = Number of Cells, Surface Conditioning, and Flow Rate

Surface Conditioning – Staph Epidermidis Adheres Only to Fibronectin

(Raad)– Staph Aureus Adheres to Fibronectin, Fibrinogen,

and Laminin (Raad) – Gram Negative Organisms Adhere to Fresh

Human Blood (Murga)Turbulent Flow Enhances Adhesion (Donlan)

Donlan RM, Costerton JW. Biofilms: Survival Mechanisms of Clinically Relevant Microorganisms. Clinical Microbiology Reviews, APR. 2002, 167-193

INTRALUMINAL PATHWAY

IV CONNECTOR

Hub

EXTRALUMINAL PATHWAY

Insertion Site

Skin

Catheter

Extraluminal and Intraluminal Strategies

• Effective Surface Disinfection/Skin Antisepsis

• Prevent Active and Passive Micro-organism Migration

• Minimize Fibrin Adhesion

Practice/Product Partnership

Product

PracticePatient

Call for the Manufacture of devices that involve fail-safe engineering advances aimed at further mitigation of risk of infection in the complex hospital environment. LA Mermel LA, Marschall J,ireply to Ciavarella Infection Control and Hospital Epidemiology Letters to the Editor 2009

Technical Devices as well as a set of simple preventive measures may be useful for preventing major CR-BSIs Timsit JF Jama 2009

Extraluminal Fluid Pathway Protection

Contamination – Skin Antisepsis– Minimize Moisture

Migration– Prevent

Microorganism Entry with dressing management

Product PartnershipActive in presence of BloodResidual Effect

Total Insertion site barrierZone of InhibitionComplete Skin ContactAbsorbs Moisture

IV CONNECTOR

Intraluminal Pathway

Contamination /MigrationSwabbing

AdhesionPrevent Fibrin Build-upBy Flushing Success

ColonizationMinimize Habitat Availability byMinimizing their Food Source by eliminating Heparin

Septum surface Septum Seal Fluid Pathway Dead Space Internal Mechanism Clamping sequence Visibility Reflux Flushing Solution

Jarvis WR, Choosing the best design for intravenous needleless connectors to prevent HA-BSI. ICT, August 2010

Practice/Product Partnership

Septum Disinfection

Septum: Protects the Intraluminal Pathway

Septum SurfaceNeedle Free Device (NFD)

Intraluminal Protection Device (IPD)

Septum Seal

Before Swabbing

After Swabbing

Gaps

Before SwabbingAfter Swabbing

After Connection After Connection

No Compression

Under Compression

NFD IPD

After Swabbing

Hydrophobic MaterialSmooth SurfaceNo Gaps

IPD Disinfection

Nelson Laboratories , Inc., Salt Lake City, UT 2007 lab # 395445 & 398575

Swab Cap Technology

Company ProductHospira

Effect-IV

Excelsior Swab Cap

IveraCuros Port Protector

Bard Site-Scrub

Migration:

Microbial Barrier Design

Fluid Pathway Covered When Not Activated

Fluid Pathway

Have Either a: Single Barrier, Single Seal, or Single O-Ring For Fluid Pathway Protection

Needle Free Systems IPDFirst Barrier

Second Independent Barrier

Biofilm Colonization

Cook, Meyer, Luchsinger 2007

IPS:93.0% - 99.9 % Less

Device Migration Mean numbers per day CFU’s >= 15 on 4 types bacteria, p < .0001 bacteria E. coli, Staph Aureus, Staph Epi, Pseudomonus.

CFU > 15 Reported to Be Related to infection/sepsis.

Chernecky C. (2010) Comparison of Bacterial CFUs in 5 Intravenous connectors. Clin Nurs Res , 19 (4) 416-428

Device ION Coat/Imp Sept/FPW Effectiveness

MaxGuard™ AG Imp FPW 24 hr

UltraSite® AG AG Imp FPW 96 hr

V-Link AG C FPW 96 hr

SilverClave®/MicroClave®

AG Imp FPW silicone seal

96 hr

InVision-Plus® CS AGCH

Imp SeptumFPW

7 Days

Practice/Product Partnership

Microbial Comparison

Product NameSilver

Clave®/MicroClave®

 Ultrasite®

Ag V-Link MaxGuard™

  InVision-Plus® CS

Day 1 Day 4 Day 1 Day 4 Day 1 Day 1 Day 4 Day 7

Staphylococcus aureus 5.18 5.22 4 3 4.94 3.2 4.2 4.2MRSA 4.52 4.28 3.8 4.3 4 4 3.2 5.5 7.0Staphylococcus epidermidis 4.7 4.84   4 4.97 4.0 4.0 6.0MRSE 4.7 4.3VRE 4.08 4.78 4 5.14Candida albicans         4.8 2.6 3.3 2.9Acinetobacter baumannii           3.8 4.5 5.4Pseudomonas aeruginosa 6.28 6.28 3.9 4.6 4 5.58 4.3 4.3 4.5Klebsiella pneumoniae 6.04 6.27 4.7 4.6 4.85 5.0 5.5 5.1Escherichia coli         4 5.19 4.1 5.2 4.9Entero C 4Entero A 4.3 5.3

Mean CFU’s for 4 Consecutive Daysin-vitro

Figure 5: Mean CFU’s for 4 consecutive days in vitro.Figure 5: Mean CFU’s for 4 consecutive days in vitro.

