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MISC535-3ADB (12/08) Research is Prevention HAIs and Needleless Connectors Deb Richardson, RN, MS, CNS.

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Presentation on theme: "MISC535-3ADB (12/08) Research is Prevention HAIs and Needleless Connectors Deb Richardson, RN, MS, CNS."— Presentation transcript:

1 MISC535-3ADB (12/08) Research is Prevention HAIs and Needleless Connectors Deb Richardson, RN, MS, CNS

2 MISC535-3ADB (12/08)

3 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 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

4 MISC535-3ADB (12/08) Practice Recommendation Strategies 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

5 MISC535-3ADB (12/08) Practice Recommendation Strategies to Prevent Central Line-Associated Bloodstream Infections in Acute Care Hospitals Approaches that should NOT be considered a routine part of CLABSI prevention 1. 1.NO antimicrobial prophylaxis for catheter insertion or dwell 2. 2.NO routine replacement of CVCs or arterial catheters 3. 3.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

6 MISC535-3ADB (12/08) Topics for Discussion Factual Information – –HAI Rates – –Reimbursement Impact – –Regulatory Issues – –Mandatory Reporting Technology Review – –Evolution – –Current Products Research/Publication Update Questions

7 MISC535-3ADB (12/08) 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

8 MISC535-3ADB (12/08) 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, Public Health Reports. Vol. 122, March-April 2007.

9 MISC535-3ADB (12/08) 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, Public Health Reports. Vol. 122, March-April 2007.

10 MISC535-3ADB (12/08) Healthcare Associated Infections Deaths/yr. 90,000 deaths/yr over 240 per day 2 Average length of stay 21.1 days vs. 4.5 days 1 (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 Campaign to prevent antimicrobial resistance in healthcare settings. ww.cdc.gov/drugresistance/healthcare/problem.htmww.cdc.gov/drugresistance/healthcare/problem.htm

11 MISC535-3ADB (12/08) 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

12 MISC535-3ADB (12/08) Attributed Financial Burden is High Reference: MedMined, June 2005 Study of 232,651 admissions from 13 hospitals 95% 221,225 The 5% of patients acquiring infection eroded $56MM in profits No HAIs 5% 11,426 % Patients # Patients 100% 232,651 With HAIs 63% Reduction in profits

13 MISC535-3ADB (12/08) 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

14 MISC535-3ADB (12/08) Public Awareness Headlines Headlines –AARP Bulletin (March 2009) Killer Germs; Superbugs Kill 90,000 patients a year. Killer Germs; Superbugs Kill 90,000 patients a year. Government and Consumer Groups Government and Consumer Groups –Consumers Union Go to: State Hospital Infection Disclosure Laws Go to: State Hospital Infection Disclosure Laws –Leapfrog Group Provides ratings of 1,300 US Hospitals Provides ratings of 1,300 US Hospitals –Centers for Medicare and Medicaid Services (CMS) Reports quality information on hospitals Reports quality information on hospitals –Committee to Reduce Infection Deaths –www.safecarecampaign.org Victoria Nahum, patient advocate Victoria Nahum, patient advocate

15 MISC535-3ADB (12/08) Mandatory Reporting Mandatory Reporting of Infections – –www.cms.hhs.gov/hospitalqualityinits/www.cms.hhs.gov/hospital States that have passed legislation – –www.floridacomparecare.govwww.floridacomparecare.gov States with study bills – – NC, IN, AZ, OH, NM, and AK

16 MISC535-3ADB (12/08) Mandatory Reporting of HAIs state_legislation/state_legislation.htm

17 MISC535-3ADB (12/08) Pennsylvania Pennsylvania Health Care Cost Containment Council (PHC4) 1 st State with Public Reporting Data, ,668 HAIs, $613.7 Million (estimate total additional payment) PHC4 Research Brief. Hospital-acquired Infections in Pennsylvania. Issue No. 9. March 2006

18 MISC535-3ADB (12/08) Mandatory Reporting Issues No Standardization – –Some states publish info/some dont – –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?

19 MISC535-3ADB (12/08) Bloodstream Infections Facts 87% of primary bacteremia attributed to vascular access 87% of primary bacteremia attributed to vascular access Crude mortality 10% - 40% Crude mortality 10% - 40% Prolonged hospitalization days Prolonged hospitalization days Attributable cost $34,000 - $56,000 per stay Attributable cost $34,000 - $56,000 per stay 80,000 CRBSIs occur in ICUs each year 80,000 CRBSIs occur in ICUs each year million occur outside ICU million occur outside ICU Annual cost to the healthcare system is $296 million - $2.3 billion (US) 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:

20 MISC535-3ADB (12/08) Causative Agent Reservoir Portals of Exit & Entry Means of Transmission Susceptible Host How Infections Are Transmitted

