hand hygiene spio iia poa · 2016. 3. 16. · requirements kramer a, rudolph p, kampf g, pittet d....
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Hand Hygiene
One Integrated Approach to Protect Your System.
CAL STAT PLUS® ANTISEPTIC HANDRUB WITH ENHANCED EMOLLIENTS
SUPERIOR CLINICAL PERFORMANCE THAT ENCOURAGES COMPLIANCE
EXCELLENTMOISTURIZATION
CHG COMPATIBLE MRSA & VRE
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References: Fendler EJ, Ali Y, Hammond BS, Lyons MK, Kelly MB, Vowell NA. The impact of alcohol hand sanitizer use on infection rates in an extended care facility. American Journal of Infection Control 2002;30:226-33. Cal Stat Plus Antiseptic Handrub with Enhanced Emollients Healthcare Personnel Handwash Data #310-301-1181.
CalStat Plus Handrub Ethanol Gel Product thickened with carbomer* 4% CHG Product
Clinical Antimicrobial Efficacy Healthcare Personnel Handwash Study
Application 1 Application 2
Ave
rage
Log
Red
uctio
n fr
om B
asel
ine
5 -
4.5 -
4 -
3.5 -
3 -
2.5 -
2 -
1.5 -
1 -
0.5 -
0 -
4.12
3.93
2.43
4.41
2.15
3.62
The Tentative Final Monograph for Health-Care Antiseptic Drug Products; Proposed Rule (TFM) published in the Federal Register June 17, 1994 is the FDA’s principal regulation that sets the clinical performance standards for antiseptic hand hygiene products in the healthcare industry.
MEETING & EXCEEDING CLINICAL STANDARDS
As Healthcare professionals - you are routinely exposed to a range of pathogenic microorganisms every day.
You should expect superior clinical performance from the hand hygiene products you use daily. Commercially available products are not equivalent in antimicrobial performance to products that are specifically formulated and clinically tested to meet the Food and Drug Administration’s (FDA) clinical efficacy standards.
HAND HYGIENE DESIGNED FOR HEALTHCARE
Superior in log reduction to a marketed 4% chlorhexidine gluconate (CHG) healthcare personnel handwash product.
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Antiseptic handwash products
that contain CHG provide residual
activity after washing by leaving an
antimicrobial residual on the skin.
Alcohol handrubs must be
compatible with the CHG residual
where CHG is the primary antiseptic
wash product used. Compatibility
is demonstrated if there is no
decrease in residual CHG activity
after applying a hand hygiene
product.
PATIENTS MATTERFAST AND EFFECTIVE ANTIMICROBIAL PERFORMANCE
Reference: Efficacy of Cal Stat Plus Antiseptic Handrub with Enhanced Emollients Versus Pathogenic Microorganisms Using a Time Kill Study #310-302-1181.
*Community-Acquired Methicillin Resistant Staphylococcus aureus USA 300 was obtained from Michigan Department of Community Health (MDCH).
Test Organism
Average Log10 Reduction at: Percent Kill at:
15 sec 30
60 sec
15 sec
30 sec
60 sec
Acinetobacter baumannii 19606 7.23 7.23 7.23 >99.99999 >99.99999 >99.99999
Acinetobacter iwolfii 15309 5.47 5.47 5.47 >99.999 >99.999 >99.999
Citrobacter freundii 8090 7.10 7.10 7.10 >99.99999 >99.99999 >99.99999
Enterobacter aerogenes 35028 7.01 7.01 7.01 >99.99999 >99.99999 >99.99999
Enterobacter cloacae 10699 7.08 7.08 7.08 >99.99999 >99.99999 >99.99999
Enterobacter gergoviae 33028 7.10 7.10 7.10 >99.99999 >99.99999 >99.99999
Enterococcus faecalis 29212 7.02 7.02 7.02 >99.99999 >99.99999 >99.99999
Enterococcus faecium (VRE) 51559 6.72 6.72 6.72 >99.9999 >99.9999 >99.9999
Percent Reduction Against MRSA
100 -90 -80 -70 -60 -50 -40 -30 -20 -10 -0 -
15 seconds
Per
cent
Red
uctio
n
30 seconds 60 seconds
In a time kill study, Cal Stat Plus Handrub significantly reduced the bacterial counts of transient pathogenic organisms including MRSA, VRE and Community Acquired MRSA
Percent Reduction Against VRE
15 seconds
Per
cent
Red
uctio
n
30 seconds 60 seconds
100 -90 -80 -70 -60 -50 -40 -30 -20 -10 -0 -
MRSA & VRE
Reference: Compatibility of Cal Stat Plus Antiseptic Handrub with Enhanced Emollients with Chlorhexidine Gluconate (CHG) Residual # 310-303-1181
Compatibility of CHG Residual with Cal Stat Plus
CHG CHG + Cal Stat Plus
Log
Red
ucti
on
6.00 -
5.00 -
4.00 -
3.00 -
2.00 -
1.00 -
0.00 -
5 Minutes3 Hours
Staphylococcus aureus ATCC 6538
Carbomer Incompatibility
Carbomer, a polymer commonly used to thicken alcohol handrubs, can inactivate the CHG residual on skin. Cal Stat Plus handrub utilizes a patented polymer technology that is compatible with CHG
6.00 -
5.00 -
4.00 -
3.00 -
2.00 -
1.00 -
0.00 -
Compatibility of Marketed Alcohol Products with a CHG Residual
CHG Residual
CHG Residualand Product A
(containing carbomer)
CHG Residualand Product B
(containing carbomer)
Ave
rag
e Lo
g R
educ
tio
n 4.23
0.640.72
Staphylococcus aureus ATCC 6538
n=12
1Greten,Z., Klein, D., Kaiser, N., Dell’ Aringa, B., Karanja, P.Inactivation of Residual CHG Activity by Thickened Alcohol Solutions,APIC 2004 Annuual Conference, Phoenix, AZ, June 2004.
