AUGUST !998. VOL 68. NO 2. Dyer. Gerenraich • \Va;/hont.r •

Testing a New Alcohol-FreeHand Sanitizer to Combat Infection

ollowing universal precautions is an in tegra Ipart of OR staff members' responsibilities inperioperative patient care. The precautionsmandate routine hand washing with soap andwater before and after all patient contact, and

especially before invasive procedures. Althoughintended to reduce the posroperari e risk of infec-tion of healing incisions and wounds. universal pre-caurions.vincluding hand washing, are followedonly 55% of the rime in the nation's hospitals.'

The contributing factors behind this insuffi-cient hand washing are manifold: however, identi-tied principal causes include the following.• Direct patient caregivers are handling an exces-

sive patient load. Conservative estimates indi-cate that physicians attend to 20 to 30 patientsper day, and other health care personnel (eg.nurses, physical therapists, respiratory thera-

pists) may have as many as 200 patient contactsper day.

• The repeated hand washing required for that vol-ume of patients causes dryness and subsequentmicroabrasions of the skin.'

• The skin on the hands bas a short period of timeto recover between washings.

These factors, among others. have led to a greatincrease in the use of rinse-free instant hand sani-tizers as a supplement to proper hand washing withsoap and water.

The most widely used hand sanirizers are gelsand foams. that rely on alcohol as the main antimi-crobial ingredient. Alcohol, however. solubilizesand strip away sebum and lipids that guard againstbacterial infections of the skin.'; Extern ive use ofalcohol-containing hand sanitizcrs actually increasesthe skin '5 susceptibility to infection by transient dis-

ease-causing bacteria. This situa-tion can increase the chancesof spreading d iscase-ca usi ngmicroorganisms among patients.

The threat of spreading dis-ease could be avoided by usingalcohol-free hand sanitizers thatcomplement. rather than compro-mise. the natural barrier func-tion of the skin. An acceptablea lcoho l-free formula wouldrequire an antimicrobiaJ agentthat kills it wide variety of dis-ease-causing microorganisms,including gram-positive andgram-negative bacteria. fungus,and molds. This formula alsowould need to allow the activeingredient to penetrate the skinwhile minimizing skin irritation.

ABSTRACTUniverSal precautions require that perioperotive health core per-

sonne~ wash their hands before and after all patient contact Timeconstraints, however, can make adhering to universal precautions,including proper hand washing. difficult. Some perioperative healthcore workers, therefore, routinely use rinse-free hand sonitizers tosupplement normal hand washing. This study evaluated lmmedlcteand persistent antimicrobial effectiveness of two alcohol-containinghond sanitizers ond a novel surfactant ollontoin, benzalkoniumchloride (SAB) hand sanitizer using a federally approved effective-ness protocol. Results indicate that all three products were equallyeffective after a single application. After repeated use, the alcohol-containing sonitizers did not meet federal performance standards,and the alcohol-free sanitizer did. These properties and others illus-trated in this article indicate that the nonflammable, alcohol-freeSAB hond sanitizer is the most favorable of the rinse-free hand sonl-rlzer formulas for normal hand washing. AORN J 68 (August 1998)239-251.

DA VlD L. DYER; KENNETH B. GERENRAICH; PETER S. WADHAMS

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Such a formula is obtained by combining cer-tain surfactants and allantoin with the widely usedantimicrobial agent. benzalkonium chloride. Thisformula is known as a surfactant, allantoin, andbenzalkonium chloride (SAB) sanitizer.

ESTAaLISHING THE HYPOTHESISBased on this information, researchers at

Woodward Laboratories. Inc. Los Alamitos, Calif,hypothesized that the prolonged use of alcohol-con-taining hand sanitizers would be less effective atdegerming the skin than an alcohol-free SAB sani-tizer. To test this, they used a protocol validated bythe US Food and Drug Administration (FDA) forthe performance of health care personnel antiseptichand washes.' This protocol was developedspecifi-cally to fest the degerming effectiveness- of hand-wash preparations with extended use and is accept-ed as a national clinical standard for such perfor-mance testing>

UTERATURE REVIEWThe literature review for this study indicated

that rinse-free hand sanitizers are, by definition,intended for degerrning skin without the aid of rins-ing with water. This type of product has steadilygained popularity in professional circles as a sup-plement [0 hand washing with soap and water. Thetypes of rinse-free hand sanirizers generally aregrouped into two broad caregorie• alcohol-based products and• alcohol-free products,

The need for immediate and persistentprotection. The FDA clearly seeks both an immedi-ate and persistent degerming activity in antisepticpreparation by its definitiun of a personneldi 0 infectanr:

a non-! rri far iug . on I imicrobial -coutaini ngpreparation designed [or frequent use andwhich will reduce the number of transientmicroorganisms to a baseline level after ade-quare washing, rinsing, and drying, Suchpreparations also are expected to have abroad antimicrobial spectrum. be fast-acting,and persistent.'

