Becton, Dickinson and Company (BD), a leading global medical technology company, today announced it has received US Food and Drug Administration (FDA) approval for BD ChloraPrep skin preparation with sterile solution, the only fully sterile chlorhexidine gluconate (CHG) antiseptic skin preparation commercially available in the US.
Image: BD receives FDA approval for fully sterile chlorhexidine gluconate antiseptic skin preparation. Photo: Courtesy of The U.S. Food and Drug Administration/Wikipedia.
This new BD ChloraPrep product uses a proprietary and patented process to sterilize the antiseptic solution inside the sealed ampoules located in the BD applicator. With the new sterilization process in place, the BD ChloraPrep solutions portfolio that undergo this proprietary added level of sterility will now be labeled as a “sterile solution” on all packaging.
“At BD, we are constantly exploring new opportunities to protect patients and advance health,” said Michael Garrison, worldwide president of Surgery at BD. “The FDA approval of BD ChloraPrep antiseptic skin preparation with sterile solution ensures that the solution inside of the applicator receives the same level of sterilization as the applicator itself to help further reduce the risk of intrinsic contamination.”
Following FDA hearings in 2012 focused on sterility of skin antiseptic products and subsequent label changes in 2013, BD determined to proactively address the sterilization challenge in the U.S. Over the last six years, BD has invested in the development of an innovative sterilization process that not only can handle the volume of product demanded, but also improves overall efficiency versus traditional sterilization methods.
“The idea of contaminated antiseptic solutions seems counter-intuitive because the function of an antiseptic is to kill bacteria,” said Donald E. Fry, M.D., a nationally recognized expert in infection prevention. “Outbreaks of highly resistant bacteria and spore contamination have been reported with contaminated antiseptic products in the past. Now with a fully sterilized skin preparation product, BD is assisting health care providers with a tool to enhance patient safety by the reduction of risk from intrinsic contamination in antiseptic solutions.”
Source: Company Press Release.