Core Medical Equipment http://www.who.int/medical_devices/en/index.html © Copyright...

Core Medical Equipment




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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WHO/HSS/EHT/DIM/11.03


© World Health Organization 2011


All rights reserved. World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland


(tel.: +41 22 791 3264; fax: +41 22 791 4857). Requests for permission to reproduce or translate


WHO publications – whether for sale or for noncommercial distribution – should be addressed to


WHO Press, at the above address (fax: +41 22 791 4806; e-mail: permissions@who.int).


The designations employed and the presentation of the material in this publication do not


imply the expression of any opinion whatsoever on the part of the World Health Organization


concerning the legal status of any country, territory, city or area or of its authorities, or concerning


the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border


lines for which there may not yet be full agreement.


The mention of specific companies or of certain manufacturers’ products does not imply that


they are endorsed or recommended by the World Health Organization in preference to others of


a similar nature that are not mentioned.


Errors and omissions excepted, the names of proprietary products are distinguished by initial


capital letters.


All reasonable precautions have been taken by the World Health Organization to verify the


information contained in this publication. However, the published material is being distributed


without warranty of any kind, either expressed or implied. The responsibility for the interpretation


and use of the material lies with the reader. In no event shall the World Health Organization be


liable for damages arising from its use.




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Analyzer, Laboratory, Hematology, Blood Grouping, Automated


Anesthesia Unit


Apnea Monitors


Aspirator


Auditory Function Screening Device, Newborn


Bilirubinometer


Blood Gas/pH/Chemistry Point of Care Analyzer


Blood pressure monitor


Bronchoscope


Cataract Extraction Units


Clinical Chemistry Analyzer


Colonoscope


Cryosurgical Unit


Cytometer


Defibrillator, External, Automated; Semiautomated


Defibrillator, External, Manual


Densitometer, Bone


Electrocardiograph, ECG


Electrosurgical Unit


Fetal Heart Detector, Ultrasonic


Fetal monitor


Glucose Analyzer


Hematology Point of Care Analyzer


Hemodialysis Unit


Immunoassay Analyzer


Incubator, Infant




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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n Laser, CO2


Laser, Ophthalmic


Mammography unit


Monitor, Bedside, Electroencephalography


Monitor, Central Station


Monitoring System, Physiologic


Monitor, Telemetric, Physiologic


Peritoneal Dialysis Unit


Pulmonary function analyzer


Radiographic, Fluoroscopic System


Radiotherapy Planning System


Radiotherapy Systems


Remote-afterloading brachytherapy system


Scanning System, CT


Scanning System, Magnetic Resonance Imaging, Full-Body


Scanning System, Ultrasonic


Transcutaneous Blood Gas Monitor


Ventilator, Intensive Care


Ventilator, Intensive Care, Neonatal/Pediatric


Ventilator, Portable


Videoconferencing system, Telemedicine


Warming Unit, Radiant, Infant


Whole Blood Coagulation Analyzer




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Core medical equipment
“Core medical equipment” refers here to technologies that are commonly considered as important or


necessary for specific preventive, diagnostic, treatment or rehabilitation procedures carried out in most


health care facilities.


Today, there are more than 10,000 types of medical devices available. The selection of appropriate medical


equipment always depends on local, regional or national requirements; factors to consider include the type


of health facility where the devices are to be used, the health work force available and the burden of disease


experienced in the specific catchment area. It is therefore impossible to make a list of core medical equipment


which would be exhaustive and/or universally applicable.


With that being said, we have reproduced hereafter a set of core medical equipment fact sheets which have


been issued by the ECRI Institute and the GMDN Agency, with a view to raising stakeholders’ awareness


about their existence and their functionality.


Each fact sheet displays a type of medical equipment, the health problems addressed by the device, the


operation procedures, its typical size, weight and price range, and infrastructure requirements for effective


and safe use. Technologies are placed into context of existing nomenclature systems; they are not specific


to any brand, model or vendor. The equipment is classified under the following categories: therapeutic,


diagnostic, chronic disease and child health.


The WHO Department of Essential Health Technologies is planning to continuously update the list of core


medical equipment and make it publicly available on the WHO website for information purposes, subject to


the disclaimers here below.


WHO has not reviewed the safety, efficacy, quality, applicability, or cost acceptability of any of the technologies


referred to hereafter. Therefore, inclusion of the aforesaid fact sheets herein does not constitute a warranty of


the fitness of any technology or of any resulting product and any future development thereof, for a particular


purpose. Besides, the responsibility for the quality, safety and efficacy of each technology or each resulting


product remains with its developer, owner and/or manufacturer.


WHO will not be held to endorse nor to recommend any technology or any resulting product thereof, as such


or in preference to others of a similar nature.


WHO does not warrant or represent that the use of the technologies or the resulting products thereof is,


or will be, in accordance with the national laws and regulations of any country, including but not limited to


patent laws. WHO disclaims any and all liability and responsibility whatsoever for any injury, death, loss,


damage or other prejudice of any kind whatsoever that may arise as a result of, or in connection with, the


procurement, distribution and/or use of any technology referred to hereafter, or of any resulting product and


any future development thereof.


Developers, owners and/or manufacturers of the technologies or resulting products thereof shall not, in any


statement of an advertising, commercial and/or promotional nature, refer to the inclusion of their technologies


in this publication. In no case shall the latter use the WHO name and/or the emblem, or any abbreviation


thereof, in relation to their business or otherwise.


Disclaimer




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Blood grouping systems perform basic blood processing tests


that include ABO grouping and subgrouping, Rh and other


red cell phenotyping, and antibody detection. These tests


determine factors that can cause transfusion reactions such


as red cell hemolysis, anaphylaxis, and other immunologic and


nonimmunologic effects.


Product description
Floor-standing or benchtop device includes a rack or tray onto


which patient blood sample tubes are loaded; the samples are


mixed with reagents to determine blood type and the results are


displayed on a monitor; cabinets or compartments store reagent


vessels; a monitor, keyboard, mouse, and printer (or entire


computer) may be connected for programming, data entry, and


to view and print testing results.


Principles of operation
Blood tube containing ethylenediamine-tetraacetic acid (EDTA)


anticoagulant is loaded onto the analyzer, and the operator


usually centrifuges them to separate the RBCs from the plasma.


Automated analyzers typically resuspend the RBCs in saline and


load the diluted samples onto microplates to which reagents


(known antisera) have been added. Blood group identity occurs


when the known antiserum, containing antibodies, clumps


(agglutinates) RBCs that have a corresponding antigen. Bar-


code labels provides a means of sample tracking.


Operating steps
Technicians load tubes into the sample tray and keep reagents


fi lled; tests are programmed either via a touchscreen panel on


the instrument, a computer, or the required test information is


on the tube’s printed bar code.


Reported problems
Operators should be aware of the risk of exposure to potentially


infectious bloodborne pathogens during testing procedures and


should use universal precautions, including wearing gloves, face


shields or masks, and gowns.


Use and maintenance
User(s): Laboratory technician


Maintenance: Biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Hospital, blood bank, clinical


laboratory


Requirements: Line power, water supply,


benchtop or fl oor space, biohazard disposal


Product specifi cations
Approx. dimensions (mm): 1,000 x 1,750 x


900


Approx. weight (kg): 50-500


Consumables: Reagents, blood tubes


Price range (USD): 115,000 - 225,000


Typical product life time (years): 5-7


Shelf life (consumables): EDTA: 1 year


Types and variations
Benchtop or fl oor-standing


Analyzer, Laboratory, Hematology, Blood Grouping, Automated
UMDNS GMDN
16817 Analyzers, Laboratory, Hematology, Blood Grouping,


Automated
56712 ABO/Rh(D) blood grouping analyser IVD,


automated


Other common names:
Blood type analyzer, ABO blood typing system, AB0 blood typing system;Blood Grouping System




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Anesthesia units dispense a mixture of gases and vapors and


vary the proportions to control a patient’s level of consciousness


and/or analgesia during surgical procedures.


Product description
An anesthesia system comprises of a gas delivery platform,


a data analysis and distribution system, and physiologic and


multigas monitors (optional in most units), which indicate levels


and variations of several physiologic variables and parameters


associated with cardiopulmonary function and/or gas and


agent concentrations in breathed-gas mixtures. Manufacturers


typically offer a minimum combination of monitors, alarms, and


other features that customers must purchase to meet standards


and ensure patient safety.


Principles of operation
Because O2 and N2O are used in large quantities, they are usually


drawn from the hospital’s central gas supplies. Vaporizers add a


controlled amount of anesthetic vapor to the gas mixture. An


automatic ventilator is generally used to mechanically deliver


breaths to the patient. The ventilator forces the anesthesia gas


mixture into the patient’s breathing circuit and lungs and, in a


circle breathing system, receives exhaled breath from the patient


as well as fresh gas. A scavenging system captures and exhausts


waste gases to minimize the exposure of the operating room


staff to harmful anesthetic agents. Scavenging systems remove


gas by a vacuum, a passive exhaust system, or both.


