New Prevantics® Device Swab from PDI Receives FDA 510k Market Authorization

The only Chlorhexidine Gluconate/alcohol solution that has received market authorization by the U.S. Food and Drug Administration (FDA) intended for use to disinfect needleless access sites prior to use.

News provided by

PDI

Sep 09, 2014, 12:08 ET

ORANGEBURG, N.Y., Sept. 9, 2014 /PRNewswire/ -- PDI, manufacturer of market-leading infection prevention products and solutions, announced the introduction of Prevantics^®Device Swab, the only Chlorhexidine Gluconate/alcohol solution that has received market authorization from the U.S. Food and Drug Administration (FDA) for disinfecting needleless access sites prior to use on ports and hubs.

"The CDC Guidelines for the Prevention of Intravascular Catheter-Related Infections state that some clinical evidence shows disinfection of devices with chlorhexidine/alcohol solutions appear to be the most effective method to reduce colonization,"¹ said Hudson Garrett, PhD, MSN, MPH, FNP, CSRN™, VA-BC™, Vice-President, Clinical Affairs for PDI. "PDI is pleased to announce a new solution for disinfecting needless access sites prior to use on ports and hubs."

Prevantics^® Device Swab features a 3.15% Chlorhexidine Gluconate (w/v) and 70% Isopropyl Alcohol (v/v) formulation and 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.

"This new product innovation is a testament to our commitment to empower and equip healthcare professionals with the most advanced solutions to win the fight against preventable infections," added Joe DeBelle, Director of Marketing at PDI.

The Prevantics^® Device Swab joins the Prevantics^® skin antiseptics products which include the 1.0 mL Swab, 1.6 mL Swabstick and 5.1 mL Maxi-Swabstick designed for preoperative and pre-injection skin preparation. For more information on Prevantics^®, visit www.pdihc.com

About PDI
PDI helps reduce preventable infections, control healthcare costs, and ultimately help save lives by delivering a broad range of evidence-based, market leading skin antisepsis, environmental hygiene and patient care solutions. PDI's expertise in making a difference in the community and healthcare environments extends throughout the United States and worldwide. www.pdihc.com

¹ Guidelines for the Prevention of Intravascular Catheter-Related Infections, Healthcare Infection Control Practices Advisory Committee (HICPAC), US Centers for Disease Control and Prevention, 2011.

SOURCE PDI