BIOPATCH

1. BIOPATCH Protective Disk with CHG Manufactured by ETHICON, INC. Johnson & Johnson Company

2. Jamie L Hamm RN, BSN, VA-BCOwner of Vascular Access Plus Vascular Access Plus is a third party vendor. We do not promote any specific product or supplier.

3. PRODUCT DESCRIPTION • BIOPATCH is a protective disk with CHG is a hydrophilic polyurethane absorptive foam with Chlorahexidine Gluconate (CHG). • The foam material absorbs up to 8 times its own weight in fluid, while the CHG incorporated into the dressing inhibits bacterial growth under the dressing. • Chlorahexidine Gluconate is a well-known antiseptic agent with broad-spectrum antimicrobial and antifungal activity

4. HOW SUPPLIED • BIOPATCH is supplied sterile • Each package contains a single disk. • BIOPATCH is intended for single use only. DO NOT resterilize. • Store at room temperature

6. INDICATION FOR USE • BIOPATCH containing ChlorahexidineGluconate is intended for use as a hydrophilic wound dressing that is used to absorb exudate and to cover a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: • IV catheters, central venous lines, arterial catheters, dialysis catheters, peripheraly inserted coronary catheters, mid-line catheters • Drains, chest tube • Externally placed orthopedic pins • Epidural catheters • Also intended to reduce local infections, catheter-related blood stream infections (CRBSI) and skin colonization of microorganisms commonly related to CRBSI, in patients with central venous or arterial catheters

7. PRECAUTIONS • BIOPATCH should not be placed over infected wounds. It is not intended to be used as a treatment of percutaneous device-related infections. • DO NOT use BIOPATCH on premature infants or children < 1 year of age. The Safety and Effectiveness of BIOPATCH has not been established in children under 16 years of age. • DO NOT use BIOPATCH on patients with a known sensitivity to chlorhexidine gluconate.

8. CLINICAL TRIAL RESULTS • Controlled randomized clinical trial • 687 Subjects with 1699 central venous or arterial catheter insertion sites in two centers • Patients randomized to the BIOPATCH treatment group experienced no serious device-related adverse events • RESULTS Showed • The use of BIOPATCH resulted in a statistically significant 44% reduction in the incidence of local infection. • The use of BIOPATCH resulted in a statistically significant 60% reduction in the incidence of catheter-related blood stream infections • The use of BIOPATCH showed statistically significant reduction in skin colonization of microorganisms commonly associated with CRBSI.

9. Pediatric Clinical Trial Results • Trial was performed on 16 total patients, ages 3 days to 15 years to evaluate effectiveness of BIOPATCH in the management of insertion or exit sites of indwelling CVCs. • RESULTS showed….. • No cases of catheter-related infections were reported during the trial • Compared to the institution’s standard therapy: • BIOPATCH resulted in better appearance of entrance/exit sites in 56% of cases • less irritation of entrance/exit sites in 50% of cases • better entrance/exit site protection in 94% of cases

10. Over time the BIOPATCH may turn yellow in color. This coloration does not reduce the antimicrobial efficacy of the dressing PLEASE NOTE:

11. How do I apply the BIOPATCH to my Patient?

13. Key Points of BIOPATCH Application • The BIOPATCH has to be flat on the skin • Change the BIOPATCH every 7 days • Change the BIOPATCH if the patch is “PUFFY” and therefore in ineffective • Do not use the BIOPATCH on children < 1 year of age • It is not recommended clinically for peripheral IV sites • If the BIOPATCH is applied at insertion it eliminated the 24 hour dressing change after vascular access insertions • Call Vascular Access Plus for questions or concerns in regards to application of the BIOPATCH at 855-PICC-VAP

14. QUESTION and ANSWER 1. Do I use the BIOPATCH on the patient with a central line that is not a PICC line? YES….The BIOPATCH will be used on the insertion site of all central line insertions…that includes subclavian, femoral and jugular placed central lines, PICC lines, and ports. There is a larger BIOPATCH for dialysis catheters.

15. QUESTION and ANSWER 2. What if the patient is admitted to my facility and a BIOPATCH is not in place at the insertion site? Change the dressing…You always want to adhere to the policy and procedures at your facility and put the BIOPATCH in place to adhere to those policies and provide your patient with a decrease risk of infection by using the BIOPATCH. If the BIOPATCH is already in place when the patient arrives..examine the dressing..determine if it needs change..otherwise VA+ recommends changing it on your scheduled dressing change day. If the dressing is not dated or is soiled in anyway…change it!

16. QUESTION and ANSWER 3. When I take off the opsite to change the dressing, the BIOPATCH gets all wrapped around the PICC line and I am afraid of pulling out the PICC line, what can I do differently? Pay attention when you are putting the BIOPATCH on to start with. Do not put the slit on the patch around the PICC line and turn it or wrap it around it. You want the BIOPATCH to just come off with the opsite when you remove it…so position the slit of the BIOPATCH to just come off with the opsite. The slit can lay sideways or up and down. Refer back to the video

17. QUESTION and ANSWER 4. There is a lot of oozing of blood at the insertion site of the PICC line….What do I do with the BIOPATCH? When there Is blood oozing at the insertion site the BIOPATCH is ineffective. Remove the BIOPATCH and control the bleeding with a pressure dressing if needed for 24 hours…then change the dressing and reapply the BIOPATCH when the oozing has stopped.