1/25/2017 Temperatureandhumidityinthestorageareaofsterilematerials:aliteraturereview

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BrunaCamilaQuartimdeMoraesIKazukoUchikawaGrazianoII

I RN.DoctoralstudentoftheGraduatePrograminAdultHealthNursing, Relatedlinks
UniversityofSoPauloSchoolofNursing.SoPaulo,SP,Brazil. Share
caquartim@yahoo.com.br
II RN.FullProfessoroftheMedicalSurgicalNursingDepartmentat More
UniversityofSoPauloSchoolofNursing.SoPaulo,SP,Brazil.
kugrazia@usp.br More

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ABSTRACT

Therecommendationsfortemperature(T)andrelativehumidity(RU)forthestorageofsterilizedmaterialsin
SterilizationCentralSupply(SCS)varyaccordingtodifferentsources,andarenotbasedontheoretical
frameworksorexperiments.Thepracticeshowsdifficultiesincontrollingtheseparameters,leadingtodoubts
regardingthemaintenanceofthesterilityofthesematerials.Thisarticleproposed,throughaliteraturereview,
toidentifyandanalyzetherecommendationsforTandRUforthesterilestoragearea.Wedidnotfindany
literaturethatjustifiesthereferredrecommendations.Sevenarticleswereincludedwhichanalyzedthe
variablesTandRUinthestorageareaasfactorsthatcouldaffectthesterilityofthematerials,andshowed
contradictoryresultsregardingthesefactors'interferenceinmaintainingthesterilityofthematerials.

Descriptors:MaterialsTemperatureHumiditySterilizationMaterialsmanagement,hospital

RESUMEN
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Biendiversassonlasrecomendacionesreferentesalatemperatura(T)yhumedadrelativadelaire(UR)enel
almacenamientodematerialesesterilizadosenCentralesdeMaterialesyEsterilizacin(CME),sinquetales
recomendacionesestnbasadasenreferencialestericosoexperimentos.Laprcticamuestradificultadpara
controlarestosparmetros,generandodudasencuantoalriesgoparaelmantenimientodelaesterilidadde
estosmateriales.Esteartculopropuso,apartirdeunarevisinbibliogrficaintegrativa,identificaryanalizar
lasrecomendacionesreferentesalaTyURindicadasparaelsectordeguardadodematerialesenlaCME.No
seencontrliteraturaquejustifiquetalesrecomendaciones.Fueronincluidassietepublicacionesqueanalizaron
lasvariablesTyURdelreadealmacenamientocomofactoresquepuedenafectarelmantenimientodel
materialesterilizadoypresentaronresultadoscontradictoriosencuantoalainjerenciadedichosfactoresenel
mantenimientodelaesterilidaddelosmateriales.

Descriptores:MaterialesTemperaturaambienteHumedadEsterilizacinAdministracindematerialesde
hospital

INTRODUCTION
TheCentralSterileSupply(CSS)Depaetmenthastheabilitytoreceive,clean,disinfect,repair,sterilize,store
anddistributematerialsusedinhealthcare(1).

Thestorageofmaterialsisoneofthecriticalpointsinmaintainingtheirsterility,andthereare
recommendationsregardingenvironmentalconditionsthatmustbemetinthestorageareas.Amongthem,we
highlightthecontroloftemperature(T)andrelativehumidity(RH)(28).

TheCollegiateBoardResolution(ResoluodaDiretoriaColegiadaRDC)No.50regulatesthenecessityofair
conditioninginstorageanddistributionroomsholdingsterilematerialsandclothing(9),althoughpracticeshows
thatnotallCSSarecapableofmeetingtheseregulations,eitherduetotechnical,structuralorfinancialissues.

Therearealsosomerecommendationsmadebothbyassociationsandbyindependentauthorswhichaimto
standardizetheTandRHofthestorageenvironment.

SummaryofrecommendationsastotemperatureandhumidityinthestorageofmaterialssterilizedinaCSS
(Chart1)

ThesterilizationmanualofthePaulistaAssociationfortheStudyandControlofHospitalInfection(APECIH)
recommendsthatthestorageareahasarelativeairhumiditybetween35%70%andtemperaturebetween
18C22C.Therecommendationsjustifythebeliefthattheseconditionsareunfavorabletomicrobialgrowth
andfavorabletopackaging,despitethefactthatthereisanabsenceofscientificevidencetoconfirmthe
recontaminationofthesterilizeditemswhentheseconditionsarenotpresent.Intheserecommendationsthe
intervalproposedfortheRHdrawsourattention(2).

