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-BSI ICU Data 684/day 28/hour

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: Non-ICU Patients ICU Patients

The … Biofilm Formation 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) 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,

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 Partnership Active in presence of Blood Residual Effect Total Insertion site barrier Zone of Inhibition Complete Skin Contact Absorbs Moisture

IV CONNECTOR Intraluminal Pathway Contamination /Migration Swabbing Adhesion Prevent Fibrin Build-up By Flushing Success Colonization Minimize Habitat Availability by Minimizing their Food Source by eliminating Heparin Contamination /Migration Swabbing Adhesion Prevent Fibrin Build-up By Flushing Success Colonization Minimize Habitat Availability by Minimizing 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 Surface Needle Free Device (NFD) Intraluminal Protection Device (IPD)

Septum Seal Before Swabbing After Swabbing Gaps Before Swabbing After Swabbing After Connection No Compression Under Compression NFD IPD After Swabbing Hydrophobic Material Smooth Surface No Gaps

IPD Disinfection Nelson Laboratories, Inc., Salt Lake City, UT 2007 lab # &

Swab Cap Technology Company Product Hospira Effect-IV Excelsior Swab Cap Ivera Curos 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 SystemsIPD First Barrier Second Independent Barrier

Biofilm Colonization Cook, Meyer, Luchsinger 2007 IPS: 93.0% % 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)

DeviceIONCoat/ImpSept/FPWEffectiveness MaxGuard™AGImpFPW24 hr UltraSite® AGAGImpFPW96 hr V-LinkAGCFPW96 hr Silver Clave®/MicroClave® AGImpFPW silicone seal 96 hr InVision-Plus® CSAG CH ImpSeptum FPW 7 Days Practice/Product Partnership

Microbial Comparison Product Name Silver Clave®/MicroClave® Ultrasite® AgV-Link MaxGuard™ InVision-Plus® CS Day 1Day 4Day 1Day 4Day 1 Day 4Day 7 Staphylococcus aureus MRSA Staphylococcus epidermidis MRSE VRE Candida albicans Acinetobacter baumannii Pseudomonas aeruginosa Klebsiella pneumoniae Escherichia coli Entero C 4 Entero A

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: /

Flushing Primary Fibrin Removal Action

Pathway Design NFDIPD Straight-Through Fluid Pathway Priming Volume 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 Nelson Laboratory, Inc., Salt lake City, UT Lab # , #456810, #

IPS: Blood Clearing - Adult Nelson Laboratories, Inc., Salt Lake City, UT 2009 Lab #

Reflux Provides Repeated Surface Conditioning Events Associated with Occlusions

NFS: Luer Activated Clamp Before Disconnection

NFS: Positive Pressure Clamp After Disconnection

IPS: Zero Fluid Displacement No Clamping Sequence

Reflux No Clamping Sequence 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 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 ;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 Days Pre/Post PRE-IPD INFECTION RATE POST-IPD INFECTION RATE INFECTION DECREASE MEAN DECREASE PER CONNECTOR TYPE TO IPD Positive mechanical 5.16 SD 2.95 ICU-CA ,000/15, MICU-CO / MICU-PA7 + 72,766/ MICU-NV ,458/8, SICU-CO ,121/1, Split septum 4.15 SD 1.9 ICU-TX8 + 87,251/6, LONG-TERM-TN ,479/10, Negative mechanical 2.53 SD 0.4 Hospital wide-FL ,139/20, Long Term - TN ,257/10, Oncology-NY6 + 62,477/ 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 =

Practice/Product Partnership Facilit ates Care & Maintenance IP NF 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.

Intraluminal Protection Care & Maintenance Therapeutic Regimen Design Features Patient VAD Practice IPS Fail-Safe Engineering Positive Patient Outcomes

Questions & Answers Thank You !