When it comes to safety, doing what is right for patients is at the forefront of innovation and business practices at BD. Recently, our commitment to innovation and making sure patients in the hospital get better, not sicker came to life once again when the Food and Drug Administration (FDA) approved ChloraPrep™ with Sterile Solution, the only fully sterile chlorhexidine gluconate surgical antiseptic skin preparation available in the U.S.
Despite genuine efforts and adherence to best practices to ensure patient safety, risk can exist in non-sterile antiseptics — the very thing designed to protect patients. In 2012, the FDA held a hearing to discuss non-sterile antiseptic products that are not required to be sterile but were widely thought to be, given their purpose to disinfect. Subsequently in 2013, the FDA requested label changes to state whether a solution is sterile on its packaging. While a product labeled as non-sterile does not suggest that it is contaminated with bacteria, it does indicate that the contents have not been sterilized individually.
This risk of contamination in the skin antiseptic space was our motivation to create ChloraPrep™ with Sterile Solution, adding a layer of assurance to an already-proven product and providing peace of mind for health care providers and their patients. Traditionally, ChloraPrep™ applicators have been sterilized at the end of the manufacturing process, but the solution inside of the applicators was not treated with a separate sterilization process. Over the course of six years, we invested in research and development to establish an innovative process that sterilizes the antiseptic solution inside the ChloraPrep™ ampoules, to ensure both solution and applicators are sterile. The FDA approval of our fully sterile product is a testament to doing what is right, not because it was required, but because we recognized an emerging issue and challenged ourselves to innovate for better patient care and outcomes.
Our commitment to leading the way in skin antiseptics ahead of clinical guidelines, mandates and regulations reinforces BD’s purpose of advancing the world of health.