Operating steps
A mask is placed over the nose and mouth. The anesthesia


unit dispenses a mixture of gases and vapors and varies the


proportions to control a patient’s level of consciousness


and/or analgesia during surgical procedures. The patient is


anesthetized by inspiring a mixture of O2, the vapor of a volatile


liquid halogenated hydrocarbon anesthetic, and, if necessary,


N2O and other gases.


Reported problems
One of the greatest dangers of anesthesia is hypoxia, which


can result in brain damage or death, though the administration


of concentrated O2 (100%) may be toxic. Gas with excessive


CO2 concentration, an inadequate amount of anesthetic agent,


or dangerously high pressure may cause hypoventilation,


compromised cardiac output, pneumothorax, and asphyxiation.


Contamination of the anesthesia breathing circuit may lead to


nosocomial infections.


Use and maintenance
User(s): Anesthesiologist, nurse anesthetist,


medical staff


Maintenance: Biomedical or clinical engineer/


technician, medical staff, manufacturer/


servicer


Training: Initial training by manufacturer,


operator’s manuals, user’s guide, some


manufacturers offer offsite training or remote


training


Environment of use
Settings of use: Hospital (surgery),


ambulatory surgery centers


Requirements: Uninterruptible power source,


O2 fail-safe and hypoxic mixture fail-safe


systems, gas cylinder yokes for O2 if central


supplies fail, internal battery (for units with


automatic ventilators) capable of powering


the unit for at least 30 minutes


Product specifi cations
Approx. dimensions (mm): 1,500 x 700 x 700


Approx. weight (kg): 130


Consumables: Anesthetic agents, tubing,


masks


Price range (USD): 5,000 - 100,000


Typical product life time (years): 8-10


Shelf life (consumables): Variable


Types and variations
Cart mounted, ceiling mounted, wall mounted,


mobile


Anesthesia Unit
UMDNS GMDN
10134 Anesthesia Units 47769 Anaesthesia unit, mobile


Other common names:
Anesthesia machines; Anaesthesia apparatus; Gas-machine, anesthesia




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Apnea monitors detect the cessation of breathing (apnea) in


infants and adults who are at risk of respiratory failure and


alert the parent or attendant to the condition. Some prolonged


respiratory pauses result in low oxygen concentration levels in


the body, which can lead to irreversible brain damage and, if


prolonged, death.


Product description
The components of apnea monitors depend specifi cally on


the type. However, in general they are composed of a set of


sensors which obtain the information of different physiological


parameters. This information is passed to a micro computer


system, which analyses the sensors’ information and determines


if apnea is occurring.


Principles of operation
Monitors that use impedance pneumography detect small


changes in electrical impedance as air enters and leaves the


lungs and as the blood volume changes in the thoracic cavity.


Mattress-type motion sensors typically monitor changes in the


capacitance or resistance of a mattress transducer. Pneumatic


abdominal sensors also detect breaths as changes in pressure.


More direct methods of respiration detection monitor the airfl ow


into and out of the lungs; these include thermistors, proximal


airway pressure sensors, and carbon dioxide (CO2) sensors.


Operating steps
The apnea monitor is attached to the patient using appropriate


sensor for the measurement technique (e.g., mattress motion


sensor, pneumatic abdominal sensors, thermistors, proximal


airway pressure sensors, carbon dioxide (CO2) sensors, cannula).


Once connected, as the patient breathes, the unit monitors


different body parameters. If an alarm sounds, the operator


must attend the patient immediately.


Reported problems
Apnea monitors may fail to alarm during an episode because


they sense artifact (artifacts include vibrations, heart activity,


patient movement). Electromagnetic emissions from electronic


devices (other electronics or equipment) can also cause


interference, possibly leading to false breath and heartbeat


detection. Impedance pneumographs are more subject to


cardiovascular artifact. Misinterpreting impedance changes


because of heartbeats perceived as breaths frequent when


instrument sensitivity is not adjusted.


Use and maintenance
User(s): Nurse, medical staff, home care


providers


Maintenance: Biomedical or clinical engineer/


technician, medical staff, manufacturer/


servicer


Training: Initial training by manufacturer,


operator’s manuals, user’s guide


Environment of use
Settings of use: Hospital, home, ambulatory


care center, nursery


Requirements: Uninterruptible power source,


battery backup


Product specifi cations
Approx. dimensions (mm): 150 x 120 x 120


Approx. weight (kg): 0.75


Consumables: Batteries, cables, electrodes/


sensors


Price range (USD): 200 - 5,000


Typical product life time (years): 8


Shelf life (consumables): NA


Types and variations
Stand-alone, modular


Apnea Monitors
UMDNS GMDN
12575 Monitors, Bedside, Respiration, Apnea 35194 Respiratory apnoea monitoring system


Other common names:
Cardiorespiratory monitors; Monitor, recording, apnoea




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Most surgical procedures require suctioning to remove blood,


gas, tissue, or other foreign materials and irrigating fl uids that


accumulate in the operative fi eld and obstruct the surgeon’s


view. Portable or mobile aspirators can be used if there is no


central vacuum system or if suctioning is required in areas that


do not have vacuum inlets.


Product description
Surgical aspirators consist of a line-powered vacuum pump, a


vacuum regulator and gauge, a collection canister, and an optional


bacterial fi lter. Plastic tubing connects these components,


completing an open-ended system that continuously draws


tissue debris and fl uid from the surgical fi eld to the collection


canister. The gauge allows the user to set a safe limit for


suctioning, to assess the performance of the vacuum pump,


and to detect leaks or blockages. Units are either portable or


mounted on a stand or cart for mobility.


Principles of operation
Various pump confi gurations include rotary-vane, diaphragm,


and piston. Each mechanism alternately increases and decreases


the vacuum and/or chamber volume, creating suction. Air is


drawn from the external tubing into the chamber, drawing


aspirate into a collection canister. Most surgical aspirators


have an overfl ow-protection assembly that prevents fl uid from


overfl owing into the pump and valves.


Operating steps
Operator powers on unit and selects appropriate suction level


and inserts suction tip into patient cavity. Collection canisters


should be monitored and emptied if they come close to capacity.


Reported problems
Suction regulators must be accurate; suction levels that are too


high can cause tissue damage. Some models operate at high


noise levels that can eclipse the volume of alarms for other


devices. A pump containing aspirated fl uid can be a source


of contamination. Changing or cleaning the suction tip during


surgeries or other use can help reduce infection risk. Operators


should follow universal precautions, including wearing gloves,


face shields or masks, and gowns.


Use and maintenance
User(s): Surgeons, assisting surgeons, nurses,


respiratory therapists, other medical staff


Maintenance: Biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: OR, patient bedside, home,


long-term care, ER


Requirements: Line power, biohazard disposal


Product specifi cations
Approx. dimensions (mm): 300 x 400 x 800


Approx. weight (kg): 5-25


Consumables: Tubing, collection canisters,


liners, batteries


Price range (USD): 160 - 5,000


Typical product life time (years): 8-10


Shelf life (consumables): Rubber tubing: 10 yrs


Types and variations
Portable (sometimes considered a separate


category of emergency aspirators) or on


a cart; disposable or reusable canisters;


waterproof designs. The three types of pumps


used in surgical aspirators are rotary vane,


diaphragm, and cylinder piston


Aspirator
UMDNS GMDN
10217 Aspirators, Surgical 10217 Surgical suction system


Other common names:
Suction unit, suction pump, evacuator, vacuum pump




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Devices that allow hearing impairments to be detected quickly


so that any speech and language defi ciencies can be addressed


with early intervention programs. If hearing impairments are


not detected early in life, social, emotional, and intellectual


development (e.g., speech and language acquisition, academics)


can be affected. Permanent childhood hearing loss is the most


common defect that can be diagnosed at birth.


Product description
Devices consisting of a main testing system with a display screen


and ear tips, earmuffs, or electrodes; the unit can be table- or


cart-mounted.


Principles of operation
Once the ear probe(s) or electrodes are in place, infant


screening tests are performed using either auditory brainstem


response (ABR) or otoacoustic emissions (OAEs). ABR, an


electrophysiologic assessment, is used to measure the auditory


system’s response to sound. A soft click (usually 35 to 50 decibels


[dB]) is presented to the ear(s) via earphones or probes. OAE


is a screening method based on measuring the integrity of the


outer hair cells in the cochlea (inner ear). A soft click (usually 25


dB) is presented, and a small microphone measures the acoustic


response that is returned from the baby’s ear via a probe in the


ear canal.


