Medical-Device-Science-Introduction醫(yī)療設(shè)備科學(xué)導(dǎo)論課件

1、Lectures on Medical BiophysicsDepartment of Biophysics, Medical Faculty, Masaryk University in BrnoLectures on Medical BiophysicsMedical Devices: IntroductionLectures on Medical BiophysicsDepartment of Biophysics, Medical Faculty, Masaryk University in Brno2Medical Devices: IntroductionLMedical Biop

2、hysicsIn Medical biophysics we will be dealing with the physical principles of biomedical methods and devices and their interactions with the human body - which makes them useful in health care, including patient and user safety aspects and healthcare quality issues. The physical processes in living

3、 organisms and the effects of physical factors on them are important as background information.3Medical BiophysicsIn Medical bLinksNatural sciences (physics, chemistry and biochemistry, biology)Morphological disciplinesPhysiology and pathological physiologyClinical disciplines (almost all!)4LinksNat

4、ural sciences (physicsRecommended textbook This textbook and all the presentations shown in the lectures provide the information necessary to be successful in the exam!5Recommended textbook This textHow to study?Studying medical biophysics, there is no problem with the amount of knowledge which is n

5、ecessary to master, but with understanding the physical principles and their application. Memorisation without understanding will not be sufficient to have a success at the exam. 6How to study?Studying medical Medical Devices : Introduction 7Medical Devices : IntroductionWhat is a Medical Device?“an

6、y instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used on human beings for the purpose of:diagnosis, prevention, monitoring, treatment or alleviation of d

7、isease,diagnosis, monitoring, treatment, or alleviation of or compensation for an injury or handicap,investigation, replacement or modification of the anatomy or of a physiological process,control of conception and which does not achieve its principal intended action in or on the human body by pharm

8、acological, immunological or metabolic means, but which may be assisted in its function by such means.” (MDD Article 1(2a)8What is a Medical Device?“any The EU Medical Device DirectivesThe Medical Devices Directive (MDD) (93/42/EEC, OJ L169 p0001-0043) : from bandages, tongue depressors, thermometer

9、s to contact lenses, stethoscopes, splints, first-aid kits, breathalysers, heart valves and imaging equipmentThe In-Vitro Diagnostic Medical Devices Directive (IVDD) (98/79/EC OJ L331 p0001-0037): reagents, control standards, test-kits, equipment intended for the in-vitro examination of human specim

10、ens e.g. blood grouping reagents, pregnancy test kits, Hepatitis B test kitsThe Active Implantable Medical Devices Directive (AIMDD) (90/385/EEC OJ L189 p0017-0036): active (i.e. include an energy source) implants or partial implants e.g. heart pacemakersMost countries have transposed these directiv

11、es into a single national legislation (e.g. UK Medical Devices Regulations 2002)9The EU Medical Device DirectivHealthCare ActivitiesPreventionDiagnosisCurative (therapeutic)RehabilitationPalliative care (when cure is not possible)10HealthCare ActivitiesPreventioMedical Imaging Devices (in vivo diagn

12、osis)X-ray projection imagingComputerised Tomography (CT)Ultrasound (USI), Doppler imagingMagnetic resonance imaging (MRI)Radionuclide imaging (nuclear medicine)ThermographyEtc.11Medical Imaging Devices (in viTheoretical background:Ionising radiation (origin, measurement, interactions with matter),

13、properties of atoms and nucleus, radioactivity, basic terms of acoustics, electromagnetic spectrum. Medical Imaging Devices (in vivo diagnosis)12Theoretical background: MedicaMedical Laboratory Devices (in vitro diagnosis)sample separation, centrifugation etcelectrophoresis, capillary electrophoresi

14、s pH / ISE meters particle / cell countersspectrophotometers flow cytometry microscopyHPLC (chromatography)clinical chemistryhaematologyimmunologyscintillation systemsgenetic analysis 13Medical Laboratory Devices (inTheoretical background:Structure of biopolymers, properties of water and electrolyte

15、s, electric properties of living matter, galvanic cell, sedimentation of particles, dosimetry, light absorption Medical Laboratory Devices (in vitro diagnosis)14Theoretical background:MedicalPhysiological Measurement Devices (in vivo diagnosis)Instruments for measuring physical and chemical variable

16、s in vivoThermometers Cardiovascular physiology: blood pressure monitors, flowmeters, pulsed Doppler US systemsElectrophysiology: ECG, EEG, EMGAudiology and ophthalmologyRespiratory physiology: spirometers, pulse oximetry, impedance pneumograph.Endoscopes15Physiological Measurement DeviPhysiological