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TheBrazilianSocietyofOperatingRoomNurses,AnestheticRecoveryandCentralSterileSupply(Sociedade
BrasileiradeEnfermeirosdeCentroCirrgico,RecuperaoAnestsicaeCentraldeMateriaiseEsterilizao
SOBECC)recommendskeepingcontrolofTaround25CandRHbetween30%60%,notshowinga
justificationforeitherguideline(3).

TheAssociationofPerioperativeRegisteredNurses(AORN)recommendsTlessthanorequalto24CandRH
lessthanorequalto70%(4).Itdoesnotdetailthereasonsforthechoiceofthesevalues.

TheAmericanInstituteofArchitects(AIA)recommendedaRHofamaximumvalueof70%anddoesnotspecify
thedesiredT,norarejustificationsmentioned(5).

TheAssociationfortheAdvancementofMedicalInstrumentation(AAMI)recommendsthattheTshouldnot
exceedamaximumof24C,citingcomfortforemployees,inadditiontoaffirmingthatbacteriathriveathigher
temperatures,andsuggeststhatlowtemperaturescanreducebacterialgrowthingeneral,includingonthe
surfaceofpackages (13).ItfurtherrecommendsthattheRHshouldnotexceed70%,affirmingthathigh
humiditypromotesmicrobialgrowth.Noreferencesaremadetostudiesjustifyingtheseassertions(6).

RenownedAmericanauthors(7)suggestthatTmustbemaintainedbetween18Cand22CandRHbetween
35%and70%,withoutmentioninganytheoreticalbasistojustifytheserecommendations.

Anotherauthor (8)suggestsvaluesofTbetween18Cto22CandRHbetween35%50%,arguingthatthe
maintenanceofoptimalconditionsminimizesthepotentialforcontaminationofsterileproductsandjustifying
thattheRHestablishedpreventsprematuredamagetomaterialsandsealingofthepackages,althoughthe
authordoesnotlistthescientificstudiessubstantiatingtheseclaims.

Storageandsupplyroomsofsterilizedmaterialsareoftenadjacenttothesterilizationareawherethe
autoclavesarelocated,whicheliminatessteamattheendoftheprocess,constantlyelevatingboththeRHand
theToftheenvironment.

Basedontheabove,thequestionis:WouldallarticlesbesubjectedtotheriskofcontaminationwhentheT
andtheRHofthestorageareaareoutsidethestandardsspecified?

Iftheobjectiveofthepackagesistokeepthegoodssterilizeduntiltheyareused,includingstorageand
transport(10),wouldthequalifiedpackagesnotalsoservethepurposeofprotectingthesterilizedcontentsinthe
manyvariationsofTandrelativehumidityoftheenvironment?

Asanexample,forthequalificationofsurgicalgradepaperforthepurposeofobtainingregistrationwiththe
NationalHealthSurveillanceAgencyinBrazil(ANVISA),anacceleratedagingtestmustbeperformedat37C,
50Candatstandardtemperatureinsidearefrigerator(4C)inordertodeterminethatthepackagedoesnot
undergoanychangeinphysicalproperties,includingthemicrobialbarrier,evenafter6months'exposureat
thesetemperatures(11).

Giventhatinternalquestionsmustseekanswersbasedonscientificevidence(12),thisresearchhasasits
objectivetoidentifyandanalyzethetheoreticalfoundationsthatledtotheestablishmentofparametersforT
andRHoftheenvironmentofthestoragesectorofsterilizedmaterialsaspossiblesourcesofcontaminationof
storedmaterials.

METHOD
Weperformedanintegrativereviewofthescientificliteratureinordertoanswerthequestion:Whatarethe
theoreticalfoundationsthatguidethedefinitionofthevaluesofTandRHinthestorageareaofsterilized
materials?

WeusedthedatabasesMEDLINE,PUBMEDandLILACS,withthefollowingkeywordsoftheMedicalSubject
Headings(MESH):timefactors,surgicalinstruments,sterilization,productpackaging,temperatureand
humidity.Byanalyzingthetitleandabstract,weselectedthearticlesthatincludedrecommendationsfor
conditionsofTand/orrelativehumidityinthestorageofautoclavedhealthproducts.Thepublicationsthatmet
theinclusioncriteriawereincludedinfull.Weexcludedarticlesthatdidnotrefertostorageofsterilematerials,
articlesnotcharacterizedasprimarystudies,thatdidnotreportconditionsofTandRHinthestorageareaof
autoclavedmaterialsand/orthatdidnotrefertohealthproducts.