Operating steps
For OAE screening the screener places a miniature earphone


and microphone in the infant’s ear. Sounds are played, and a


response is measured. If the infant hears normally, an echo is


refl ected into the ear canal and is measured by the microphone.


If there is no hearing loss, no echo can be measured. For ABR


testing, sounds are played into an infant’s ears. Electrodes are


placed on the baby’s head to detect responses. This measures


how the hearing nerve responds to sounds and can identify


infants with a hearing loss.


Reported problems
Users may experience diffi culty inserting probes into the ear


canal. Improper probe fi tting can increase the referral rate.


Proper insertion technique is easily learned, but the operator


usually needs some instruction. Some units have alarms for


improper probe placement. Proper earphone placement and


electrode impedances during setup and continuous monitoring


during testing are important. Obstruction in earphones (tips or


muffs) or myogenic interferences should be monitored during


automatic checks.


Use and maintenance
User(s): Audiologist; medical staff


Maintenance: Medical staff; technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Hospital; clinic


Requirements: Stable power source


Product specifi cations
Approx. dimensions (mm): 195 x 70 x 30


Approx. weight (kg): 0.25


Consumables: NA


Price range (USD): 2,995 - 22,000


Typical product life time (years): 7


Shelf life (consumables): NA


Types and variations
Units may be table- or cart-mounted.


Auditory Function Screening Device, Newborn
UMDNS GMDN
20167 Auditory Function Screening Devices, Newborn 58019 Otoacoustic emission system, battery-powered


Other common names:
Automated Hearing Screening Devices; Newborn Auditory Function Screening Devices; Newborn Hearing Screening
Devices; Universal Newborn Hearing Screening Systems




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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In healthy full-term neonates, bilirubin can rise to peak levels of


5 to 13 mg/dL between the second and fi fth days of life before


decreasing to normal levels between the fi fth and seventh days.


This produces jaundice, a yellowish discoloration of the skin, eyes,


and mucous membranes. Monitoring bilirubin concentration is


also important in children and in adults where elevated levels


may indicate a pre-hepatic, hepatic, or post-hepatic metabolic


disorder.


Product description
These devices come in a variety of physical confi gurations. They


may be relatively small, single-purpose hand-held instruments


that are simple to operate and are designed to measure the


concentration of bilirubin in the blood. They are often located in


neonatal intensive care units for rapid on-site bilirubin analysis,


which is essential for determining a proper treatment method.


Bilirubinometers may also be confi gured as larger benchtop


analyzers or stand-alone units.


Principles of operation
Bilirubin concentrations are determined either by whole


blood or serum analysis using spectrophotometric methods


or by skin-refl ectance measurements. The three methods of


spectrophotometric analysis are the direct spectrophotometric


method, the Malloy-Evelyn method, and the Jendrassik-Grof


method.


Operating steps
Blood samples are required for spectrophotometric analysis.


The analysis technique depends on both the type or types of


bilirubin being measured and the age of the patient (neonate


versus child or adult). Cutaneous bilirubinometers do not require


a blood sample. A light-emitting sensor is placed on the infant’s


skin (optimally on the forehead or sternum). The refl ected light


is split into two beams by a dichroic mirror, and wavelengths of


455 nm and 575 nm are measured by optical detectors.


Reported problems
Rapid changes in hydration (body water content) during


therapy can cause fl uctuations in blood bilirubin concentrations,


making assay results uncertain. Photo-oxidation (light-induced


breakdown) of bilirubin occurs if samples are exposed to light


for more than a few hours. Therefore, blood samples should be


protected from exposure to light.


Use and maintenance
User(s): Operator, medical staff


Maintenance: Medical staff; technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Hospital; clinic


Requirements: Stable power source


Product specifi cations
Approx. dimensions (mm): 110 x 150 x 200


Approx. weight (kg): 3.4


Consumables: NA


Price range (USD): 3,100 - 7,000


Typical product life time (years): 6 to 8


Shelf life (consumables): NA


Types and variations
Benchtop; stand-alone; handheld


Bilirubinometer
UMDNS GMDN
15109


16166


Bilirubinometers


Bilirubinometers, Cutaneous


47988


16166


Bilirubinometer


Cutaneous bilirubinometer


Other common names:
Analyzers, Bilirubin; Bilirubin Analyzers; Jaundice Meters; Indirect Bilirubinometers




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Analyzers used to measure blood gas, pH, electrolytes,


and some metabolites in whole blood specimens. They can


measure pH, partial pressure of carbon dioxide and oxygen,


and concentrations of many ions (sodium, potassium, chloride,


bicarbonate) and metabolites (calcium, magnesium, glucose,


lactate). They are also used to determine abnormal metabolite


and/or electrolyte levels in blood and the patient’s acid-base


balance and levels of oxygen/carbon dioxide exchange.


Product description
Handheld device or benchtop device, sometimes placed on a


cart, with a display (usually LCD), a keypad to enter information,


and a slot to insert a test strip or sample tube. Some models


may have alarms, memory functions, touchpens, USB ports to


transfer data to a computer, and/or a small storage compartment


for reagents.


Principles of operation
Blood gas/pH analyzers use electrodes to determine pH, partial


pressure of carbon dioxide, and partial pressure of oxygen in


the blood. Chemistry analyzers use a dry reagent pad system


in which a fi lter pad impregnated with all reagents required for


a particular reaction is placed on a thin plastic strip. Electrolyte


analyzers use ion-selective electrode (ISE) methodology in


which measurements of the ion activity in the solution are made


potentiometrically using an external reference electrode and an


ISE containing an internal reference electrode.


Operating steps
Whole blood samples are placed in tubes, on reaction cuvettes,


or on test strips, and loaded into the analyzer. The operator may


select the tests being performed on the sample using a keypad


or connected computer.


Reported problems
Operators should be aware of the risk of exposure to potentially


infectious bloodborne pathogens during testing procedures and


should use universal precautions, including wearing gloves, face


shields or masks, and gowns.


Use and maintenance
User(s): Medical staff


Maintenance: Laboratory technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Hospital, patient bedside,


physician offi ce, clinical laboratory, home


Requirements: Battery-operated handheld


devices do not have special settings


requirements; benchtop units require line


power


Product specifi cations
Approx. dimensions (mm): 100 x 300 x 400


Approx. weight (kg): 1-5 for handheld units;


15-25 for benchtop units


Consumables: Reagent cartridges or test


strips, batteries


Price range (USD): 150 - 165,000


Typical product life time (years): 4-6


Shelf life (consumables): Reagents: 1-2 years


Types and variations
Handheld, portable, benchtop


Blood Gas/pH/Chemistry Point of Care Analyzer
UMDNS GMDN
18853 Analyzers, Point-of-Care, Whole Blood, Gas/pH/


Electrolyte/Metabolite
56661 Blood gas analyser IVD, automated


Other common names:
POC Analyzer, blood gas analyzer




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Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
NIBP is an essential indicator of physiologic condition. As one of
the most frequently used diagnostic tests, it indicates changes
in blood volume, the pumping effi ciency of the heart, and the
resistance of the peripheral vasculature. Vital signs monitors are
used to measure basic physiologic parameters so that clinicians
can be informed of changes in a patient’s condition. Depending
on their confi guration, these units can measure and display
numerical data for NIBP, oxygen saturation, and temperature.


Product description
Automatic electronic sphygmomanometers noninvasively
measure and display a patient’s arterial blood pressure. The main
unit includes controls and a display; it also includes appropriate
attached cuffs, probes, and sensors that make possible sequential
and/or simultaneous measurements of the parameters. Some of
the NIBP monitors can be used as vital sign monitors with the
real-time measuring and display of two or more of the vital signs.
These monitors typically consist of portable or mobile electronic
units. The monitor may be connected to the line and/or powered
by internal batteries. Many devices may also perform continuous
monitoring during transportation or at the bedside. Vital signs
physiologic monitors are intended mainly for periodic automated


measuring of the parameters of one or more patients.


Principles of operation
Automatic electronic sphygmomanometers (NIBP monitors)
measure by the use of sound and detection of blood sound
turbulence (Korotkoff sounds). A microphone positioned against an
artery compressed by the device cuff detects the Korotkoff sounds,
enabling the unit to directly determine systolic and diastolic values
blood pressure values. NIBP is usually measured using cuffs and
either auscultatory or oscillometric techniques. The measurement
of temperature is typically accomplished using an intraoral sensor,
and SpO2 is determined using pulse oximetry sensors. These
monitors typically consist of portable or mobile electronic units
that facilitate movement from one location to other; the monitor
may be connected to the line and/or powered by internal batteries.


Operating steps
The cuffs, probes, and sensors are attached to the patient, and
then the monitor will begin taking intermittent or continuous
measurements as selected by the clinician. The devices may
remain at a patient’s bedside or can be transported by a caregiver
for vital signs spot checking throughout a care area. Alarms (e.g.,
for high blood pressure or low oxygen saturation) can typically
be set by caregivers and can be manually temporarily silenced.