A hand steri Iizer ' s immediate antimicrobialeffectiveness is based on the physical removal andimmediate inactivation (ie, within 60 to 180 sec-onds of exposure to the antimicrobial agent) of

microorganisms residing on the hands. The persis-tent antimicrobial effectiveness of a hand sanitizeris defined as its microbiocidal activity after up tosix hours of the product's application,"

Alcohol-based products. These products varygreatly in composition, rangi-ng from 54% i '0-

propanol to 70% ethanol.' The choice of tbis typeof rinse-free antimicrobial product often is subjec-tive and mainly based on factors such as cost. pres-ence of emollients in the formula, fragrances, deliv-ery vehicle (eg, gel, foam), size, and marketing.Selection is less often based on the product's effec-tiveness at eliminating bacteria after a singleapplication.

Although alcohol-based formulas that complywith federal composition standards generally areconsidered effective, alcohol-based antiseptic hand-wash preparations are flammable and do notdemonstrate persistent antimicrobial activity. Also,repeated use often can cause drying and irritation ofthe skin." Alcohol strips the skin of essential oilsand sebum, which act as a natura'! protective barrieragainst bacterial infection and precipitate protein."When applied to wounds or raw surfaces, therefore,it not only increases the risk of injury, but alsoforms a coagulum under which bacteria may subse-quently thrive.!" It is, therefore, not useful for thedisinfection of open lesions or abraded, inflamedskin. Together, these and other adverse propertiesgreatly limit the alcohol-based antimicrobial prod-uct's immediate effectiveness and increase thechances for the spread of infection.

Chlorhexidine and hexachlorophane. The per-sistent antimicrobial activity sought: by the FDA hasbeen demonstrated by using the alcohol-free com-pounds of chlorhexidine and .hexachlorophane witha water rinse." These compounds, however, havenot been extensively used in rinse-free hand antisep-tic application, in part because they are neitherabsorbed nor dissipated quickly enough to be con-venient or user-friendly, and in part because theyhave aesthetically displeasing side effects such asodor. Additional limitations include a relatively nar-row antimicrobial spectrum of certain compounds.such as triclosan."

Benzalkonium chloride. Benzalkonium chloride(BAC) is an alcohol-free, antimicrobial compoundthat has been widely used in the health care industryfor more than 60 years in formulas for preservatives,surface cleansers, sterilizing agents, and topical anti-septic sprays.'-' The chemical properties of BAC

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make it a good candidate for persistent antimicrobialactivity in mammalian tissue. Extensive exposure tocertain nonaicohol antimicrobial agents, includingsome surfacranrs. however, can make it have a detri-mental effect on the skin unless the active ingredientis formulated with compounds that mitigate thiseffect.

A unique balance of penetration and nonirritationis attained when BAC is combined with surfacrantsand allantoin. 111i.s type of alcohol-free sanitizer for-mula is absorbed rapidly into the skin with littleimpact on the skin'S natural barrier function andis pre-dicted to be more useful and effective as a rinse-freehand sanitizer than alcohol-containing formulas.

THI;OR,ETICAI. ANn COIIICEP11JAL FftAIIIIEWOR,KPurpose of the study. The goal of the study

was to provide information about the effectivenessof rinse-free hand sanitizers when used as a upple-rnent to normal hand wa ihing. The study wasdesigned to evaluate the immediate and persistentantimicrobial properties of two types of alcohol-containing. rinse-free hand sanitizers (ie, 62%ethanol, 70<Jo ethanol) and an alcohol-free SAB

Table 1~ :p

Alcohol-based hand washesSolution I. Active ingredient: Ethyl alcohol (ie, 62%vaVvol). Other ingredienis: Isopropyl alcohol, wdfer,emOllients, and thickener,Solution 2. Active ingredient: Ethyl alcoho! (ie, 70"/0vol/vol). Olher ingredients: Emulsifying wax, methylglucelh 20, pOlyoxyelhylene, stear,] ether, andcylcomettlicone.

