The Challenge

Placement of a vascular access device increases the risk of bloodstream infection

Nearly all hospitalized patients have a vascular access device inserted to support their treatment, and approximately 87 percent of bloodstream infections are associated with the presence of an intravascular device.1 

The CDC estimates approximately 250,000 incidents of Catheter-Related Bloodstream Infections (CRBSIs) occur annually in the United States.2 Although attributable mortality due to CRBSIs is not clear, these infections are associated with higher costs, mortality rates, and number of hospital-days.2,3

Our Solution

The design of your needlefree intravenous (IV) connectors plays a substantial role in your ability to limit hospital-acquired bloodstream infections (HA-BSIs).4

All of our needlefree IV connectors incorporate our market-leading5 ClaveTM technology and are designed to keep patients and healthcare workers safe by providing a mechanically and microbiologically closed system for vascular access applications.

Our closed needlefree connectors feature pioneering reversed split-septum, straight internal fluid path technology to help reduce the ingress and colonization of bacteria. Not only do these devices provide enhanced patient safety through innovative needlefree technology, but they have also been proven to provide an effective microbial barrier against bacteria transfer and contamination.6,7,8

Clave Infection Control Technology

Head-to-head studies show Clave technology outperforms other connectors

In a study of the bacteria transfer and biofilm formation properties of needlefree connectors, ICU Medical's MicroClave had a lower bacterial transfer rate than all other connectors and outperformed all connectors tested in terms of bacterial transfer and colonization over a 96-hour period.8

The study measured the difference among connectors in the passage rate of bacteria from the connector surface through the catheter and into the bloodstream over time, and compared biofilm formation within the connectors, catheter hub, and catheter lumen.

In a separate study, researchers pointed to MicroClave's ability to provide clinicians with an enhanced level of protection from bacteria being transferred from external surfaces into the patient's bloodstream as an important benefit in their fight to eliminate catheter-related bloodstream infections (CRBSIs).14

Connector Overall Mean Log (CFU/Flush)* p Value
MicroClave 2.5 ≤0.0001
ClearLink 3.6 ≥0.0677
MaxPlus 4 ≥0.0677
Connector Connector Log Density Hub Log Density Catheter Log Density
MicroClave 2.123 1.871 1.011
ClearLink 2.591 2.368 1.101
MaxPlus 3.432 2.398 1.980

*calculated as the Least Squares Mean

In addition to bacterial transfer at the point of vascular access, thrombus formation increases the risk of catheter-related bloodstream infections for patients. Fibrin, blood components, and biofilm can amass,14 creating a rich culture medium for bacterial growth that has been shown to result in microorganisms entering the bloodstream.15 

Our Clave NeutronTM catheter patency device is the only device FDA-cleared to prevent the four known causes of displacement associated with needlefree connectors. These causes are connection or disconnection of a luer, syringe plunger compression, patient vascular pressure changes (i.e., coughing or sneezing), and IV solution container run-dry which may cause multiple forms of reflux into a catheter.16 The Clave Neutron utilizes ICU Medical’s Clave needlefree connector technology, and has been shown to help reduce catheter occlusions by 50%.17

Additional Infection Control Measures

Maximize infection control compliance with easy-to-use disinfecting technology

Needlefree IV connectors play an essential role in the reduction of CRBSI, but nursing guidelines still suggest that clinicians swab connectors before each access.18 Unfortunately, swabbing technique and compliance with these policies may vary, and visual confirmation of connector disinfection may be difficult.

ICU Medical SwabCap disinfecting technology can be a vital element in your efforts to help minimize infection risks and improve swabbing compliance. SwabCap’s patented disinfecting cap design has been shown to help enhance the barrier to bacterial ingress while helping you standardize disinfection protocols.19

One study showed using of SwabCap resulted in a 34% HA-CLABSI Reduction 20

Infection control technology designed to help prevent bacterial contamination21

Unlike other caps that only disinfect upon application, SwabCap’s patented thread cover design gives it the unique ability to continue disinfecting both the connector’s surface and threads for up to seven days, if not removed, for maximum safety and compliance.22

