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Monday, August 31, 2015
Infection risks in ultrasound diagnostics minimize new technology offers … – Presseportal.de (press release)
Hamburg(ots)-ultrasoundprobesarecomplexmedicaldevices,whichareoften,transrectalattransvaginal,abdominalandintra-operativeinvestigationsareused.Sincetheprobescancomeintocontactincontactwithmucousmembranes,damagedskin,infectedtissueandblood,theyaresubjecttostricttreatmentguidelines.Bytrophon®EPRitisnowenablesanautomatedandvalidatedvirucidal(highlevel)disinfectionaccordingtoRKI/DVVperform2012Design.Sothetransferofpathogensisminimizedandpatientsafetycanbesignificantlyincreased.Furtheradvantagesoftheautomatedreprocessing,thetimesavingsandtheeliminationofpollutingchemicals.Asaresult,aconcernthathasexpressedthemajorityofsurveyedgynecologistsandurologistsinthecontextofamarketstudy.Theseobjectivescannowberealizedmorerecentlywiththenewdisinfectionsysteminpracticeandclinic-takingintoaccountcurrentlegalrequirementsandmedicalneeds.
ultrasoundsareusedverywidelyinclinicalpracticeandperceivedasadiagnosticmeasurewithoutcomplicationsandpotentialsideeffects.Forthisitisnecessarytocomplywithappropriatehygienicprecautions,becauseeverypatientistobeconsideredaspossiblecarriersofpathogens,fromtheriskofinfectionforotherpatientsaswellasforthemedicalpersonnelmayexist.
disinfectionmethoddecidesonpatientsafety
Forthisreason,ultrasonicprobesaccordingtotheCommissionforHospitalHygieneandInfectionPreventionRecommendations(KRINKO)attheRobertKochInstitute(RKI)andtheFederalInstituteforDrugsandMedicalDevices(BfArM)classifiedascriticalorsemi-criticalmedicaldevicesinClassA.Thismakesthemsubjecttostricttreatmentguidelines-aminimumrequirementforthisequipmentisavirucidal(highlevel)disinfectingaftereachpatientbeingexaminedinaccordancewithRKIandGermanAssociationfortheControlofVirusDiseases(DVV)of2012.
wipeandimmersiondisinfectionmountainsmedicalandlegalrisks
Traditionalmethodsinthetreatmentofultrasonicprobesaregenerallyconnectedtoamanualpreparationastheimmersionmethodortheuseofwipes.However,manualprocessesarepronetoinconsistencies.Thisappliestoanincreasedriskoftransmissionofpathogensbyapplicationerrors,suchas.Forexampleintheuseofdisinfectantswithlimitedormediumspectrum.Ontheotherpotentialdrawbacksinqualitymanagementcanariseasbothdisinfectionprocedurescannotoronlypartiallybevalidatedintermsofsafety,consistencyandreproducibilityoftheirresults.Ultimately,however,alsoappliestoultrasoundprobesthattheirtreatmentmustbecarriedoutwithsuitablevalidatedmethodstoevaluatethesafetyandhealthofpatients,usersandotherpersonsnottojeopardize(MPBetrVO§4(2)
trophon®EPR.:evidence-basednewstateaccordingtoScienceandTechnology
Asustainablesolutionforrapid,automatedandvalidateddisinfectionofultrasoundprobesoffersthetrophon®EPR.UsingaH2O2aerosolisinavalidated7mindisinfectioncycledirectlyinexaminationroombactericidaltheultrasoundprobe,fungicidalandvirucidal(highlevel)disinfected.Afterdisinfectioncycle,theprobeisimmediatelyonthepatientcanbeused.
Incontrasttoprevioustreatmentmethodsofultrasoundprobes,thetrophon®EPRprovidesthreekeyadvantagesoverpreviousmanualdisinfectionmethods:.
1Microbiologicalspectrumofactivity
trophon®EPRisprovenbactericidal,fungicidalandvirucidal(highlevel).Thehigh-levelvirucidalhasbeendemonstratednotonlyintheCarrierTestbyRKI/DVV2012butallrelevanttestviruseswerereducedpracticeduringthedisinfectioncycleintheTrophonchamberaccordingtotheGuideline.Thisisofparticularclinicalrelevance,asonlythecompletecoverageoftherequiredspectrumofactivityensurespatientsafetyintheuseofultrasoundprobes.
