FDA Approves ChloraPrep One-Step Sepp Applicator

OVERLAND PARK, Kan. -- Medi-Flex, Inc., announces that its commercial antiseptic ChloraPrep One-Step Sepp applicator (2 percent w/v chlorhexidine gluconate and 70 percent v/v isopropyl alcohol) has been approved for marketing by the United States Food and Drug Administration as a patient pre-operative skin preparation and as a patient pre-injection preparation. The product will be available January 16.

"The introduction of an FDA-approved chlorhexidine skin prep may prove to be the most significant intervention in the prevention of catheter-related bacteremia in the last several decades," said Robert Garcia, BS, MMT (ASCP), CIC and assistant director of infection control at Brookdale University Hospital and Medical Center. "Chlorhexidine's broad antibacterial spectrum and persistent activity after application, in conjunction with no-touch applicators, should provide an effective new tool in the fight against nosocomial infections."

More than 200,000 Americans contract nosocomial infections annually. These preventable infections, which represent the fourth-leading cause of mortality among Americans, cost the healthcare industry billions of dollars and create hardships for both patients and hospitals. One common cause of nosocomial infections are microorganisms found on the patient's skin.

ChloraPrep has been proven to significantly reduce the number of microorganisms on intact skin. It is the only FDA-approved 2 percent w/v chlorhexidine gluconate and 70 percent v/v isopropyl alcohol formulation available in the United States. In addition, ChloraPrep is the only antiseptic that meets new recommendations for skin antisepsis published by the Centers for Disease Control and Prevention (CDC). The CDC guidelines state a preference for a 2 percent chlorhexidine-based antiseptic solution for preparation of the skin prior to catheter insertion.

Studies show that ChloraPrep is effective in killing a broad spectrum of microorganisms on the skin. ChloraPrep is also long lasting. One 30-second application of ChloraPrep is persistent in killing bacteria for more than 48 hours.

Designed for hands-off aseptic application to smaller areas, the 0.67 mL Sepp applicator is the latest in the ChloraPrep line. ChloraPrep is also available in a 1.5 mL Frepp applicator and applicators in the 3.0 mL and 10.5 mL sizes for larger prep sites.

Other ChloraPrep One-Step Sepp product benefits:

-- Unique non-linting tip controls flow, allowing for little excess and no

mess

-- Longer shelf-life ampoule won't dry out like swabsticks or pads

-- Exclusive triple-wall construction for the safest ampoulized applicator

available

-- ChloraPrep is clear, not sticky and doesn't stain the skin

The ChloraPrep One-Step Sepp applicator is the latest product created by Medi-Flex, Inc., an Overland Park, Kan.-based company that manufactures a broad range of aseptic skin prepping products used in hospitals throughout the country.

Source: PRNewswire