SAB hand washSolution 3. Active ingredient: Benzalkonium chloride(ie, 0.13% vel/vel). Other ingredients: Water, hvdrox-yproPv1methyi cellulose, propylene glycol, cocomido-propyl betaine, cocomidopropylamine oxide, cetyl,Ifimethyl ammonium chloride, quoiernum- 12, lrnidozo-lidinyl urea, qualemium·15, allanfoin, methyl poroben,propyl poraben, eucalyptol, methyl soucvlore, andirie/hanolamine.Control soapIvory hand cleanser. Ingredients: Water, sodium laurefhsulfate, sodium lauryl sulfate, cocamidapropyl betaine,and fragrance.

hand sanitizer (ie, 0.133% HAC. 0.5% allantoin).Study design. An FDA-mandated protocol was

used to measure the effectiveness of sanitizer prod-ucts on hands that have been heavily contaminatedwith Serratia marcescens bacteria, a pathogen com-mon in hospital-acquired infections. The testis use-ful for identifying formulas that are effective. first-line defenses against massive personal contamina-tion, The FDA protocol recommends a water rinse;however, the formulas were intended for use with-out a water rinse. Antimicrobial performance thuswas determined both with a water rinse and withouta water rinse in separate sets of experiments.

The bacteria Serratia marcesceus used in thisstudy grows in red-colored colonies. allowingre earohers to track only the fate of bacteria intro-duced on the hand for the purposes of the test.Before testing, all Serratia stocks were found to besusceptible to gentamicin, according 10 NationalCenter of Clinical Laboratory Standards." Theexperiments were conducted in an environmentallycontrolled clinical research laboratory, and datawa gathered from February to September 1997.

Test solutions. The antimicrobial hand-washpreparations were two commercially available alco-hol-based formulas and one alcohol-free SAB for-mula (Table 1). The rronantirnicrobial control hand-wash formula that was used for the initial baselinewash-establishing the mechanical reduction ofbacteria-was the commercially available Ivoryhand cleanser, Although Ivory soap was used as arepresentative of nonantirnicrobial hand cleansers,other nonanrimicrobial cleansers would have servedas an adequate control because the principaldegerrning action of any cleanser that lacks anantirnicrobialiy active ingredient occurs through amechanical removal of bacteria and not by a directimpact on bacterial viability.

Table 2DIS11UBUIJON OFSUBJEC'l'S AND CONDITIONS

Formula Condition Number of subjects

SAB solution wittl rinse 21without rinse 14

62% ethanol with rinse i7wflhout rinse 16

70% ethanol with rinse 5without rinse 5

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Table 3HAND SANmZER EFFECI1VENESS PROTOCOl.

1.Cultures of Serratia marcescens (ie, eosv-lo-countred-colored bacteria) are prepared to a concentration ofapproximately loe bacteria per milliliter of inoculum, ondeffectiveness is established through a series ofcontamination and washing cycles.2. Subjects wash their hands using the control soap.3. A baseline is determined by inoculation of the subjects'hands followed by immediate sampling using lhe glovejuice method, whIch is used for each opproprlme contami-nation ond wash cycle.4. A conlrol value for the mechanical degerming activtlyis sent through a contamination and wash cycle using thecontrol soop.

5.The fest subjects proceed lhrough a series oll 0wash cycles with the lest solution. Ten minutespass between each contamination and wosh cycle,and the entire series is accomplished in approximatelytwo hours.6. Glove juice samples to establish antisepticeffectiveness are token after the firsi~ third, seventh, and1nth contamination and wash cycles, os required by theUS Food and Drug Administration.

7. A similar procedure is used for both Ule rinse andnonrinse protocols.

Subject recruitment and exclusion criteria. Inall. 78 healthy adults participated voluntarily in thestudy and were broken down into test groups forthe three formulas (Table 2). The total group com-prised 56% men and 44% women. ranging in agefrom 18 to 47 years. None of the subjects had clini-cally evident dermatoses or injuries to their handsor had used topical or systemic antimicrobial agentsor any other medication known to affect the micro-bial flora of the skin.