In a simulated skin model study, Cal Stat Plus handrub did not reduce the antimicrobial CHG residual on the skin.
Hypoallergenic
Clinical testing with a Repeat Insult Patch Test showed no skin sensitization. Results from 201 adult volunteers tested indicated that there was no dermatologic evidence of sensitization after repeated applications of Cal Stat Plus handrub
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*EN 1500:1997. Chemical disinfectants and antiseptics-Hygienic handrub-Test method and requirements Kramer A, Rudolph P, Kampf G, Pittet D. Limited efficacy of alcohol-based hand gels. Lancet 2002; 359:1489-90.
SHOULD NOT BE AN OUTCOME OF COMPLIANCE.DAMAGED HANDS
Enhanced Emollients A 63% isopropyl alcohol handrub, Cal Stat has a patented polymer technology
that is the clinically proven solution for maintaining skin health while providing superior antimicrobial efficacy.
Before After
Cha
nges
in S
kin
Hyd
ratio
n fr
om
Bas
elin
e S
KIC
ON
uni
t
Graph 2: Changes in Skin Hydration 1 Hour Post 2 Applications
Cal Stat PlusHandrub
Provon® Moisturizing Hand and Body Lotion
Huntington® Brand Accent Plus® Amino Lotion
Vaseline® Intensive
Care® Lotion
Untreated
250 -
200 -
150 -
100 -
50 -
0 -
-50 -
WITH PERFORMANCEGraph 1: Changes in Skin Hydration at 1 and 2 Hours Post One Application
Cal Stat Plus Handrub Endure 320 Purell 2 in 1 Untreated
Reference: Skin Moisturization Study with an Alcohol Hand Rub HTR Study: 04-123124-112
60 -
50 -
40 -
30 -
20 -
10 -
0 -
-10 -
-20 -
1 hour 2 hour 1 hour 2 hour
1 hour 2 hour
1 hour 2 hour
Cha
nges
in S
kin
Hyd
ratio
n fr
om B
asel
ine
SK
ICO
N u
nit
CONNECTING COMPLIANCE
Reference: Forearm Controlled Application Test for Estimating the Relative Efficacy of Moisturizing Lotions HTR Study 04-124004-112Provon is a registered trademark of GOJO Industries, Inc.Huntington and Accent Plus are registered trademarks of Ecolab, Inc.Vaseline Intensive Care is a registered trademark of Unilever Supply Chain, Inc.
Hydration for up to 2 hours after 1 application
Moisturizes as well as lotion
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STERIS Corporation5960 Heisley RoadMentor, OH 44060-1834 • USA440-354-2600 • 800-548-4873www.steris.com
Solutions designed to service you best when they are connected. Facing unforeseen challenges together with a single vision.
That is the power of...
PRODUCT PART NUMBER PACKAGE SIZE
1181-03 4 oz 72 per case
1181-49 2 oz 96 per case
1181-87 1 liter 12 per case
1181-RP 15 oz* 18 per case*with pumpette
For more information, please contact your STERIS account manager.
Document # M3116EN.2007-03, Rev. BGPSI Printed 3/2015, XXX©2015 by STERIS Corporation. All rights reserved. Printed in USA.
Ordering Information
Just one more tool in STERIS’s arsenal to stop the spread of germs.
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