vailable kill. keep killing. - outpatient surgery · pdf filebetadine sterile ® eye prep...
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Kill.Keep killing.
Clinical studies* have proven the efficacy and persistence of Hibiclens,demonstrating how it goes to workon germs and provides a cumulativeeffect that continues to kill germslong after your shift is over.The most recent study observed agarplates that were inoculated with staphaureus. Hands were washed withHibiclens, and then pressed onto the inoculated plates – palms down.The plates were then incubated and a whitish film of staph aureus grew inareas not affected by Hibiclens.
For persistent antiseptic activity, you’re in the clear with Hibiclens.®
From the makers of Hibiclens® and Biogel®. www.regentmedical.com.Regent, Biogel, Hibiclens, Regent logo, Biogel logo, and Hibiclens logo,are trade marks of Regent Medical, Ltd. Distributed by Regent Medical,Americas, LLC, Norcross, GA 30092. ©2005 Regent Medical, Ltd. All rights reserved.
*Test on file.**The darker color in the hand print shows the cumulative effect
of Hibiclens on staph aureus, the fifth day of use, 6 hours afterthe final daily handwash.The persistence of Hibiclens provides extra protection.Recommended antiseptic procedures of your institution shouldbe followed when using Hibiclens.
Hibiclens, armed with its 4% Hibitane (CHG)formulation immediately killed germs and displayed a cumulative effectthat didn’t know when to quit.In fact, this demonstrationshowed the antiseptic stillkilling on the fifth day of useand 6 hours after the final daily handwash.**
Immediately kill and keep killing germs withHibiclens. For more information, call 1-800-843-8497.
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Before surgeryYou can prep,
or you can ChloraPrep®
chlorhexidine gluconate 2% w/v & isopropyl alcohol 70% v/v
Medi-Flex, Inc. • 800-523-0502 • www.chloraprep.com©2005 Medi-Flex, Inc. ADV-103 1/05
ChloraPrep® is an FDA approved preoperative skin preparation,proven to be fast-acting, broad-spectrum, and persistent.
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OutpatientSurgery
www outpatientsurgery.net
One-Stop Guide toSurgical Skin PrepsA 16-page pullout designed to make the task of evaluating skin preps quick and convenient for you.BETADINE® 5% Ster ile
Ophthalmic Prep Solution(povidone-iodine ophthalmic solution) (0.05% avail able iodine)
� Only Povidone-Iodine Product Indicated for Use on the Eye� Dual Use: Corneal Irrigation and Periocular Antiseptic� Correct Isotonic Balance � Non-irritating � Sterile
BETA
DIN
E® Eye P
rep Why Risk Im prop er ly
Mixed So lu tions?
Availablein
Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 761341-800-TO-ALCON (1-800-862-5266) Outside US: Contact Your Local Alcon Representative
©2003 Alcon, Inc. DIS109 Printed in USACircle 55 on Reader Service Card
One-Stop Guide toSurgical Skin Preps
ANSWERS TO ALL YOUR QUESTIONS
• HOW QUICKLY DOES THE PREP START WORKING?
• DO YOU NEED SPECIAL REMOVAL SOLUTIONS?
• HOW LONG SHOULD EACH PREP TAKE?
• DO BLOOD, SALINE OR ALCOHOL CHALLENGES
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OutpatientSurgery
www outpatientsurgery.net
WEAKEN OR INACTIVATE IT?
EFFICACYEFFICIENCY COMPATIBILITY PRODUCT INFORMATION
In Vitro Testing** In Vivo Testing**
Product Manufacturer Uses
FDA
Category*
Kill Rate
(%)
Time to
Achieve Kill
Rate (min)
Meet FDA log
Reduction
Standards? Persistence
Inactivated or
Weakened by any
Known Substances?
Water
Soluble? # Application Steps
Required
Application/
Contact Time
Required Drying
Time On Skin
Compatible
with all
Gloves?
Irritating to
Mucous
Membranes/Eyes?
Active
Ingredient(s) Stain?
Available
Applicators Sizes Flammable? Removal Procedure
Primary Benefits
(manufacturer’s claims) Other Considerations
DuraPrepSurgicalSolution
3Mwww.3M.com
Patient pre-op skin prep. Not for use near eyes, in ears
or on mucous membranes.
