BD introduces first fully sterile chlorhexidine gluconate antiseptic skin preparation
Global medical technology company BD (Becton, Dickinson and Company) has received Food and Drug Administration (FDA) approval for BD ChloraPrep skin preparation with sterile solution. In a press release issued April 30, 2019, BD claims the product is “the only fully sterile chlorhexidine gluconate (CHG) antiseptic skin preparation commercially available in the U.S.”
The company explained that BD ChloraPrep 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.
The company said in the release that following FDA hearings in 2012, which focused on sterility of skin antiseptic products and subsequent label changes in 2013, BD invested over the next several years the development of a sterilization process that, unlike traditional processes, could handle the volume of product demanded while simultaneously improving overall efficiency and patient safety.
BD's proprietary sterilization process was designed to achieve a minimum sterility assurance level (SAL) of 10-6, the same level required for injectable products. The SAL indicates there is less than 1 in 1 million chance that a sterile BD ChloraPrep applicator containing sterile solution will contain a single, viable microorganism following terminal sterilization of the ampoules through BD's new sterilization process. While a product labeled as non-sterile does not suggest that it is contaminated with bacteria, it indicates that the contents have not been sterilized individually.
"The idea of contaminated antiseptic solutions seems counter-intuitive because the function of an antiseptic is to kill bacteria," said Donald E. Fry, MD, a nationally recognized expert in infection prevention, in the press announcement. "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 healthcare providers with a tool to enhance patient safety by the reduction of risk from intrinsic contamination in antiseptic solutions."
