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AAMI CI86 Cochlear Implant Systems – Requirements for Safety, Functional Verification, Labeling, and Reliability
Reporting
AAMICI-86StandardsCommi3ee
TerryZwolan,Ph.D.UniversityofMichiganCochlearImplantProgram
JulieVerhoff,Ph.D.,AuD
JoeDimaggioChildren’sHospital
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Disclosures
• CochlearAmericasAdvisoryBoardMember• InsMtuteforCochlearimplantTraining
• CourseDirector,Instructor
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AAMI CI-86 Mo3va3on for developing a US standard for CIs: Establish uniform guidelines for reliability repor3ng
• Manufacturer’sdevice-reliabilityreports• EuropeanconsensusstatementoninternaldevicefailuresandexplantaMon(noauthorslisted,2005)
• InternaMonalclassificaMonofreliabilityforimplantedcochlearimplantreceiversMmulators(Ba3meretal.,2010)
• CISoWFailuresConsensusDevelopmentConferenceStatement(Balkanyetal.,2005)
• ISO5841-2:2000:ReporMngclinicalperformanceofcardiacpacemakers
• Limita'ons:SubjecMvitywaspermi3edininclusionofdata.Forexample,notallexplanteddeviceswerereported,suchasthoseremovedformedicalreasons
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Exis3ng Standards
• BSEN45502-2-3:2010AcMveimplantablemedicaldevices.ParMcularrequirementsforcochlearandauditorybrainstemimplantsystems
• ISO14708-7:2013Implantsforsurgery--AcMveimplantablemedicaldevices--Part7:ParMcularrequirementsforcochlearimplantsystems
• ExisMngstandardshavelimitaMons(i.e.theydonotcoverreliabilityreporMng)
• ThesestandardsservedasausefulreferenceforAAMICI-86
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AAMI CI86: Development Timeline
• 2010:TheFDAsubmi3edanewworkitemproposaltoAAMIfordevelopmentofthisstandard
• Associa'onfortheAdvancementofMedicalInstrumenta'on(AAMI):AhealthcaretechnologynonprofitandstandardsdevelopingorganizaMon
• Between2010and2017
• CICommi3eewasformedandmet15Mmes• DocumentwasdraWedandrevised
• 4Commi3eeDraW(CD)documentsissuedforballotandsomeweresubmi3edforpubliccomment
• 2014,2015,2015,2016
• ANSI/AAMICI86:2017(Ed.1)publishedJuly6,2017
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So what does a “standard” mean?
• Standard:Setofguidelinesthatamanufacturercanvoluntarilycomplyto
• ANSIEssenMalRequirementsforstandarddevelopmentstate“Thestandardsdevelopmentprocessshouldhaveabalanceofinterests.ParMcipantsfromdiverseinterestcategoriesshallbesoughtwiththeobjecMveofachievingbalance.”
• ForAAMI/CI-86thoseinterestcategoriesincluded• Regulatoryandgeneralinterest/organizaMons• CImanufacturers• Clinicians
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AAMI CI CommiJee Member Affilia3ons • Fourcochlearimplantmanufacturers
• AdvancedBionics• Cochlear• MED-EL• O'con/Neurelec
• FDA• Clinicians/Academiciansfromavarietyofsegngs
• AmericanNeurotologySociety• ChaNeringChildren• GallaudetU.• SwedishMedicalCenter• U.California-Irvine• U.IowaHospitalandClinics• U.Maryland• U.Michigan• ArizonaEarCenter
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AAMI CI CommiJee Members • CedricNavarro(Co-chair)• JulieVerhoff(Co-chair)• VasantDasika• WilliamRegnault• SrinivasNandkumar• CharlesFinley• EdwardOverstreet• BruceGantz• AnilLalwani• MichaelPecht• MarkSyms
• Fan-GangZeng• Mar'nZimmerling• TeresaZwolan• SeanBundy• DouglasBackous• EricKhosravi• ManfredPieber• KevinCrowe• BhanuSood• BomjunKwon• LilianeTessa
AAMIStandardsDirectors:JenniferMoyer&ColleenEllioN
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How AAMI CI-86 will impact clinicians
• AAMICI-86willprovidecliniciansandrecipientswithimprovedinformaMonregardingdevicereliability
• ImpactstheinformaMondevicemanufacturersprovidetotheFDAaboutdevices
• ImpactstheinformaMonweandourpaMentsreceiveaboutcochlearimplantproducts
• SuchinformaMonwillenablecliniciansandpaMentstomakebe3er,moreinformeddecisionsaboutcochlearimplants
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Not having a standard has impacted pa3ent care • Reliabilityisimportant
• ReliabilityreportsforcontemporaryinternaldevicesvaryamongCImanufacturers.CliniciansandpaMentsareconfused.
• Reliabilityofexternalcomponentsisimportanttoo,yetmanufacturersrarelyreportonthereliabilityofexternally-worncomponents
TheStandard:
• Twolevelsofrequired,periodicreporMngthatincludesdetailed,proprietaryreportsforregulatoryauthoriMesandsimplifiedreportsforthepublicandclinicalcommunity.
• Eachmanufacturerwillreporttheirpublicdataontheircompanywebsiteusingaformatandexplanatorylanguagethatiscommonacrossallmanufacturers,aidingpaMentsandcliniciansininterpreMngreliabilitydata.
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CUMULATIVEREMOVALPERCENTAGE(CRP)• ManufacturerswillprovideinformaMonaboutthepercentageofimplanteddevicesworldwidethathavebeenremovedfollowingimplantaMon.ThisnumberisthecumulaMveremovalpercentage(CRP).