Reported problems
Problems associated with monitors are often user-related.
Poor cuff placement or sensor preparation and attachment
are most commonly reported. Cables and lead wires should
be periodically inspected for breaks and cracks. Automatic


electronic sphygmomanometry and pulse
oximeters may have the inability to effectively
monitor patients with certain conditions (e.g.,
tremors, convulsions, abnormal heart rhythms,
low blood pressure)


Use and maintenance
User(s): Physicians, nurses, other medical staff


Maintenance: Biomedical or clinical engineer/


technician, medical staff, manufacturer/


servicer


Training: Initial training by manufacturer,


operator’s manuals, user’s guide


Environment of use
Settings of use: Hospital (all areas),


ambulatory surgery centers


Requirements: Battery, uninterruptible power


source, appropriate cuffs/sensors


Product specifi cations
Approx. dimensions (mm): 100 x 150 x 200


Approx. weight (kg): 3


Consumables: Batteries, cables, sensors/


electrodes, cuffs


Price range (USD): 580 - 4,500


Typical product life time (years): 10


Shelf life (consumables): NA


Types and variations
Roll stand, portable, pole or bed mounts


Blood pressure monitor
UMDNS GMDN
18325


18326


25209


Sphygmomanometers, Electronic, Automatic,
Auscultatory


Sphygmomanometers, Electronic, Automatic,
Oscillometric


Monitors, Physiologic, Vital Signs


16173 Automatic-infl ation electronic
sphygmomanometer, non-portable


Other common names:
Vital signs monitoring units; noninvasive blood pressure (NIBP) monitors; auscultatory sphygmomanometers;
oscillometric sphygmomanometers; oscillotonometers, spot check monitors; spot checking; Recorder,
sphygmomanometer, automatic




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© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
Devices that are introduced at the nose or mouth to observe


distal branches of the bronchi. Through working channels in the


bronchoscope, the physician can sample lung tissue (e.g., when


pulmonary malignancies are suspected), instill radiographic


media for bronchographic studies, perform laser therapy, remove


foreign objects, suction sputum for microbiological culturing,


insert catheters, and perform diffi cult intubations.


Product description
These devices consist of a proximal housing, a fl exible insertion


tube ranging from 0.5 to 7.0 mm in diameter, and an “umbilical


cord” connecting the light source and the proximal housing.


The proximal housing, which is designed to be held in one hand,


typically includes the eyepiece (fi beroptic models only), controls


for distal tip (bending section) angulation and suction, and the


working channel port.


Principles of operation
The bronchoscope (either fl exible or rigid) is inserted into


the airways, usually through the mouth or nose. Sometimes


the bronchoscope is inserted via a tracheostomy. Rigid


bronchoscopes are used for the removal of foreign bodies


while fl exible video bronchoscopes are intended to provide


images of a patient’s airways and lungs. Images provided by


the bronchoscope can be focused by adjusting the ocular on


the scope’s proximal housing. A video bronchoscope uses a


charge-coupled device (CCD) located at the distal tip of the


scope to sense and transmit images, replacing the image guide


and eyepiece. These images can then be recorded, printed,


stored on digital media, or transmitted to another location for


simultaneous viewing.


Operating steps
If a rigid bronchoscope is used, the patient will require anesthesia


before insertion into the airway via either the mouth or nose. For


procedures using fl exible bronchoscopes, the patient’s throat


will be numbed and the tube is then inserted into the airway via


either the mouth or nose. Video bronchoscopes are also inserted


via the mouth or nose, but have the benefi t of permitting the


physician to see the patient’s airways on an external monitor,


rather than through an eyepiece.


Reported problems
Despite the remote location of the light source, some of the


heat produced by the lamp is transmitted to the tip of the


bronchoscope. Bronchospasms and abnormal heartbeats may


occur in patients with respiratory or cardiac disorders. Bronchial


perforations can occur if biopsy brushes or other instruments


are forced out of the bronchoscope’s distal end and meet


resistance. Other complications may include loss of biopsy


brushes, or breakage of biopsy forceps.


Use and maintenance
User(s): Dedicated operator


Maintenance: Medical staff; technician;


biomedical or clinical engineer; central


sterile processing technician for cleaning and


disinfecting


Training: Supervised training with experienced


users


Environment of use
Settings of use: Endoscopy suite; operating


room; intensive care unit (rarely)


Requirements: Stable power source; access


to anesthesia and patient monitoring; oxygen


and suction should be available; access to


PACS or x-ray viewbox; bronchoscopy suite


should have direct external ventilation, HEPA


fi ltration


Product specifi cations
Approx. dimensions (mm): 600


Approx. weight (kg): 2.3


Consumables: NA


Price range (USD): 3,560 - 53,120


Typical product life time (years): 4 to 5


Shelf life (consumables): NA


Types and variations
Flexible; fl exible video; rigid


Bronchoscope
UMDNS GMDN
15073


17662


15074


Bronchoscopes, Flexible


Bronchoscopes, Flexible, Video


Bronchoscopes, Rigid


35461


44921


17662


15074


Flexible fi breoptic bronchoscope


Flexible ultrasonic bronchoscope


Flexible video bronchoscope


Rigid bronchoscope


Other common names:
Bronchial Endoscopes; Video Bronchoscopes




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© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Devices intended to break up and remove cataractous lenses of


the eye. Cataracts inhibit the transmission of light to the retina


and cause a painless blurring of vision. Cataracts are caused


by changes in the chemical composition of the lens associated


with many factors including age, environment, drugs, systemic


diseases, traumatic eye injuries, certain diseases of the eye, and


genetic or birth defects.


Product description
These units consist of a hollow probe (i.e., a phaco probe) that


includes an irrigation sleeve, an oscillating tip that converts


electric energy into ultrasonic waves, and a channel for


aspiration of lens fragments; the units also include a vacuum


pump and controls for the output levels, irrigation rate, and


mode of operation. CSUs (cryosurgical units) apply a refrigerant


(cryogen) to withdraw heat from target tissue either through


direct application or indirectly through contact with a cryogen-


cooled probe.


Principles of operation
These devices are intended to remove cataractous lenses by the


insertion of a probe that cuts and emulsifi es the lenses using


ultrasonic waves (phacoemulsifi cation).


Operating steps
An incision is made to gain access to the eye’s anterior


chamber. A viscoelastic material is then infused to deepen the


anterior chamber. After removing the anterior lens capsule


and hydrodissecting the lens to separate it from the cortex


and capsule, the surgeon inserts a phacoemulsifi cation probe


tip. The probe tip oscillates rapidly creating ultrasonic waves


that cut tissue. The cataractous lens is emulsifi ed and the lens


fragments are then aspirated from the eye through the hollow


tip of the phacoemulsifi er.


Reported problems
Thermal lesions to the sclera and cornea due to insuffi cient


irrigation and aspiration fl ow; metal fragments being left


in patients’ eyes following phacoemulsifi cation and of


phacoemulsifi cation units failing to vacuum; torn posterior


capsule due to high vacuum; postoperative endophthalmitis


resulting from bacterial contamination; surgically induced


astigmatism; corneal burns.


Use and maintenance
User(s): Surgeon


Maintenance: Medical staff; technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals; supervised training with experienced


surgeons


Environment of use
Settings of use: Operating room


Requirements: Stable power source


Product specifi cations
Approx. dimensions (mm): 245 x 220 x 154


Approx. weight (kg): 5.6


Consumables: NA


Price range (USD): 13,000 - 105,000


Typical product life time (years): 10


Shelf life (consumables): NA


Types and variations
Modular (in console); stand-alone; portable


Cataract Extraction Units
UMDNS GMDN
17596


11068


Phacoemulsifi cation Units, Cataract Extraction


Cryosurgical Units, Ophthalmic


45071


11068


Phacoemulsifi cation system generator


Ophthalmic cryosurgical system, mechanical


Other common names:
Phacoemulsifi cation Units; Phacoemulsifi ers; Cryoextractors; Cryosurgical Systems; Erysiphakes; Extractors, Cataract;
Fragmatomes; Cryophthalmic unit; unit, cryotherapy, ophthalmic




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
Perform tests on whole blood, serum, plasma, or urine samples


to determine concentrations of analytes (e.g., cholesterol,


electrolytes, glucose, calcium), to provide certain hematology


values (e.g., hemoglobin concentrations, prothrombin times),


and to assay certain therapeutic drugs (e.g., theophylline),


which helps diagnose and treat numerous diseases, including


diabetes, cancer, HIV, STD, hepatitis, kidney conditions, fertility,


and thyroid problems.


