Transcript BioSeal CVC for Venous Access Sites The Seal The

Keep Access Sites Dry and Intact
BioSeal CVC for Venous Access Sites
BioSeal CVC is a topical
powder made of a
hydrophilic polymer and
potassium ferrate.
The powder’s mechanism
of action forms an
occlusive seal to protect
an access site and keep it
dry and intact.
BioSeal CVC Powder
Colorized scanning electron microscopy
The Seal
The “BioSeal” allows “nothing
in, nothing out”.
 Occlusive seal
 Keeps microbial nutrients from
getting out
 Prevents microbes from getting
in
 Minimizes unscheduled dressing
changes, meaning less exposure
to potential microbes
Seal
Extra
powder
SEM photography of a 5 Fr. Catheter. Note the
occlusive seal that has formed around the line.
The Seal
Above the Seal
Bacteria full of water and salts come in
contact with the powder on the top side of
the seal (H2O & Ca++, Na+, K+)
2. The bacteria dries.
3. The moisture pulled from the bacteria contain
salts. The cations of these salts are exchanged
for H+ (acidic), creating a low pH environment
(~2) above the seal.
1.
Desiccation + Low pH (~ 2) = Microbial Barrier
Below the Seal
BioSeal Powder floats on the blood – it doesn’t
penetrate the seal. This results in a neutral pH below
the seal.
5 Fr catheter
BioSeal CVC - A Microbial Barrier
Microbial Strike-Through (Barrier) Test Results*
7-days Incubation
Test Sample
Control
NG
NG
NG
NG
NG
NG
NG
NG
G
G
G
G
G
G
G
G
S. aureus MRSA ATCC 33591a
S. epidermidis MRSE ATCC 51625 a
E. faecalis VRE ATCC 51575 a
S. aureus ATCC 6538 b
P. aureginosa ATCC 9027 b
E. coli ATCC 8739 b
C. albicans ATCC 10231 b
A. ATCC 16404 b
7-Day with Daily Rechallenge Test Results*
MRSA ATCC 33591
CFU at Initial
Contact
Log Reduction
After 24 hours
After 48 hours
After 72 hours
After 96 hours
After 120 hours
After 144 hours
After 168 hours
VRE ATCC 51575
MRSE ATCC 51625
Sample
Control
Sample
Control
Sample
Control
2.1 x 106
2.2 x 106
3.4 x 106
3.1 x 106
1.7 x 106
1.8 x 106
>5.3
>5.3
>5.3
>5.3
>5.3
>5.3
>5.3
NR
NR
NR
0.2
0.3
NR
NR
>5.5
>5.5
>5.5
>5.5
>5.5
>5.5
>5.5
NR
NR
NR
NR
NR
NR
NR
>5.2
>5.2
>5.2
>5.2
>5.2
>5.2
>5.2
NR
NR
NR
0.3
0.3
0.4
NR
*These data have not been evaluated by the Food and Drug Administration
CDC Guidelines
Guidelines for the
Prevention of
Intravascular CatheterRelated Infections
Replace catheter-site dressing if the
dressing becomes damp, loosened,
or visibly soiled (146,210). Category
IB
Biopatch’s Current Study
Chlorhexidine-Impregnated Sponges
and Less Frequent Dressing Changes
Jean-Francois Timsit, MD, PhD
 Decreased the risk of major CRBSI’s by 60%
 “However, unscheduled dressing changes
for soiling and leakage were common.”
(40-50% unplanned)
“Prevention of CRBSI: Make it easy
to do the right thing and make it
hard to do the wrong thing.”
Faisal Masud M.D., FCCP
Medical Director,
Cardiovascular Intensive Care Unit
Methodist DeBakey Heart Center
Multiple, unplanned dressing changes are not “easy”
Proven Efficacy
Journal of Vascular and Interventional Radiology,
January 2008; 19: 72-79.
Comparative Evaluation for Hemostasis in
Percutaneous Arterial, Venous, and Arteriovenous
Dialysis Access Procedures.
Current JAVA Study (Summer 2010)
Results from a published, peer-reviewed clinical trial of BioSeal CVC
usage for 418 PICC lines at Florida Hospital:
Elimination of 48-hour dressing change
~40% reduction in Catheter-related Bloodstream Infections (CRBSIs)
according to a post-hoc review of documentation
No site infections or other complications
Florida Hospital has added BioSeal CVC to their PICC line insertion
protocol.
Infections & PICC Infection Rate (Period 1 vs. Period 2)†
†Data
PICC Line
Days
Totals
PICCS
Inserted
PICC
Infection
Rate
Period
Months
No. PICC
Infections
1
May-Oct
12
25232
3210
0.4756
2
Nov-Apr
7
24323
2850
0.2878
were collected by hospital unit/dept. but not tabulated as such because of absence of trend.
Infection Control
 Eliminates blood and exudate nidus for microbes
 Minimizes both planned and
unplanned dressing changes
 Microbial barrier
 Eliminates variation- easy to do
the right thing and very hard to
do the wrong thing
BIOSEAL CVC Ordering Information
Order Number
Product Description
LP606
6 Applications per Box*
LP636
24 Applications per Case*
* Each application includes bottle, Powder
Containment Device (PCD), PCD foam insert,
product description label and Patient Discharge
Instructions.
More Biolife Products
Other Biolife product offerings include:
BioSeal Advanced
Biolife’s powder technology
that controls external
bleeding from arterial
access procedures