Suction临床评估报告范例

CLINICALEVALUATIONREPORTPortableSuctionUnit】sModelTypes:SU-660SU-770SU-990SU-991CONTENTSGeneralDetailsDescriptionofthedeviceanditsintendedapplicationIntendedTherapeuticand/orDiagnosticIndicationsandclaimsContextofevaluationandchoiceofclinicaldatatypesSummaryoftheClinicalDataandAppraisalDataAnalysisConclusionsGeneralDetailsProductName:PortableSuctionUnitsManufacturer:GemmyIndustrialCorp.Office:7F.No.106,MinChuanW.Road,Taipei,TaiwanPlant:6F.No.532、534,ChongChengN.Rd.,SanChongCity,TaipeiCounty,TaiwanTel:886-2-25531456Fax:886-2-25538389,25573218E-mail:gemmy888@.tw;gemmy888@Nameofproduct:PortableSuctionunitsMode/Type：SU-660,SU-770,SU-990,SU-991Product’sbriefing:ThisequipmentisClassIIPortablesuctionpumpswithhandlesandvacuumregulator.Themainscordusedisdetachable.Thedifferenceamong4modelsaretheenclosure.Thenon-conductivesiliconsuctionpipeistheappliedpart,whichdoesnottouchthehumanbody.ModelsSU-990andSU-991arewithadditionaljackforbatterypowersource.SU-990iswithadditionalrechargeable11.1Vdclithium-ionbatteryandcontrolcircuit.Nospecialprotectionagainsttheuseintheenvironmentofignitablegases.DescriptionofthedeviceanditsintendedapplicationTheSuctionunitmainuseistousethesuctioneffectattractssicknessmouthinothersecretionorsecretions,mayuseinotherattractstheactivity.ThisequipmentisClassIIPortablesuctionpumpswithhandlesandvacuumregulator.Themainscordusedisdetachable.Thedifferenceamong4modelsaretheenclosure.Thenon-conductivesiliconsuctionpipeistheappliedpart,whichdoesnottouchthehumanbody.ModelsSU-990andSU-991arewithadditionaljackforbatterypowersource.SU-990iswithadditionalrechargeable11.1Vdclithium-ionbatteryandcontrolcircuit.Nospecialprotectionagainsttheuseintheenvironmentofignitablegases.Electricalportablenasalsuctionunits(andjars)supplyacontrollablevacuumsourceformedicalsuction/drainageofnasalfluids.Typicallytheywillbeusedwherenopipedsuctionisavailableandrelyonbatteryfortheiroperation(alsocanbeused/chargedviathemains),andassucharesuitableforfieldortransportuse.EtcToprovideanefficientperformanceofvacuumaspirationformostproceduresofsuctionEnvironmentsuchashomecare,sputumsuction,fluidsuctionetc.ThepowercordwithcigarettelighterplugforSU-990andSU-991isavailableforuseinambulance,helicopter,clinicsandhomecareenvironmentoranyplacewhere12VDCisavailable.ChargebatteryofSU-990byturningpowerswitch“CHARGE”positioncapableofsustainingadequateoperationfor1.5hoursmaxfromthefullloadofbatteryidealforuseinanyplaceincaseofpowerfailureforemergencypurpose.Refertooperationmethodestablishedbythemedicaltechnologyorqualifiedandmedicalpersonnel.IntendedTherapeuticand/orDiagnosticIndicationsandclaimsOnlyprovideuserauxiliary,notherapeuticefficacy.SuctionUnits,thepowersuctionpumpwithasuctioncupandsuctiontubebysuffering'sAirwayorrespiratorysupportsysteminremovinginfectedmaterial.Thissuctionmachineismainlytoassisthospitalmembersorcare,alternate.Patientsdoaccepttracheotomysuctioningaction.Accordingtoitsintendeduse,theSuctionUnitsisnotanin-vivodevice,nordoesitpossessadiagnosticortherapeuticfunction.Therearenomeasurableclinicaloutcomesinwhichthedeviceisindicatedtodeliverorachieve.Stage1*Identifyclinicaldatafrom?Literaturesearching&/or?Clinicalexperience&/or?ClinicalinvestigationProduceclinicalevaluationreporte3Stage1*Identifyclinicaldatafrom?Literaturesearching&/or?Clinicalexperience&/or?ClinicalinvestigationProduceclinicalevaluationreporte3ContextofevaluationandchoiceofclinicaldatatypesContextofevaluationThesuctionunitshavebeenwidelyusedforyearsandhavebeenconfirmeditsperformanceandsafetyinclinicalsettings.Thetypeofourproductshasmaturedinthemarket.Itisuseistousethesuctioneffectattractssicknessmouthinothersecretionorsecretions,mayuseinotherattractstheactivity,andithasnotherapeuticefficacy.choiceofclinicaldatatypesStage2Appraisalofindividualdatasets?Suitability?ContributionofresultstodemonstrationofperformanceandsafetyAnalysisofrelevantdata?Suitability?Strengthofoverallevidence?ConclusionsaboutperformanceandsafetyLiteraturesearchesshouldbecarriedoutaccordingtothefollowingprotocolScopeoftheliteraturesearch:Safety,performance,adverseeventmessageofsuctionunitsMethods:Dateofsearch:2015.10Nameofperson(s)undertakingtheliteraturesearch:CHIENWEL-LPeriodcoveredbysearch:Thepast20yearsofsafety,performance,adverseeventsonsuctionequipmentLiteraturesourcesusedtoidentifydata:FDASFDAWANFANGDATAAdverseeventreportdatabases(e.g.MAUDE)EMCandLVDtestreportofSuctionunitsDatabasesearchdetails:searchterms(keywords,indexingheadings：)medicalsuctionequipmentmediumused：ComputernetworkSelectioncriteriausedtochoosearticles:Preliminaryscreeningbasedonthecontentsoftheliteratureandclinicalevaluationofthescopeofrelevance.OutputsAttachcopyofliteraturecitationsretrievedfromeachdatabasesearchDataselectionprocessAttachflowchartandassociatedtablesshowinghowallcitationswereassessedforsuitabilityforinclusionintheclinicalevaluationSummaryoftheClinicalDataandAppraisalApplicabilityEvaluationSuctionunitsbasedontheevaluationofcontentanddocumentretrievalagreementsbySchemeandFormoftheretrievedfilepreliminaryapplicabilityidentified.DocumentretrievalDocumentretrievaloutputassociatedwiththeevaluationofthecontentisasfollows:ZHANGZhi-xue,ZHANGHai-ying,JIAOMan-zhe.DevelopmentandApplicationofMedicalSuctionEquipmentVerificationDevice.ValueEngineering.2014,(5):R472JIANGZhou.IntroductiontoMedicalNegativePressureSuctionDetection.ValueEngineering.2014,(29):TH789TANGLiming,LIUTiebing,CHENChen,ZHUXingxi,TongQingying.Designofportableemergencysuctionapparatus.MEDICALJOURNALOFTHECHINESEPEOPLE'SARMEDPOLICEFORCES.2009,20(2):TH77Developmentofaportablesuctionunitforfirst-aiduse.CHINESEMEDICALEQUIPMENTJOURNAL.2002,23(1):TH772+.2AppIicationofImprovedCIosedEndotracheaISuctiononPatientsWithSeverePneumonia.ChineseGeneralPractice.2015,(11):R563.1NiShengyue,DongYa,XuYinquan,ZhangHao,LinZhenlangL,iangZhiqiang.TheAssessmentofapplyingclosedendotrachealsuctionsystemonpostoperativecardiacpatients.ChineseJournalofThoracicandCardiovascularSurgery.2014,30(12)HONGDie-wen.Theprogressofthecomplicationsandpreventionofsputumsuction.INTERNATIONALJOURNALOFNURSING.2009,28(10):R472MedicalcentrifugalsuctionImprovement.PRACTICALCLINICALMEDICINE.2001,15(3):R197.39TANGJinglong,WANGYue,XUHong,LIJingli.APreliminaryStudyontheClassiifcationRegularPatternofNon-PoweredSuctionApparatusDeviceIntendedforNegativePressureWoundTherapy.ChineseJournalofMedicallnstrumentation.2015,(4):R197.39R955TH771ZHUShu-sen,RENGuo-rong.MaintenanceandTroubleshootingoftheModelYB.DX23DElectricSuctionApparatus.ChinaMedicalDevices.2015,(4):R197.39Improvementandapplicationofelectricsuctiondevice.MODERNMEDICINE&HEALTH.2007,23(6):R4WANGYu,TANGLi-ming,TONGQing-ying,LIUTie-bing,QIShi-tao,ZHUXing-xi.Fundamentals,TypesandTechnologyDevelopmentofMedicalAttractor.CHINAMEDICALDEVICES.2011,26(4):R197.39TH789TANGLi-ming,LIUTie-bing,HUXin-yong,TONGQing-ying,WUGuang-ming,MAOJian-qiang.DesignofHandholdEmergencySuctionApparatus.CHINESEMEDICALEQUIPMENTJOURNAL.2009,30(1):TR826.1H778ThetestreportofSuctionunitsUNST/SG/AC.10/11Rev.5/Amend.1ManualofCriteria,PartIII,sub-section38.3IEC62133FirstEditionIEC/EN60601-1Medicalelectricalequipment(Part1:Generalrequirementsforbasicsafetyandessentialperformance)IEC60601-1-2:2014Emission:CISPR11:2009+A1:2010,ClassB,IEC61000-3-2:2014&IEC61000-3-3:2013Immunity:IEC61000-4-2:2008,IEC61000-4-3:2010,IEC61000-4-4:2012,IEC61000-4-5:2005,IEC61000-4-6:2013,IEC61000-4-8:2009,IEC61000-4-11:2004ENISO10079-1:2009,ISO10079-1:1999EMCandLVDtestreportPotentiallyrelevantliteratureidentifiedthroughthesearch(copyofallcitations)Literatureexcluded,withreasonsthroughLiteratureretrievedformoredetailedassessmentLiteratureexcludedfromclinicalevaluation,withreasonsLiteraturewithrelevantuseabledataincludedintheclinicalevaluation,byoutcome:DeviceperformancesomeliteraturewilladdressissueofbothperformanceandsafetyDevicesafety*Devicecomparability(ifapplicable)

someliteraturewilladdressissueofbothperformanceandsafetyTableD1SampleAppraisalCriteriaforSuitabilitySutabilityCriteriaDescriptionGradingSystemAppropriatedeviceWerethedatageneratedfromthedeviceinquestion?D1ActualdeviceAppropriatedeviceapplicationWasthedeviceusedforthesameintendeduse(e.g.,methodsofdeployment,application,etc.)?A1SameuseAppropriatepatientgroupWherethedatageneratedfromapatientgroupthatisrepresentativeoftheintendedtreatmentpopulatione.g.,age,sex,etc.)andclinicalcondition(i.e.,disease,includingstateandseverity)?P1ApplicableAcceptablereport/datacollationDothereportsorcollationsofdatacontainsufficientinformationtobeabletoundertakearationalandobjectiveassessment?R1HighqualitySampleAppraisalCriteriaforDataContributionTableD2SampleAppraisalCriteriaforDataContributionDataContributionCriteriaDescriptionGradingSystemDatasourcetypeWasthedesignofthestudyappropriate?T1YesOutcomemeasuresDotheoutcomemeasuresreportedreflecttheintendedperformanceofthedevice?O1YesFollowupIsthedurationoffollow-uplongenoughtoassesswhetherdurationoftreatmenteffectsandidentifycomplications?F1YesStatisticalsignificanceHasastatisticalanalysisofthedatabeenprovidedandisitappropriate?S1YesClinicalsignificanceWasthemagnitudeofthetreatmenteffectobservedclinicallysignificant?C1Yes

DataanalysisDataContribution數據貢獻EvaluationContentLiteratureDataDescriptionGradingSystemMedicalelectricalequipmentEvaluationLVDTestReportSuctionUnitsLVDTestReportWerethedatageneratedfromthedeviceinquestion?D1ActualdeviceElectromagneticCompatibilityEvaluationEMCTestReportSuctionUnitsEMCTestReportWerethedatageneratedfromthedeviceinquestion?D1ActualdeviceresidualriskevaluationRiskManagementReportSuctionUnitsRiskManagementReportWerethedatageneratedfromthedeviceinquestion?D1ActualdeviceAppraisalofSuitabilityandClinicalEvaluationDevelopmentandApplicationofMedicalSuctionEquipmentVerificationDevice.WANFANGDATAWasthedeviceusedforthesameintendeduse?A1SameuseIntroductiontoMedicalNegativePressureSuctionDetection.WANFANGDATAWasthedeviceusedforthesameintendeduse?A1SameuseDesignofportableemergencysuctionapparatus.WANFANGDATAWasthedeviceusedforthesameintendeduse?A1SameuseDevelopmentofaportablesuctionunitforfirst-aiduse.WANFANGDATAWasthedeviceusedforthesameintendeduse?A1SameuseAppIicationofImprovedCIosedEndotracheaISuctiononPatientsWithSeverePneumonia.WANFANGDATAWasthedeviceusedforthesameintendeduse?A1SameuseTheAssessmentofapplyingclosedendotrachealsuctionsystemonpostoperativecardiacpatients.WANFANGDATAWasthedeviceusedforthesameintendeduse?A1SameuseTheprogressofthecomplicationsandpreventionofsputumsuction.WANFANGDATAWasthedeviceusedforthesameintendeduse?A1SameuseMedicalcentrifugalsuctionImprovement.WANFANGDATAWasthedeviceusedforthesameintendeduse?A1SameuseAPreliminaryStudyontheClassiifcationRegularPatternofNon-PoweredSuctionApparatusDeviceIntendedforNegativePressureWoundTherapy.WANFANGDATAWasthedeviceusedforthesameintendeduse?A1SameuseMaintenanceandTroubleshootingoftheModelYB.DX23DElectricSuctionApparatus.WANFANGDATAWasthedeviceusedforthesameintendeduse?A1SameuseImprovementandapplicationofelectricsuctiondevice.WANFANGDATAWasthedeviceusedforthesameintendeduse?A1SameuseFundamentals,TypesandTechnologyDevelopmentofMedicalAttractor.WANFANGDATAWasthedeviceusedforthesameintendeduse?A1SameuseDesignofHandholdEmergencySuctionApparatus.WANFANGDATAWasthedeviceusedforthesameintendeduse?A1SameusePerformanceBasedontheaboveanalysisofclinicaldata,retrieveinformationrespectivelyGEMMYproductapplicationandperformanceevaluationofclinicalaspectswerecomparedobtainedGEMMYSuctionunitscompliance.DocumentretrievalapplicabilityofArticle6EvaluationandClinicalEvaluationsection,significantlyandconsistentlydemonstratetheperformanceoftheidentificationGEMMYSuctionunitscanprovemostcompleteperformanceequipment,thehospital'sclinicalapplications,scientificresearchandapplicationofanalysisofthesedataarefrom,sotheconsistencyliteraturehasstatisticallysignificantclinicalimportanceandresults.PerformanceevaluationForthepurposeofensuringclinicaleffectsandthelimitationsofuse,suctioningperformancetestswereconductedwithotherproductshavingthesameuseconditions,operatingprinciple,specificationsandpropertiesasoursinordertovalidateequivalentperformancefulfillmentwhenappliedtoclinicaluse.Asaresultoftest,GEMMYSuctionUnitsshowed650mmHg,anDdoctor’sFriendSuctionUnitswithSTURDYSuctionUnitsshowed600mmHg.Therefore,itisconsideredthatthemaximumvacuumofourcompanyandothercompaniesaresimilar.Asaresultoftest,GEMMYSuctionUnitsshowed25LPM,anDdoctor’sFriendSuctionUnitswithSTURDYSuctionUnitsshowed22-24LPM.Therefore,itisconsideredthatthesuctionflowofourcompanyandothercompaniesaresimilar.SafetyEvaluationPass60601-1safety,nocompliantfrom2012-2016,riskmanagementrevieweachyear.BiologicalAnalysisvacuumGemmySuctionUnitsdoesnotprovidesuctioncups,cannulaesets,bacteriafiltersincontactwithpatients.SafetyTheGEMMYSuctionunitswassoldtoWorldwidefrom1999inthehospital,theclinicalnurseanddoctorgetthefeedbackfromthepatienttobepositive,thereisnoadvisorynotice,recalltobeactiveafterthepostmarketing.TheproductwassoldtoSaudiArabiafrom2000tobe200000pcsinthehospital,theclinicalnurseanddoctorgetthefeedbackfromthepatienttobepositive,thereisnoadvisorynotice,recalltobeactiveafterthepostmarketing.GEMMYSuctionunithasbeenintroducedintothemarketformorethan20yearsanddistributedinandtoareasmainlyofAsianandArab.Almost500thousandSuctionunitshadbeensoldandnocustomercomplaintregardingfunctionsorsafetyhasbeenreportedtoGEMMY.ProductLiteratureandInstructionsforUseWitht