CHG transparent film dressing gets FDA approval
October 06, 2012 - United States Of America
Avery Dennison Medical Solutions, a business unit of Avery Dennison Corporation, announced that it 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 1 through day 7. Additionally, the dressing is non-cytotoxic, exhibiting a grade 0 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.
“We look forward to making CHG antimicrobial technology more accessible for clinicians and their patients with the BeneHold Transparent Film Dressing," said Howard Kelly, vice president and general manager, Avery Dennison Medical Solutions. "This product will expand our vascular access offering and help ensure that more users can benefit from the latest advancements in vascular access care."
Until now, there has been limited success in incorporating CHG into a solvent acrylic adhesive. 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 many 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.
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 1 through day 7. Additionally, the dressing is non-cytotoxic, exhibiting a grade 0 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.
“We look forward to making CHG antimicrobial technology more accessible for clinicians and their patients with the BeneHold Transparent Film Dressing," said Howard Kelly, vice president and general manager, Avery Dennison Medical Solutions. "This product will expand our vascular access offering and help ensure that more users can benefit from the latest advancements in vascular access care."
Until now, there has been limited success in incorporating CHG into a solvent acrylic adhesive. 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 many 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.