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Research is Prevention HAIs and Needleless Connectors

Research is Prevention HAIs and Needleless Connectors. Deb Richardson, RN, MS, CNS. SHEA/IDSA Practice Recommendation October 2008. Compendium of Strategies to Prevent HAIs in Acute Care Hospitals Contains four device- and procedure-associated HAI practice recommendations Prevention of CLABSI

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Research is Prevention HAIs and Needleless Connectors

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  1. Research is PreventionHAIs and Needleless Connectors Deb Richardson, RN, MS, CNS

  2. SHEA/IDSA Practice RecommendationOctober 2008 • Compendium of Strategies to Prevent HAIs in Acute Care Hospitals • Contains four device- and procedure-associated HAI practice recommendations • Prevention of CLABSI • Prevention of VAP • Prevention of CAUTI • Prevention of SSI • Contains 2 organism-specific HAI categories • MRSA transmission • CDI • Announced - October 8, 2008 • Available for free download on the SHEA and IDSA websites • Supported by: • Joint Commission • American Hospital Assoc. • HICPAC (Healthcare Infection Control Practices Advisory Committee) • APIC

  3. Practice RecommendationStrategies to Prevent Central Line-Associated Bloodstream Infections in Acute Care Hospitals • Catheter Insertion Recommendations - Catheter insertion checklist • Hand Hygiene • Avoid femoral vein in adults • All inclusive catheter cart/kit • Maximal sterile barrier • CHG for skin preparation • Post-Insertion Recommendations • Disinfect catheter hubs, needleless connectors, and injection ports before accessing the catheter with CHG/Alcohol or 70% alcohol • Remove non-essential catheters • Dressing changes with CHG-based antiseptic

  4. Practice RecommendationStrategies to Prevent Central Line-Associated Bloodstream Infections in Acute Care Hospitals • Approaches that should NOT be considered a routine part of CLABSI prevention • NO antimicrobial prophylaxis for catheter insertion or dwell • NO routine replacement of CVCs or arterial catheters • Do not routinely use positive-pressure needleless connectors with mechanical valves before a thorough assessment of risks, benefits, and education regarding proper use • Routine use of the currently marketed devices that are associated with an increased risk of CLABSI is not recommended. **This recommendation is supported by the three studies, Rupp, Salgado, and Field

  5. Topics for Discussion • Factual Information • HAI Rates • Reimbursement Impact • Regulatory Issues • Mandatory Reporting • Technology Review • Evolution • Current Products • Research/Publication Update • Questions

  6. Presentation Objectives • Participants will be able to: • Discuss the current rates and financial impact of CR-BSI on the US Healthcare system • Review current needleless technologies available today • Describe recent research/publication activities regarding needleless access device use

  7. The Facts • Healthcare Acquired Infections (HAIs) • 1.7 Million patients diagnosed with HAIs each year • 33,269 Newborns in High Risk Nurseries • 19,059 Newborns in Well Baby Nurseries • 417,946 Adults and Children in ICUs • 1,266,851 Adults and Children Outside the ICU Klevens, R. Monina. Estimating Health Care-Associated Infections and Deaths in U.S. Hospitals, 2002. Public Health Reports. Vol. 122, March-April 2007.

  8. The Facts • 98,987 estimated deaths annually associated with HAIs • 35,967 Pneumonia • 30,665 BSIs • 13,088 UTIs • 8,025 SSIs • 11,062 Other sites Klevens, R. Monina. Estimating Health Care-Associated Infections and Deaths in U.S. Hospitals, 2002. Public Health Reports. Vol. 122, March-April 2007.

  9. Deaths/yr. Healthcare Associated Infections http://www.cdc.gov/ncidod/dhqp/pdf/hicpac/infections_deaths.pdf http://www.cancer.org/downloads/STT/CAFF2005f4PWSecured.pdf http://www.cdc.gov/hiv/topics/surveillance/resources/reports/2002supp_vol8no1/table2.htm • 90,000 deaths/yr  over 240 per day2 • Average length of stay 21.1 days vs. 4.5 days1 (with/without HAI) • 70% due to organisms resistant to at least one key antibiotic (i.e., MRSA, VRE)2 1 PHC4 Research Brief. Hospital-acquired Infections in Pennsylvania. Issue No. 9. March 2006 2 Campaign to prevent antimicrobial resistance in healthcare settings. ww.cdc.gov/drugresistance/healthcare/problem.htm

  10. The Facts • HAIs Cost More Than $4.5 billion annually • JCAHO and NQF are focused on prevention efforts • HAI prevention is a top focus for professional organizations such as: SHEA and APIC AND • As of October 2008 Medicare no longer pays for certain preventable conditions • CRBSIs included in this list Reder A. Public Reporting of HAIs: Where do we stand now? Infection Control Today. August 2007. http://www.infectioncontroltoday.com/articles/403/78h177171286324.html

