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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
Disclosures
• CochlearAmericasAdvisoryBoardMember• InsMtuteforCochlearimplantTraining
• CourseDirector,Instructor
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
So what does a “standard” mean?
• Standard:Setofguidelinesthatamanufacturercanvoluntarilycomplyto
• ANSIEssenMalRequirementsforstandarddevelopmentstate“Thestandardsdevelopmentprocessshouldhaveabalanceofinterests.ParMcipantsfromdiverseinterestcategoriesshallbesoughtwiththeobjecMveofachievingbalance.”
• ForAAMI/CI-86thoseinterestcategoriesincluded• Regulatoryandgeneralinterest/organizaMons• CImanufacturers• Clinicians
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
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
How AAMI CI-86 will impact clinicians
• AAMICI-86willprovidecliniciansandrecipientswithimprovedinformaMonregardingdevicereliability
• ImpactstheinformaMondevicemanufacturersprovidetotheFDAaboutdevices
• ImpactstheinformaMonweandourpaMentsreceiveaboutcochlearimplantproducts
• SuchinformaMonwillenablecliniciansandpaMentstomakebe3er,moreinformeddecisionsaboutcochlearimplants
Not having a standard has impacted pa3ent care • Reliabilityisimportant
• ReliabilityreportsforcontemporaryinternaldevicesvaryamongCImanufacturers.CliniciansandpaMentsareconfused.
• Reliabilityofexternalcomponentsisimportanttoo,yetmanufacturersrarelyreportonthereliabilityofexternally-worncomponents
TheStandard:
• Twolevelsofrequired,periodicreporMngthatincludesdetailed,proprietaryreportsforregulatoryauthoriMesandsimplifiedreportsforthepublicandclinicalcommunity.
• Eachmanufacturerwillreporttheirpublicdataontheircompanywebsiteusingaformatandexplanatorylanguagethatiscommonacrossallmanufacturers,aidingpaMentsandcliniciansininterpreMngreliabilitydata.
CUMULATIVEREMOVALPERCENTAGE(CRP)• ManufacturerswillprovideinformaMonaboutthepercentageofimplanteddevicesworldwidethathavebeenremovedfollowingimplantaMon.ThisnumberisthecumulaMveremovalpercentage(CRP).
• TherearedetailedproceduresregardingdeviceanalysisandreporMngoffindings
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.
Device Category Repor3ng
SAMPLE
SAMPLE
SAMPLE
SAMPLE
ManufacturerswilladdiMonallyreportFailedComponentReturnRate(FCCR),whichdescribessoundprocessorreliability.FCCR=thepercentageofthetotalnumberoffailedprocessorsreceivedwithinthelastmonthcomparedtothetotalnumberofthesameprocessorsoldintheUSbytheendofthatmonth.
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)
Other important regulatory features
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
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
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
Manufacturer reliability repor3ng to regulatory bodies (Annex E)
• Containsexamplesofhowreliabilitydataaretobereportedtoregulatorybodies
• Suchreportsdifferfromthosereportedtothepublic(contain3and12monthanalysisintervals)willbeproprietarytothemanufacturerandnotavailabletothepublic
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.