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Ascomplementarystrategiesweconsultedmanualsandguidesofassociationsresponsibleformaking
recommendationsforactionsdevelopedatCSS,aswellasexistinglaws,andmanuallyconsultedthecollections
oflibrariesattheUniversityofSoPauloSchoolofNursing(EEUSP),CentralLibraryoftheFederalUniversity
ofSoPaulo(UNIFESP)andthelocalcollectionoftheInfectionControlCommissionoftheSoPauloHospital,
connectedtoUNIFESP,aswellastheBrazilianSocietyofSurgicalCenterNurses,AnesthesiaRecovery,
SterilizationandMaterialStorageCenter(SOBECC).Wealsoconductedasearchinordertofindtheprimary
referencescitedbythearticlesselected.

Therewerenorestrictionsonthelanguagesoftheworksfound,andalthoughthebibliographicresearchdoes
notpresentanytimerestrictionsforthesearchofthepublications,theoldeststudyfounddatesbackto1971.

RESULTS
Contrarytoexpectations,nostudieswerefoundthatassessedonlytheinfluenceofTandRHinmaintainingthe
sterilityofitemsstoredinaMaterialandSterilizationCenter.Thearticlesfoundreportexperimentsperformed
withtheaimofassessingthevalidityperiodofthesterilityofmaterialsstoredindifferenttypesofpackaging.
Intheseexperiments,thecontrolinclusionofTandUToftheenvironmentwasjustifiedascontrollingexternal
orsecondaryvariablesandwereincludedinthestudybecausetheyallowedtheanalysisofinterferenceof
thesefactorsinmaintainingthesterilityofmaterials.

Wefound109articlesofthese,onlyfourmettheinclusioncriteria(Chart2)andthreearticleswereselected
throughthesearchintree.Therepeatedarticleswerediscarded.

Summaryofexperimentsthatincludedtheevaluationofthecontrolimpactoftemperatureandhumidity
onthemaintenanceofmaterialssterility

Acomparativeresearchperformedattwohospitalsinordertodeterminehowlongmaterialswouldremain
sterilewhenstoredunderdifferentclimateconditions,openorclosed(covered)shelves,anddifferenttypesof
packagesobservedcontaminationofthecontentsrelatedprimarilytothetypeofshelfused,butdidnotrelate
thecontaminationfoundwiththevariationsofTandRHbecausethesedidnotvarysignificantlyinthehotand
coldmonths.TheTaveraged25CandtheRHrangedbetween35%and48%,leadingtheauthorstoconclude
thatnoevidencewasfoundtocorrelatethecontaminationdirectlywithatmosphericchanges(14).

Thesameauthors(15)conductedanotherexperiment,inadditiontothepreviousstudy,tocomparethe
maintenanceofthesterilityofmaterialswhentheywerepreparedandstoredunderthemostadverse
conditionsofpackagingandshelvingobservedinthepreviousexperiment.ThevaluesofTweremaintained
between21.1Cand26.7CandRHbetween30%and55%.Theresultsalsoshowedcontaminationunrelatedto
theclimateconditionsofthematerialstorageenvironment.

Anotherstudy(16)performedwiththeaimofanalyzingthemaintenanceofsterilityofpackagesduringdifferent
periodsandstorageconditions,includingvariouspackages,typeofshelvesandcontrolledplacesversussites
withoutenvironmentalcontrolandhandling,showednostatisticalsignificanceregardingthecontaminations
found.

Anexperiment(17)wasconductedtocomparetheshelflifeofsterilizedmaterialswiththe"eventrelated"
control.Thisparadigmassumesthatthesterilizedandsuitablypackagedmaterialremainsinthisconditionuntil

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thepackageisdamaged,whichmayoccurduetohumidity,tears,dentsorbreakageoftheseal (18).The
sterilizedsamplesweredistributedintofiveareasofahospitalsomewithcontrolofTbymeansofair
conditioning,andotherswithout.Noneofthesamplesanalyzedshowedcontamination.

