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1、AACCSeptember 2009:Volume35,Number 9HigherStandardsontheWayforGlucoseMeters?FDASeekingISORevisiontoImprovePerformanceRequirementsByBillMaloneCriticssaybloodglucosemetersneedtighterstandards.TheFDAwillconsidertighteningstandardsforstrip-basedbloodglucosemete
2、rs,echoingtheconcernsofmanyintheclinicallabfieldwhohavewarnedforadecadethatthemetersarenotreliable.InaletterdatedJune24,FDACommissionerMargaretHamburg,MD,alsoacknowledgedanissuethathasbeenagrowingconcernamonglaboratorians—thatpooroutcomesinrecenttightglucos
3、econtrol(TGC)trialsmightbe,inpart,duetotheuseoferror-pronemetersinsteadofmoreaccuratepoint-of-careinstruments.Together,riskstopatientswhorelyonmetersforadministeringinsulinorglucose,aswellasproblemsforhospitalswhichusethemforTGC,haveraisedthestakesintheagen
4、cy’schoicetostandbythe7-year-oldISOguidelinethatestablishedtheminimumperformancecriteriaformeters.TocomplywiththeISO15197document,95%ofameter’svaluesmustbewithin20%ofthereferencemethodforglucosevalues≥75mg/dLandwithin15%forlowervalues.However,criticssaythis
5、errorrateisunacceptableduetothefactthatpatientsdependontheirmeterstotakeactionandpreventhypoglycemiaandotherevents.Ina2001paper,JamesBoyd,MDandDavidBruns,MD,usedcomputermodelingtodemonstratethatverylargeerrorsininsulindosescouldoccurwhenpatientsusemeterswit
6、hgreaterthanabout15%totalerror(ClinChem2001;47:209–214).“Ifyouwant95percentofinsulindosestobecorrect,youneedaCVthat’s1percentor2percent,andabiasof1or2,”saidBruns,professorofpathologyatUniversityofVirginiainCharlottesvilleanddirectorofclinicalchemistryandtox
7、icologyatUniversityofVirginiaHealthSystem.“Now,that’sprobablynotrealisticforglucosemeters—it’smorethequalityofresultsthatcomeoutofamainlabwithgoodequipment.Butwethinkitisrealistictotryandavoidverylargeerrorsininsulindose,andthatrequiresmetersthatdobettertha
8、nplusorminus20percent,andmorelike15percenttotalerror.”BalancingActSuchcriticismofthecurrentstandardisnotunknowntoFDA.Consideringrecenttechnologicaladvancements,theagencyhasrecommendedthattheminimumperf
