Preventing central venous catheter-associated bloodstream infections: Development of an antiseptic barrier cap for needleless connectors

Abstract

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. 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. 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). 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.