Chart3

Agroupofresearchersinterestedinconfirmingthepossibilityofalongsterilityvalidityperiodstoredsmall
instrumentspackedandsterilizedinanoperatingroomwithcontrolledhumidity,andevaluatedthem
microbiologicallyforaperiodofupto96weeks.Agroupofinstrumentswasstoredinthesameenvironment,
butwithoutpackaging,constitutingthepositivecontrolgroup.Noneofthesamplespackagedshowed
contamination,whiletheunpackagedgroupshowedcontaminationofallsamples,exceptforthefirsttwo
analyzed(19).

Inordertovalidatethesterilizationperiodoftwohospitals,onewithtemperaturecontrolinthestorageareaof
sterilizedmaterialsandtheotherwithout,sampleswerestoredattheCSSandanalyzedastomicrobiological
contaminationfordifferentstorageperiods.Thecontaminationfoundwasconsideredaccidentalandtheauthors
concludedbyrecommendingtheperformanceofstudiestoevaluatetheeffectofRHandTonstorageof
sterilizedmaterials,sinceintheexperimenttheyconductedtherewasnoacclimationofthesamplesinthe
areasofstorageofthematerial (20).

Ina1977report,boxesofsurgicalinstrumentsfoundstoredfor43yearsinthebasementofahospitalwithout
anyenvironmentalcontrolwerefoundtohavenoviablemicroorganisms(21).

DISCUSSION
TherearerecommendationsfromofficialorganizationsinthehealthcarefieldregardingparametersofTand
RHforthestorageenvironmentofsterilizedmaterialsatCSS.Therecommendedvaluesfortemperaturerange
from18Cto25C,whiletheRHrangefrom30%to70%(28).

Althoughtherecommendationsarefromofficialbodies,nonepresentedresearchprovingtheimpactof
environmentalfactors,TandRH,onthemaintenanceofsterilityofthestoredmaterialssomepresentedno
justificationatallfortherecommendationsmade.

Theexperimentalresearchpublicationsfoundthroughthisliteraturereviewwerecarriedoutprimarilyto
evaluatethestorageconditionsofmaterials,inordertoendorseorchangethevaliditydateofsterility,orto
evaluatethemicrobialbarrierpropertiesofthepackages,andnotwiththemainpurposeofevaluatingthe
impactofTandRHonthecontaminationofthestoredarticles.

Inviewofthismajorgapinknowledge,itwaspossibletorealizethefragilityofCBRNo.50requirements,as
wellastherecommendationsmentioned,sinceonecansaywithconfidencethattherearenodatathatcan
elucidatetheimportanceofcontrollingthesevariablesinthestorageroom.

TheanalysisofpoorinfluenceofTandRHshownbythearticlesfoundrevealedcontaminationinexperimental
situationsundercontrolledconditionswithintheparametersestablishedintheliterature,andabsenceof
contaminationwhentheseparameterswerenotcontrolled,minimizingtheimportanceofsuchcontrolsinthe
maintenanceofsterilityofmaterialsduringtheirstorage.

CONCLUSION
Inspiteofthemanymethodologiesemployedintheresearch,thecontradictionsfoundintheresultsraise
doubtsregardingtheimportanceofthesecontrols,whichreinforcesthethesisthattheTandRHofthe
environmenthaslittleornoimpactonthemaintenanceofsterilityofmaterialswhichhavebeenproperly
packaged.

Thegapintheliteraturepointedoutbythisreviewindicatestheneedforthedevelopmentofwelldesigned
experimentalresearchthatcandefinitivelydeterminetherelevanceor(nonrelevance)ofthecontrolofTand

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RHintheenvironmentwheresterilizedmaterialsarestored,fromthebeliefthatqualifiedpackagingprotectsits
contentsfromadverseenvironmentalconditions,includingthereinvariationsofTandRH.

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Correspondenceaddressedto:
CamilaQuartimdeMoraesBruna
Av.Rouxinol,161Apto.101Moema
CEP04516000SoPaulo,SP,Brazil

Received:05/03/2011
Approved:12/09/2012

Allthecontentsofthisjournal,exceptwhereotherwisenoted,islicensedundera CreativeCommons
AttributionLicense

Av.Dr.EnasdeCarvalhoAguiar,419
05403000SoPauloSP/Brasil
Tel./Fax:(5511)30617553

reeusp@usp.br

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