Transcription
1SggATDEPARTMENTOF HEALTHAND HUMANSERVICESFOOD AND DRUG ADMINISTRATION CENTERFOR DEVICESAND RADIOLOGICALOPHTHALMICDEVICESPANEL96TH MEETING.–-.3Thursday,September2 , 19998:30 a.m.—Silver Spring Holiday InnSilver Spring, MarylandMILLERREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666HEALTH
2SggPARTICIPANTS‘ames P. McCulley, M. D., Chairmanlara M. Thornton, Executive Secretary[ark A. Bullimore, MCOptom,We J. Higginbotham,M.D.reel Sugar, M.D.rose S. Pulido, M.D.ranice M. Jurkus, O.D.Ph.D.CONSULTANTS;cott M. MacRae, M.D. eo J. Maguire, M.D.XJEST DISCUSSANT)an Z. Reinstein,M.D.,M.S.,FRCS ynn Morris, Consumer Representativeflarcia W. Yaross, Ph.D., Industry Representative?DA.- .1. Ralph Rosenthal, M.D., Director,Division of Ophthalmic Devicesand Corneal Implants)onna R. Lochner, Chief, IntraocularBranchZverette T. Beers, Ph.D. , Acting Chief, DiagnosticandSurgical Devices Branchandluynh T.N. Hoang, Electrical Engineer, DiagnosticSurgical Devices Branch)avid Whipple, Associate Director,Division of Ophthalmic Devices--—.MILLER REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666
Sgg3—Call to Order,IIIntroductoryJamesRemarks,4P. McCulleyPostmarked Evaluationat FDA’s Center for DevicesRadiologicalHealth, Larry G. Kessler, SC.D.Branch4Ms . Thorntonand9Updates:Donna Lochner, Chief of the Intraocularand Corneal Implants Branchand SurgicalDr. Beers, Acting Chief, DiagnosticDevices BranchConflictof InterestIIComments,A. RalphOpen PublicStatement,Sara M. ThorntonRosenthal272729HearingFormal Oral Presentations:Michael Bartell, Microtech,Inc.Douglas E. Mastel, Mastel PrecisionGeorge H. Myers, Hawken IndustriesOpen Public24Hearing324250Discussion:with keratomesSession I: Problems AssociatedSession II: Probable CausesSession III: Steps to Mitigate ProblemsRank Ordering of Identified Problems----MILLER REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-66665585167194
ISgg—412IICall5Iof the OphthalmicThorntonDevicewe proceedyou here,8have9wouldlike to remind10sheetin the registration11room here.a few shortIIThoseI willturnmeetingit to Missand welcomeGood morning,Beforetoday.to the Ninety-sixthremarks.MS. THORNTON:712Panel.for introductory6and IntroductionsWelcomeDR. MCCULLEY:34to OrderannouncementseveryoneI wouldtoday’sliketo signarea,who wantwithto all ofagenda,to make,Iand Iin on the attendancejust outsideto participatethe meetingin the paneland.-.13publicdiscussion14who15that . That16today’sis overthereYou shouldmakescheduled19The meetingdates22232425IIare on the FDA webdevicesIIouta notefor NovembertentativelyforAll handoutsfortable.that the panel18-19scheduledAlso,that haveon the tablea list of thosemeetinghas beencancelled.for the yearsite at www.dot.fda.govsubsection.sheetsregistration.E-e Williams,to registerare at the registrationtentatively21to see Ms. Annat one of the tables,1820needis a separatemeeting17—groupin the medicaloutsidedatesI have putyearfor the2000.Messagesparticipants,for the panelinformationMILLERmembersor special2000and FDAneedsREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(2o2) 546-6666shouldbe
5Sgg——1irectedthrough2illiams,3lso ShirleyAnn Ree Williamswho are availableMeeksis thereThose who have45anticipation6eated7hem can as well.a reservationdiscussionThoseroomforwillwho may wishbeto joinat the designatedtable.know ill be seated11,imit of two participantsthatanyoneon a first-come,For thosethereare diskettes14lork sheetfor the keratome15:eratome16registration17lave transferred18:hat we can all benefit.submissions.tableand needask that you turn them21node .Lastly,will23into the microphone24really25are goingbasis,discussionTheytodayto be speakingMILLERyourlaptoptheand the outlineforare availablethereat theafteryoufor the use of otherscell phonesall meetingyourbecauseayou may copyto be returnedoff or putand givewithany one group.from whichof you with20importantfirst-servethe information,For choseto this nowof you who have brought:omputers,510(k)comingrepresenting1322at the registrationtime.10i9Lataniathe open publicYou should12of Missrequestedat the appropriate9—-—“Missand pagers,sowethem on the vibrationparticipantsnamewe haveclearly?pleaseThisisa lot of peopleinto the microphoneREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666speakwhoand probablya