I^ 99.999 1 minute (earliest time
tested)
Yes Kills bacteria con-tacting the film forup to 12 hours aftera blood and saline
challenge
None No One-step paint Begins killingbacteria on
contact
2 to 3 minutes Yes Yes/Moderate eyeirritant
Isopropyl alcohol74%/iodophor (avail-
able iodine 0.7%)
Yes but removable frommost materials
Self-contained,unit-dose applicator
6mL, 26mL Yes while wet.Not
flammablewhen dry.
Intended to be left onskin. Can be removed
with 3M RemoverLotion or alcohol-saturated gauze.
Dries to a polymer film that enhancesdrape adhesion, optimizes the persistent
effects of iodine, and resists wash-off.
Soap can interfere with adherence; skin must be clean,
dry and residue-free before application. Keep fingers/toesseparated until dry to prevent
skin-to-skin adherence.
Betadine 5%OphthalmicSterile PrepSolution
Alcon Laboratories Periocular prepping and ocular irrigation
NDA Not Available Not Available Yes (periocular skin
testing)
Not Available Not Available Yes For lashes and lid margins: Apply twice. For lids, brows and
cheeks: Apply 4 times.For ocular surfaces:
Irrigate once.
Ocular surfaces:2 minutes
Not Applicable Yes No Povidone iodine 5%(0.5% available iodine)
Yes No(bottles)
30mL No Flush from ocular sur-faces after 2 minutes
No premixing required.
PovidoneIodine Prepand ScrubSolutions
Aplicare, Inc.www.aplicare.com
Patient pre-op skin prep I Average log reduction >7.0
3 minutes Yes^^ Not Measured None known whenused at full strength
on intact skin
Yes Traditional two-stepscrub and paint
operation
Scrub for 5 minutes, blotwith steriletowel, apply
paint, allow todry
Dependent onmany factors
(ambient tempera-ture, humidity,patient’s skin,
surgical site, forexample)
No known reaction with
gloves
No/No Scrub solution 7.5%povidone-iodine(0.75% available
iodine); prep (paint)solution 10% povi-done-iodine (1%available iodine)
Will not stainnatural fabrics
or skin
Bottles, pumpspray bottles,
saturatedsponges
2-, 4-, 8-, 16-,32- and 128-ozbottles, 2-oz
sprayer, wingsponges, stick
sponges
No Use soap and water toremove from skin and
natural fabrics
Fast acting, broad spectrum, cost effective, non-flammable and non-
irritating. Saturated stick and wingsponges offer sterile liquid and sterile
applicator. Pump spray offers touchless,uniform application of paint.
Scrub CarebrandPrevail-Fx
Cardinal Healthwww.cardinal.com/scrubcare
Patient pre-op skin prep I 99.9999 15 seconds Yes Low bacterialcounts through 96
hours (3.3 logreduction at 96
hours)
Inactivated by solution containing
greater than 25%whole blood
Fluid resistant One step 30 seconds 2 to 3 minutes Yes Yes, due to alcohol Isopropyl alcohol72.5%/povidone iodine8.3% (0.83% available
iodine)
Yes. Removablewith sodiumthiosulfate solutions.
One-step, self-containedapplicator
10mL, 40mL Yes while wet.Not
flammablewhen dry.
High-pH soap andwater or rubbing
alcohol
Offers high log reductions. Maintains persistence through 96 hours post-
application. Large amount of solution inone applicator. No special remover lotion
or sharps disposal required (no glass ampoule).
Scrub Carebrand PVP-ISolutions
Cardinal Healthwww.cardinal.com/scrubcare
Patient pre-op skin prep.(Tested safe for mucous
membrane and eye preps.)
I 99.9609 3 minutes Yes Low bacterialcounts through
24 hours
Inactivated by solution containing
greater than 25%whole blood
Yes Traditional two-stepscrub and paint
operation
5 minutes toprep
Blot dry Yes No Povidone iodine 7.5%scrub solution (0.75%available iodine) and
10% paint solution (1%available iodine)
Yes. Removablewith sodiumthiosulfate solutions.
Standard prepkits,
impregnatedfoil pouches, bulk bottles
2-oz to 1-galsizes, 4-oz gel,also availablein prep trays
No Water High efficacy with traditional methods ofprep. No limitations on areas of use. Wide
variety of prep trays obviate need for expensive customization.
