Avery Dennison’s Transparent Film Dressing Cleared by FDA

Chicago, Ill.-based Avery Dennison Medical Solutions, a business unit of Avery Dennison Corporation, has received a 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 reportedly demonstrate the new dressing’s antimicrobial efficacy across a broad range of bacteria and yeast commonly found in catheter-related blood stream infections.

According to Avery Dennison, 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 intravenous 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 during the first seven days, the company reported. Additionally, the dressing is non-cytotoxic (not toxic to biologic cells). 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 of 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 is designed to address 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, company officials report.

The dressing’s anticipated U.S. release is fall 2013. Avery Dennison is currently preparing the technical files necessary to earn the CE Mark to market the dressing in the European Union.

Avery Dennison Medical Solutions is focused on pressure-sensitive adhesives for medical applications.