6Sgg——1ot of discussion2hat the transcriber3nformation.and the summaryNow , at this time45elcome6taffr7,re withand introduceour new panelDr. Leo Maguirem AssociateProfessor;chool , and a consultant11Lt the Mayo12:erves as Chairman13;ommitteeon Ophthalmic14:ditorialboard15Uornea.16 n corneal17{eratorefractive18 egenerationi9issues .Assistantis our new panelm22College23of Ophthalmology24extensive25surgery,and alhealthis Dr. Dan Reinstein,of Ophthalmologyat the Weillin New York,sub-specialtyand is on thetoand publictodayat the Universityophthalmicof Ophthalmologyof O hthalmolomon e isof OphthalmologyAcademyand its applicationdiscussantfellowshipwhoat the Mayo MedicalJournalhas publishedsurgery,of CornelldiscussantDr. MaguireProceduresProfessorand the FDAconsultant.to the Departmentand associated21a specialtime.of the AmericanOur guest20the panelof the Americantopographyget accurateand our guessin Rochester.Dr. Maguireimportantlike to extendof Ophthalmology10ClinicI wouldconsultantbe verywriterto the publicus for the first89on, and it willgoingand a Professorof Paris,trainingand ultrasoundREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666MedicalFrance.He hasin refractive
7Sgg—— —1ioengineering,2efractive3nd use of a new4hat provides5ne micronprecision.6ethnologyin the assessment7 ith a focus8.nd healing9:linical interests10and combinesDr. Reinsteinsurgery.3D veryresponsesI would12:hemselves,13 aross.hasfrequencyincludeultrasoundcornealHe has pioneeredof underlyingin LasikHisthe assessmentwithand PRK,mechanismsspecialand managementofsurgery.like to now ask the panelthe remaininglayerssurgicalthe cornea.of refractivesystemthe use of thisof the corneawithinofled the developmentof individualon the study.he complications11highpachymetryin his practicethesepanel,startingto introducewithDr. Marcia. halmology,19nember.University,23ProfessorScott MacRae,panelmember2hairmanandof Optometry,The Ohioof the DepartmentMILLERofat Chicago;OregonpanelHealthSciencesand consultant.Dr. MarkDR. MCCULLEY:2425of IllinoisDR. BULLIMORE:22California,ProfessorJoel Sugar,Universityformerin Irvine,ofto the panel.DR. MACRAE:20I am directorYaross.at AllerganDR. SUGAR:1721MarciaDR. YAROSS:14Bullimore,StateJim McCulley,AssociateUniversity.Professorof Ophthalmology,REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666andUniversityof
sgga81TexasSouthwestern2MedicalSchoolDR. HIGGINBOTHAM:3Chair,University45the sCollegeof Ophthalmic11Pulido,JaniceDR. ROSENTHAL:10Schoolof Ophthalmology,DR. JURKUS:8Eve Higginbotham,of MarylandDR. PULIDO:in Dallas.of d Headofof Illinois,Professorof OptometryRalphProfessorofin Chicago.Rosenthal,Director,Devices.MS. THORNTON:Thankyou very much.12like to note that we are expecting13consumer14Marian15had a fallingI wouldthe appearancejustof our—— -rep. She is missingMacsaiwhois a voting[Laughter]17--wantedand hasn’tto note19thatbeenableWe, in the FDA, wouldour appreciation21from their busy22like to turn it over23Rosenthalhas asked24McCulley,do you wantIto the panelschedulesto attend.to takeMILLEROkay.She hasBut she willfor the timetoday.I believebe back.at thistheyDr. Kessler’s--So I justlike to extendto Dr. McCulley.DR. MCCULLEY:of the panel.to join us hereto followas is Dr.off of her bicyclefor the record.2025memberout or a falling1618from the table,havetimetakenI wouldDr.remarks.So, Dr.it from here?The agendaREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666indicatesthat Dr.
