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BD Gets FDA Approval For BD ChloraPrep Skin Preparation With Sterile Solution

Becton, Dickinson and Company or BD (BDX), a medical technology company, said Tuesday that it has received approval from the U.S. Food and Drug Administration or FDA for BD ChloraPrep skin preparation with sterile solution, the only fully sterile chlorhexidine gluconate or CHG antiseptic skin preparation commercially available in the U.S.

BD noted that the 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 will now be labeled as a "sterile solution" on all packaging.

Michael Garrison, worldwide president of Surgery at BD said, "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."

According to BD, the new BD ChloraPrep sterile solution will include a mark to indicate that it is sterile.

The company noted that it developed this mark to distinguish sterile solution from non-sterile antiseptic skin preparations, even though it is not required by the FDA,. In 2013, the FDA asked manufacturers to voluntarily change labeling on products - sterile vs. non-sterile - to further educate customers on the issue.

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