In addition, study participants were required tohave a nail length of no greater than 2 rnrn andwere not allowed to wear artificial nails. Inltialwork had indicated [hat long or artificial nails shel-tered bacteria from the action of [he hand sanitizersand rignificantly skewed result'. Similarly, peoplew irh nonrernovable adornments (eg, rings thatcould not be removed, bandages) were not allowed:to participate in the study because these physicalbarriers protect bacteria from antimicrobial com-pounds.

Data collection. The study began with a one-week pretest conditioning period during which sub-jeers were not allowed to use medicated soaps.strong acids or bases, and other antimicrobial prod-ucts. The antimicrobial effectiveness of the handsanitizer was judged by a series of hand contami-nations tbat were followed by washes with either acontrol, nonantimicrobial soap or the test formulas(Table 3).

Glove juice sampling. Researchers used theFDA-approved glove juice sampling technique forbacteria collection.1) Subjects removed all jewelry and adornments

from hands.2) Five mL of Serratia marcescens inoculum were

spread over subjects' bands for 45 seconds.3) Hands were allowed to air dry for two minutes.4) Polyethylene gloves containing 50 mL of collec-

tion fluid each were placed 011 the subjects'hands and secured above the wrists with rubberbands.

5) Collection fluid was spread over the subjects'hands and massaged for one minute in a sran-dardized manner to ensure uniform recovery ofthe collection sample.

6) Collection samples from the hands were pooledand immediately plated onro tripticase soy agar(TSA) mediums with both neat samples and ser-ial dilution cultures to guarantee accuratecolony counts.

The procedure allowed for a complete sampling ofthe surface area of each hand below rhe wrist.

Testing: After the pretest conditioning week,subjects hands were contaminated as describedand then sampled. The number of bacteria recov-ered from the unwashed hands represented thebaseline. which v as representative of the maxi-mum bacterial contamination that the unprotectedskin could retain. After this, hands were recontam-inated and then washed with 5 grams of a nonan-tirnicrob ial soap as a control for mechanicaldegerming action alone. The bacteria remaining onthe hands were sampled and plated. After thIs. sub-jects' hands were contaminated. washed with 5grams of the appropriate test sanitizer. and sam-pled. This last step (ie, conraminare, wash. sample)was repeated 10 times, wirh five minutes elapsingbefore the start of the next contamination. wash,and sample cycle. This resulted in a IO-minuterecovery period between the subjects' aCIOa]wash-ing with [be test soap.

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STATISTICAL ANALYSESAND CALCULATIONS

Statistical analyses wereconducted using the Student's I

[est with the aid of Statview sta-tistical analysis software. Datapresented in this document repre-

AUGUST [998, VOL 68, NO 2• Dyer' Gerenraich • Wadhams'

sent the mean and the standard error of the meanfor the number of subjects in each test group.

All of the raw data (ie, bacterial colony counts)were converted to a log., scale to be compatiblewitb the calculation model used. Briefly, the logwscale deals with exponents such that the log., of100 (ie, 102) is 2. For example, if 1,000 bacteria arecounted. that number could be expressed in a power

5 le-n 4.E

In the second series of tests, the 30·seconcirinse step was omitted, and sampling wasperformed immediately after washing to testthe sanitizers ' effectiveness without a water rinse.In each type .of test (ie, with or without a waterrinse). bacteria remaining on the hands was sam-pled and plated after the first, third, seventh, and10th washes.

Collecting cultures. Cul-tures of FDA ..mandated Serratiamarc escens were preparedaccording to the method stated inthe FDA protocol. Stock bacteriawere grown to a concentration ofapproximately I x 10H viablebacteria per milliliter of growthmedium (ie, Trypsin soy broth).Cultures were agitated beforeuse. No neutralizers were used inthe collection fluid; this prevent-ed the buildup in the subjects'skin of neutralizer that wouldskew the results. The collectionfluid had a pH of 7.8 and con-sisted of• 0.04% KH1PO~,• 1.0% K,HPOj, and• 0.1 % Triton X-lOO.

Within three minutes ofacquisition, samples from borhthe alcohol-based and SAB anti-septic band sanitizerswere dilut-ed using the collection fluid thatcontained the appropriate neu-tralizers and were plated forgrowth on the TSA medium."Cultures were grown overnightat 37° C (98.6° F) before count-ing. Washing and rinsing, whenapplicable, were conductedunder running lap water thatcontained less than one viablebacterium per milliliter.

--G- SAB...... -<)-...... 62% ethanol

JI

7

--0--- 70% ethanol

3

Wash number

Dashed fine representsfhe minimum reduc-fion rector required forperformance by the USFood end Drug Admin·istration.

r-lO

Dolo represent mestandard error of themean.

