Disinfection of needleless catheter connectors and access ports with alcohol may not prevent microbial entry: The promise of a novel antiseptic-barrier cap

Background. Needleless valve connectors for vascular catheters are widely used throughout the United States because they reduce the risk of biohazardous injuries from needlesticks and exposure to bloodborne pathogens, such as human immunodeficiency virus and hepatitis C virus. Patients with long-term central venous catheters are at significant risk of acquiring catheter-related bloodstream infections caused by microbes that gain access through the connection between the administration set and the catheter or an injection port. Most healthcare practitioners wipe the membranous septum of the needleless connector or the injection port with 70% alcohol before accessing it. We report a simulation study of the efficacy of conventional alcohol disinfection before access, compared with that of a novel antiseptic-barrier cap that, when threaded onto a needleless luer-activated valved connector, allows a chlorhexidine-impregnated sponge to come into continuous contact with the membranous surface; after removal of the cap, there is no need to disinfect the surface with alcohol before accessing it. Methods. One hundred five commercial, needleless luer-activated valved connectors, each accessible by a blunt male-connector luerlock attachment, were purchased from 3 manufacturers and were tested. The membranous septum of each test device was first heavily contaminated with similar to 105 colony-forming units of Enterococcus faecalis and then was allowed to dry for 24 hours. Fifteen of the contaminated devices were not disinfected (positive controls), 30 were conventionally disinfected with a commercial 70% alcohol pledget, and 60 had the antiseptic cap threaded onto the connector and then removed after 10 minutes. The test connectors were then accessed with a sterile syringe containing nutrient broth media, which was injected, captured on the downstream side of the intraluminal fluid pathway, and cultured quantitatively. Results. All 15 control connectors (100%) showed massive transmission of microorganisms across the membranous septum (4,50010,000 colony-forming units). Of the 30 connectors accessed after conventional disinfection with 70% alcohol, 20 (67%) showed transmission of microorganisms (442-25,000 colony-forming units). In contrast, of the 60 connectors cultured after application of the novel antiseptic cap, only 1 (1.6%) showed any transmission of microorganisms (P < .001) Conclusions. The findings of this study show that, if the membranous septum of a needleless luer-activated connector is heavily contaminated, conventional disinfection with 70% alcohol does not reliably prevent entry of microorganisms. In contrast, the antisepticbarrier cap provided a high level of protection, even in the presence of very heavy contamination. This novel technology deserves to be studied in a clinical trial.