Avery Dennison Medical Solutions has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new chlorhexidine gluconate (CHG) transparent film dressing, known as BeneHold CHG Transparent Film Dressing. In-vitro test data demonstrate the new dressing’s antimicrobial efficacy across a broad range of bacteria and yeast commonly found in catheter-related blood stream infections.
Tests show that the dressing is appropriate for applications where the spread of infection is a concern and moisture management is required, such as the securement of IV catheters. The patent-pending CHG adhesive formulation used on the dressing is transparent to allow visualization of the access site—a critical parameter for vascular access professionals, including nurses and infection-control specialists.
In-vitro test data also show that the BeneHold CHG Transparent Film Dressing demonstrates a significant reduction in bacteria and yeast from day one through day seven. Additionally, the dressing is non-cytotoxic, exhibiting a grade zero profile (ISO 10993). High antimicrobial efficacy can often be associated with cytotoxic effects, commonly due to the concentration of the antimicrobial agent present in the product.
Until now, there has been limited success in incorporating CHG into a solvent acrylic adhesive the company said. Current CHG products on the market include a dressing with a CHG-impregnated island and a CHG-impregnated protective film disk that is covered with a secondary dressing. The BeneHold CHG Transparent Film Dressing addresses the limited site visibility of some of the existing products.
Although the CHG adhesive formulation will initially be commercialized as a transparent film dressing, potential future applications could include surgical incise films and post-op dressings.
The BeneHold CHG Transparent Film Dressing will be sold and marketed in the U.S. and in other countries worldwide via select commercial partnerships. Anticipated commercial availability in the U.S. is fall 2013. Preparation of the technical file for European Union CE mark certification is in progress.