* P::; 0.05

Figure 1 • Hand sanitizer effectiveness performance with a wafer rinse.

---.1~}--

....... (; .SAB

62% ethono!70% ethanol

4 -

i

3 7

--{)---

Dashed line representsthe minimum reduc-tion factor required forperformance by Ihe USFood ond Drug Admin-istronon,

i

iODOlO represent Ihestandard error of themeon.

Wash numberk Ps 0.05

Figure 2 • Hand sanitizer effectiveness performance without a water rinse.

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The SAB hand sanitizer's

degerming effectiveness

increased throughout the

hand contamination protocol.

of 10, as 1 x Hy; thu • the log., value of 1,000 is 3.This method of converting bacteria counts to logvalues effectively reduces the statistical variationsin bacteria counts from person to person and is use-ful in comparative studies.

In these experiments, researchers calculated avalue called a reduction factor (RF). which is oneway to measure how well a test solution decreasesthe amount of bacteria on subjects' hands. It is calcu-lated as

RF = logw (baseline bacterial countj=-loglO (postwash bacterial count)

If 10,000 bacteria, therefore, were recoveredfrom the hands for the baseline, and only 100 wererecovered after the wa rh with the test solution, theRF value would be 2. Another way to Lookat RF isif the RF is 2, then 99% of all bacteria have beenkilled; if the RF is 3, 99.9% have been killed. andso on.

A small value for RF means that there was onlya small reduction in the number of bacteria on thehands after washing with the test formula. Mostnonantimicrobial soaps and sanitizers will give anRF of approximately 2 in this type of test. In con-trast, a large value for RF means that there was alarge reduction in the number of bacteria on thehands. The FDA-approved protocol used for thisstudy requires a minimum RF of 2 after the firsthand wash. and a minimum RF of 3 after the 10thband wash.

RESULTSThe first series of experiments was performed to

compare the effectiveness of the SAB hand sanitizerformula to a commercially available ethanol-basedformula (ie. 62% vel/vel) with the inclusion of a 30-

second water rinse. The results show that, after a sin-gle hand wash, both the SAB hand sanitizer formulaand the 62% ethanol-based hand sanitizer formulabad a degerming activity that was approximately20% greater than the degerming activity of the con-trol nonantirnicrobial hand wash (Figure I). Both thealcohol-based and SAB hand-wash formulas demon-strated an RF value of2.8 ± 0.2.

The degerming efficacy of the alcohol-basedhand wash decreased during the remainder of thehand contamination and wash cycles, falling to alevel that was below the minimum acceptable FDAstandard of RF = 3. In contrast. the degerming effec-tiveness of the novel SAB hand sanitizer formulaincreased over the course of the hand contaminationand wash cycles required by the protocol.

Rinse-free testing. Both of the hand-wash for-mulas examined are intended for use without rinsingwith water; thus, the above protocol was modified sothat the 30-second water rinse was omitted. Theresults showed that the ethanol-containing handwash had a moderate degerming action compared tothe control nonantimicrobial hand wash after the firsthand wash (Figure 2). The degerming effectivenessof UIC remaining hand contamination and decontami-nation cycles was markedly decreased for the 62%alcohol-based sanitizer. The degerming activity ofthe SAB hand sanitizer formula paralleled the resultsobtained with the rinsing protocol and showed asteady increase in germicidal activity throughout thecourse of the experiment. exceeding tbe FDA mini-mum standard.

Greater ethanol concentration testing. Themost anrirnicrobially active ethanol concentrationslie in the range of 50% to 70% vel/vel in water; rhus,researchers were cur io us to know whether anincreased ethanol concentration in an ethanol-basedsanitizer would improve antimicrobial performance.The researchers, therefore. examined the effective-ness of a different. commercially available hand san-itizer that also contained emollients, but had anethanol concentration of70% (ie. vol/vol).

The results show that. although the 70%ethanol formula initially performed better than the62% formula. antimicrobial effectiveness decrea edas before with successive washes in both the rin "eand nonrinse protocols. Although the initial washwith the SAB sanitizer produced approximately thesame RF as the 709'0 erhanol-conraining formula inthe rinse protocol. subsequent washes with the SABformula produced bacterial reductions greater than

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the 70% ethanol formula. Likewise, in the nonrinseprotocol, the SAB formula's effectiveness wasapproximately the same after the first wash, butwas significantly greater than the 70% ethanol for-mula for subsequent contamination and recontami-nation cycles.

