BioPatch - Vascular Access Plus

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Protective Disk with CHG
Manufactured by ETHICON, INC.
Johnson & Johnson Company
Vascular Access Plus is a third party vendor. We do not
promote any specific product or supplier.
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
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
INDICATION FOR USE
 BIOPATCH containing Chlorahexidine Gluconate 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
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.
CLINICAL TRIAL RESULTS
 Controlled randomized
 RESULTS Showed
clinical trial
 The use of BIOPATCH resulted
in a statistically significant 44%
 687 Subjects with 1699
reduction in the incidence of
central venous or arterial
local infection.
catheter insertion sites in
 The use of BIOPATCH resulted
two centers
in a statistically significant 60%
 Patients randomized to the
reduction in the incidence of
BIOPATCH treatment
catheter-related blood stream
group experienced no
infections
serious device-related
 The use of BIOPATCH showed
adverse events
statistically significant
reduction in skin colonization
of microorganisms commonly
associated with CRBSI.
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
PLEASE NOTE:
Over time the BIOPATCH may turn
yellow in color. This coloration
does not reduce the antimicrobial
efficacy of the dressing
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
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.
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!
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
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.
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