title: Preventing central venous catheter-associated bloodstream infections: development of an antiseptic barrier cap for needleless connectors.
abstract: BACKGROUND
  Reports of outbreaks associated with the use of needle-free valve connectors suggest 2 common risk factors: (1) poor adherence to disinfection practices before use and (2) a design that allows contamination when not in use. Swabbing a membranous septum with 70% isopropyl alcohol may not eliminate septal surface contamination. Frequent access through and handling of needle-free connectors also puts patients at increased risk of central venous catheter-related bloodstream infections (CR-BSIs). A novel antiseptic barrier cap has been designed to maintain health care worker safety and eliminate the vulnerabilities of existing systems to contamination and CR-BSIs for patients at risk.
  
  
  METHODS
  A prospective in vitro study compared the effectiveness of standard disinfection of needleless luer-activated valve connectors with 70% isopropyl alcohol and the effectiveness of an antiseptic barrier cap that, when threaded onto a luer-activated connector, rapidly sterilizes a heavily contaminated surface. Standard disinfection was done by 3- to 5-second swabbing using a sterile commercial pledget of 70% isopropyl alcohol. The antiseptic barrier cap comprises an outer cap with internal female threads and a spike inside the closed end, a capsule containing 0.25 mL of 2% chlorhexidine gluconate in 70% isopropyl alcohol, and a sponge between the septum and the capsule. When the cap is threaded onto a luer-adaptable needleless connector, the spike ruptures the capsule, saturating the sponge with the antiseptic.
  
  
  RESULTS
  All 15 (100%) of the precontaminated positive control connectors not disinfected before entry showed transmission of Enterococcus faecalis across the membranous septum (4500-28,000 colony-forming units), and 20 (67%) of 30 connectors disinfected with 70% alcohol showed transmission (442-25,000 colony-forming units). Of 60 needle-free connectors disinfected with the antiseptic barrier cap, 1 (1.6%) showed transmission (P < .001).
  
  
  CONCLUSIONS
  An antiseptic barrier cap was highly effective in sterilizing the septum of a needle-free valve connector and preventing entry of any microorganisms, even with heavy contamination of the septum. This new technology should now be evaluated in a clinical trial with CR-BSI as the primary outcome measure.
authors.affiliation: Menyhay Healthcare Systems LLC, Fresno, CA, USA. menyhay@psnw.com
authors.forename: Steve Z
authors.initials: SZ
authors.lastname: Menyhay
authors.forename: Dennis G
authors.initials: DG
authors.lastname: Maki
mesh_terms: D019840:2-Propanol; D002405:Catheterization, Central Venous / Q000009:adverse effects / Q000295:instrumentation*; D002408:Catheters, Indwelling / Q000009:adverse effects; D002710:Chlorhexidine / Q000031:analogs & derivatives; D003428:Cross Infection / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D004202:Disinfectants; D004203:Disinfection / Q000295:instrumentation* / Q000379:methods; D004866:Equipment Contamination / Q000517:prevention & control*; D004867:Equipment Design / Q000009:adverse effects / Q000295:instrumentation; D006801:Humans; D011446:Prospective Studies; D012307:Risk Factors
chemical_list: D004202:Disinfectants; C010882:chlorhexidine gluconate; D019840:2-Propanol; D002710:Chlorhexidine