Subjective testing, In addition to these objectiveresults, subjects were asked to subjectively evaluatethe condition of their hands after the completion ofthe formula tests. A significant number of subjects(ie, 47%) who hac! completed the test protocol withthe alcohol-based hand sanitizer formulas-r-either inthe rinse or nonrinse protocol-reported palmar painor discomfort. After visual inspection, these subjectswere found to have pronounced swelling that was, insome Instances, accompanied by erythema of thepalmar tissues. Also, the group that used ethanol-containing products tended to indicate some discom-fort in palmar surfaces for one to several days afterthe test, In contrast, none of the subjects that usedthe SAB hand sanitizer formula reported any pain 0.1'

discomfort of their hands after completing either therinse or the nonrinse protocol.

DISCUSSIONThe Centers for Disease Control and Prevention

(CDC) has stated that hand washing is the singlemost important factor in the prevention of diseaseand the spread of infections. Offlcials at the CDCestimate that one-third of all hospital-acquired infec-tions are avoidable and are caused by a lack ofadherence to established infection control practicessuch as hand washing. t6

This insufficient hand washing has led to a greatincrease in the use of waterless hand sanitizers byhealth care personnel. This study evaluated the effec-tiveness of two ethanol-containing hand sanirizersand a novel SAB, ethanol-free hand sanitizer usingan FDA-approved protocol.

After a single application, the alcohol-free Sc\.Bsanitizer and both alcohol-based formulas reducedbacteria more than a control uonantimicrobial hand-wash formula. When the protocol was repeated omit-ting the water rinse, similar results were achieved.This illustrated that the first time either of thesetypes of prod ucts is used on any given day.degerming activity results that exceeds the federalrequirements for antiseptic hand washes.

To be of any value in a health care setting,however, a hand antiseptic should give persistentantimicrobial activity with repeated use. According-

None of the subjects who

used the SAB hand sanitizer

reported any pain or

discomfort after use.

Iy, the alcohol-free SAB sanitizer, with or withoutthe water rinse, produced increased antimicrobialeffectiveness over time with no adverse effects, Incontrast to this. repeated use of the alcohol-basedsanitizer's produced a decrease in antimicrobialeffectiveness over time and was accompanied byswelling, erythema, and discomfort of the palmarsurface of subjects' hands. importantly. by the com-pletion of both the rinsing and nonrinsing protocols,antimicrobial persistence of the SAB formula wasso pronounced that its performance exceeded feder-al requirements for antiseptic hand washes by atleast 50%. The tested alcohol-based hand sanitizers,however. failed to meet this federal standard in boththe rinse and nonrinse protocols.

In summary, the study showed• the SAB hand sanitizer formula had a greater sus-

tained degenning activity than the alcohol-con-taining hand sanitizer formula,

• the alcohol-containing hand sanitizer became lesseffective with repeated use and irritated the handsof subjects, and

• the SAB hand sanitizer formula became moreeffective without irritation after repeated use.

LlIl1lIT'AT'IONSAND DIRECTIONSFOR FUTURE STUDY

A potential limitation to this study is that it wascarried out in the controlled environment of a clini-cal research laboratory on model pathogens artifi-cially introduced onto the hands of subjects accord-ing to a federally approved [est protocol. Futureresearch. therefore, would need to include studies ofthe impact on nosocornially derived infections inclinics, in which either an alcohol-containing Or analcohol-free hand sanitizer was routinely used tosupplement normal hand washing.

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Also, the interval between washes for each of thesanitizers tested in this study was 10 minutes-anamount of time chosen to model rne effects of fre-quent, acute use, as might occur in a clinical environ-ment that requires 10 to l2 patient contacts per hour.It would be informational, however, to perform thetests described in this document allowing a greaterperiod of Limebetween consecutive washes.