Product description
Chemistry analyzers can be benchtop devices or placed on a cart;


other systems require fl oor space. They are used to determine


the concentration of certain metabolites, electrolytes, proteins,


and/or drugs in samples of serum, plasma, urine, cerebrospinal


fl uid, and/or other body fl uids. Samples are inserted in a slot or


loaded onto a tray, and tests are programmed via a keypad or


bar-code scanner. Reagents may be stored within the analyzer,


and it may require a water supply to wash internal parts. Results


are displayed on a screen, and typically there are ports to


connect to a printer and/or computer.


Principles of operation
After the tray is loaded with samples, a pipette aspirates a


precisely measured aliquot of sample and discharges it into the


reaction vessel; a measured volume of diluent rinses the pipette.


Reagents are dispensed into the reaction vessel. After the


solution is mixed (and incubated, if necessary), it is either passed


through a colorimeter, which measures its absorbance while it is


still in its reaction vessel, or aspirated into a fl ow cell, where


its absorbance is measured by a fl ow-through colorimeter. The


analyzer then calculates the analyte’s chemical concentrations.


Operating steps
The operator loads sample tubes into the analyzer; reagents may


need to be loaded or may already be stored in the instrument. A


bar-code scanner will read the test orders off the label on each


test tube, or the operator may have to program the desired tests.


After the required test(s) are run, the results can be displayed


on-screen, printed out, stored in the analyzer’s internal memory,


and/or transferred to a computer.


Reported problems
Operators should be aware of the risk of exposure to potentially


infectious bloodborne pathogens during testing procedures and


should use universal precautions, including wearing gloves, face


shields or masks, and gowns.


Use and maintenance
User(s): Laboratory technician


Maintenance: Laboratory technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Clinical laboratory


Requirements: Adequate benchtop or fl oor


space, water supply, line power, biohazard


disposal


Product specifi cations
Approx. dimensions (mm): 500 x 700 x 1,000


Approx. weight (kg): 30-700


Consumables: Reagents, sample cells


Price range (USD): 10,000 - 465,000


Typical product life time (years): 5-7


Shelf life (consumables): Reagents: 1-2 years


Types and variations
Some chemistry analyzers can be interfaced


to an automated immunoassay analyzer to


decrease operator intervention and possibly


improve workfl ow.


Clinical Chemistry Analyzer
UMDNS GMDN
16298 Analyzers, Laboratory, Clinical Chemistry,


Automated
35918
56676


Laboratory urine analyser IVD, automated
Laboratory multichannel clinical chemistry
analyser IVD, automated


Other common names:
Biochemistry analyzer




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© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Colonoscopes are used for the removal of foreign bodies, excision


of tumors or colorectal polyps (polypectomy), and control of


hemorrhage. Routine colonoscopy is important in diagnosing


intestinal cancer, the second leading cause of cancer deaths in


the United States. These endoscopic procedures reduce the need


for invasive surgical diagnostic and therapeutic procedures.


Product description
These devices consist of a proximal housing, a fl exible insertion


tube, and an “umbilical cord” connecting the light source and the


proximal housing. The proximal housing, which is designed to


be held in one hand, typically includes the eyepiece (fi beroptic


models only), controls for distal tip (bending section) angulation


and suction, and the working channel port. Colonoscopes have


several hollow channels for suction, water and air delivery, and


insertion of accessory instruments and cannulae. The distal tip


of video colonoscopes includes a charge-coupled device (CCD)


that serves as a small camera and electronically transmits the


image from the CCD to an external video-processing unit.


Principles of operation
Video colonoscope insertion tubes contains a fi beroptic light


bundle, which transmits light from the light source to the tip of


the endoscope. Each fi beroptic bundle consists of thousands


of individual glass fi bers coated with glass causing internal


refl ections that allow light transmission through the fi ber even


when it is fl exed. The light is used to illuminate the fi eld of view


in the patient’s colon. Video images are detected by the CCD


and are then transmitted to the video processor and then display


monitors or recording devices.


Operating steps
The patient typically lies on his or her side on a procedure table.


Patients typically will require anesthesia or conscious sedation


before insertion of the colonoscope. The colonoscope is inserted


into the colon via the rectum by a gastroenterologist. Video


images are typically viewed throughout the procedure on a video


monitor. These images can then be recorded, printed, stored on


digital media, or transmitted to another location for simultaneous


viewing. The gastroenterologist manipulates the direction of the


device using controls on the colonoscope control housing.


Reported problems
Although rare, trauma to the colon and adjacent organs during


colonoscopy can result in complications such as bleeding, peritonitis,


and appendicitis. ECRI Institute has received reports of diffi culty


in inserting forceps through the instrument channel of contorted


colonoscopes, causing delays in procedures. Problems have


occurred related to blockage of the air channel from inadequately


rinsed disinfectant or retrograde fl ow of protein material into the


channel during a procedure. Also, patient infection is a common


mainly from improper cleaning and disinfection procedures.


Use and maintenance
User(s): Gastroenterologist


Maintenance: Medical staff; technician;


biomedical or clinical engineer; central


sterile processing technician for cleaning and


disinfecting


Training: Supervised training with experienced


users


Environment of use
Settings of use: Gastroenterology lab or suite,


operating room


Requirements: Stable power source; access


to anesthesia and patient monitoring; oxygen


and suction should be available; endoscopy


suite should have direct external ventilation,


HEPA fi ltration


Product specifi cations
Approx. dimensions (mm): 1,700


Approx. weight (kg): 5


Consumables: NA


Price range (USD): 25,000 - 41,000


Typical product life time (years): 4 - 5


Shelf life (consumables): NA


Types and variations
Video; fi beroptic


Colonoscope
UMDNS GMDN
10950 Colonoscopes 36117 Flexible video colonoscope


Other common names:
Endoscopes; video endoscopes; Video colonoscope, fl exible; Video colonoscope




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These devices provide an accepted treatment modality within


the fi elds of dermatology, oral surgery, gynecology, urology,


otolaryngology, proctology, and ophthalmology. They can be


used to treat malignant and benign tumors, acne, warts, and


hemorrhoids.


Product description
These devices are available as consoles or as stand-alone or


handheld units. Consoles are freestanding units that typically


contain cryogen gas cylinders, pressure regulators, indicators,


and operating controls. They are usually battery powered and


can be equipped with a probe-tip fi beroptic light source for


transillumination of tissue. Stand-alone units consist of a tank, a


pressure regulator, and a probe attached by tubing to the tank.


Handheld units are lightweight, portable CSUs that typically


use liquid nitrogen as the cryogen and are either reusable or


disposable (with individual gas cartridges).


Principles of operation
CSUs apply a refrigerant (cryogen) to withdraw heat from target


tissue either through direct application or indirectly through


contact with a cryogen-cooled probe. There are two basic types


of CSUs: those that use liquid nitrogen and those that use nitrous


oxide (N2O), carbon dioxide (CO2), or other compressed gases.


All CSUs employ either a closed or an open system. In a closed-


system CSU, the cryogen fl ows through an insulated shaft in the


hollow probe, cools the tip, and is exhausted back through the


probe. Open-system CSUs apply cryogen directly to the target


tissue. CSUs using N2O or CO2 are not usually suitable for use


as open systems because cryogen “snow” would build up on


the target tissue and insulate the lesion from the cryogen spray.


Liquid nitrogen CSUs can be either open or closed.


Operating steps
A surgeon will use a cryosurgical unit to introduce a refrigerant to


target tissue (e.g., wart, tumor) either through direct application


(dabbing or spraying on) or through a cryogen-cooled probe


(e.g., gun-type or pencil-shaped with either a curved or straight


tip). Cryosurgically treated tissue is usually left in situ and


allowed to become necrotic and slough off.


Reported problems
Few device-related problems have occurred with the use of


CSUs. Of continued concern is the mechanical integrity of the


units, especially the probe tips, because they are exposed to


temperature and pressure extremes. Also potential damage to


tissue outside of the treatment zone is a concern.


Use and maintenance
User(s): Surgeon


Maintenance: Medical staff; technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals; supervised training with experienced


surgeons


Environment of use
Settings of use: Operating room


Requirements: Stable power source


Product specifi cations
Approx. dimensions (mm): 690x360x660


Approx. weight (kg): 72


Consumables: Liquid nitrogen or other


compressed gases


Price range (USD): 535-95000


Typical product life time (years): 10


Shelf life (consumables): Variable


Types and variations
Console; stand-alone; handheld unit


Cryosurgical Unit
UMDNS GMDN
18051


11067


Cryosurgical Units


Cryosurgical Units, General-Purpose


11067 Cryosurgical system, mechanical


Other common names:
Cryoextractors; Cryoprobes; Cryostats; Cryo Units; CSU; Probes, Cryosurgical




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© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Used to diagnose and/or prognose leukemia, lymphoma,


immunodefi ciency disorders such as HIV infection, autoimmune


disease, and fetal abnormalities, and to evaluate the success of


transplantation procedures. Also used in cancer diagnosis and


research to evaluate drug resistance, detect tumor cell DNA


aneuploidy, immunophenotyping, and analyzing tumor cell


proliferation. Can be adapted to provide a rapid, sensitive, and


cost-effective way to detect, characterize, and identify bacteria.