Scrub CarebrandExidine
Cardinal Healthwww.cardinal.com/scrubcare
Patient pre-op skin prep.Not for use near eyes, in ears
or on mucous membranes.
NDA Not Available Not Available Yes Goodpersistence
None Yes Two coats required 4 minutes total(2-minute scrub,
blot, 2-minutescrub, blot)
Blot dry Yes Yes Chlorhexidine gluconate 2% & 4%
Will stain brownif launderedwith bleach-containingdetergents
Standard prepkits or bulk
bottles
4-oz to 1-galsizes in bulk;also in prep
trays
No Water For patients with iodine sensitivity.
Techni-CareSurgicalScrub, Pre-and Post-OpSolution
Care-Tech Laboratories, Inc.www.caretechlabs.com
Patient pre-op skin prep.Safe for mucous
membranes.
I/III† 99.99 30 seconds Yes†† >6 hours None Yes One step 2-minute exposure time
Not necessary Yes No/Mild eye irritant Chloroxylenol 3.0%(PCMX)/
cocamidopropyl PG-dimonium chloride
phosphate 3.0%
4-ounce sizeavailable withfood-grade dye
for surgeonswho prefer skin
stain
No(bottles and
pumps)
4-oz to 1-galsizes; 12-mL
unidose;scrub/prep
brushes
No Intended to remain on skin
Transdermal penetration. Non-toxic byoral ingestion. Can be used in a bottle
warmer. Contains no alcohol. Contains emollients/skin conditioners.
Low allergic reaction ratio.
Can be used for incision/sitemaintenance and wound care.
O N E - S T O P G U I D E T O S U R G I C A L S K I N P R E P S
OutpatientSurgery
*Prep product categories: Category I: Generally recognized as safe and effective, not misbranded; Category II: Not generally recognized as safe and effective or misbranded; Category III: Available data insufficient to classify as safe and effective, further testing required. NDA: New Drug Application.**Per FDA’s proposed standards in the Tentative Final Monograph: “Kill rate” is the % of a standardized collection of common pathogens and their clinical isolates killed after prep application. The “log reduction standards” measure how well the prep reduces the microbial load on the skin. FDA suggests reductions of up to 2 log10/cm2 on dry skin sites (abdomen) and up to 3 log10/cm2 on moist sites (inguinal area) within 10 minutes of prep application. According to the FDA proposal, a product is “persistent” when microbial skin counts stay below baseline for 6 hours post-prep.^FDA lists this isopropyl alcohol concentration as category I. Iodophor is not listed but many iodine-containing ingredients are; the company says iodophor is an iodine that is buffered to reduce skin irritation. The TFM does not categorize the combination formula. ^^Scrub and prep tested separately. Each product meets the proposed standards, according to the manufacturer.†Chloroxylenol 3.0% is categorized by FDA as “I” for safety and “III” for effectiveness in the 1994 TFM. The firm notes that the ingredient was “monographed” by FDA prior to 1987 and has a long history of international use. Cocamidopropyl PG-dimonium chloride phosphate 3.0% has not been categorized, nor has the combination formula. ††Care-Tech’s in-vivo test results are expressed as “99.8% reduction for 24 hours on occluded sites,” which the company says exceeds the FDA TFM log-reduction standards.
Cardinal Health prep products offer superior efficacy and convenience
Scrub Care® Prep Trays
• Scrub Care® PVP-I solutions are broad spectrum, fast acting
and long lasting
• Proven safe, effective and nonirritating
• Variety of sizes and application methods allows for a customized
prep for many types of procedures
Prevail-Fx® One-Step Prep Solution
• 99.999% bacterial kill in 15 seconds
• 30-second, one-step application reduces valuable prep time
• Tested against 25 ATCC microorganisms and clinical isolates
• Two sizes available, 40mL and 10mL, for a variety of procedural needs
Scrub Care® Prep Trays and Prevail-Fx® One-Step Patient Prep
Cardinal HealthPrep Products 1500 Waukegan RoadMcGaw Park, IL 60085
www.cardinal.com/scrubcare
© Copyright 2005. Cardinal Health, Inc. or one of its subsidiaries.All rights reserved. (MC2329)
How much do you know about your prep?
For more information on the entire
line of Scrub Care® prep products,
including efficacy and safety data,
please visit our web site at
www.cardinal.com/scrubcare.
