AAMI-PB70-2003

AmericanNationalStandardANSI/AAMIPB70:2003AAMIAssociationfortheAdvancementofMedicalInstrumentationLiquidbarrierperformanceandclassificationofprotectiveapparelanddrapesintendedforuseinhealthcarefacilitiesTheObjectivesandUsesofAAMIStandardsandRecommendedPracticesItismostimportantthattheobjectivesandpotentialusesofanAAMIproductstandardorrecommendedpracticeareclearlyunderstood.TheobjectivesofAAMI'stechnicaldevelopmentprogramderivefromAAMI'soverallmission:theadvancementofmedicalinstrumentation.Essentialtosuchadvancementare(1)acontinuedincreaseinthesafeandeffectiveapplicationofcurrenttechnologiestopatientcare,and(2)theencouragementofnewtechnologies.ItisAAMI'sviewthatstandardsandrecommendedpracticescancontributesignificantlytotheadvancementofmedicalinstrumentation,providedthattheyaredraftedwithattentiontotheseobjectivesandprovidedthatarbitraryandrestrictiveusesareavoided.Avoluntarystandardforamedicaldevicerecommendstothemanufacturertheinformationthatshouldbeprovidedwithorontheproduct,basicsafetyandperformancecriteriathatshouldbecon-sideredinqualifyingthedeviceforclinicaluse,andthemeasurementtechniquesthatcanbeusedtodeterminewhetherthedeviceconformswiththesafetyandperformancecriteriaand/ortocomparetheper-formancecharacteristicsofdifferentproducts.Somestandardsem-phasizetheinformationthatshouldbeprovidedwiththedevice,includingperformancecharacteristics,instructionsforuse,warningsandprecautions,andotherdataconsideredimportantinensuringthesafeandeffectiveuseofthedeviceintheclinicalenvironment.Recommendingthedisclosureofperformancecharacteristicsoftennecessitatesthedevelopmentofspecializedtestmethodstofacilitateuniformityinreporting;reachingconsensusonthesetestscanrepresentaconsiderablepartofcommitteework.Whenadraftingcommitteedeterminesthatclinicalconcernswarranttheestablishmentofminimumsafetyandperformancecriteria,refereetestsmustbeprovidedandthereasonsforestablishingthecriteriamustbedocumentedintherationale.Arecommendedpracticeprovidesguidelinesfortheuse,care,and/orprocessingofamedicaldeviceorsystem.Arecommendedpracticedoesnotaddressdeviceperformanceperse,butratherproceduresandpracticesthatwillhelpensurethatadeviceisusedsafelyandeffectivelyandthatitsperformancewillbemaintained.Althoughadevicestandardisprimarilydirectedtothemanufac-turer,itmayalsobeofvaluetothepotentialpurchaseroruserofthedeviceasafumeofreferencefordeviceevaluation.Similarly,eventhougharecommendedpracticeisusuallyorientedtowardshealthcareprofessionals,itmaybeusefultothemanufacturerinbetterunderstandingtheenvironmentinwhichamedicaldevicewillbeused.Also,somerecommendedpractices,whilenotaddressingdeviceperformancecriteria,provideguidelinestoindustrialpersonnelonsuchsubjectsassterilizationprocessing,methodsofcollectingdatatoestablishsafetyandefficacy,humanengineering,andotherprocessingorevaluationtechniques;suchguidelinesmaybeusefultohealthcareprofessionalsinunderstandingindustrialpractices.IndeterminingwhetheranAAMIstandardorrecommendedpracticeisrelevanttothespecificneedsofapotentialuserofthedocument,severalimportantconceptsmustberecognized:AllAAMIstandardsandrecommendedpracticesarevoluntary(unless,ofcourse,theyareadoptedbygovernmentregulatoryorprocurementauthorities).Theapplicationofastandardorrecom-mendedpracticeissolelywithinthediscretionandprofessionaljudgmentoftheuserofthedocument.EachAAMIstandardorrecommendedpracticereflectsthecollectiveexpertiseofacommitteeofhealthcareprofessionalsandindustrialrepresentatives,whoseworkhasbeenreviewednationally(andsometimesinternationally).Assuch,theconsensusrecommendationsembodiedinastandardorrecommendedpracticeareintendedtorespondtoclinicalneedsand,ultimately,tohelpensurepatientsafety.Astandardorrecommendedpracticeislimited,however,inthesensethatitrespondsgenerallytoperceivedrisksandconditionsthatmaynotalwaysberelevanttospecificsituations.Astandardorrecommendedpracticeisanimportantreferenceinresponsibledecision-making,butitshouldneverreplaceresponsibledecisionmaking.Despiteperiodicreviewandrevision(atleastonceeveryfiveyears),astandardorrecommendedpracticeisnecessarilyastaticdocumentappliedtoadynamictechnology.Therefore,astandardsusermustcarefullyreviewthereasonswhythedocumentwasinitiallydevelopedandthespecificrationaleforeachofitsprovisions.Thisreviewwillrevealwhetherthedocumentremainsrelevanttothespecificneedsoftheuser.Particularcareshouldbetakeninapplyingaproductstandardtoexistingdevicesandequipment,andinapplyingarecommendedpracticetocurrentproceduresandpractices.Whileobservedorpotentialriskswithexistingequipmenttypicallyformthebasisforthesafetyandperformancecriteriadefinedinastandard,professionaljudgmentmustbeusedinapplyingthesecriteriatoexistingequip-ment.Nosinglesourceofinformationwillservetoidentifyaparticularproductasunsafe.Avoluntarystandardcanbeusedasoneresource,buttheultimatedecisionastoproductsafetyandefficacymusttakeintoaccountthespecificsofitsutilizationand,ofcourse,cost-benefitconsiderations.Similarly,arecommendedpracticeshouldbeanalyzedinthecontextofthespecificneedsandresourcesoftheindividualinsti