510(k) Clearance For CHG Transparent Film Dressing Offers Defence Against Catheter-Related Infection

In short

Avery Dennison Medical Solutions has announced that it has received 510(k) clearance from the U.S. 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.

Background

Current dressing products on the market which include the antimicrobial agent CHG are limited because of the difficulty in incorporating the compound into a solvent acrylic adhesive. Current approaches include building impregnated islands of CHG  and one offering is a CHG-impregnated protective film disk that is covered with a secondary dressing. Both are said by Avery Dennison to suffer limitations due to site visibility. The company says its new offering takes the form of a transparent film dressing, although potential future applications could include surgical incise films and post-op dressings.

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 visualisation 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.

Company comments

“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.”

Availability

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.

Source: Avery Dennison Medical Solutions, Business Wire