References

  1. Ryder, M. Catheter-related infections: It's all about biofilm. Topics Adv Pract Nurse Journal. 2005 [cited 2006 Sept 11]; 5(3). Available www.medscape.com/viewarticle/508109.
  2. Centers for Disease Control and Prevention. Reduction in central line-associated bloodstream infections among patients in intensive care units-Pennsylvania, April 2001-March 2005. MMWR Morb Mortal Wkly Rep 2005;54:1013-1016.
  3. Blot SI, Depuydt P, Annemans L, et al. Clinical and economic outcomes in critically ill patients with nosocomial catheter-related bloodstream infections. Clin Infect Dis 2005;41:1591-1598.
  4. Jarvis W, MD. Choosing the Best Design for Intravenous Needleless Connectors to Prevent Bloodstream Infections. Infection Control Today, August 2010 (http://www.infectioncontroltoday.com/articles/2010/07/ choosing-the-best-design-for-intravenous-needleless-connectors-to-prevent-bloodstream-infections.aspx.)
  5. 2016 GHX market data on single-sterile sales of standalone needleless connectors and single-sterile sales of extension sets with needleless connectors. February 27, 2016.
  6. Ryder M, James G, Pulchini E, Bickle L, Parker A. Differences in bacterial transfer and fluid path colonization through needlefree connector-catheter systems in vitro. Presented at the Infusion Nursing Society Meeting, May 2011.
  7. Moore C, RN, MBA, CIC. Maintained Low Rate of Catheter-Related Bloodstream Infections (CR-BSIs) After Discontinuation of a Luer Access Device (LAD) At an Academic Medical Center. Poster presented at the annual Association for Professionals in Infection Control and Epidemiology (APIC) Conference 2010, Abstract 4-028.
  8. Ryder M, RN, PhD. Comparison of Bacterial Transfer and Biofilm Formation on Intraluminal Catheter Surfaces Among Twenty Connectors in a Clinically Simulated In Vitro Model. Presented at World Congress Vascular Access (WoCova) 2018.
  9. JD Brown, HA Moss, TSJ Elliott. The potential for catheter microbial contamination from a needleless connector. J Hosp Infect. 1997.; 36:181-189.
  10. Yebenes J, Delgado M, Sauca G, Serra-Prat M, Solsona M, Almirall J, et al. Efficacy of three different valve systems of needlefree closed connectors in avoiding access of microorganisms to endovascular catheters after incorrect handling. Crit Care Med 2008;36: 2558–2561.
  11. Bouza E, Munoz P, Lopez-Rodriguez J, et al. A needleless closed system device (Clave™) protects from intravascular catheter tip and hub colonization: a prospective randomized study. J Hosp Infect. 2003; 54:279-287.
  12. Guideline for the Prevention of Intravascular Catheter-Related Bloodstream Infections, Final Issue Review, 2011.
  13. Data on file at ICU Medical. Low Volume Flush Characteristics of Unique Needlefree Connectors M1-1223 Rev. 1
  14. Breznock EM, DVM, PhD, Diplomate ACVS, Sylvia CJ, DVM, MS, BioSurg, Inc. The in vivo evaluation of the flushing efficiency of different designs of clear needlefree connectors, March 2011
  15. Ryder M. The role of biofilm in vascular catheter-related infections. N Dev Vasc Dis. 2001;2:15-25.
  16. ICU Medical Clave Neutron 510(k) K100434, June 24, 2010
  17. ICU Medical Study Summary. Observational In-Vivo Evaluation of the Neutron™ Needlefree Catheter Patency Device and its Effects on Catheter Occlusions in a Home Care Setting, 2011.
  18. Infusion Nurses Society (INS): Infusion Nursing Standards of Practice, 2011
  19. Posa P. Improving IV Connector Disinfection by Using Human Factors Engineering to Identify Effective, Nurse-Friendly Solutions. Poster presented at the APIC 4th Annual Conference. June, 2013.
  20. Kamboj M, Blair R, Bell N, et al. Use of Disinfection Cap to Reduce Central-Line–Associated Bloodstream Infection and Blood Culture Contamination Among Hematology-Oncology Patients. Infection Control & Hospital Epidemiology. December 2015. 36:12.
  21. Wright M, Tropp J, Schora D, et al. Continuous passive disinfection of catheter hubs prevents contamination and bloodstream infection. American Journal of Infection Control. 2012.
  22. ICU Medical Study Summary. Thirty-Second Disinfection Study for SwabCap™, 2019

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