• TherearedetailedproceduresregardingdeviceanalysisandreporMngoffindings
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EXPLANTEDDEVICECATEGORIES• In the reporting, explanted devices will be broken down into 4 categories:
1) Medical reason for explant
2) Non-medical reason for explant
3) Inconclusive/no fault found (NFF): Failure analysis unable to identify the underlying cause
4) Combined – the percentage of all medical, non-medical, and inconclusive (CRP)
• Devices are required to undergo a complete full destructive analysis before they are eligible for the inconclusive category
• Data will be stratified by patient population and reported both separately and combined for patients greater than or less than 10 years of age.
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Device Category Repor3ng
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ManufacturerswilladdiMonallyreportFailedComponentReturnRate(FCCR),whichdescribessoundprocessorreliability.FCCR=thepercentageofthetotalnumberoffailedprocessorsreceivedwithinthelastmonthcomparedtothetotalnumberofthesameprocessorsoldintheUSbytheendofthatmonth.
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The Standard Includes Tools for Clinicians and the public SeveralinformaMveannexeshavebeenincludedintheAAMICI86standardthatprovideclinicianswithtoolstounderstanddeviceanalysis,reporMng,andaidpaMentsininterpreMngreliabilitydata:
AnnexA:ClinicalidenMficaMon&managementofdevicefailures
• ProvidessuggesMonsforpre-,peri-,andpost-operaMveconsideraMonswhendiscussingand/orevaluaMngdevicefailures
AnnexB:Clinicalchecklist
• ForcompleMonbyclinicianstoensureconsideraMonofstepsthatshouldbetakentoevaluatedevicefuncMonandalsotonotesignsandsymptomsthatmayberelatedtomalfuncMonofacochlearimplant.ThisinformaMonistobesharedwiththedevicemanufacturerpriortodeviceexplantandanexplantkitmustbeobtainedfromthemanufacturerpriortoexplantaMon.
AnnexC:Returnedimplantanalysisreporttemplate
• Providesanexampleofhowdevicemanufacturerswillreporttheresultsofthefulldeviceanalysis
AnnexD:IndicaMonsofperformancedecline
• Providesalistofsymptomsclinicianscanwatchforthatmayindicateadevicefailure
AnnexH:ReliabilityreporMngtemplateforthepublicandclinicalcommunity(previouslydescribed)
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Other important regulatory features
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Requirements for Device Labeling • InformaMononuse,warnings,andhazards
• Specifica'onsheets:acommonsetofinformaMontodescribe• Implant• Electrode• Sound-processingstrategy(ies)• Soundprocessor(s)• Remote-control
• Devicereliabilityreports:uniformlygenerated• Useprescribedfailure-analysisstepstocategorizeexplants• ReportcumulaMveexplantrates;straMfybyexplantcategory&pt.age• Makepubliclyavailableonmfgr’swebsite,update2x/year• ManufacturerswillprovidedocumentaMontoclinicstoassisttroubleshooMng,explantaMon&returnofdevices
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Describes How A Manufacturer Shall Characterize a CI Device System in a Regulatory Submission
• GeneraldescripMonofdevice,intendeduses,andmodeldesignaMons• Inventoryofsystemcomponents• InterconnecMonbetweenimplantableandnon-implantableparts• Wirelesstechnology• Systemhardware• SystemsoWware(includingsoundprocessingstrategies)• ElectrodespecificaMonandcharacterisMcs• FeaturesofclinicalfigngsoWware• ElectricalSMmulaMon
• Methodology/circuitry• Waveforms• ProvisionsforsafesMmulaMon
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A Device Shall Meet Design & Verifica3on Requirements • Electrical
• SMmulaMon• Ba3ery
• Thermal• Mechanical
• SafetyofelectrodearrayinserMon• Manufacturing
• HermeMcity• Moisturelevels
• BiocompaMbility• Sterility,packaging,andshipment• Safeuseinvariousintendedenvironments(e.g.,MRI)
• Testsamplesizesmayberisk-based
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Manufacturer reliability repor3ng to regulatory bodies (Annex E)
• Containsexamplesofhowreliabilitydataaretobereportedtoregulatorybodies
• Suchreportsdifferfromthosereportedtothepublic(contain3and12monthanalysisintervals)willbeproprietarytothemanufacturerandnotavailabletothepublic
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Conclusion
• ANSI/AAMICI86hasbeenpublishedandisavailableintheAAMIstore:h3p://my.aami.org/store/SearchResults.aspx?searchterm=CI86&searchopMon=ALL
• ThisisanimportantnewCIstandardthatrepresentsthecollaboraMveeffortofclinicians,devicemanufacturers,andregulatorypersonneltoimprovereporMngofdevicereliability
• Thestandardhasseveralbenefits,includingprovisionofinformaMontocliniciansandrecipients:
• Thatwillhelpdetermineifadeviceexplantiswarranted
• Thatwilleducatecliniciansregardingtherootcauseofinternaldevicefailures,includingmedical,device-related,andunknownforbothchildrenandadults
• Thatwilleducatecliniciansregardingtherootcauseofsoundprocessorfailures,includingmechanical,electrical,moisture,orunknown
• ProvidesuniformityinreporMngreliabilityinformaMonbymanufacturers,makingiteasierforexisMngandprospecMvepaMents,parents,clinicians,andresearcherstointerpretandcomparereliabilityinformaMonacrossdevices.