  11. Attributed Financial Burden is High Study of 232,651 admissions from 13 hospitals 63% Reduction in profits No HAIs With HAIs The 5% of patients acquiring infection eroded $56MM in profits % Patients # Patients 95% 221,225 100% 232,651 5% 11,426 Reference: MedMined, June 2005

  12. The Facts • Regulatory Impact • JCAHO • 2009 National Patient Safety Goals • Reduce the risk of HAIs • Manage as sentinel events all identified cases of death or major loss of function associated with a HAI • Implement best practices or evidence-based guidelines to prevent CLABSI • CDC • National Healthcare Safety Network (NHSN) • Previously National Nosocomial Infection Surveillance (NNIS) • Available to all hospitals • Data available to all healthcare facilities and the general public

  13. Public Awareness • Headlines • AARP Bulletin (March 2009) • “Killer Germs”; Superbugs Kill 90,000 patients a year. • Government and Consumer Groups • Consumers Union • www.stophospitalinfections.org • Go to: State Hospital Infection Disclosure Laws” • Leapfrog Group • www.leapfroggroup.org • Provides ratings of 1,300 US Hospitals • Centers for Medicare and Medicaid Services (CMS) • www.hospitalcompare.hhs.gov • Reports quality information on hospitals • Committee to Reduce Infection Deaths • www.hospitalinfection.org • www.safecarecampaign.org • Victoria Nahum, patient advocate

  14. Mandatory Reporting • Mandatory Reporting of Infections • www.cms.hhs.gov/hospitalqualityinits/ • States that have passed legislation • www.floridacomparecare.gov • States with study bills • NC, IN, AZ, OH, NM, and AK

  15. Mandatory Reporting of HAIs http://www.apic.org/Content/NavigationMenu/GovernmentAdvocacy/MandatoryReporting/state_legislation/state_legislation.htm

  16. Pennsylvania • Pennsylvania Health Care Cost Containment Council (PHC4) • 1st State with Public Reporting Data, 2004 11,668 HAIs, $613.7 Million (estimate total additional payment) PHC4 Research Brief. Hospital-acquired Infections in Pennsylvania. Issue No. 9. March 2006

  17. Mandatory Reporting Issues • No Standardization • Some states publish info/some don’t • Some measure processes/some HAIs • Some use administrative data • Some report organisms (e.g., MRSA) • Will we see mandatory reporting move from a State to a Federal level?

  18. Bloodstream Infections Facts • 87% of primary bacteremia attributed to vascular access • Crude mortality 10% - 40% • Prolonged hospitalization 5 - 20 days • Attributable cost $34,000 - $56,000 per stay • 80,000 CRBSIs occur in ICUs each year • 1.2-1.4 million occur outside ICU • Annual cost to the healthcare system is $296 million - $2.3 billion (US) William R. Jarvis, M.D., “Preventing Central Venous Catheter (CVC)-Associated Bloodstream Infections in 2005: Is Zero Realistic?” Oral presentation at the Infusion Nurses Society Annual Meeting (May 2005, Ft. Lauderdale, FL). Mermel LA. New Technologies to prevent intravascular catheter-related bloodstream infections. Emerging Infectious Diseases. 2001;7:197-199.

  19. How Infections Are Transmitted Reservoir Means of Transmission Susceptible Host Causative Agent Portals of Exit & Entry

  20. Susceptible Host Risk Factors Acuity of illness Less than 1 year of age or over 60 Immunocompromised Underlying disease processes Loss of skin integrity Prolonged hospitalization Existing infections Malnutrition In ICU Type of catheter Frequency of manipulation of the catheter

  21. Portals of Entry Inadequate hand washing Insertion experience Disinfection of skin site Contaminated infusate Field or ER insertion Multiple entries into the system (hubs, injection ports, stopcocks)

  22. CRBSI Reduction Strategies Procedure Procedure Process • CVC Insertion Cart • Insertion Checklist/Bundle Process Product • Coated CVCs/NCs • CHG dressings/discs • Staff Awareness • Measuring Compliance

  23. Product EvaluationNeedleless Access Devices Procedure Process Procedure • Change Frequency • Blood draw via cap Process Design • Smooth Surface • Any gaps or crevices • Clear vs. Opaque • Complex Fluid Path • Aseptic Technique • Cleaning cap prior to each access • Flushing effectiveness