21 MISC535-3ADB (12/08) 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

22 MISC535-3ADB (12/08) 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)

23 MISC535-3ADB (12/08) Coated CVCs/NCs CHG dressings/discs Procedure Process CVC Insertion Cart Insertion Checklist/Bundle Staff Awareness Measuring Compliance CRBSI Reduction Strategies Process Procedure Product

24 MISC535-3ADB (12/08) Smooth Surface Any gaps or crevices Clear vs. Opaque Complex Fluid Path Aseptic Technique Cleaning cap prior to each access Flushing effectiveness Procedure Process Change Frequency Blood draw via cap Product Evaluation Needleless Access Devices Process Procedure Design

25 MISC535-3ADB (12/08) Needleless Access Devices Technology Review

26 MISC535-3ADB (12/08)

27

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

29 MISC535-3ADB (12/08) RESEARCH & PUBLICATION HISTORY

30 MISC535-3ADB (12/08)

31 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 BSIs 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

32 MISC535-3ADB (12/08) Contamination of Mechanical Valve Needleless Devices May Contribute to Catheter-related Bloodstream Infections 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. Tobi Karchmer, et al, SHEA 2006 Poster

33 MISC535-3ADB (12/08) Impossible to visually confirm complete flushing. Internal mechanisms obscure fluid path 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. Opaque housing hides incomplete flushing of media based fluids Gap cannot be accessed for disinfection and can lead to fluid path contamination Gap around plunger harbors bacteria Potential Impact HCWs may not adequately clean the intricate surface details before access, leading to fluid path contamination. Factor Difficulty cleaning access surface 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, Potential Risk Factors for Bloodstream Infections Associated with Mechanical Valves Dr. William Jarvis presented his thoughts around potential risk factors for BSIs associated with mechanical valves as follows:

34 MISC535-3ADB (12/08) Difficulty cleaning access surface Potential Risk Factors for Bloodstream Infections Associated with Mechanical Valves

35 MISC535-3ADB (12/08) Gap around plunger harbors bacteria Potential Risk Factors for Bloodstream Infections Associated with Mechanical Valves

36 MISC535-3ADB (12/08) 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) Opaque housing hides incomplete flushing of media based fluids Potential Risk Factors for Bloodstream Infections Associated with Mechanical Valves

37 MISC535-3ADB (12/08) Internal mechanisms obscure fluid path Potential Risk Factors for Bloodstream Infections Associated with Mechanical Valves

38 MISC535-3ADB (12/08) 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

39 MISC535-3ADB (12/08) 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

40 MISC535-3ADB (12/08) 2007 Publications 2007 – –Geelong Hospital, Victoria, Australia reports a 2.2 fold increase in BSIs 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 BSIs after switching from split septum to mechanical valve Clinical Infectious Diseases – –Medical University of South Carolina reports a 2.7 fold increase in BSIs 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

41 MISC535-3ADB (12/08) 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 patients with Hickman Catheters (SL and DL) Hem/Onc Unit 2.6 infections vs 5.8 infections per 1000 catheter-days

42 MISC535-3ADB (12/08) 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

43 MISC535-3ADB (12/08) Research Summary Recent Publications 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 Cassandra D. Salgado, et al. Infection Control and Hospital Epidemiology, June 2007, Vol. 28, No. 6 –Summary: 59 bed long-term care facility 59 bed long-term care facility SS/Interlink vs Alaris Smartsite vs SS/Interlink SS/Interlink vs Alaris Smartsite vs SS/Interlink Three-fold increase in BSI rates Three-fold increase in BSI rates

44 MISC535-3ADB (12/08) Study to evaluate effectiveness of closed, luer SS device in reducing CRBSI Adult Medical ICU Previously used PPMV CRBSI rate (PPMV): 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 22 nd Annual Conference, Savannah, GA Research Summary

45 MISC535-3ADB (12/08) 410 bed acute care facility in SE Study performed in MSICU ( ) 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 Research Summary

46 MISC535-3ADB (12/08) 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

47 MISC535-3ADB (12/08) 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 i nternal 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. Microbial Colonization of Needleless Connectors

48 MISC535-3ADB (12/08) 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 1.Cassandra D. Salgado, et al. Infection Control and Hospital Epidemiology, June 2007, Vol. 28, No Mark E. Rupp, MD. Outbreak of bloodstream infection temporally associated with the use of an intravascular needleless valve. CID 2007; 44 (1 June): Based on the information available today……..

49 MISC535-3ADB (12/08) M. D. Anderson Cancer Center Experience closed luer split-septum/prior-SSBC Avoided MVs 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

50 MISC535-3ADB (12/08) 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!

51 MISC535-3ADB (12/08) Be Informed about the product Be aware of changes in products that may have an impact on your outcomes Communicate with others in your institution who may be involved in the introduction of new technology Utilize available resources/information to assist in making informed decisions & improving patient outcomes Summary


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