Sgg–-91Larry Kessler,23iometrics,3 valuation4 ealth’. Dr. Kessler?willat FDA’s6Centerof Surveillancefor DevicesEvaluationDevices7Officegive us a presentationPostmarked5on postmarkedand Radiologicalat FDA’sand RadiologicalDR. KESSLER:ThankyouandCenterforHealthfor the introduction,8‘4cCulley, and thankyou to Dr. Rosenthaland Sara9for the opportunityto talkthe other10. -.Director,to you aboutDr.Thorntonside ofthe house.11[Slide]12Most often,13side of the Center14going15and the critical16its postmarkedthe panelfor Devices[Slide]18In aboutthe20for Devices21challenges22the pivotal23postmarkedmethodsbit aboutthe panelHealth.the postmarkedcan playin helpingI amsideFDA withresponsibilities.1719see the premarketand Radiologicalto talk to you a littleroleand gueststwelveof deviceminutespostmarkedand Radiologicalin accomplishingrole thatI willdescribeevaluationHealth.at the CenterI will presentthis mission,the advisorya few ofpaneltheand thencan playdescribeinevaluation.24[Slide]25To do that,I needMILLERto give you an overviewREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666of the
Sgg101way we penswe workworld.at the CenterMostwe recognizefrom device9and we 5the industry,16should17alsoFromdeviceout here--designmajorityof ians,increasinglydesign,from thein the medicalhappensis the vastdeviceFDA gets8patients,devicesin medical7of the actionat the FDA,customers,for Devicesinvolvedevolutioninvolvedthe lab and benchtestingof devicesprocedures,thereas any producttowardin thistesting,obsolescence,tie of a timedefinitelyand then,to theonce we startis a long pre-goesFDAand then a longer—-havehaveprocessfrequentbackat FDA. All of theseand accuratecommunityperiod19separate20in the postmarkedperiod,21statutoryas is nor otheris placedWe e,toand wehereandin this diagram.In the postmarkedthatfeedbackto the clinicalthe clinicalelsewhere18evaluationmechanismsand thatthatat leastto monitoris as muchto makeon the marketthe Medicaltalk to you aboutwe haveDeviceremainsproductof FDA’ssure that asafe andReportingfor a few minutes.MILLER REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666fiveProgram.ThenII will
Sgg111talk for quite2authoritythat we have3authoritywhich4not talk about5field6FDA’s postmarked7this morning.the postmarketat FDA, as wellis connectedprogram,surveillanceas our post-approvalto PMA typeour cts.I willnor our veryare alsoprocedures.criticalTimelargepartslimitsofme a 3period14talking15for many,16issuein the postmarkedof clinicalabouttestingmanyyears.practice19pointand effects20but in general.21years22the world23that medical24the bedside25sophisticatedhospitalsafetyof you knowin the Uniteddramatically.technologyis beingfastertechnologya very briefwiththemin communitysetting.I wantWhatpushedtofor this panelfor the pastStatesand faster.we areis a criticalnot so muchthatandperiod.in usershrunkfaster,afteror associatedof a devicein particular,stayshavebodiesof changeMostget reviewedbut a lot of the productsin the postmarkedperformanceto this oneSome productsSo, long-termfor evaluationareFor many productsand by the FDA,are in people’s18Iby panelquestionsperiod?is an issue.approvedAlso,1why do we care? Whatsafety17—a bit abouttwentyand elsewhereis happeninginisfrom the hospitalIncreasinglyis at the bedsideMILLER REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666of you, yourto