Product description
Automated cytometers in which cells are dispersed in fl uid


suspension and fl ow one at a time through a narrow beam of


light, typically from a laser. Each cell generates optical signals


that are measured and analyzed. These cytometers include


a cell transportation system, a laser for cell illumination,


photodetectors for signal detection, and a computer-based


management system.


Principles of operation
Specifi c dyes and fl uorochromes are used to mark structures in


or on the cells. These dyes bind to specifi c cellular components,


such as DNA, cellular enzymes, membrane surface markers,


or other antigens. Cells are suspended in a liquid stream and


transported in a single-cell path to the analysis chamber.


They are illuminated by a beam of high-intensity light. When


exposed to light of a particular wavelength, the fl uorochromes


will fl uoresce, emitting light of a longer wavelength than the


incident light they absorb. A detection system analyzes each


cell at a rate of up to 10,000 cells/second.


Operating steps
Sample cells must be treated with reagents and are loaded


into the instrument. The operator may have to program the


desired wavelength and parameters measured using a computer


connected to the instrument.


Reported problems
Operators should be aware of the risk of exposure to potentially


infectious bloodborne pathogens during testing procedures and


should use universal precautions, including wearing gloves, face


shields or masks, and gowns.


Use and maintenance
User(s): Laboratory technician


Maintenance: Laboratory technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Clinical laboratory


Requirements: Adequate benchtop or fl oor


space, line power


Product specifi cations
Approx. dimensions (mm): 600 x 450 x 500


Approx. weight (kg): 50-100


Consumables: Reagents, sample cells


Price range (USD): 27,000 - 250,500


Typical product life time (years): 5-7


Shelf life (consumables): Fluorescent dyes: 1


year


Types and variations
Cell-sorting capabilities can separate and


analyze specifi c cell types within the sample;


model may have multiple lasers or an


autoloader.


Cytometer
UMDNS GMDN
16867


16503


Cytometers, Automated, FlowCytometers,
Automated, Flow, Sorting


57839 Flow cytometry analyser IVD, automated


Other common names:
Flow cytometer, reticulocyte analyzer, cell sorter




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Health problem addressed
Fully automated external defi brillators (AEDs) deliver a high-


amplitude current impulse to the heart in order to restore normal


rhythm and contractile function in patients who are experiencing


ventricular fi brillation (VF) or ventricular tachycardia (VT) that


is not accompanied by a palpable pulse.


Product description
AEDs determine whether defi brillation is needed and


automatically charge and discharge to deliver a shock.


Semiautomated units analyze the ECG and charge in preparation


for shock delivery, but the operator activates the discharge.


AEDs typically include a memory module or PC data card,


disposable adhesive defi brillation electrodes, a display to give


status messages (patient and/or defi brillator), to display the


ECG waveform, or to prompt the user to initiate a shock.


Principles of operation
Automated defi brillators analyze the ECG rhythm to determine


if a defi brillation shock is needed; if it is, the defi brillator warns


the operator and automatically charges and discharges. Most


of these defi brillators use a single pair of disposable electrodes


to monitor the ECG and deliver the defi brillator discharge, but


some also incorporate ECG displays. The simple design and ease


of use of automated defi brillators requires very little training


and operational skill.


Operating steps
The operator attaches two adhesive defi brillator electrodes to


the cables or directly to the AED and applies the electrodes to


the patient. The AED will automatically analyze the rhythm to


determine whether defi brillation is necessary. In fully automatic


models, a shock is then automatically delivered when the rhythm


analysis determines it is necessary. In semiautomatic units the


user is prompted to deliver the shock.


Reported problems
Failure can be caused by defi brillator malfunction, poor


electrode application, inappropriate energy selection, a cardiac


physiologic state not conducive to defi brillation, or rechargeable


battery issues. First- and second-degree burns are especially


likely to occur during repeated defi brillation attempts (which


require successively higher energies) at the paddle or electrode


sites because a high current fl ow through a small area and/or


increased resistance (due to dried gel).


Types and variations
Portable, carrying case


Use and maintenance
User(s): Emergency medical services (EMS),


police offi cers, fi refi ghters, traditional


targeted responders (e.g., security guards,


fl ight attendants), nontraditional responders


(e.g., offi ce staff, family members), any


hospital staff trained in advance life support


(ALS) or basic life support (BLS).


Maintenance: Biomedical or clinical engineer/


technician, medical staff, out of hospital (e.g.,


airlines, shopping centers, emergency medical


servicers), manufacturer/servicer


Training: Initial training by manufacturer,


operator’s manuals, user’s guide


Environment of use
Settings of use: Hospital, emergency transport,


emergency medical services, patient homes,


public building or other public settings


Requirements: Fully charged battery/good


battery care and maintenance procedures


in place, uninterruptible power source (to


power and recharge batteries), proper sized


shock pads or electrodes, maintenance


procedures to monitor shelf life of shock pads


or electrodes, as well as errors returned by


internal testing trials.


Product specifi cations
Approx. dimensions (mm): 100 x 250 x 200


Approx. weight (kg): 2.5


Consumables: Batteries, cables, electrodes/


pads (with gel)


Price range (USD): 1,300 - 2,300


Typical product life time (years): 10


Shelf life (consumables): 1-2 years for


disposable electrodes/pads


Defi brillator, External, Automated; Semiautomated
UMDNS GMDN
17116


18500


Defi brillators, External, Automated


Defi brillators, External, Semiautomated


48049


48048


Non-rechargeable professional semi-
automated external defi brillator


Rechargeable professional automated external
defi brillator


Other common names:
AEDs, automated external defi brillators, automatic external defi brillators, semiautomated defi brillators, and shock-
advisory defi brillators, PADs, automated public-access defi brillators




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© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Defi brillators are lifesaving devices that apply an electric shock


to establish a more normal cardiac rhythm in patients who are


experiencing ventricular fi brillation (VF) or another shockable


rhythm.


Product description
The defi brillator charges with a large capacitor. For external


defi brillation, paddles are needed to discharge on the patient’s


chest. Disposable defi brillation electrodes may be used as an


alternative. For internal defi brillation small concave paddles are


used. An ECG monitor included is used to verify a shockable


rhythm and the effectiveness of treatment. Many defi brillators


can be equipped with optional monitoring capabilities, such as


pulse oximetry, end-tidal carbon dioxide and NIBP.


Principles of operation
Defi brillators typically have three basic modes of operation:


external defi brillation, internal defi brillation, and synchronized


cardioversion. (Sync mode uses a defi brillator discharge to correct


certain arrhythmias, such as VT; a shock is delivered only when


the control circuits sense the next R wave. The delivery of energy


is synchronized with and shortly follows the peak of the R wave,


preventing discharge during the vulnerable period of ventricular


repolarization.) An audible/visible indicator inform when the


capacitor is charged and the device is ready. ECG monitoring


can be performed before, during, and after a discharge, usually


through ECG electrodes, although most external paddles and


disposable electrodes have ECG monitoring capability. Many


defi brillators are equipped with optional monitoring capabilities


(SpO2, ETCO2, temperature, NIBP).


Operating steps
Apply the paddles to the patient’s chest and discharges the


defi brillator. Synchronized cardioversion (sync mode) uses a


defi brillator discharge to correct certain arrhythmias, such as


VT. After verifying that the sync marker pulse appears reliably on


the R wave, the operator presses and holds the paddle discharge


buttons; a shock is delivered only when the control circuits sense


the next R wave. The delivery of energy is synchronized with and


shortly follows the peak of the R wave, preventing discharge


during the vulnerable period of ventricular repolarization, which


is represented by the T wave.


Reported problems
Failure can be caused by defi brillator malfunction, poor


electrode application, inappropriate energy selection, a cardiac


physiologic state not conducive to defi brillation, or rechargeable


battery issues. First- and second-degree burns are especially


likely to occur during repeated defi brillation attempts (which


require successively higher energies) at the paddle or electrode


sites because a high current fl ow through a small area and/or


increased resistance (due to dried gel).


Use and maintenance
User(s): Physicians, nurses, other medical staff


Maintenance: Biomedical or clinical engineer/


technician, medical staff, manufacturer/


servicer


Training: Initial training by manufacturer,


operator’s manuals, user’s guide


Environment of use
Settings of use: Hospital, emergency transport


Requirements: Fully charged battery/good


battery care and maintenance procedures


in place, uninterruptible power source (to


power and recharge batteries), proper sized


shock pads or electrodes, maintenance


procedures to monitor shelf life of shock pads


or electrodes, as well as errors returned by


internal testing trials.


