A Key To CR-BSI Reduction:
A Key To CR-BSI Reduction:
Practice/Product PartnershipPractice/Product Partnership
DisclosureDisclosure Speaker Bureauu
– RyMed Technologies Consultant Clinical Education Issues
– Baxter Healthcare– Hospira – RyMed Technologies – Catheter Connection
Investor– RyMed Technologies
Author– Elsevier
CR-BSICR-BSIICU Data
684/day
28/hour
http://www.mcclatchydc.com/2010/12/09/105047/hospitals-will-report-patient.html
The Problem… Care & MaintenanceThe 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 FormationThe 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)
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 PartnershipPractice/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 ProtectionExtraluminal Fluid Pathway Protection
Contamination – Skin Antisepsis– Minimize Moisture
Migration– Prevent
Microorganism Entry with dressing management
Product PartnershipProduct Partnership
Active 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
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 PartnershipPractice/Product Partnership
Septum DisinfectionSeptum Disinfection
Septum: Protects the Intraluminal Pathway
Septum SurfaceSeptum SurfaceNeedle Free Device (NFD)
Intraluminal Protection Device (IPD)
Septum SealSeptum 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 DisinfectionIPD Disinfection
Nelson Laboratories , Inc., Salt Lake City, UT 2007 lab # 395445 & 398575
Swab Cap TechnologySwab Cap Technology
Company Product
Hospira Effect-IV
ExcelsiorSwab Cap
IveraCuros Port Protector
Bard Site-Scrub
Migration: Migration:
Microbial Barrier DesignMicrobial 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 IPD
First Barrier
Second Independent Barrier
Biofilm Colonization Biofilm Colonization
Cook, Meyer, Luchsinger 2007
IPS:93.0% - 99.9 % Less
Device MigrationDevice 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 PartnershipPractice/Product Partnership
Microbial ComparisonMicrobial 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 4.2
MRSA 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 5.14
Candida 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 4.5
Klebsiella 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 4.9
Entero C 4Entero A 4.3 5.3
Mean CFU’s for 4 Consecutive Daysin-vitro
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
FlushingFlushing
Primary Fibrin Removal Action
Pathway DesignPathway Design
NFD IPD
Straight-Through Fluid Pathway
Priming Volume 0.027 mL
No Dead Space
Minimal Fibrin Build-up
Blood Clearing Comparison 1 mL of bovine blood injected into connector and then flushed with 1mL 0.9% saline
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 IPS: Blood Clearing - Adult
Nelson Laboratories , Inc., Salt Lake City, UT 2009 Lab # 454363
RefluxReflux
Provides Repeated Surface Conditioning Events
Associated with Occlusions
NFS: Luer Activated Clamp Before DisconnectionNFS: Luer Activated Clamp Before Disconnection
NFS: Positive Pressure Clamp After DisconnectionNFS: Positive Pressure Clamp After Disconnection
IPS: Zero Fluid DisplacementNo Clamping SequenceIPS: Zero Fluid DisplacementNo Clamping Sequence
RefluxReflux
No Clamping Sequence – Eliminates confusion– Eliminates ongoing education requirements– Minimizes reflux episodes related to usage– Promotes ease of use
EvidenceEvidence
Systematic Reviews and Meta-analysis
Randomized Controlled Trials
Class 3 Product
SHEA/IDSA Practice Recommendations
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
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 FDA Post Market Surveillance
Practice-based researchPractice-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 Infection Rates By Connector Type/ 1000 catheter Days
Clinical Study OverviewClinical 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 & MaintenancePractice/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 ProtectionIntraluminal Protection
Care & MaintenanceTherapeutic Regimen Design Features
Patient
VAD
Practice
IPS
Fail-Safe Engineering
Positive Patient Outcomes
Questions & Answers
Thank You !
Questions & Answers
Thank You !