.2Legalcertaintybyvalidation
trophon®EPRisavalidatableprocess.Allcriticalprocessparameters(time,temperatureanddosage)areexaminedinthecontextofoperationalqualificationwithexternalmeasuringinstruments,toensurethattheinstalleddeviceconformstostrictmanufacturerspecifications.Qualityassuranceiscarriedoutbyhighlydevelopedprimaryandverifyingsensorsinsidethedeviceandchemicalindicators.Thus,thedisinfectionperformanceisensuredforeachcycleandthefullyautomaticpreparationprocessisconsideredtobevalidated.Theoperatorofthevalidationreportforitsdocumentationismadeavailablesothatlegalsecurityexists.Anautomaticprocessdocumentationcanbedonepercyclebymeansofexpression.
.3Environmentallyfriendly,safetechnology
Thankstotheself-containedsystemofexposuretotoxicorhazardouschemicalsisexcluded.Afterthedisinfectioncycle,thehydrogenperoxideisreducedbyacatalyticdecompositionsystemsafetooxygenandwater,anddischargedtotheoutside.Sincetheunitisnotonlytheprobebuttheentireprobe,includingthehandledisinfected,proventoreducetheriskofcrosscontamination.Thesystemsupportsnearlyallmodelsofultrasoundprobes,asthesehaveundergoneincooperationwiththemanufacturersduringthedevelopmentphaseextensivecompatibilitytesting.
Thefactthattheseissueshaveahighpriorityamongphysicians,wasevidencedbythesurveyofgynecologistsandurologistsinthecontextofaprocessperformedbytheGelszusCorporateconsultancystudy.Around80%ofphysiciansseeariskinthetransmissionofgerms,formorethanhalfofthehedgeagainstlawsuitsbypatientsisanimportantcriterionfortheuseoftrophon®EPR.About65%ofusersofdippingmethodfordisinfectingcalltoshortentheprocessingtimeandtherenunciationofchemicalsthanotherbenefitswithaviewtooptimizingtheworkorganization.
orientationonmedicalneed:patient,legalandsafetyatwork
trophon®EPRistheonlysoftware-controlled,automatic,validated,approvedbyallleadingmanufacturersdisinfectionsystemforultrasonicprobes,theinGermanyisavailableandprovenvirucidal(highlevel)disinfectionof(semi-)criticalultrasoundprobesallowsadisinfectioncycleofsevenminutesandisthereforesuitableforuseindailyroutineuseofhospitalsandmedicalpractices.Thenewmedicaldevicemeetsalltherequirementsforhigh-leveldisinfection(HLD),whichareprescribedbylawbasedonthemedicaldeviceclassificationaccordingtoKRINKO/BfArMrecommendation,inGermany.
SeveralyearsofpracticalexperiencearealreadyfromvariousclinicsoftheUSA-includingtheMayoClinicandJohnsHopkinsHospital-before.Untilthelaunchoftrophon®EPRultrasoundprobeswereintheUnitedStatesprocessedexclusivelybymeansofimmersiondisinfection,becausetheFDArequiresaHLD.
DevelopedwasthenewdisinfectionsystemofNanosonicsLtd.basedinSydney.ThemedicaltechnologycompanyhasISO13485certificationandproducesatitsAustraliansitefortheworldmarket.InGermanyandAustriathetrophon®EPRissoldthroughMieleProfessional.
Formoreinformationabouttrophon®EPRunderwww.miele-professional.de/trophon
AboutNanosonics:
NanosonicsLtd.islistedontheAustralianStockExchange(ASX:NAN)quotedcompanywithheadquartersinSydney,Australia.Toreducewiththeaimofinfectionsandtheirtransmission,Nanosonicsdevelopedbasedonaworldwideuniquetechnologyapplicationsfordisinfectionandsterilizationofreusablemedicalinstruments.ThefirstproductofNanosonicsisautomated,validatedUltrasoundTransducerDisinfection.FormoreinformationaboutNanosonicspleasevisitwww.nanosonics.com.au
Contact:
NinaPassoth
Kastanienallee1414050Berlin
Tel.:+49(0)30-3052373
Fax:+49(0)30-3042216E
-mail:passoth@gmx.net
NanosonicsEuropeGmbH
RalfSchmähling
PoppenbüttelerBogen6622399Hamburg
Tel.:+49(0)40-46856885
Fax:+49(0)40-46856179
Email:info@nanosonics.eu
www.nanosonics.com.au
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