AAMI CI86 Cochlear Implant Systems – Requirements for ... · AAMI CI86 Cochlear Implant Systems...

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.