To place an order, call your Cardinal Health
sales representative or customer service
at 1.800.964.5227.
Betadine® Brand Microbicides promptly killmost gram-positive and gram-negativebacteria, as well as most viruses,fungi/yeasts, mycobacteria and protozoa –which makes them ideal for hand hygieneprior to patient care, surgical handscrubbing, and for topical degerming ofpatients’ skin prior to surgery and othermedical procedures.
“…antimicrobials increase thelikelihood of killing potentiallypathogenic bacteria.”*
*APIC Guidelines forHandwashing and HandAntisepsis in Health CareSettings. Am J Infect Control.1995;23:251-269.
“...handwashing can result inreductions inpatient morbidityand mortality from nosocomialinfection.”*
CL
EAN HANDS
SAVE LIVES
®
Insist on
BETADINE®
Microbicides
© 2005, Purdue Frederick, Stamford, CT 06901-3431 C7027-AD 1/05
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3M Infection Prevention Solutions.A Vital Step in Infection Prevention.
3M™ Avagard™ (Chlorhexidine Gluconate 1% Solution and Ethyl Alcohol 61% w/w) Surgical and Healthcare PersonnelHand Antiseptic with Moisturizers combines proven ingredients for effective, persistent antimicrobial activity with a uniqueemollient base clinically proven to reduce dryness and skin breakdown. It’s the only waterless, brushless hand antisepticthat is FDA-approved.* For more information call the 3M Health Care Customer Helpline at 800-228-3957.
*Unlike products rated FDA-compliant, Avagard surgical hand antiseptic has undergone FDA review andapproval (NDA-21074 June 7, 2001). So you have the confidence of knowing that all studies, testing andclinical research have been scrutinized, along with product claims and application instructions.
3M Technology delivers immediate,persistent antimicrobial activitywithout water or scrubbing.
Six Hour Persistence.Ninety Seconds to Apply.
© 3M 2004. All Rights Reserved. TM-0310
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EFFICACYEFFICIENCY COMPATIBILITY PRODUCT INFORMATION
In Vitro Testing** In Vivo Testing**
Product Manufacturer Uses
FDA
Category*
Kill Rate
(%)
Time to
Achieve Kill
Rate (min)
Meet FDA log
Reduction
Standards? Persistence
Inactivated or
Weakened by any
Known Substances?
Water
Soluble? # Application Steps
Required
Application/
Contact Time
Required Drying
Time On Skin
Compatible
with all
Gloves?
Irritating to
Mucous
Membranes/ Eyes?
Active
Ingredient(s) Stain?
Available
Applicators Sizes Flammable? Removal Procedure
Primary Benefits
(manufacturer’s claims) Other Considerations
Actiprep Healthpointwww.healthpoint.com
Patient pre-op skin prep. Not for use near eyes, in ears
or on mucous membranes.
I >99.9 15 seconds Yes 2 log reductionsmaintained at
24 hours
None Yes One step Begins killingbacteria on
contact
<2 minutes Yes Yes Alcohol 73% Yes. Basic soapremoves the
stain.
No(bulk solution)
2- and 16-ozbottles
Yes, while wet Soap and water CHG- and iodine-free. Exceeds FDArequirements when used alone. Whenused as a ‘prep system’ that includes a
pre-op shower with Triseptin body wash,prep site maintains significant microbial
reductions 48 hrs post-op. Alcohol-based, fast acting.
Contains a film former to aiddrape adherence.
ChloraPrep Medi-Flexwww.medi-flex.com
Patient pre-op skin prep. Not for use near eyes, in ears
or on mucous membranes.
NDA 99.99 15 seconds Yes At least 48 hours Some lotions containing lecithin
Yes One step 30 seconds (drysites), 2 minutes
(wet sites)
Dry sites: 30 seconds. Wet sites: 1 minute.
Yes Yes Chlorhexidine gluconate 2%/
isopropyl alcohol 70%
No Unit doseapplicators
3.0- and 10.5-mL dosed
applicators;0.67 mL SEPP
& 1.5mLFrepp
applicatorsfor small sites
Yes, while wet Intended to be left on skin
Fast acting, broad spectrum, persistent. Chlorhexidine 2% is preferred for preventing catheter-related
bloodstream infections (CDCGuidelines Category IA).