IPS

Chernecky C., (2010) In Vitro Comparisons of Two Antimicrobial Intravenous Connectors. Clin Nurs Res doi: 10.1177/1054773810375300

Flushing

Primary Fibrin Removal Action

Pathway DesignNFD IPD

Straight-Through Fluid PathwayPriming Volume 0.027 mLNo Dead SpaceMinimal Fibrin Build-up

Blood Clearing Comparison 1 mL of bovine blood injected into connector and then flushed with 1mL 0.9% saline

Nelson Laboratory, Inc., Salt lake City, UT Lab # 451681.1, #456810, # 456811

IPS: Blood Clearing - Adult

Nelson Laboratories , Inc., Salt Lake City, UT 2009 Lab # 454363

Reflux Provides Repeated

Surface Conditioning Events

Associated with Occlusions

NFS: Luer Activated Clamp Before Disconnection

NFS: Positive Pressure Clamp After Disconnection

IPS: Zero Fluid DisplacementNo Clamping Sequence

Reflux

No Clamping Sequence – Eliminates confusion– Eliminates ongoing education requirements– Minimizes reflux episodes related to usage– Promotes ease of use

Evidence

Systematic Reviews and Meta-analysis

Randomized Controlled Trials

Class 3 Product

SHEA/IDSA Practice Recommendations

Approaches that should not be considered a routine part of CLABSI prevention

– Do not routinely use positive-pressure needleless connectors, with mechanical valves before a thorough assessment of risks, benefits, and education regarding proper us (B II) Routine use of the currently marketed devices that are

associated with an increased risk of CLABSI is not recommended

Marschall j, Mermel LA, et. Al. Strategies to prevent central line-associated bloodstgream infections in Acute Care Hospitals. Infection control and hospital epidemiology. Pct 2008 29;supplement1:s22-s30

FDA Post Market Surveillance

Practice-based research

Randomized Controlled Not Real World Limits Generalization Interventions do not

lend themselves to blinding

Expensive

Comparative Effectiveness All interventions are

considered to determine the relative contribution of each

Minimal patient selection criteria maximize generalizability and external validity

Blinding not necessary Quicker and Less

Expensive

CONNECTOR TYPE PRE + POST- IMONTHS OF

DATA COLLECTION

Cath DaysPre/Post

PRE-IPD INFECTION

RATE

POST-IPD INFECTION

RATE

INFECTION DECREASE

MEAN DECREASE PER

CONNECTOR TYPE TO IPD

Positive mechanical

5.16SD 2.95

ICU-CA 12 + 48 3,000/15,202 3.7 0.0 3.7 MICU-CO 24 + 24 722/1218 4.2 08 3.4 MICU-PA 7 + 7 2,766/2605 4.3 1.5 2.8 MICU-NV 12 + 12 2,458/8,558 11.4 1.4 10.0 SICU-CO 24 + 24 1,121/1,607 7.1 1.2 5.9Split septum 4.15

SD 1.9 ICU-TX 8 + 8 7,251/6,901 2.9 0.1 2.8 LONG-TERM-TN 20 + 20 10,479/10,234 6.0 0.5 5.5

Negative mechanical

2.53SD 0.4

Hospital wide-FL 12 + 12 16,139/20,096 3.3 1.2 2.1

Long Term - TN 8 + 20 4,257/10,234 3.2 0.5 2.7

Oncology-NY 6 + 6 2,477/2331 3.7 0.9 2.8

Infection Rates By Connector Type/ 1000 catheter Days

Clinical Study Overview

Total Pre Catheter Days/Infection 50,670/228 Total Post Catheter Days/Infection 68,752/40

Significance p = 0.0008

Practice/Product Partnership Facilitates Care & Maintenance

IPNF

15 -30 Second Swab

Pulsetile Large Volume Flush Does Not Clear Dead Space

Clamping Sequence

Swabbing 3-5 Twists

Saline Flush Only

5 mL or Less Clears – No Dead Space

No Clamping Sequence

5

As knowledge, technology, and health-care settings change, infection control and prevention measures also should change.

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5110a1.htm

Intraluminal Protection

Care & MaintenanceTherapeutic Regimen Design Features

Patient

VAD

Practice

IPS

Fail-Safe EngineeringPositive Patient

Outcomes

Questions & Answers

Thank You !