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A Key To CR-BSI Reduction:

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

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A Key To CR-BSI Reduction:

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  1. A Key To CR-BSI Reduction: Practice/Product Partnership

  2. Disclosure • Speaker Bureauu • RyMed Technologies • Consultant Clinical Education Issues • Baxter Healthcare • Hospira • RyMed Technologies • Catheter Connection • Investor • RyMed Technologies • Author • Elsevier

  3. CR-BSI ICU Data 684/day 28/hour http://www.mcclatchydc.com/2010/12/09/105047/hospitals-will-report-patient.html

  4. The Problem… Care & Maintenance Non-ICU Patients ICU Patients 1. Mermel L, Farr B, Sheretz R. Guidelines for the management of intravascular catheter-related infections. Clinical Infectious Diseases. 2001;32:1249-1272.

  5. 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

  6. IV CONNECTOR Extraluminal and Intraluminal Strategies INTRALUMINAL PATHWAY Hub • Effective Surface Disinfection/Skin Antisepsis • Prevent Active and Passive Micro-organism Migration • Minimize Fibrin Adhesion EXTRALUMINAL PATHWAY Skin Insertion Site Catheter

  7. 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 Practice/Product Partnership Patient Practice Product

  8. Contamination Skin Antisepsis Minimize Moisture Migration Prevent Microorganism Entry with dressing management Extraluminal Fluid Pathway Protection

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

  10. Intraluminal Pathway IV CONNECTOR • Contamination /Migration • Swabbing • Adhesion • Prevent Fibrin Build-up • By Flushing Success • Colonization • Minimize Habitat Availability by • Minimizing their Food Source by eliminating Heparin

  11. Practice/Product Partnership • 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

  12. Septum Disinfection Septum: Protects the Intraluminal Pathway

  13. Septum Surface Intraluminal Protection Device (IPD) Needle Free Device (NFD)

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

  15. IPD Disinfection Nelson Laboratories , Inc., Salt Lake City, UT2007 lab # 395445 &398575

  16. Swab Cap Technology

  17. Migration:

  18. Microbial Barrier Design Needle Free Systems IPD First Barrier Have Either a: Single Barrier, Single Seal, or Single O-Ring For Fluid Pathway Protection Second Independent Barrier Fluid Pathway Fluid Pathway Covered When Not Activated

  19. Biofilm Colonization IPS: 93.0% - 99.9 % Less Cook, Meyer, Luchsinger 2007

  20. 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

  21. Practice/Product Partnership

  22. Microbial Comparison

  23. Figure 5: Mean CFU’s for 4 consecutive days in vitro. Figure 5: Mean CFU’s for 4 consecutive days in vitro. Mean CFU’s for 4 Consecutive Daysin-vitro IPS Chernecky C., (2010) In Vitro Comparisons of Two Antimicrobial Intravenous Connectors. Clin Nurs Res doi: 10.1177/1054773810375300

  24. Flushing Primary Fibrin Removal Action

  25. Pathway Design NFD IPD Straight-Through Fluid Pathway Priming Volume 0.027 mL No Dead Space Minimal Fibrin Build-up

  26. 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

  27. IPS: Blood Clearing - Adult Nelson Laboratories , Inc., Salt Lake City, UT2009 Lab # 454363

  28. Reflux • Provides Repeated Surface Conditioning Events • Associated with Occlusions

  29. NFS: Luer Activated Clamp Before Disconnection

  30. NFS: Positive Pressure Clamp After Disconnection

  31. IPS: Zero Fluid DisplacementNo Clamping Sequence

  32. Reflux • No Clamping Sequence • Eliminates confusion • Eliminates ongoing education requirements • Minimizes reflux episodes related to usage • Promotes ease of use

  33. Evidence Systematic Reviews and Meta-analysis Randomized Controlled Trials Class 3 Product

  34. 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

  35. FDA Post Market Surveillance

  36. Practice-based research Randomized Controlled 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 • Not Real World • Limits Generalization • Interventions do not lend themselves to blinding • Expensive

  37. Infection Rates By Connector Type/ 1000 catheter Days

  38. Clinical Study Overview • Total Pre Catheter Days/Infection 50,670/228 • Total Post Catheter Days/Infection 68,752/40 Significance p = 0.0008

  39. Practice/Product Partnership Facilitates Care & Maintenance NF IP 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

  40. 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

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

  42. Questions & AnswersThank You !

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