Product specifi cations
Approx. dimensions (mm): 250 x 300 x 250


Approx. weight (kg): 5.5


Consumables: Batteries, cables, paddles/


electrodes, gel


Price range (USD): 1,000 - 25,000


Typical product life time (years): 6-7


Shelf life (consumables): 1-2 years for


disposable electrodes/pads


Types and variations
Cart mounted, carry case


Defi brillator, External, Manual
UMDNS GMDN
11134 Defi brillators, External, Manual 37806 Manual external defi brillator


Other common names:
Battery-powered defi brillators, cardioverters, defi brillator/monitor/ pacemakers, external biphasic defi brillators, external
monophasic defi brillators, and monitor/defi brillators; DC-defi brillator, high-energy (including paddles)




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
The primary purpose of these noninvasive measurements is to


detect quantitative decreases in bone mass related to metabolic


bone diseases such as osteoporosis and to assess effi cacy of


treatment.


Product description
Central DXA devices (dual-energy x-ray absorptiometers) use


a dual-energy x-ray source to assess bone mineral content in


the axial skeleton. These devices have a large, fl at table and


an “arm” suspended overhead. Ultrasonic bone densitometers


measure broadband ultrasonic attenuation (BUA) and speed of


sound (SOS), to provide a quantitative ultrasound index of the


appendicular skeleton. Peripheral devices measure bone density


in the wrist, heel or fi nger. The pDXA device is much smaller than


the Central DXA device. It is a portable box-like structure with a


space for the foot or forearm to be placed for imaging.


Principles of operation
DXA systems use one of two methods to create a dual-energy


spectrum from an x-ray source. One method involves alternating


pulses of low-and high-voltage power applied to the x-ray tube.


The attenuation values of the resulting low- and high-energy


x-rays are then measured separately. The other method applies a


constant potential to the x-ray source while using a K-edge fi lter


to separate the energy spectrum into two narrow energy bands.


An energy-discriminating detector with a dual-channel analyzer


counts the resultant photons. Ultrasonic bone densitometry


systems do not rely on a radiation source but instead use sound


waves to measure the integrity of the appendicular skeleton,


typically through the calcaneus or phalanges of the fi ngers.


Operating steps
This examination is usually done on an outpatient basis. In the


Central DXA examination, the patient lies on a padded table.


An x-ray generator is located below the patient and an imaging


device, or detector, is positioned above. To assess the spine,


the patient’s legs are supported on a padded box to fl atten the


pelvis and lower (lumbar) spine. To assess the hip, the patient’s


foot is placed in a brace that rotates the hip inward. In both


cases, the detector is slowly passed over the area, generating


images on a computer monitor.


Reported problems
No serious reports concerning the functioning of DXA scanners.


Use and maintenance
User(s): Bone densitometry technician


Maintenance: Medical staff; technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Hospitals, medical offi ces


(central DXA); mobile health vans, drugstores


(pDXA)


Requirements: Stable power source; shielding


for treatment room and control room (central


bone densitometers)


Product specifi cations
Approx. dimensions (mm): 840 x 737 x 483


Approx. weight (kg): 181


Consumables: NA


Price range (USD): 9,180 - 199,000


Typical product life time (years): 12 to 15


Shelf life (consumables): NA


Types and variations
Central bone densitometers; peripheral bone


densitometers


Densitometer, Bone
UMDNS GMDN
17152


18382


17747


Densitometers, Bone


Densitometers, Bone, Ultrasonic


Densitometers, Bone, X-Ray, Dual-Energy
Absorptiometry


38314


37661


Bone absorptiometric radionuclide system


Bone absorptiometric x-ray system, dual-
energy


Other common names:
Absorptiometers, X-Ray, Dual-Energy; Central DXA Systems; DEXA Systems; Diagnostic Bone Absorptiometer;
Dual-Energy Densitometers; Dual-Energy X-Ray Absorptiometers; DXA Systems; Peripheral DXA Systems (pDXA);
Radionuclide Systems; Ultrasonometers; Absorptiometer, dual-photon; RI bone mineral analyser; Dual-energy x-ray
absorptiometry (DEXA) system




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
Electrocardiographs detect the electrical signals associated


with cardiac activity and produce an ECG, a graphic record of


the voltage versus time. They are used to diagnose and assist in


treating some types of heart disease and arrhythmias, determine


a patient’s response to drug therapy, and reveal trends or


changes in heart function. Multichannel electrocardiographs


record signals from two or more leads simultaneously and


are frequently used in place of single-channel units. Some


electrocardiographs can perform automatic measurement and


interpretation of the ECG as a selectable or optional feature.


Product description
ECG units consist of the ECG unit, electrodes, and cables. The 12-lead


system includes three different types of leads: bipolar, augmented


or unipolar, and precordial. Each of the 12 standard leads presents


a different perspective of the heart’s electrical activity; producing


ECG waveforms in which the P waves, QRS complex, and T


waves vary in amplitude and polarity. Single-channel ECGs record


the electric signals from only one lead confi guration at a time,


although they may receive electric signals from as many as 12 leads.


Noninterpretive multichannel electrocardiographs only record the


electric signals from the electrodes (leads) and do not use any


internal procedure for their interpretation. Interpretive multichannel


electrocardiographs acquire and analyze the electrical signals.


Principles of operation
Electrocardiographs record small voltages of about one millivolt


(mV) that appear on the skin as a result of cardiac activity. The


voltage differences between electrodes are measured; these


differences directly correspond to the heart’s electrical activity.


Each of the 12 standard leads presents a different perspective of the


heart’s electrical activity; producing ECG waveforms in which the P


waves, QRS complex, and T waves vary in amplitude and polarity.


Other lead confi gurations include those of the Frank system and


Cabrera leads. The Frank confi guration measures voltages from


electrodes applied to seven locations—the forehead or neck, the


center spine, the midsternum, the left and right midaxillary lines,


a position halfway between the midsternum and left midaxillary


electrodes, and the left leg.


Operating steps
After the electrodes are attached to the patient, the user selects


automatic or manual lead switching, signal sensitivity, frequency-


response range, and chart speed. In some units, the operator can


choose the lead groupings, their sequence, and the recording


duration for each group. In standard 12-lead tracings, signals from


each group of leads (i.e., bipolar, augmented, precordial) can be


recorded for 2.5 seconds. For a rhythm strip, one lead (usually lead


II) is recorded for a full 12 seconds.


Reported problems
Because electrocardiographs have electrical


safety standards that are well established and


adhered to by all major manufacturers, few


problems are associated with their use. Of


these, the most common is artifact or noise


(e.g., broken electrode wires, poor electrode


cleaning or improper application, poor skin


preparation, patient movement, baseline


drift, and interference). Incorrect placement


of ECG leads can cause an abnormality to


be overlooked. Chest wall thickness can also


affect diagnostic accuracy.


Use and maintenance
User(s): Physicians, nurses, other medical staff


Maintenance: Biomedical or clinical engineer/


technician, medical staff, manufacturer/


servicer


Training: Initial training by manufacturer,


operator’s manuals, user’s guide


Environment of use
Settings of use: Hospital (all areas), family


medicine practices and other medical offi ces


Requirements: Uninterruptible power source,


battery backup, appropriate electrodes


Product specifi cations
Approx. dimensions (mm): 120 x 400 x 350


Approx. weight (kg): 6


Consumables: Batteries, cables, electrodes


Price range (USD): 975 - 6,000


Typical product life time (years): 10


Shelf life (consumables): 1-2 years for


disposable electrodes/sensors


Types and variations
Portable, cart, desktop, tabletop


Electrocardiograph, ECG
UMDNS GMDN
16231


18330


18329


17687


11413


Electrocardiographs, Multichannel, Interpretive


Electrocardiographs, Multichannel, Interpretive,
Signal-Averaging


Electrocardiographs, Multichannel, Noninterpretive


Electrocardiographs, Multichannel, Noninterpretive,
Signal-Averaging


Electrocardiographs, Single-Channel


16231


17687


11413


Interpretive multichannel electrocardiograph


Signal-averaging multichannel
electrocardiograph


Single-channel electrocardiograph


Other common names:
Computer-assisted electrocardiographs; interpretive ECG machines; interpretive electrocardiographs; automated
electrocardiographs; EKG machines; Electrocardiograph multichannel;




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
Devices intended for surgical cutting and for controlling


bleeding by causing coagulation (hemostasis) at the surgical


site. Electrosurgery is commonly used in dermatological,


gynecological, cardiac, plastic, ocular, spine, ENT, maxillofacial,


orthopedic, urological, neuro- and general surgical procedures


as well as certain dental procedures.