17、 Measurement Devices (in vivo diagnosis)Theoretical background:Introduction to thermodynamics, basic laws of hydrodynamics, origin of bioelectric potentials, properties of sound and light, ear and hearing, eye and vision, mechanical properties of living matter16Physiological Measurement DeviECG (aka

18、 EKG)sphygmomanometerScreen of a multipurpose clinical monitor17ECG (aka EKG)sphygmomanometerSPaediatric Intensive Care18Paediatric Intensive Care18Endoscopy19Endoscopy19Radiotherapy DevicesX-ray and electron, resp. hadron beams from accelerators (shape, direction, and intensity of beam changed ofte

19、n continuously)gamma-ray beams from tele-isotope radioactive sources like Co-60treatment planning systems simulatorsbrachytherapydosimetersLinear acceleratorLeksell gamma knife20Radiotherapy DevicesX-ray and Radiotherapy DevicesTheoretical background:Ionising radiation (origin, measurement, interact

20、ions with matter), properties of atom nucleus, radioactivity, biological effects of ionising radiation, dosimetry.21Radiotherapy DevicesTheoreticaPhysical therapy DevicesElectrotherapyUV and IR therapyShortwave diathermyUltrasound therapyLaser therapyMuscle stimulatorLaser therapy unitUltrasound the

21、rapy unitShortwave diathermy22Physical therapy DevicesElectrPhysiotherapy DevicesTheoretical backgroundBiological interactions of ultrasound, electromagnetic fields, electric current, infrared, visible and ultraviolet light, laser principle.23Physiotherapy DevicesTheoreticPOC (Point of Care) Devices

22、Address clinicians requirements for rapid access to information to support critical care decisionsAdvances in microelectronics and biosensor tools have brought technology to the bedside in a miniaturized form. Examples:Performing blood tests at the patients side rather than in a central laboratorypo

23、rtable ultrasound imaging devices24POC (Point of Care) DevicesAddSurgical Theatre Devices, LithotripsyOperating lampsanaesthesiaelectrocauterycryosurgery25Surgical Theatre Devices, LithSurgical Theatre Devices, LithotripsyTheoretical backgroundBiological interactions of ultrasound, electromagnetic f

24、ields, electric current, infrared, visible and ultraviolet light, laser principle, low temperatures, acoustic shock waves26Surgical Theatre Devices, LithSurgical Theatre Devices27Surgical Theatre Devices27Surgical Theatre Devices28Surgical Theatre Devices28Prosthetic Devices - ImplantsRobotic device

25、 for knee prosthesis implantation29Prosthetic Devices - ImplantsRProsthetic Devices Artificial Organs“Artificial heartCochlear implantRetinal implantVentilatorCardiopul-monary bypass30Prosthetic Devices ArtificiProsthetic Devices Artificial Organs“Stents are inserted into the damaged blood vessels,

26、oesophagus etc. They are often made of a metal with a shape memory“ nitinol, which adopts the intended shape when heated to body temperature.31Prosthetic Devices ArtificiDisposable Medical DevicesSuction catheterUmbilical cord clampI.V. cannulae32Disposable Medical DevicesSuctDevices for Self-testin

27、g (home devices)device for self-testing: any device intended by the manufacturer to be able to be used by lay persons in a home environmentthermometers, pressure measuring instruments etctest kits (pregnancy, glucose levels in blood used by diabetes patients etc)Blood glucose meter33Devices for Self

28、-testing (homDevices for Performance Evaluation of Devicesdevice for performance evaluation: devices to check the performance of medical devices are also considered as medical devicesTesting contrast resolution in XRI34Devices for Performance EvaluaWhat is the Purpose of this Course?Create awareness

29、 that medical devices should be used effectively and safely (reduce patient, occupational and others risk to a minimum)Use medical devices in a professional and scientific mannerAppreciate uses of medical devices in the clinical areas and in researchHave an idea of the devices used in other professi

30、ons35What is the Purpose of this CoSome Competences for Users of Medical DevicesWhat is expected the doctor does with or knows about the deviceState the specific diagnostic, therapeutic etc outcomes expected when using the deviceExplain the physics principles underpinning the functioning of the devi

31、ce and the device use protocols Describe the structure of commercially available devices including user option settings and controlsIdentify possible health hazards (e.g. mechanical, electrical, radiation etc) to patient, self and colleaguesDescribe measurable objective device performance indicators which are directly related to device effectiveness or safety36Some Competences for Use