PDI’s Prevantics Device Swab Receives FDA Market Authorization

Clinical investigators recently released results from the first and only randomized, cross-over, prospective, comparative effectiveness clinical study evaluating the benefits of a 3.15% Chlorhexidine Gluconate (CHG) and 70% Isopropyl Alcohol over 70% Isopropyl Alcohol alone in disinfecting needleless connectors.

The study was funded by the US Centers for Disease Control and Prevention (CDC) Epicenters Program and executed by Rush University in Chicago. The results were presented at the 2014 IDWeek Conference in Philadelphia on October 11, 2014.

The findings align with CDC Guidelines which state: “Some studies have shown that disinfection of the devices with chlorhexidine/alcohol solutions appears to be most effective in reducing colonization.”  The investigators determined that the CHG and alcohol scrub resulted in less needleless connector contamination than an alcohol scrub at a five second scrub time.  

PrevanticsDevice Swab from PDI, leading provider of infection prevention solutions, is the only 3.15% Chlorhexidine Gluconate and 70% Isopropyl Alcohol solution that has received market authorization from the U.S. Food and Drug Administration (FDA) for disinfecting needleless access sites prior to use.

“This study answers a previously unknown clinical question about the most efficacious antiseptic for disinfection of needleless access sites and also ideal prep times,” said Hudson Garrett, PhD, Vice-President, Clinical Affairs for PDI. “This study demonstrates the importance of targeted efforts to reduce contamination on needleless access sites and ensure evidence-based practices for disinfection of needleless access sites.”

The PDI Prevantics^® Device Swab is fully compliant with the evidence-based guidelines and recommendations from the US Centers for Disease Control and Prevention (CDC), the Infusion Nurses Society, the Association for Vascular Access, and the Association for Professionals in Infection Control and Epidemiology.