Povidone-Iodine PrepSolutions
Medlinewww.medline.com
Patient pre-op skin prep. Not for use near eyes, in ears
or on mucous membranes.
I >99.9 Within 60 seconds
Not Available Not Available(Some persistencedue to film-forming
capability)
High concentrationsof organics and
non-organic ions(chlorine and other
halogens, for example)
Yes One step (optional pre-cleansing)
3 to 5 minutes,until dry
Generally 2 to 5minutes
Yes Yes Povidone iodine 10%(1% available iodine)
Yes but can beremoved
Saturatedrayon preppad, rayonswabstick,
polyurethanesponge stick,polyurethanewing sponge
4-oz, 8-oz,pint, quart,
gallon bottles
No 70% isopropyl alcohol- or
1% sodium thiosulfate-impregnated gauze or
cloth
Broad spectrum. Effective against gram(+) and gram (-) bacteria, yeasts and
molds. Virucidal.
BetadineSolution
Purdue Products L.P.www.purduepharma.com
Patient pre-op skin prep. I 100 3 minutes (89% at 15 seconds)
Yes 6 to 8 hours Blood, pus, proteins Yes Traditional two-stepscrub and paint
operation
At least 2 minutes
None. Air dry ifdesired.
Not Available No/5% PVP-Isolution can be used
in the eye
Povidone-iodine 10%(1% available iodine)
Yes No 1/2-, 4-, 8-, 16-, 32-oz;1 gallon
No Wash off with water orwipe with alcohol pad
Proven effective. Reduces bacteria thatcan potentially cause skin
and wound infection.
Avoid pooling beneath thepatient. Prolonged exposure may
cause skin irritation.
Hibiclens Regent Medicalwww.us.regentweb.net
Patient pre-op skin prep.Not for use near eyes, in ears
or on mucous membranes.
NDA For S. epidermidis:99.375% at 20 sec.
99.96% at 1 minute^
See prior column
Yes At least 6 hours Anionic compounds Yes Two steps(repeat
application required)
2 minutes perapplication
None. Dry withsterile towel.
Yes Yes Chlorhexidine gluconate (CHG) 4%
Will stain brownif laundered
with bleach-con-taining deter-
gents
No 4-, 8-, 16-, 32-oz;
1 gallon
No None necessary Broad spectrum, persistent microbial kill.A “gold standard” of antiseptics.
Triadineand TriadPlus PVP-I10% PrepSolutions
Triad Disposableswww.triad-group.net
Patient pre-op skin prep. Safe for wounds and mucous membranes.
I Most organismskilled within
2 minutes
2 minutes Yes Some persistence(<1 day)
Reducing agentssuch as sodium thiosulfate; also
weakened by bloodand organic matter
Yes Three steps: After cleaning skin,
apply prep, repeat twice
1 to 5 minutes Complete dryingnot required
Yes No/No Povidone-iodine 10%(1% available iodine)
Does not stainskin (washes off
with water).May stain someclothes. Lemonjuice followedby immediatewashing may
remove persist-ent stains.
Pre-saturatedswabsticks,
sponge sticks,prep pads
2-, 4-, 8-, 16-,32-oz;
1 gallon
No Sterile gauze/sterile water
Flip-top bottles have easy-open wing-tabsafety seal. Triad Plus solutions/gels are
designed for procedural kit and tray manufacturers. Bottles can withstand
deep vacuum EtO cycles without leaking.
O N E - S T O P G U I D E T O S U R G I C A L S K I N P R E P S
OutpatientSurgery
*Prep product categories: Category I: Generally recognized as safe and effective, not misbranded; Category II: Not generally recognized as safe and effective or misbranded; Category III: Available data insufficient to classify as safe and effective, further testing required. NDA: New Drug Application.**Per FDA’s proposed standards in the Tentative Final Monograph: “Kill rate” is the % of a standardized collection of common pathogens and their clinical isolates killed after prep application. The “log reduction standards” measure how well the prep reduces the microbial load on the skin. FDA suggests reductions of up to 2 log10/cm2 on dry skin sites (abdomen) and up to 3 log10/cm2 on moist sites (inguinal area) within 10 minutes of prep application. According to the FDA proposal, a product is “persistent” when microbial skin counts stay below baseline for 6 hours post-prep.^Tested on a weaker (0.05%) CHG formulation than that in the prep product (4%).