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 EXCELLENT MOISTURIZATION CHG COMPATIBLE MRSA & VRE

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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

  • 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.

  • 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

  • *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

  • 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.