Sgg—121parents,yourauntsand uncles,2productsthat can be used3professionally4can be usedat home5We ainedand makingeffectivelyphysicians,is a trick,-- whendoes not eslookfor effectivenessstafftrialsadverseis importantseentrainedin a homecareexperienceevents,of technologyandyou havewiththe home,can be.safethe same way and patientslife-threateningsettings,thatside, whereclinicalthat productand otherbyand not all productsthat productsdevelopedthatin the hospitalnursesto you on the premarketfrom highlysureandin settings,to 15One of the mechanisms16problemsis the Medical17manufacturers18FDA, as well19incidents . musthaveUnfortunately,observedBy law,tonearin the countryassociatedto FDA,withand all seriousby law, to manufacturers,that responsibilityin the breach.MILLERat thoseinjuriescalledfacilitiesAll deathsto be reported,24facilities.isand seriousto be reported[Slide]Program.or somethingall userrequirements.for lookingReportingdeathsas malfunctions2325Devicereport1990,we haveWe getREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666of user95% of the
gram5information,reportswe get everyand only6eventin the Medicalinformation.8willa devicedescription,event9litigiousreportsThey providetalk t ofetc.have verysignalsin a minute,environmenteventsDeviceto includeUnfortunately,7of adverse2% to 3% do we get from userInformationis supposedyearlimitedto FDA,andbut in an increasinglyin the hospitalsetting,whenan10adverse11the risk manager-- the firstjob of the risk manager12hospitalsettingis to ensurethat his facility13facilitydoesn’tget sued,14reporting15getting16from the lmosta lot of reportsthatperspective,But, we have a trainedactions20[Slide]21Most commonly,22voluntaryreports23that had to do with24reported25inspectionshave verystaffin the postmarkedwe do directedcomfortsome concerns,in facilitiesissueswithor heraboutlimitedupinformationto dealwith15 nursewe get a s-- some physiciansand we have gonein aSo, we windof aboutreportsthe job ofto thinkand it is hardin the last yearMILLERlaterauthorities.who look at the 100,000certainany product,and thento the FDA or otherIhaveand doneto find out if we couldREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666support
orting5retinal6cataract7promotionbasedon reportsProgram,photicsurgery,9We have10allow11special12postmarked13or post-approval14those.15Thesesurveillance,16had imilarand youdroppedFDA the authoritydatato addressto the post-approval23PMA products,24of approvaland urersconcerns.are conductedwithin 1990 andauthority.authoritystudiesfamiliarand left us withto requirepostmarked522,of approvalmandatedsurveillancethatto the FDA in athe requiredof that programpostmarkedauthoritiesare probablyand a discretionaryIn 1997 FDAMAof ’98.are Section522 was originallya requiredparta reportduringillegalpostmarkedand conditionsstudiesone onmicroscopesin Septemberof industryDevicealerts,recentlytwo authoritiesSectionprovideslenses,we have had thethe Medicalfrom operatingtwo separateus to requireway.fromin ’95, and moreof contact[Slide]few years,to put out two safetyinjuries825in the lasttoIt is quiteonlyreferstoas conditionsstudies.Bothof theseauthoritiesare seen as complementsMILLER REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666
15Sgg—10 premarket2djust3he market4r marketing5lost-approvaland in some waysreview,the pre-and postmarketbalancewe may havesome minorwhereconcerns[Slide]7The most)ostmarket9)ublic healthand allowessentialsurveillancepartstudy;ituations . We may get medical11idverse events12 postmarkedor injuriesstudyAlso,in technology15 ostmarketstudy.Anotherand I willonconcernsto be handledin the18[Slide]19Originallyconditionsof use orFDA to requireis how willcollect22of designs23period24and definitiverandomized25the postmarkedperiod,data.rangeguidancerecommendingof studytrialsto try andof the kindin the postmarkeddesigns,or case-controlall the way downMILLERsurveillanceapproachesA more recentthat we anticipatewiderheavyathe data be used,postmarkedfairlyconducton.in the required21is a muchindustrya minute.we used“for cause”of unusualto that in juststudy authoritiesanythe criticalfromthatis goingmay cause20postmarkedto conductreportsand requestkey questioncome backof tryingdevicenew or expanded volutions17productspostmarkedis to identifyto see what1416us toand allowand this can comequestion,1013themallowperiod.68evenfrom detailedstudiesto somethingREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666asin
