Precautions:
The dressing should not be placed over infected wounds. This device is not intended to treat catheter-related bloodstream infections (CRBSIs) or other percutaneous device-related infections. This device has not been studied in a randomized clinical study to determine its effectiveness in preventing such infections.
Active bleeding at insertion sites should be stabilized before applying the dressing.
Do not stretch the dressing before applying it to the skin. Dressings applied under tension can cause trauma to the skin.
To ensure good adhesion and to help prevent skin irritation, remove detergent residues and allow all skin preparations and protectants to dry completely before applying the dressing to the skin.
For proper use, clinicians should be trained in the use of this device.
Warnings:
- Do not use BD ChoraShield™ IV dressing with CHG antimicrobial on premature infants or infants younger than two months of age. Use of this product on premature infants may result in hypersensitivity reactions or necrosis of the skin.
- For external use only. Do not allow contact of this device with ears, eyes, mouth or mucous membranes.
- Do not use this device on patients with a known hypersensitivity to chlorhexidine gluconate. Adverse reactions such as irritations, sensitization and generalized allergic reactions have been reported with the use of chlorhexidine gluconate.
- Stop using the BD ChoraShield™ IV dressing with CHG antimicrobial if the patient experiencing symptoms such as: wheezing or difficulty breathing, swelling face, hives that quickly progress to more serious symptoms, severe rash or shock (which is a life-threatening condition that occurs when the body is not getting enough blood flow). These symptoms are associated with an allergic reaction to CHG.
- Literature searches found hypersensitivity reactions associated with the topical use of chlorhexidine gluconate have been reported in several countries. Caution should be used when using chlorhexidine containing preparations, and the patient should be observed for the possibility of hypersensitivity reactions.
- If allergic reactions occur, discontinue use immediately and, if severe, contact a physician.
- Do not use on immunocompromised patients or patients with underlying skin pathology which compromises the epidermal barrier. Use of this product may result in erosive contact dermatitis.
- Intended for a single patient use only.
- Do not reuse. As with all adhesive-based products, adhesive effectiveness and functionality can decline after the first use in the product will not perform as specified. Reuse may lead to infection or other illness/injury.
- Store in a cool, dry place. Keep away from direct sunlight. Do not store above 25°C/77°F. Do not use of packaging is damaged. Do not resterilize.
PICC = peripherally inserted central catheter; PIV = peripheral intravenous.
*In vitro testing shows that the transparent film of the BeneHold™ CHG IV Dressing provides a barrier to viruses 27 nm in diameter or larger if the dressing remains intact. These results have not been studied with regard to prevention of viral infection. No clinical study has been conducted regarding the ability of the dressing to prevent viral infections.
References:
1. Carty, N., Wibaux, A., Ward, C., Paulson, D., and Johnson, P. “Antimicrobial activity of a novel adhesive containing chlorhexidine gluconate (CHG) against the resident microflora in human volunteers.” J Antimicrob Chemother. 2014, 69(8):2224-2229.
