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cheryl ferraro
cheryl ferraro's picture
chlorhexidine Gluconate IV securement dressings

Recently we have been trying to switch our biopatch to the 3M Tegaderm CHG dressing. It has been a real battle due to the fact that the FDA has only approved the Tegaderm CHG as a securement dressing. Standards of care recommend using a chlorhexidine impregnated dressing but our IC department including the MD does not want to let go of the biopatch which has FDA backup for reducing CRBSI. "How come after 8 years the 3M dressing has not been able to get FDA to state it reduces CRBSIs" is what IC keeps saying. You can not see the insertion site with the biopatch! How can a company promote their dressing when you should be able to see the insertion site and you cant.
What have other companies done to get their IC department on board when FDA is not stating that the dressing is designed to reduce CRBSI even though they say (FDA) that 3Ms dressing is substantially equivalent?
Any suggestions?

Wendy Erickson RN
It seems to me that the issue

It seems to me that the issue was the fact that the CHG gel lays over the top of the PICC wings and insertion site and that no CHG gets to the skin under the PICC. The Biopatch, when placed correctly, does get under the insertion site and onto the skin all the way around it. I may be wrong, but that is what I remember.

Wendy Erickson RN
Eau Claire WI

 Your IC is making an

 Your IC is making an assumption that both manufacturer have submitted a request to the FDA. I think this is only a matter of what the various manufacturers have submitted to the FDA. Change in language for product instructions requies clearnace by the FDA. One company has sought this clearnace and one may not have. Assess the evidence on both products to make your decision. Lynn

Lynn Hadaway, M.Ed., RN, BC, CRNI

Lynn Hadaway Associates, Inc.

126 Main Street, PO Box 10

Milner, GA 30257


Office Phone 770-358-7861

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