Medical Device ScienceIntroduction医疗设备科学导论

LecturesonMedicalBiophysicsDepartmentofBiophysics,MedicalFaculty,MasarykUniversityinBrnoMedicalDevices:IntroductionLecturesonMedicalBiophysicsDepartmentofBiophysics,MedicalFaculty,MasarykUniversityinBrnoMedicalBiophysicsInMedicalbiophysicswewillbedealingwiththephysicalprinciplesofbiomedicalmethodsanddevicesandtheirinteractionswiththehumanbody-whichmakesthemusefulinhealthcare,includingpatientandusersafetyaspectsandhealthcarequalityissues.Thephysicalprocessesinlivingorganismsandtheeffectsofphysicalfactorsonthemareimportantasbackgroundinformation.LinksNaturalsciences(physics,chemistryandbiochemistry,biology)MorphologicaldisciplinesPhysiologyandpathologicalphysiologyClinicaldisciplines(almostall!)RecommendedtextbookThistextbookandallthepresentationsshowninthelecturesprovidetheinformationnecessarytobesuccessfulintheexam!!!Howtostudy?Studyingmedicalbiophysics,thereisnoproblemwiththeamountofknowledgewhichisnecessarytomaster,butwithunderstandingthephysicalprinciplesandtheirapplication.Memorisationwithoutunderstandingwillnotbesufficienttohaveasuccessattheexam.MedicalDevices:IntroductionWhatisaMedicalDevice?“anyinstrument,apparatus,appliance,materialorotherarticle,whetherusedaloneorincombination,includingthesoftwarenecessaryforitsproperapplicationintendedbythemanufacturertobeusedonhumanbeingsforthepurposeof:diagnosis,prevention,monitoring,treatmentoralleviationofdisease,diagnosis,monitoring,treatment,oralleviationoforcompensationforaninjuryorhandicap,investigation,replacementormodificationoftheanatomyorofaphysiologicalprocess,controlofconceptionandwhichdoesnotachieveitsprincipalintendedactioninoronthehumanbodybypharmacological,immunologicalormetabolicmeans,butwhichmaybeassistedinitsfunctionbysuchmeans.”(MDDArticle1(2a))TheEUMedicalDeviceDirectivesTheMedicalDevicesDirective(MDD)(93/42/EEC,OJL169p0001-0043):frombandages,tonguedepressors,thermometerstocontactlenses,stethoscopes,splints,first-aidkits,breathalysers,heartvalvesandimagingequipmentTheIn-VitroDiagnosticMedicalDevicesDirective(IVDD)(98/79/ECOJL331p0001-0037):reagents,controlstandards,test-kits,equipment…intendedforthein-vitroexaminationofhumanspecimense.g.bloodgroupingreagents,pregnancytestkits,HepatitisBtestkitsTheActiveImplantableMedicalDevicesDirective(AIMDD)(90/385/EECOJL189p0017-0036):active(i.e.includeanenergysource)implantsorpartialimplantse.g.heartpacemakersMostcountrieshavetransposedthesedirectivesintoasinglenationallegislation(e.g.UKMedicalDevicesRegulations2002)HealthCareActivitiesPreventionDiagnosisCurative(therapeutic)RehabilitationPalliativecare(whencureisnotpossible)MedicalImagingDevices(invivodiagnosis)X-rayprojectionimagingComputerisedTomography(CT)Ultrasound(USI),DopplerimagingMagneticresonanceimaging(MRI)Radionuclideimaging(nuclearmedicine)ThermographyEtc.Theoreticalbackground:Ionisingradiation(origin,measurement,interactionswithmatter),propertiesofatomsandnucleus,radioactivity,basictermsofacoustics,electromagneticspectrum….MedicalImagingDevices(invivodiagnosis)MedicalLaboratoryDevices(invitrodiagnosis)sampleseparation,centrifugationetcelectrophoresis,capillaryelectrophoresispH/ISEmetersparticle/cellcountersspectrophotometersflowcytometrymicroscopyHPLC(chromatography)clinicalchemistryhaematologyimmunologyscintillationsystemsgeneticanalysisTheoreticalbackground:Structureofbiopolymers,propertiesofwaterandelectrolytes,electricpropertiesoflivingmatter,galvaniccell,sedimentationofparticles,dosimetry,lightabsorption…MedicalLaboratoryDevices(invitrodiagnosis)PhysiologicalMeasurementDevices(invivodiagnosis)InstrumentsformeasuringphysicalandchemicalvariablesinvivoThermometersCardiovascularphysiology:bloodpressuremonitors,flowmeters,pulsedDopplerUSsystemsElectrophysiology:ECG,EEG,EMGAudiologyandophthalmologyRespiratoryphysiology:spirometers,pulseoximetry,impedancepneumograph….EndoscopesPhysiologicalMeasurementDevices(invivodiagnosis)Theoreticalbackground:Introductiontothermodynamics,basiclawsofhydrodynamics,originofbioelectricpotentials,propertiesofsoundandlight,earandhearing,eyeandvision,mechanicalpropertiesoflivingmatter…ECG(akaEKG)sphygmomanometerScreenofamultipurposeclinicalmonitorPaediatricIntensiveCareEndoscopyRadiotherapyDevicesX-rayandelectron,resp.hadronbeamsfromaccelerators(shape,direction,andintensityofbeamchangedoftencontinuously)gamma-raybeamsfromtele-isotoperadioactivesourceslikeCo-60treatmentplanningsystemssimulatorsbrachytherapydosimetersLinearacceleratorLeksellgammaknifeRadiotherapyDevicesTheoreticalbackground:Ionisingradiation(origin,measurement,interactionswithmatter),propertiesofatomnucleus,radioactivity,biologicaleffectsofionisingradiation,dosimetry….PhysicaltherapyDevicesElectrotherapyUVandIRtherapyShortwavediathermyUltrasoundtherapyLasertherapyMusclestimulatorLasertherapyunitUltrasoundtherapyunitShortwavediathermyPhysiotherapyDevicesTheoreticalbackgroundBiologicalinteractionsofultrasound,electromagneticfields,electriccurrent,infrared,visibleandultravioletlight,laserprinciple….POC(PointofCare)DevicesAddressclinicians’requirementsforrapidaccesstoinformationtosupportcriticalcaredecisionsAdvancesinmicroelectronicsandbiosensortoolshavebroughttechnologytothebedsideinaminiaturizedform.Examples:Performingbloodtestsatthepatient'ssideratherthaninacentrallaboratoryportableultrasoundimagingdevicesSurgicalTheatreDevices,LithotripsyOperatinglampsanaesthesiaelectrocauterycryosurgerySurgicalTheatreDevices,LithotripsyTheoreticalbackgroundBiologicalinteractionsofultrasound,electromagneticfields,electriccurrent,infrared,visibleandultravioletlight,laserprinciple,lowtemperatures,acousticshockwaves…SurgicalTheatreDevicesSurgicalTheatreDevicesProstheticDevices-ImplantsRoboticdeviceforkneeprosthesisimplantationProstheticDevices–„ArtificialOrgans“ArtificialheartCochlearimplantRetinalimplantVentilatorCardiopul-monarybypassProstheticDevices–„ArtificialOrgans“Stentsareinsertedintothedamagedbloodvessels,oesophagusetc.Theyareoftenmadeofametalwitha„shapememory“–nitinol,whichadoptstheintendedshapewhenheatedtobodytemperature.DisposableMedicalDevicesSuctioncatheterUmbilicalcordclampI.V.cannulaeDevicesforSelf-testing(‘homedevices’)'deviceforself-testing`:anydeviceintendedbythemanufacturertobeabletobeusedbylaypersonsinahomeenvironmentthermometers,pressuremeasuringinstrumentsetctestkits(pregnancy,glucoselevelsinbloodusedbydiabetespatientsetc)BloodglucosemeterDevicesforPerformanceEvaluationofDevices'deviceforperformanceevaluation`:devicestochecktheperformanceofmedicaldevicesarealsoconsideredasmedicaldevicesTestingcontrastresolutioninXRIWhatisthePurposeofthisCourse?Createawarenessthatmedicaldevicesshouldbeusedeffectivelyandsafely(reducepatient,occupationalandothers’risktoaminimum)UsemedicaldevicesinaprofessionalandscientificmannerAppreciateusesofmedicaldevicesintheclinicalareasandinresearchHaveanideaofthedevicesusedinotherprofessionsSomeCompetencesforUsersofMedicalDevicesWhatisexpectedthedoctordoeswithorknowsaboutthedeviceStatethespecificdiagnostic,therapeuticetcoutcomesexpectedwhenusingthedeviceExplainthephysicsprinciplesunderpinningthefunctioningofthedeviceandthedeviceuseprotocolsDescribethestructureofcommerciallyavailabledevicesincludinguseroptionsettingsandcontrolsIdentifypossiblehealthhazards(e.g.mechanical,electrical,radiationetc)topatient,selfandcolleaguesDescribemeasurableobjectivedeviceperformanceindicatorswhicharedirectlyrelatedtodeviceeffectivenessorsafetyCont...Demonstratesalevelofcapabilityintheuseofthedevicethatensurestherequiredlevelofeffectivenesswhilstminimisingrisktopatient,selfandothersExplainslimitationsofthedeviceandcontraindicationsforuseDescribestheimpactoneffectivenessandriskarisingfromdevicemalfunctionorinappropriateuserprotocolDemonstratestimelydevicemalfunctionrecognitionandlocalproceduresforreportingsuchfaultsDemonstratesskillinpreventivemaintenanceandqualitycontrolincludingcalibrationofthedeviceappropriateforusersDemonstratesanawarenessthatadeviceshouldbecheckedbeforeuseandinthecaseofre-usabledevicesleftinaconditionforsubsequentuseDemonstratesadherencetoInternational,European,Nationalandlocallegislationand/orregulationsregardingtheuseofthedevicePresentationdesign:LucieMornsteinováLastrevision:August2012Authors:CarmelJ.Caruana,VojtěchMornsteinLanguagerevision:CarmelJ.Caruana