Sgg—— 161;imple as a de]6But conducting7Frustrating.8 echnology9requestedWhy?makes10she industry113oing a study12or third13lessensthe incentive14alreadyis outdatedobsolete.study,and the clinicaland gettingor edstudies19wonderful20it. So, the incentive21study22not so exciting.EvenThere24community25so, conductingthereMILLERdecidedonon a secondSo, it reallywhichmuch.is lack of the industrythoughwe requirethe newslikelyto be,knewstudiesthem,“great!that whenhealthonceThisa postmarkedcan bein theis alreadyin use.is not so interestingREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666is awe approvedconcerninterestagain,tofrom mostto conducta publicthe technology,postmarkedagency andon a productis a lack of clinicalbecausetheused veryfor industryto address:imes we havewe are alreadyproduct. “ We basicallyin tryingofofhaveof product.is granted,are notespeciallysystemevolutioncommunityto do a studysuch studies.orcan be veryA numberand not being16qualitybut the timegoing,generationfrankly,keeps,studiesof all, rapidstudieshistoryto the GMPs.postmarkedFirsta postmarkedgenerallypromulgatedis similar523of the complaintthat the manufacturerthe relatively15----review
stion4DA as well5nd figure6rhere I am goingas panelWhenhaveis the rightto leave8frustratingmembersout what[Slide]not so publishable.the lack of a clearlyis the most79becauseand botha responsibilityquestiontheto tryto ask and thatpost-approval522 authorityto ensurething,publicisyou.considering;omes from Sectionspecifiedthatstudies,;tudy, we needthe question11 sk is of primarywe are going12:his question13Incentives14:eally serious.So we reallywant15importantthat we wantto do. We need16Specify17olinical18tihat will we do withDo we reallyin the postmarkeditor from a post-approval10important.whetherperiod,toneed to answerbecausethe lackof——for doingstudythe publichealthor regulatoryAnd there19.-.these20out safetyalerts21on a routine22expand23done24community25onlyrelevanceto makethem wellaresure it is anto clearlyand we wantof answeringto notethethe question.the data?is a varietyChangeTherefrom a regulatoryhealthout aheadbasedwe can do -- putadvisories.is a varietyperspectiveMILLERof thingsthe labeling;and the industry,if we figureand doingquestion,or publicbasis.indications.studiesWe do thosechangeof thingsindications;thatcan bethat help the clinicalon postmarkedstudies,of time what we reallyREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666wantbutto
18Sgg10 and clearly2Thanks3DR. MCCULLEY:Thank5nto on the panelis having7urveillancestudy”8lne hand.9:ind of discouragedrole11hepanel’s12:hose kinds13;houldn’tit is stillit to get ourselvesThat;volving17in two ways.18)ffice of Device19md20studies21:ouple22Text year23have requested24what has happenedto them,25indus
DR. MACRAE: Scott MacRae, Oregon Health Sciences University, former panel member and consultant. DR. BULLIMORE: Dr. Mark Bullimore, Associate Professor of Optometry, The Ohio State University. DR. MCCULLEY: Jim McCulley, Professor and 2hairman of the Department of Ophthalmology, University of MILLER REPORTING COMPANY, INC. 507 C Street, N.E.
