Life Span Of Biomedical Devices - Guidance Paper Draft

Transcription

Biomedical EngineeringAdvisory GroupGuidancePaperLife span of Biomedical DevicesBackgroundAn indication of the typical age a biomedical device can be expected to be economically useful under normaloperating circumstances can be a valuable tool in asset management and financial planning activities.A table listing biomedical device categories and a typical life span for each category is published by theAmerican Hospitals Association (AHA) and is based on information gathered from the manufacturers of thedevices and from the health care professions represented by AHA.The South Australian Biomedical Engineering Advisory Group uses the AHA publication as a reference indeveloping and maintaining the following list of typical life spans which instead of AHA category names usesthe ECRI Universal Medical Device Nomenclature System of naming device categories as is used by BEAGmember health units. There are differences from the life spans nominated by the AHA to reflect BEAGmember experience in the South Australian environment.Discussion on the use of life span informationThe Life Span estimates provided in this document are a guide only and do not always indicate an age afterwhich biomedical devices should not be used.In some cases the life of a biomedical device may be longer or shorter depending on a number of factors,including the: Frequency of useNature of useEnvironment of useExperience and knowledge of the userCare and attention paid to use and operator maintenanceExistence, capability and cost of maintenance supportStage in product life cycleManagement of scheduled and unscheduled maintenanceAvailability and cost of consumables and spare partsAvailability and cost of replacement devicesRelative efficacy and effectiveness of the alternative methods and devicesBusiness and safety risks associated with continued or discontinued useStrategic and political risks associated with continued or discontinued useCompliance with current codes and standardsTechnological or clinical redundancyFunding availabilityBEAG recommends that a risk management approach is taken when developing a replacement program forBiomedical Devices and that risk factors, including those above, are considered together with the age/lifespan ratio. 2004 Biomedical Engineering Advisory Group SAlast updated March 2004

Expected Life SpansGMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS TERS101217540ABSORPTIOMETERS, X-RAY8415810ACCELEROMETERS10415893ACOUSTICAL CASEWALLS7450033ACTIVITY MONITORS7416969ADAPTER CABLES, PRESSURE TRANSDUCERS71217787ADAPTOR/CONNECTORS, ANGIOPLASTY BALLOON DILATION CATHETERS7410046AEROSOL GENERATORS10415010AIR DETECTORS, HEART-LUNG BYPASS5610051AIR SAMPLERS10417764AIRFLOW DETECTORS, AIRWAY7411588ALARMS, ENURESIS10412879ALARMS, OXYGEN DEPLETION5615089ALCOHOL ANALYZERS10412928ALTERNATING PRESSURE PADS10410082AMALGAMATORS10615090AMINO ACID ANALYZERS8217616ANAESTHESIA UNIT ABSORBERS7210140ANAESTHESIA UNIT ABSORBERS, CARBON DIOXIDE7217509ANAESTHESIA UNIT CARBON DIOXIDE ABSORBENTS7210142ANAESTHESIA UNIT GAS SCAVENGERS10210144ANAESTHESIA UNIT VAPORIZERS10210145ANAESTHESIA UNIT VENTILATORS10210134ANAESTHESIA UNITS10215014ANALGESIA UNITS7450035ANALYSERS, NERVE TRAFFIC7916996ANGIOSCOPES7616405APHERESIS UNITS7212575APNEA MONITORS10217885APNEA MONITORS, RECORDING10410172APPLICATORS7415689APPLICATORS, OTHER7416397APPLICATORS, VAGINAL7416446APPLIERS7416443APPLIERS, ANEURYSM CLIP7416444APPLIERS, CERCLAGE, ORTHOPEDIC7417684APPLIERS, HEMOSTATIC CLIP7417685APPLIERS, HEMOSTATIC CLIP, DISPOSAL7416445APPLIERS, HEMOSTATIC CLIP, REUSABLE7417673APPROXIMATORS7417674APPROXIMATORS, TENDON7417675APPROXIMATORS, VESSEL7417739ARGON BEAM COAGULATION SYSTEMS7410198ARTHROSCOPES7 2004 Biomedical Engineering Advisory Group SAPage 2 of 29

GMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS 310212ASPIRATORS, DENTAL15415016ASPIRATORS, EMERGENCY15410214ASPIRATORS, INFANT15410215ASPIRATORS, LOW VOLUME15410217ASPIRATORS, SURGICAL15410218ASPIRATORS, THORACIC15410219ASPIRATORS, TRACHEAL15415756ASPIRATORS, ULTRASONIC10410224ATAXIAGRAPHS7416303AUDIOMETERIC EVOKED POTENTIAL UNITS7410228AUDIOMETERS10410229AUDIOMETRIC BOOTHS151350000AUDIO-VISUAL EQUIPMENT7410239AUTOTRANSFUSION UNITS8610261BALANCES7610263BALANCES, ELECTRONIC7610264BALANCES, MECHANICAL101317220BAR CODE RECORDERS7610297BASAL METABOLISM UNITS8415555BATHS10615106BATHS, FREEZING7412956BATHS, PARAFFIN, PHYSICAL THERAPY15615107BATHS, TISSUE FLOATING7615108BATHS, WATER10616861BATHS, WATER, LABORATORY10616772BATHS, WATER, SHAKER7614450BATHS, WHIRLPOOL10410316BATHTUBS, PORTABLE10416337BATTERIES, MEDICAL DEVICE21317115BATTERY CHARGERS1010416889BEDS, AIR FLUIDIZED1210351BEDS, INOMETERS, CUTANEOUS10410396BIOFEEDBACK SYSTEMS10410397BIOLOGICAL MONITORING SYSTEMS10915558BLADES7912234BLADES, KNIFE10913447BLADES, SAW10616857BLOOD CELL PROCESSORS10615973BLOOD CULTURE ANALYZERS, AUTOMATIC10410429BLOOD FLOW DETECTORS, ULTRASONIC10612590BLOOD GAS MONITORS, OXYGEN8615709BLOOD GAS/pH ANALYZERS8616488BLOOD GLUCOSE MONITORS, PORTABLE8411303BOTTLES, DRAINAGE15617475BREATH ANALYZERS, ALCOHOL7 2004 Biomedical Engineering Advisory Group SAPage 3 of 29

GMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS DescriptionLifeExpectancy(years)210139BREATHING CIRCUITS, ANAESTHESIA7216987BREATHING CIRCUITS, OXYGEN ADMINISTRATION7215003BREATHING CIRCUITS, , FLEXIBLE5917662BRONCHOSCOPES, FLEXIBLE, VIDEO5915074BRONCHOSCOPES, RIGID10410510BUBBLE DETECTORS10615092BUN ANALYZERS6615111BURETS7515812CABINETS, DRYING7510534CABINETS, INSTRUMENT16615814CABINETS, LABORATORY12515205CABINETS, OTHER7510538CABINETS, TREATMENT, ULTRAVIOLET7415308CABLES, FIBREOPTIC5415754CABLES/LEADS, ECG2615779CAGES, ANIMAL7616940CALCIUM 15019CALIBRATORS, ANAESTHESIA UNIT101315785CALIBRATORS, INFUSION DROP-RATE151313114CALIBRATORS, PRESSURE TRANSDUCER151313275CALIBRATORS, RADIOISOTOPE101315020CALIBRATORS, RESPIRATORY THERAPY UNIT101317250CALIBRATORS, SPIROMETER/PNEUMOTACHOMETER15416613CALIPERS, ECG7416267CALIPERS, SKINFOLD, ELECTRONIC7410548CALORIC IRRIGATION RAS, ENDOSCOPIC8410551CAMERAS, FUNDUS81215944CAMERAS, GAMMA81216891CAMERAS, GAMMA, MOBILE101216892CAMERAS, GAMMA, STATIONARY10410552CAMERAS, IDENTIFICATION8615815CAMERAS, MICROSCOPE10615823CAMERAS, MULTI-IMAGE101310558CAMERAS, OSCILLOSCOPE10410559CAMERAS, SURGICAL7417001CAMERAS, VIDEO8417002CAMERAS, VIDEO, ENDOSCOPIC7410211CANISTERS, ASPIRATOR COLLECTION7410561CANNULAE7417640CANNULAE, LIPOSUCTION7416081CAPS10 2004 Biomedical Engineering Advisory Group SAPage 4 of 29

GMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS Description410588CARBON DIOXIDE ANALYZERS5416938CARBON DIOXIDE MONITORS, EXHALED GAS10415970CARBON DIOXIDE MONITORS, TRANSCUTANEOUS10615093CARBON MONOXIDE ANALYZERS81350074CARD WRITERS10410613CARDIAC OUTPUT UNITS6416177CARDIAC OUTPUT UNITS, DYE DILUTION7415207CARDIAC OUTPUT UNITS, OTHER7410615CARDIAC OUTPUT UNITS, THERMAL DILUTION7410635CARTS15410641CARTS, INSTRUMENT15410647CARTS, RESUSCITATION15415889CARTS, SERVICE/UTILITY25415891CARTS, SURGICAL CARE15410656CAST CUTTER VACUUMS6410655CAST CUTTERS10416340CAST CUTTERS, ELECTRIC10416341CAST CUTTERS, MANUAL15410662CASTING UNITS, DENTAL8410673CATARACT EXTRACTION UNITS7410685CATHETERS7616582CELL ANALYZERS10615113CELL SEPARATORS10616503CELL SORTERS7610778CENTRIFUGES10615115CENTRIFUGES, BLOOD BANK7616815CENTRIFUGES, CELL WASHING, AUTOMATIC8610779CENTRIFUGES, MICROHAEMATOCRIT10615117CENTRIFUGES, REFRIGERATED8610780CENTRIFUGES, TABLETOP8412597CEREBRAL FUNCTION ANALYZERS7510787CHAIRS7515690CHAIRS, ADJUSTABLE HEIGHT7510792CHAIRS, DENTAL10515723CHAIRS, OPHTHALMIC10515210CHAIRS, OTHER10510789CHAIRS,BLOOD DRAWING7510799CHAIRS. PODIATRIC15615566CHAMBERS7616335CHAMBERS, ANAEROBIC7212061CHAMBERS, HYPERBARIC15212076CHAMBERS, HYPOBARIC7816800CHARTS, EYE, VISUAL ACUITY10910824CHISELS7910825CHISELS, BONE7910827CHISELS, MASTOID10916400CHISELS, MIDDLE EAR7910828CHISELS, NASAL7 2004 Biomedical Engineering Advisory Group SALifeExpectancy(years)Page 5 of 29

GMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS Description910829CHISELS, ORTHOPEDIC7915211CHISELS, 15568CHROMATOGRAPHY EQUIPMENT7615120CHROMATOGRAPHY EQUIPMENT, GAS10615121CHROMATOGRAPHY EQUIPMENT, LIQUID7616278CHROMATOGRAPHY EQUIPMENT, LIQUID, HIGH PERFORMANCE7615122CHROMATOGRAPHY EQUIPMENT, PAPER7410839CIRCULATORY ASSIST UNITS7410846CIRCULATORY ASSIST UNITS, INTRA-AORTIC BALLOON8910861CLAMPS5910864CLAMPS, AORTA7910866CLAMPS, BONE7910867CLAMPS, BRONCHUS10910868CLAMPS, BULLDOG15916449CLAMPS, CANNULA7915878CLAMPS, CAROTID7910869CLAMPS, CIRCUMCISION10915879CLAMPS, COARCTATION7910870CLAMPS, HEMORRHOIDAL10910871CLAMPS, INTESTINAL5916450CLAMPS, OPHTHALMIC7915212CLAMPS, OTHER7916451CLAMPS, OTOGIC7910872CLAMPS, PATENT DUCTUS2915881CLAMPS, PEDIATRIC7916452CLAMPS, PENILE7915671CLAMPS, RECTAL7915025CLAMPS, SKULL7910875CLAMPS, TUBING7910876CLAMPS, UMBILICAL7916453CLAMPS, UTERINE7915882CLAMPS, VASCULAR7415013CLEANERS8410995CLEANERS, CONTACT LENS10615551CLINICAL CHEMISTRY ANALYZERS8616300CLINICAL CHEMISTRY ANALYZERS, AUTOMATED, CENTRIFUGAL7616301CLINICAL CHEMISTRY ANALYZERS, AUTOMATED, CONTINOUS FLOW7616299CLINICAL CHEMISTRY ANALYZERS, AUTOMATED, DISCRETE7616302CLINICAL CHEMISTRY ANALYZERS, MANUAL7910894CLIP APPLIERS7910895CLIP REMOVERS7915569CLIPPERS7911939CLIPPERS, HAIR7912695CLIPPERS, NAIL7910898CLIPS7910905CLIPS, ANUERYSM7 2004 Biomedical Engineering Advisory Group SALifeExpectancy(years)Page 6 of 29

GMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS Description910901CLIPS, BANDAGE7910902CLIPS, DRAPE7910903CLIPS, HEMOSTATIC7916052CLIPS, IMPLANTABLE, MALLEABLE10910904CLIPS, INSTRUMENT7910906CLIPS, IRIS10916457CLIPS, LENS IMPLANTATION7910907CLIPS, NOSE7915213CLIPS, OTHER7910908CLIPS, PENIS7910909CLIPS, SCALP7910910CLIPS, SKIN7910911CLIPS, SUTURE7910914CLIPS, TOWEL7916028CLIPS, VASCULAR7910915CLIPS, VASCULAR, VENA CAVAL7910916CLIPS, WOUND7615098COAGULATION ANALYZERS, AUTOMATED51350083COIN COUNTING MACHINES10650067COLLATOR SPACESAVERS7615142COLLECTORS, FRACTION7910950COLONOSCOPES5917665COLONOSCOPES, MUNICATION AIDS10416993COMMUNICATION AIDS, PATIENT/STAFF7417187COMMUNICATION AIDS, VOICE SYNTHESISER10410969COMPRESSION UNITS, INTERMITTENT10416837COMPRESSION UNITS, SEQUENTIAL10610972COMPRESSORS, AIR15615124COMPUTER INFORMATION SYSTEMS, LABORATORY71316902COMPUTER INTERFACES51350005COMPUTER TERMINALS, CRT51350006COMPUTER TERMINALS, HARD COPY51310977COMPUTERS5410981COMPUTERS, ECG INTERPRETATION71316276COMPUTERS, MICRO, LABORATORY71316277COMPUTERS, MINI, LABORATORY71215678COMPUTERS, NUCLEAR MEDICINE7410984COMPUTERS, PULMONARY FUNCTION LABORATORY101213281COMPUTERS, RADIOTHERAPY PLANNING SYSTEM71350004COMPUTERS, WORD PROCESSING5616456CONCENTRATORS, SPECIMEN71316280CONDUCTIVITY METERS10817525CONTACT LENSES, VISION CORRECTIVE7916767CONTAINERS7616534CONTAINERS, CRYOBIOLOGICAL STORAGE7 2004 Biomedical Engineering Advisory Group SALifeExpectancy(years)Page 7 of 29

GMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS Description616535CONTAINERS, LIQUID NITROGEN211001CONTINUOUS POSITIVE AIRWAY PRESSURE UNITS7411009CONTROLLERS10413994CONTROLLERS, TEMPERATURE10415664CONTROLLERS, TEMPERATURE, HUMIDIFIER10415665CONTROLLERS, TEMPERATURE, OTHER7616539CONTROLLERS, TEMPERATURE, PROGRAMMABLE71350050COPIERS, PHOTO, MICROIMAGE10615125COUNTERS, BACTERIA7615112COUNTERS, CELL5615132COUNTERS, CELL, DIFFERENTIAL9615126COUNTERS, COLONY8616381COUNTERS, GAMMA8412168COUNTERS, INTRAVENOUS DROP10615184COUNTERS, SCINTILLATION8415571COVERS7415765COVERS, CAMERS7415778COVERS, CLAMP10415764COVERS, FOOTSWITCH10412467COVERS, MATTRESS7612535COVERS, MICROSCOPE7615127CRYOGENIC BLOOD BANKING EQUIPMENT10411066CRYOMETERS7411067CRYOSURGICAL UNITS, GENERAL-PURPOSE10411068CRYOSURGICAL UNITS, OPHTHALMIC10411071CUFF RS7915573CUTTERS7910455CUTTERS, BONE5917117CUTTERS, MENISCUS10913041CUTTERS, PIN AND WIRE7913399CUTTERS, RING5916224CUTTERS, SUTURE10913923CUTTERS, SYRINGE AND STOSCOPES10417145CYSTOSCOPES, RIGID10616867CYTOMETERS, FLOW, CLINICAL LABORATORY7650039D.N.A. SEQUENCERS7650034D.N.A. SYNTHESIZERS7417204DATA ANALYSIS SYSTEMS, ULTRASOUND, CARDIAC71311127DEFIBRILLATOR ANALYZERS15411130DEFIBRILLATOR PADDLE TOR/MONITORS, LINE POWERED15 2004 Biomedical Engineering Advisory Group SALifeExpectancy(years)Page 8 of 297

GMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS R/MONITORS, LLATORS, AUTOMATIC7411134DEFIBRILLATORS, BATTERY POWERED7411133DEFIBRILLATORS, INTERNAL15411137DEFIBRILLATORS, LINE POWERED71350059DEMAGNETIZERS7616905DENSITOMETERS, LABORATORY, SCANNING81216548DENSITOMETERS, RADIATION10311165DENTAL DELIVERY UNITS10311156DENTAL ENGINES10311160DENTAL HAND INSTRUMENTS10316662DENTAL HAND INSTRUMENTS, ENDODONTIC7316663DENTAL HAND INSTRUMENTS, OPERATIVE10316664DENTAL HAND INSTRUMENTS, ORTHODONTIC7316667DENTAL HAND INSTRUMENTS, OTHER7316665DENTAL HAND INSTRUMENTS, PERIDONTAL7316666DENTAL HAND INSTRUMENTS, SURGICAL7316839DENTAL STONES7313938DENTAL SYRINGES7317111DENTAL SYRINGES, ANAESTHETIC7317112DENTAL SYRINGES, IRRIGATING10411179DERMATOMES101311202DEVICE STATUS TAGS71311206DIALYSATE CONDUCTIVITY METERS10411213DIALYSATE DELIVERY SYSTEMS, SINGLE PATIENT101311228DIALYSIS UNIT TEST EQUIPMENT10416018DIALYZER REPROCESSING UNITS7411230DIALYZERS101316362DIATHERMY UNIT ANALYZERS, SHORTWAVE15411244DIATHERMY UNITS10411245DIATHERMY UNITS, MICROWAVE15415874DIATHERMY UNITS, OPHTHALMIC7411246DIATHERMY UNITS, SHORTWAVE151216560DIGITAL RADIOGRAPHY LATORS, CARDIAC7916469DILATORS, CERVICAL7911256DILATORS, COMMON DUCT15911257DILATORS, ESOPHAGEAL7911259DILATORS, LACRIMAL15911260DILATORS, NASAL15915215DILATORS, OTHER7911261DILATORS, PULMONARY10911262DILATORS, RECTAL10916550DILATORS, SALIVARY DUCT7911263DILATORS, TRACHEAL10 2004 Biomedical Engineering Advisory Group SAPage 9 of 29

GMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS Description911264DILATORS, TUBAL15916468DILATORS, URETERAL7911265DILATORS, URETHRAL7911266DILATORS, UTERINE10911267DILATORS, VAGINAL10911268DILATORS, VASCULAR7615133DILUTERS10616404DILUTERS, BLOOD SERS, FLUID7616274DISPENSERS, LIQUID, LABORATORY7615136DISTILLING UNITS15616333DOSIMETERS10611295DOSIMETERS, RADIATION10911329DRILLS10911330DRILLS, BIOPSY7911331DRILLS, BONE10911332DRILLS, CANNULATED7911334DRILLS, CRANIAL10911337DRILLS, FINGERNAIL15911338DRILLS, INTERMEDULLARY7911339DRILLS, MIDDLE EAR SURGERY7911342DRILLS, PERFORATOR7911347DRIVER/ EXTRACTORS, BONE CTORS, BONE, NAIL-PIN15916868DRIVERS7910458DRIVERS, BONE STAPLE7912398DRIVERS, NAIL7417133DRYERS10615985DRYERS, LABWARE10911359DUODENOSCOPES5917654DUODENOSCOPES, VIDEO5411367DYNAMOMETERS, SQUEEZE15412599ECG MONITORS7412601ECG MONITORS, ARRHYTHMIA7413988ECG MONITORS, ALOGRAPHS10411389ECHOOPHTHALMOGRAPHS7412602EEG MONITORS101311399ELECTRICAL SAFETY ANALYZERS15411410ELECTROCARDIOGRAPH CABLE TESTERS15416231ELECTROCARDIOGRAPHS, INTERPRETIVE10411411ELECTROCARDIOGRAPHS, MULTI-CHANNEL10417687ELECTROCARDIOGRAPHS, SIGNAL AVERAGING10411413ELECTROCARDIOGRAPHS, SINGLE-CHANNEL10 2004 Biomedical Engineering Advisory Group SALifeExpectancy(years)Page 10 of 29

GMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS Description411418ELECTROCAUTERY UNITS12411422ELECTROCAUTERY UNITS, LINE POWERED15411484ELECTROCONVULSIVE THERAPY UNITS151316999ELECTRODE IMPEDANCE ANALYZERS10650058ELECTRODE PULLERS7611432ELECTRODES, BLOOD GAS, CARBON DIOXIDE5611433ELECTRODES, BLOOD GAS, OXYGEN5415033ELECTRODES, 0ELECTROLYTE ANALYZERS7616530ELECTROLYTE ANALYZERS, FLAME IC POWER ROPHORESIS EQUIPMENT8411485ELECTROSLEEP UNITS51311489ELECTROSURGICAL UNIT ANALYZERS10411490ELECTROSURGICAL UNITS10416137ELECTROSURGICAL UNITS, GENERAL PURPOSE10416138ELECTROSURGICAL UNITS, SPECIALITY15411503ELECTROTHERAPEUTIC UNITS15411504ELEVATORS7816479ELEVATORS, CORNEAL7416480ELEVATORS, DENTAL7411506ELEVATORS, ENT7411507ELEVATORS, NEUROSURGICAL7411508ELEVATORS, ORTHOPEDIC7415218ELEVATORS, OTHER7415678ELEVATORS, UTERINE7650062ELISA PLATE WASHING MACHINES7416159EMERGENCY KITS10911576ENDOSCOPIC POWER SUPPLIES10911577ENDOSCOPIC POWER SUPPLIES, BATTERY OPERATED5911578ENDOSCOPIC POWER SUPPLIES, LINE OPERATED7916403ENDOSCOPIC TEACHING ATTACHMENTS7411585ENT TREATMENT UNITS12411587ENUCLEATORS7615101ENZYME ANALYZERS5616217ENZYME IMMUNOASSAY ANALYZERS7411592ERGOMETERS10410383ERGOMETERS, BICYCLE7411600ESOPHOGEAL MOTILITY ANALYZERS7615139EVAPORATORS7411614EVOKED POTENTIAL UNITS10411620EXERCISE STAIRS7411623EXERCISERS15411625EXERCISERS, ARM7410385EXERCISERS, BICYCLE10 2004 Biomedical Engineering Advisory Group SALifeExpectancy(years)Page 11 of 29

GMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS Description411631EXERCISERS, CONTINUOUS PASSIVE MOTION15411629EXERCISERS, HAND7411630EXERCISERS, LEG AND ANKLE7415220EXERCISERS, OTHER10416442EXHAUST SYSTEMS, EYEGLASSES, SAFETY, LASER7415697EYEWEAR, 1FILES7411710FILTERS6416904FILTRATION SYSTEMS7411744FLOW TIMERS7411746FLOWMETERS7410430FLOWMETERS, BLOOD7410431FLOWMETERS, BLOOD, ELECTROMAGNETIC7416903FLOWMETERS, BLOOD, LASER7410432FLOWMETERS, BLOOD, ULTRASONIC10411748FLOWMETERS, GAS15415965FLOWMETERS, PULMONARY FUNCTION7616218FLUORESCENCE IMMUNOASSAY ANALYZERS7411692FOETAL HEART DETECTORS10411696FOETAL HEART DETECTORS, ULTRASONIC10412610FOETAL MONITORS10412612FOETAL MONITORS, pH10911774FORCEPS7911775FORCEPS, BIOPSY7916268FORCEPS, BIOPSY, FLEXIBLE ENDOSCOPIC7916270FORCEPS, BIOPSY, OTHER7916269FORCEPS, BIOPSY, RIGID ENDOSCOPIC7915760FORCEPS, BONE10915710FORCEPS, DENTAL7911502FORCEPS, ELECTROSURGICAL7911779FORCEPS, LAPAROSCOPIC7415582FRAMES7615162FREEZER MONITORS2615583FREEZERS12615144FREEZERS, BLOOD PLASMA12615145FREEZERS, LABORATORY10411814FUME EVACUATORS10650060GAS FLOW CONTROLLERS15411848GAS SAMPLING ASTROSCOPES, FLEXIBLE5417663GASTROSCOPES, FLEXIBLE, VIDEO5 2004 Biomedical Engineering Advisory Group SALifeExpectancy(years)Page 12 of 29

GMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS DescriptionLifeExpectancy(years)615102GLUCOSE ANALYZERS71350061GLUE GUNS10411895GOUGES7411912GRAFTS, SKIN51350068GRINDERS, DISC81311919GROUND FAULT CIRCUIT INTERRUPTER TESTERS151311920GROUND FAULT CIRCUIT INTERRUPTERS151311923GROUNDING SYSTEM TESTERS15415835GROUNDING SYSTEMS15411925GUIDE WIRES7411927GUIDES7411930GUIDES, DRILL7411931GUIDES, GIGLI SAW7417688GUIDES, 9HAEMODIALYSIS UNIT AIR BUBBLE-FOAM DETECTORS7411220HAEMODIALYSIS UNIT BLOOD PUMPS7411222HAEMODIALYSIS UNIT CONDUCTIVITY MONITORS7411218HAEMODIALYSIS UNITS7415039HAEMOFILTRATION UNITS7615146HAEMOGLOBINOMETERS10411941HALONGENATED ANAESTHETIC ANALYSERS7650069HALOTHANE CABINETS7411947HAMMERS7411949HAMMERS, NEUROLOGICAL7411950HAMMERS, PERCUSSION7311161HANDPIECES, DENTAL5917949HANDPIECES, SURGICAL7411960HEAD HEARING AID ANALYZERS10411967HEARING AIDS10412614HEART RATE MONITORS10415233HEART RATE MONITORS, OTHER10412618HEART RATE MONITORS, R-WAVE10411969HEART-LUNG BYPASS UNITS10411978HEAT EXCHANGERS10411973HEAT EXCHANGERS, HEART-LUNG BYPASS10413318HEAT EXCHANGERS, REGIONAL PERFUSION7615105HEATING BLOCKS7411988HEATING PADS, CIRCULATING FLUID15411989HEATING PADS, ELECTRIC10416509HEATING UNITS, HOT PACK15615304HOMOGENIZERS, TISSUE7612022HOODS, FUME15612025HOODS, ISOLATION, LAMINAR AIR FLOW10 2004 Biomedical Engineering Advisory Group SAPage 13 of 29

GMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS Description615148HOODS, MICRIBIOLOGICAL12912028HOOKS7915225HOOKS, OTHER7915673HOOKS, RECTAL7912033HOOKS, RHINOPLASTIC7912034HOOKS, SCLERAL FIXATION7912035HOOKS, SKIN7912038HOOKS, TRACHEAL7416780HOSES, COMPRESSED GAS7416982HOT DRY AIR/ FLUIDIZED MEDIUM UNITS5412047HUMIDIFIERS10415645HUMIDIFIERS, HEAT/MOISTURE EXCHANGE10412050HUMIDIFIERS, HEATED10450009HYDROGEN CLEARANCE DETECTORS7417700HYPERTHERMIA UNITS, CIRCULATING AIR7412068HYPO/HYPERTHERMIA UNITS10412078HYPOTHERMIA UNITS10412081HYSTEROSCOPES101215963IMAGE INTENSIFIERS71216593IMAGE STORAGE DEVICES, FLUOROSCOPIC7650010IMMUNOCHEMISTRY ANALYSERS7412103IMPEDANCE CARDIOGRAPHS10412621IMPEDANCE PNEUMOGRAPH MONITORS7417637IMPLANTABLE PACEMAKER ANALYSERS8412112INCUBATORS10615151INCUBATORS, AEROBIC10615152INCUBATORS, ANAEROBIC10412113INCUBATORS, INFANT15412114INCUBATORS, INFANT, TRANSPORT15615272INCUBATORS, TEST TUBE, PORTABLE10615273INCUBATORS, TEST TUBE, STATIONARY10417513INFORMATION STORAGE UNITS, OPTICAL DISK71316720INFUSION PUMP ANALYZERS15416495INFUSION PUMPS10416491INFUSION PUMPS, AMBULATORY10417159INFUSION PUMPS, AMBULATORY, INSULIN10416721INFUSION PUMPS, AMBULATORY, OTHER10415782INFUSION PUMPS, AMBULATORY, SYRINGE10413215INFUSION PUMPS, GENERAL PURPOSE10417634INFUSION PUMPS, GENERAL PURPOSE, MULTI-CHANNEL10416924INFUSION PUMPS, PATIENT CONTROLLED ANALGESIC10413217INFUSION PUMPS, SYRINGE10413220INFUSION-WITHDRAWAL PUMPS7415284INJECTORS, ANGIOGRAPHIC101217969INJECTORS, CONTRAST MEDIA, COMPUTED TOMOGRAPHY71216594INJECTORS, HAND HELD10412504INJECTORS, MEDICATION/VACCINE7412144INSUFFLATORS10 2004 Biomedical Engineering Advisory Group SALifeExpectancy(years)Page 14 of 29

GMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS Description416848INSUFFLATORS, HYSTEROSCOPIC10416849INSUFFLATORS, LAPAROSCOPIC10650036INTEGRATORS71350011INTERFACE UNITS, ANALOG71350012INTERFACE UNITS, DIGITAL51350040INTERFACE UNITS, NETWORK5450064INTRAOCULAR MICROSURGERY SYSTEMS7612185IONTOPHORESIS UNITS7417437IRRADIATORS, BLOOD10415585IRRIGATION KITS7417233IRRIGATION/DISTENTION SYSTEMS, ARTHROSCOPIC10415817ISOLATED POWER SYSTEMS15415586JARS7416347KERATOSCOPES7912235KNIFE HANDLES10912236KNIFE HOLDERS10912239KNIVES10916583KNIVES, ADENOTOME7912240KNIVES, AMPUTATING10912241KNIVES, CATARACT10912243KNIVES, DERMATOME10912244KNIVES, DURAL HOOK10912245KNIVES, EAR10912247KNIVES, KERATOME10912248KNIVES, MENISCUS7912249KNIVES, MICROTOME10915226KNIVES, OTHER7912251KNIVES, PLASTER10912252KNIVES, SCALPEL5917705KNIVES, SCALPEL, HEMOSTATIC7912253KNIVES, SKIN GRAFTING10912254KNIVES, STERNUM10912255KNIVES, TONSIL10615153LABWARE, BASIC10412268LAMINAR AIR FLOW UNITS10615279LAMINAR AIR FLOW UNITS, FIXED7916240LAPAROSCOPE HOLDERS10912293LARYNGOSCOPES7915075LARYNGOSCOPES, FLEXIBLE5915076LARYNGOSCOPES, RIGID7912294LARYNGOSTROBOSCOPES7410204LARYNX, ARTIFICIAL7412296LASERS10416944LASERS, OPHTHALMIC10416945LASERS, OPHTHALMIC, ARGON10416948LASERS, OTHER10415757LASERS, SURGICAL7416942LASERS, SURGICAL, CARBON DIOXIDE10 2004 Biomedical Engineering Advisory Group SALifeExpectancy(years)Page 15 of 29

GMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS DescriptionLifeExpectancy(years)417771LASERS, SURGICAL, CARBON-DIOXIDE, GENERAL PURPOSE7416943LASERS, SURGICAL, Nd:YAG10417447LASERS, SURGICAL, OTHER7412299LASERS, THERAPEUTIC10350057LATHES, DENTAL8412300LAVAGE UNITS8412306LAVAGE UNITS, SURGICAL81312311LEAKAGE CURRENT METERS10412326LENSOMETERS12412327LESION GENERATORS7412330LIFTS, PATIENT10412340LIGHT SOURCES10412345LIGHT SOURCES, FIBREOPTIC10412343LIGHT SOURCES, FIBREOPTIC, FLEXIBLE ENDOSCOPIC7416831LIGHT SOURCES, FIBREOPTIC, RIGID ENDOSCOPIC/MULTI-PURPOSE10412346LIGHT SOURCES, FLASH7616438LIGHT SOURCES, MICROSCOPIC15412347LIGHTS7312351LIGHTS, DENTAL15412276LIGHTS, EXAMINATION15415866LIGHTS, EXAMINATION, CEILING MOUNTED15412278LIGHTS, INFRARED15415228LIGHTS, OTHER15412282LIGHTS, SURGICAL15412283LIGHTS, ULTRAVIOLET10416386LIGHTS, ULTRAVIOLET, DENTAL ACTIVATOR8412284LIGHTS, ULTRAVIOLET, GERMICIDAL7415762LIGHTS, ULTRAVIOLET, OTHER10415731LIGHTS, ULTRAVIOLET, UVA101350013LINE CONDITIONERS10412361LINE ISOLATION MONITORS151212364LINEAR ACCELERATORS7416230LITHOTRIPTORS, ULTRASONIC107412379LITHOTRITES1216260MAGNETIC RESONANCE IMAGING (MRI) UNITS7412415MAGNETIC UNITS, THERAPEUTIC10415269MAGNETS, EYE10912421MALLETS7912423MALLETS, BONE7912423MALLETS, DENTAL7915229MALLETS, OTHER7415042MANIFOLDS, GAS15416864MANOMETER SETS7412443MARKERS, SKIN7415662MASSAGE MACHINES, PHYSICAL GES7412529MICROELECTRODE AMPLIFIERS7 2004 Biomedical Engineering Advisory Group SAPage 16 of 29

GMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS Description412530MICROELECTRODE DER APPARATUS7612536MICROSCOPES7812537MICROSCOPES, CORNEAL8412538MICROSCOPES, EAR7615588MICROSCOPES, LABORATORY15615044MICROSCOPES, LABORATORY, ELECTRON15615156MICROSCOPES, LABORATORY, LIGHT15616288MICROSCOPES, LABORATORY, PHASE CONTRAST15616439MICROSCOPES, LABORATORY, UV15412539MICROSCOPES, OPERATING10617439MICROSCOPES, STEREO10415621MICROSURGICAL INSTRUMENTS5615589MICROTOMES7615157MICROTOMES, CRYOSTAT10615158MICROTOMES, ROTARY10615159MICROTOMES, SLIDING10615160MICROTOMES, ULTRA101312540MICROWAVE LEAKAGE DETECTORS7412547MIRRORS7615590MIXERS8615161MIXERS, CLINICAL LABORATORY101217235MIXERS, X-RAY FILM CHEMISTRY10412565MOIST THERAPY PACK CONDITIONERS10650056MOTORS7417443MULTIPLE MEDICAL GAS 412712NEBULIZERS10412716NEBULIZERS, HEATED7415045NEBULIZERS, NONHEATED7412719NEBULIZERS, ULTRASONIC10912726NEEDLE HOLDERS7912729NEEDLES7912733NEEDLES, ANAESTHESIA7916774NEEDLES, ASPIRATING7912734NEEDLES, BIOPSY7912737NEEDLES, BLUNT7912738NEEDLES, CARDIAC7912740NEEDLES, DENTAL7912741NEEDLES, DIALYSIS7917834NEEDLES, EPIDURAL7912744NEEDLES, EYE7912745NEEDLES, HYPODERMIC7912748NEEDLES, INTRAVENOUS7912750NEEDLES, PNEUMOPERITONEAL7912751NEEDLES, RADIOGRAPHIC7 2004 Biomedical Engineering Advisory Group SALifeExpectancy(years)Page 17 of 29

GMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS Description912753NEEDLES, SPINAL7615163NEPHELOMETERS7616908NEPHELOMETRIC IMMUNOASSAY ANALYZERS7615103NITROGEN ANALYZERS8412768NITROUS OXIDE ANALYZERS8415614NURSE CALL SYSTEMS15412784OBSERVOSCOPES7416155OBTURATORS, SCOPES10812817OPHTHALMOSCOPES, DIRECT10812818OPHTHALMOSCOPES, INDIRECT10312829ORTHODONTIC INSTRUMENTS10416044ORTHOPEDIC EXTERNAL FIXATION SYSTEMS7415767ORTHOPEDIC EXTERNAL FIXATION SYSTEMS, FRACTURE10416059ORTHOPEDIC EXTERNAL FIXATION SYSTEMS, OTHER10416046ORTHOPEDIC EXTERNAL FIXATION SYSTEMS, SPINAL10416027ORTHOPEDIC INTERNAL FIXATION SYSTEMS7412833ORTHOPEDIC INTERNAL FIXATION SYSTEMS, FRACTURE10416031ORTHOPEDIC INTERNAL FIXATION SYSTEMS, OTHER7415766ORTHOPEDIC INTERNAL FIXATION SYSTEMS, 2844OSTEOTOMES7412845OSTEOTOMES, ORTHOPEDIC7415235OSTEOTOMES, OTHER7412846OSTEOTOMES, PLASTIC SURGERY7412849OTOSCOPES7414410OVENS, DRYING8650048OVENS, MICROWAVE7412853OXIMETERS10415199OXIMETERS, EAR10616618OXIMETERS, IN-VITRO, MULTIWAVELENGTH10417148OXIMETERS, PULSE7412855OXYGEN ADMINISTRATION KITS7412858OXYGEN ANALYSERS10415015OXYGEN ANALYSERS, SAMPLING7412873OXYGEN CONCENTRATORS10412863OXYGEN MONITORS10412592OXYGEN MONITORS, TRANSCUTANEOUS7412876OXYGEN-AIR PROPORTIONERS10412904PACEMAKER FUNCTION ANALYZERS7415993PACEMAKER PROGRAMMERS7412911PACEMAKERS, CARDIAC7412912PACEMAKERS, CARDIAC, EXTERNAL INVASIVE10416516PACEMAKERS, CARDIAC, EXTERNAL, NONINVASIVE7416330PACHYMETERS7 2004 Biomedical Engineering Advisory Group SALifeExpectancy(years)Page 18 of 29

GMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS DescriptionLifeExpectancy(years)415786PACKAGE SEALERS15416361PATIENT DATA MANAGEMENT SYSTEMS7415693PATIENT TRANSFER UNITS7412993PERIMETERS10416919PERIMETERS, MANUAL7412998PERIPHERAL VISION ANALYZERS7411226PERITONEAL DIALYSIS UNITS8615164pH METERS107612634pH MONITORS1217557PHANTOMS, BONE MINERAL DENSITY71216607PHANTOMS, RADIOTHERAPY101213010PHANTOMS, C ENLAGERS15615165PHOTOMETERS8616531PHOTOMETERS, REFLECTANCE10413037PHOTOTHERAPY UNITS10412636PHYSIOLOGIC MONITORING SYSTEMS10412647PHYSIOLOGIC MONITORING SYSTEMS, ACUTE CARE1041758810412648PHYSIOLOGIC MONITORING SYSTEMS, ACUTE CARE, BATTERYPOWEREDPHYSIOLOGIC MONITORING SYSTEMS, CARDIAC CATHETERISATION417898PHYSIOLOGIC MONITORING SYSTEMS, CARDIAC ELECTROPHYSIOLOGY7417441PHYSIOLOGIC MONITORING SYSTEMS, IMPOTENCE7415791PHYSIOLOGIC MONITORING SYSTEMS, NEONATAL10412649PHYSIOLOGIC MONITORING SYSTEMS, STRESS EXERCISE10413987PHYSIOLOGIC MONITORING SYSTEMS, TELEMETRIC10416306PHYSIOLOGIC RECORDING SYSTEMS71217960PICTURE ARCHIVING AND COMMUNICATION SYSTEMS (PACS)5416326PILL COUNTERS, PHARMACEUTICAL10650070PIPETTE GRINDERS7615663PIPETTERS10615104PLATELET AGGREGATION ANALYZERS7615002PLATELET AGGREGATION METERS7616373PLATELET AGGREGATION RECODERS, AUTOMATIC7413052PLATES, CRANIOPLASTY7616287PLATES, HOT10413056PLETHYSMOGRAPHS10413059PLETHYSMOGRAPHS, BODY71350014PLOTTERS71313074PNEUMATIC S7650043POLARIZING VIEWERS7413085POLYGRAPHS710416223POSITIONING AIDS101314271POWER METERS, ULTRASONIC151217236POWER SUPPLIES, RADIOGRAPHIC10 2004 Biomedical Engineering Advisory Group SAPage 19 of 29

GMDNDeviceCategoryCodeUMDNSDeviceGroupUMDNS Description414351PRESSURE ALARMS, AIRWAY10650080PRESSURE CYLINDERS7413100PRESSURE INFUSORS7413102PRESSURE MEASURING UNITS10417196PRESSURE MEASURING UNITS, COMPARTMENTAL10413108PRESSURE MEASURING UNITS, ESOPHOGEAL7416764PRESSURE MONITORS, BLOOD, GENERAL/INVASIVE7416763PRESSURE MONITORS, INTRACRANIAL71350015PRINTERS, DAISYWHEEL71350016PRINTERS, DOTMATRIX51350017PRINTERS, INK JET7135003

An indication of the typical age a biomedical device can be expected to be economically useful under normal operating circumstances can be a valuable tool in asset management and financial planning activities. . 12 16891 CAMERAS, GAMMA, MOBILE 10 12 16892 CAMERAS, GAMMA, STATIONARY 10 4 10552 CAMERAS, IDENTIFICATION 8