  24. Needleless Access Devices Technology Review

  25. Simple vs. Complex Simple Split Septum Complex Mechanical Valve More Complex Positive Fluid Displacement

  26. RESEARCH & PUBLICATION HISTORY

  27. Publication History • 2004 • University of Virginia observed a 61% increase in BSI rates after switching from split septum technology to a mechanical valve • Made the switch due to pump supplier change • 2005 • Wake Forest observed an increase in BSI’s after switching from split septum technology to mechanical valve • Repeated in-service of nursing staff on proper device use did not lower BSI rates • Dr. William Jarvis formed first study group to study BSI outbreak • 5 hospitals reported increases in BSI rates after switching from split septum technology to a mechanical valves • 2006 • Wake Forest reports gross bacterial contamination of two mechanical valves after removal from patients

  28. Contamination of Mechanical Valve Needleless Devices May Contribute to Catheter-related Bloodstream Infections Tobi Karchmer, et al, SHEA 2006 Poster Devices: “MVDs from 2 different manufacturers (Device A and B) and a spilt septum device (SSD) (device C) were examined over four time periods: Phase I: Device A; Phase II: Device A after ICU nursing staff education on disinfection; Phase III: Device B; Phase IV: Device C. Utilization of Device B and C was after ICU nursing staff education on use and disinfection of each device.” Key Results: “There was no difference in the proportion of contaminated devices between the 3 that were evaluated after education, although Device A and B had significantly more colony-forming units cultured.” Device A (MVD): 83% TNTC* Device B (MVD): 60% TNTC Device C (SSD): 0% TNTC* *TNTC = "Too numerous to count"... categorized as "Highly Contaminated Devices“ Conclusions: “CRBSI significantly increased in this tertiary care hospital upon the introduction of an MVD and only modestly improved following nursing staff education on device utilization. Bacterial contamination of blood drawn from all three needleless devices was common, and although it is less following improved device use, it is still considerable. Device C (SSD) appeared to have lower internal contamination. Further studies on the impact of SSD on overall CRBSI need to be preformed.”

  29. Potential Risk Factors for Bloodstream Infections Associated with Mechanical Valves • Dr. William Jarvis presented his thoughts around potential risk factors for BSI’s associated with mechanical valves as follows: Factor • Difficulty cleaning access surface Potential Impact • HCWs may not adequately clean the intricate surface details before access, leading to fluid path contamination. • Gap around plunger harbors bacteria • Gap cannot be accessed for disinfection and can lead to fluid path contamination • Opaque housing hides incomplete flushing of media based fluids • During normal manipulation, small amounts of bacteria and media-like fluids contaminate the valve. If these organisms proliferate, then they can be infused with subsequent manipulations. • Internal mechanisms obscure fluid path • Impossible to visually confirm complete flushing. W. Jarvis, M.D., “Increased Central Venous Catheter-Associated Bloodstream Infection Rates Temporally Associated With Changing From A Split Septum To A Leur Access Mechanical Valve Needleless Device: A Nation-wide Outbreak? CHCA Meeting, Chicago, IL Sept. 24, 2005.

  30. Potential Risk Factors for Bloodstream Infections Associated with Mechanical Valves • “Difficulty cleaning access surface”

  31. Potential Risk Factors for Bloodstream Infections Associated with Mechanical Valves • “Gap around plunger harbors bacteria”

  32. Potential Risk Factors for Bloodstream Infections Associated with Mechanical Valves • “Opaque housing hides incomplete flushing of media based fluids” 2006 INS Standards of Practice state: “If the integrity of the injection or access cap is compromised or if residual blood remains within the cap, it should be replaced immediately…” (S36)

  33. “Internal mechanisms obscure fluid path” Potential Risk Factors for Bloodstream Infections Associated with Mechanical Valves

  34. Baxter Interlink® Smooth Surface No Gap Clear Simple Internal Design • High Flow Rates • Accepts Needle in Emergency • BD Bifurcated Cannula Improves Flushability • Small & Light Weight • Latex-free

  35. BD Q-Syte™ Luer Access Split Septum Smooth Surface No Gap Clear Simple Internal Design • Accepts both Luer Lock and Luer Slip Connections • High Flow Rates • Small & Light Weight • Latex-free

  36. 2007 Publications • 2007 • Geelong Hospital, Victoria, Australia reports a 2.2 fold increase in BSI’s after switching from split septum to mechanical valve • Infection Control and Hospital Epidemiology • The University of Nebraska Medical Center reports a 3.3 fold Increase in BSI’s after switching from split septum to mechanical valve • Clinical Infectious Diseases • Medical University of South Carolina reports a 2.7 fold increase in BSI’s after switching from split septum to mechanical valve • Infection Control and Hospital Epidemiology • All three facilities returned to split septum and their BSI rates returned to original levels

  37. Research Summary • Recent Publications • Incidence of Catheter-Related Bloodstream Infection Among Patients with a Needleless, Mechanical Valve-Based Intravenous Connector in an Australian Hematology-Oncology Unit • Kathryn Field, MBBS et al. Infection Control and Hospital Epidemiology, May 2007, Vol. 28, No 5. • Summary: • 400-bed regional public hospital/Victoria Australia • SS/Baxter Interlink® vs MV/Abbott Clave® and CLC 2000 • Study period July 2004 through June 2005 • 98 patients with Hickman Catheters (SL and DL) • Hem/Onc Unit • 2.6 infections vs 5.8 infections per 1000 catheter-days