In the same way, the federally mandated timefor the actual hand-washing procedure was twominutes, although in vitro data indicate that the for-mulas are effective in a nonskin environment afteras little as 10 to 15 seconds. A second investiga-tional parameter for future work. therefore, couldinclude varying the hand wash duration. as well.

flECOMMENDATIONS FO~ CLINICAL PRACTICENurses in the OR face a situation that is partie-

ularly challenging in terms of maintaining handsanitization. For example, nurses may at onemoment be required to open storage drawers orhandle and move equipment, such as lights and footstools, and at the next moment be required to assistin wound dressing. In cases in which nurses mustmake the transition between equipment handlingand assisting directly with the patient. universalprecautions. such as hand washing and the wearingand changing of gloves, should take precedence. Insuuarions in which hands should be sanitizedbefore donning new gloves (eg, inadvertent conta-mination because of glove tearing) where soap andwater are not immediately available, however. thisstudy's results indicate that the alcohol-freeSAB formula would be more effective with contin-lied use than the alcohol-based formula at handsanitization.

It is recommended that perioperative health carepersonnel who have frequently been using alcohol-ba ed instant hand sanitizer' to supplement normalhand washing consider the benefits of using an effec-

tive alcohol-free instant hand sanitizer, such as theSAB sanitizer. This formula is quick-acting, does notrequire a water rinse, and, unlike alcohol-based handsanitizers, is not tlammable-a quality particularlyimportant for perioperative safety in general.

RECOMMlNDA110t.lS FOR i:DUt:ATIONThe point for clinical education that may be

gained from this study is that, although alcohol-based instant hand sanirizers are widely used inprofessional and nonprofessional circles, alcoholalso is an effective organic solvent. As such, itreadily strips away the natural chemical compo-nents of the skin (eg, sebum. lipids) that impedewater loss and bacterial infection. Frequent andprolonged use of alcohol-containing hand sanitizerproducts, therefore, can be counterproductive tohand sanitization and can damage the skin.

The results of this study are presented to helpperi operative health care professionals choose anappropriate product. for rinse-free hand sanitizationas a supplement to norma} hand washing, not toundermine the fundamental importance of properhand washing, This study further serves to educateprofessionals about the limitation of alcohol-con-raining hand sanitizers and the advantages of alco-hot-free hand sanitizers in both a peri operative andgeneral clinical setting. ~

David L Dyer .•P/tD, is the research director at Wood-ward Laboratories, tnc. Los Alamitos, Calif

Kenneth B. Gerenraich, DPM, I:' the president andchiefexecutive officer Of Woodward Laboratories. inc.L05 Alamitos. Calif

Peter S. Wadhams, DP!.4. is a podiatrist at SOUThernCalifornia Foot and Ankle Institute, Lakewood, and apart-lime researcher <J{ f\foodwGrd Laboratories, file,L(JsAtamttos. Calif.

NOTESl. J S Gamer. "Guideline for

isolation precautions in hospitals:Part I: Evolution of isolation prac-ticex," American JOI/J'l/o/ cflnfec-lion COl1!ml24 (February 1996) 24-31: G P Milack, "Universal precau-(ions and infection control:'Coniemporarv Podiatric Physician2 (February 1996) 15-16;Centersfor Disease Control. "Surveillance,

prevention, and control of nosoco-mial infections." Morbidity andMortality Weeki)' Report 41 (1992)783-787: K Griffin. "They shouldhave washed (heir hands." Hip-pocrates (February 1997) 50-56.

2. K P Wilhelm. H H Wolff. H IMaibach, "Effects of surfactant onskin hydration." in Bioengineering of'the Skill: Water and thr StratumCorneum, ed P Elsner. E Berardesca.

11I Maibach (Boca Raton. Fla: eRCPress, 1994) 257·274; D Van Neste,"Skin hydration in detergent-induceddermatitis." in Bioengineering. of theSkill: Warer and the StratumCorneum, ed P Elsner. E Bararde-:CO<1. H I Maibach (Boca Raton. Fla:CRC Press. 1994)223-2:14.

3. S C Harvey. "Antiseptics anddisinfectants: fungicides: ectopara-suicides.' in Goodman and

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Gilman's The PharmacologicalBasis of Therapeutics, sixth ed. A GGilman, L S Goodman, A Gilman.eds (New York: Macmillan Publish-ing, 1980) 964-987.

4. "Tentative final monographfor healthcare antiseptic drug prod-ucts; Proposed rule," Federal Regis-ter 59 (June 17, 1994) 31402-31452.

5. "OTC topical antimicrobialproducts," Federal Register 43 (Jim6 1978) 1210-1249.

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Reprinted with permission, AORN Journal, (68 August 1998), P 239.Copyright © AORN, Inc, 2170 S Parker Road. Suite 300, Denver, CO 80231.