  38. Research Summary • Recent Publications • Outbreak of Bloodstream Infection Temporally Associated with the Use of an Intravascular Needleless Valve • Mark E. Rupp, et al. Clinical Infectious Diseases, June 2007, Vol. 44 • Summary: • SS/Interlink vs PDMV/Alaris Smartsite Plus vs SS/Interlink • Increase in CRBSI rates with the introduction of a positive displacement connector valve and decrease after return to SS • CC = 3.87/1000 vs 10.64/1000 (p<.001) • Six month period following return to SS 5.59/1000 (p = .02) • Inpatient = 3.47/1000 vs 7.3/1000 (p=.02) • Six month period following return to SS 2.88/1000 (p = .57) • Similar results seen in 2 cooperative care transplantation units

  39. Research Summary • Recent Publications • Increased Rate of Catheter-Related Bloodstream Infection Associated with Use of a Needleless Mechanical Valve Device at a Long-Term Acute Care Hospital • Cassandra D. Salgado, et al. Infection Control and Hospital Epidemiology, June 2007, Vol. 28, No. 6 • Summary: • 59 bed long-term care facility • SS/Interlink vs Alaris Smartsite vs SS/Interlink • Three-fold increase in BSI rates

  40. Research Summary • Study to evaluate effectiveness of closed, luer SS device in reducing CRBSI • Adult Medical ICU • Previously used PPMV • CRBSI rate (PPMV): 3.148 per 1,000 catheter days • CRBSI rate (CLSS): 0 at 3, 6, 8 months after implementation • Identified significant reduction in infection rates for adult medical-ICU population Love, K. Catheter-related bloodstream infection rates decrease to zero in the ICU after implementing a closed luer access split-septum device. Poster Presentation, AVA 22nd Annual Conference, Savannah, GA. 2008

  41. Research Summary • 410 bed acute care facility in SE • Study performed in MSICU (2005-2006) • Utilized PPMV • CRBSI rate (PPMV): 7.9 per 1,000 catheter days • Evaluated CLSS device • CRBSI rate (CLSS): 4.4 per 1,000 catheter days & eventually achieved a rate of 2.36 Kirley, D., et al. Impact of changing from a luer access mechanical valve to a luer access split septum device on the reduction of central line-associated bloodstream infections in a medical surgical intensive care unit. Poster Presentation; AVA 22nd Annual Conference, Savannah, GA. 2008

  42. Portal of Entry and a Reservoir? Recent data suggests that the needleless connector could not only be a portal of entry, but also a “reservoir” Portals of Exit & Entry Reservoir

  43. Microbial Colonization of Needleless Connectors • In vitro study to evaluate presence/distribution of bacteria on external surfaces/internal fluid path of NCs after clinical use • MICU patients • All had silicone ss & internal collapsible silicone mechanical valve • Results: prevalent microorganisms (multiple species) on external surface in biofilms; internal path revealed mixed species of microorganisms • Biofilm observed covering all areas of surface in various stages of development • “Transfer of microorganisms as single cells or biofilm fragments through the connector allows for biofilm colonization on the internal lumen of the catheter and potential bacteremia” Ryder, M. et al. Microscopic examination of microbial colonization of needleless connectors. Poster Abstract 5-36, APIC 35th Annual Education Conference & International Meeting, June 15-19, 2008, Denver, CO.

  44. CRBSI & NCs Patients are 3 times more likely, on average, to develop a CRBSI with the use of a mechanical valves versus a split septum needleless system.1,2 Based on the information available today…….. • Cassandra D. Salgado, et al. Infection Control and Hospital Epidemiology, June 2007, Vol. 28, No. 6. • Mark E. Rupp, MD. Outbreak of bloodstream infection temporally associated with the use of an intravascular needleless valve. CID 2007; 44 (1 June):1408-14.

  45. M. D. Anderson Cancer Center Experience • 2003- closed luer split-septum/prior-SSBC • Avoided MV’s due to concerns related to contamination and increased risk of infection • Benefits of CLSS: • Easy to use/clean • Clear housing • Simple device • Straight/free flowing fluid path • No internal mechanism to harbor bacteria

  46. Infection Prevention Measures • Hand washing!! • Wear gloves/PPE • Skin prep prior to access and maintenance • Clean access sites prior to each entry • Frequent observation of site • Evaluate continued need for access • Incorporate central line bundle/line cart/kits • Evaluate ALL changes in the infusion system independently for any change in BSI outcomes!

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