Product description
These systems include an electrosurgical generator (i.e., power


supply, waveform generator) and a handpiece including one or


several electrodes.


Principles of operation
In monopolar electrosurgery, tissue is cut and coagulated


by completion of an electrical circuit that includes a high-


frequency oscillator and amplifi ers within the ESU, the patient,


the connecting cables, and the electrodes. In most applications,


electric current from the ESU is conducted through the surgical


site with an active cable and electrode. The electrosurgical


current exits the patient through a dispersive electrode (usually


placed on the patient at a site remote from the surgical site)


and its associated cable connected to the neutral side of the


generator. In bipolar electrosurgery, two electrodes (generally,


the two tips of a pair of forceps or scissors) serve as the


equivalent of the active and return electrodes in the monopolar


mode.


Operating steps
Electrosurgical procedures may or may not be performed


with the patient under anesthesia. The patient is prepped and


electrodes are applied to the affected areas. Electrical current


is delivered to the affected area and the surrounding tissue is


heated to cause desiccation, vaporization, or charring to remove


diseased or damaged tissue.


Reported problems
There is a risk of surgical fi re when using oxygen while performing


electrosurgery. Partial or complete detachment of the electrode


pad from the patient is a common cause of patient burns. Burns


may also result from inadequate site preparation, defective


materials or construction, or incorrect placement of the return


electrode. The second most common type of electrosurgical


injury occurs when the active electrode is inadvertently


energized while the tip is in contact with nontarget tissue.


Use and maintenance
User(s): Surgeon


Maintenance: Medical staff; technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals; supervised training with experienced


surgeons


Environment of use
Settings of use: Hospital operating room


Requirements: Stable power source; smoke


evacuation


Product specifi cations
Approx. dimensions (mm): 777 x 360 x 505


Approx. weight (kg): 28


Consumables: Active and return electrodes


Price range (USD): 1,500 - 14,000


Typical product life time (years): 7 to 10


Shelf life (consumables): Single use or variable


Types and variations
Bipolar unit; monopolar unit; monopolar/


bipolar unit


Electrosurgical Unit
UMDNS GMDN
11490


18230


18229


18231


Electrosurgical Units


Electrosurgical Units, Bipolar


Electrosurgical Units, Monopolar


Electrosurgical Units, Monopolar/Bipolar


44776 General-purpose electrosurgical diathermy
system


Other common names:
Bovies; Coagulators, Electrosurgical; Diathermy Units, Surgical; Electrocautery Units; Electrosurgical Generators;
Endometrial Ablation Systems; ESUs; Hyfrecators; Malis Coagulators; Stimulators, Muscle; Surgical Diathermy Units;
Surgical Units; Wapplers; Apparatus, electrosurgical; Surgical diathermy generator




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Ultrasonic fetal heart detectors are low-cost devices used in


a variety of healthcare settings to provide audible and visual


information about the fetus. The unit provides quick reassurance


of fetal well-being to both the mother and the healthcare worker.


Fetal heart detectors can easily detect fetal heart sounds


throughout the pregnancy, starting as early as 8 weeks. The


ability of most units to accurately calculate the fetal heart rate


has also made these devices valuable diagnostic tools.


Product description
Fetal heart detectors are devices that use ultrasonic waves to


provide audible and/or visual information. They consist of an


ultrasound-frequency electrical generator and appropriate


ultrasound transducers housed in a probe that is placed on


the maternal abdomen. Ultrasonic heartbeat detectors amplify


the audible frequency shift signal of the returned ultrasonic


waves and deliver it to speakers or headphones; the heart rate


is determined either by measuring the timing of the peaks in


the Doppler signal or, more accurately, by using automated


autocorrelation procedures. These devices can detect fetal heart


activity as soon as 10 weeks after conception. Advanced units


can even detect bidirectional blood fl ow, allowing the clinician


to evaluate maternal vessels, such as the uterine artery.


Principles of operation
Fetal heart detectors transmit high-frequency sound waves


either continuously or in pulses. In continuous-wave (CW)


units, a crystal vibrates as an electrical current passes through


it, creating and transmitting acoustic energy, while a second


crystal detects echoes from structures in the body. In pulsed-


Doppler systems, a single crystal alternately transmits periodic


bursts of ultrasonic waves and senses the echoed energy. In both


systems, the refl ected wave is reconverted to an electrical signal


that can be used to create an audible sound or a waveform.


Ultrasonic heartbeat detectors amplify the audible frequency


shift signal of the returned ultrasonic waves and deliver it to


speakers or headphones; the heart rate is determined either by


measuring the timing of the peaks in the Doppler signal or by


using automated autocorrelation procedures.


Operating steps
An acoustic coupling gel is spread over the skin to facilitate the


effi cient transmission of ultrasound waves into and out of the


body. The probe is placed against the mother’s abdomen. If the


scanned structures are in motion, the frequency of the returning


sound waves changes in proportion to the velocity and direction


of the moving structures. Fetal heart detectors amplify this


audible frequency change, known as Doppler shift, and channel


it to speakers or headphones.


Reported problems
Although researchers have yet to establish


whether a signifi cant risk exists, there is some


concern about whether exposure to ultrasonic


energy during diagnostic procedures is safe.


Many factors can affect the ability of the unit


to detect the fetal heartbeat (i.e., body fat and


blood fl ow can absorb acoustic energy). Since


pathogens may be present on the patient’s


skin, transmission of these organisms to the


transducer head commonly occurs.


Use and maintenance
User(s): Physicians, obstetric nurses,


community midwives


Maintenance: Biomedical or clinical engineer/


technician, medical staff, manufacturer/servicer


Training: Initial training by manufacturer,


operator’s manuals, user’s guide


Environment of use
Settings of use: Obstetrics (hospital, OB/GYN


practices), emergency medicine


Requirements: Battery, uninterruptible power


source (recharge batteries), appropriate


transducer with gel


Product specifi cations
Approx. dimensions (mm): 100 x 150 x 200


Approx. weight (kg): 1


Consumables: Batteries, gel


Price range (USD): 350 - 800


Typical product life time (years): 8


Shelf life (consumables): NA


Types and variations
Portable, handheld, tabletop units


Fetal Heart Detector, Ultrasonic
UMDNS GMDN
11696 Detectors, Fetal Heart, Ultrasonic 35068 Foetal heart detector, ultrasonic


Other common names:
Ultrasonic stethoscopes; fetal Dopplers; Monitor, heart rate, fetal ultrasonic; Monitor, heart sound, fetal, ultrasonic;
monitor, hemic sound, ultrasonic.




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© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Electronic fetal monitoring (EFM) provides graphic and numeric


information on fetal heart rate (FHR) and maternal uterine


activity (UA) to help clinicians assess fetal well-being before and


during labor. FHR often exhibits decelerations and accelerations


in response to uterine contractions or fetal movements; certain


patterns are indicative of hypoxia. Examination of these patterns,


the baseline level, and variability characteristics can indicate


the need to alter the course of labor with drugs or perform an


operative delivery.


Product description
Fetal monitors are bedside units that consist of a monitoring unit,


cables, and electrodes. They are designed to measure, record, and


display FHR, uterine contractions, and/or maternal blood pressure


and heart rate before and during childbirth. These monitors


may sense FHR and uterine contraction indirectly through the


mother’s abdomen and/or directly by placing an electrode on


the fetal scalp (or other exposed skin surface) and measuring the


change in pressure within the uterus. Antepartum fetal monitors


are typically used in physician’s offi ces and clinics long before the


beginning of labor. Most hospital-based monitors have additional


capabilities, including fetal and maternal ECG recording.


Principles of operation
Fetal monitors detect FHR externally by using an ultrasound


transducer to transmit and receive ultrasonic waves; the


frequency (or Doppler) shift of the refl ected signal is proportional


to the velocity of the refl ecting structure—in this case, the fetal


heart. A transducer contains one or more piezoelectric elements


that convert an electrical signal into ultrasonic energy that can


be transmitted into tissues. When this ultrasonic energy is


refl ected back from the tissues, the transducer reconverts it to


an electrical signal that can be used to create a waveform for


display and recording and an audible FHR (sound created by the


frequency shift of the ultrasonic signal).


Operating steps
Continuous electronic FHR monitoring can be performed


indirectly, by applying an ultrasound transducer to the mother’s


abdomen, or directly, by attaching an electrode assembly to


the fetus after rupture of the amniotic membranes. Uterine


contractions can be recorded along with FHR by placing a


pressure transducer on the mother’s abdomen or by directly


measuring the change in pressure in the uterus with a catheter.


Reported problems
Common errors include doubled or halved rates, masked


fetal arrhythmias, and presentation of the maternal heart


rate as the FHR. Another error is the report of false FHR


decelerations during uterine contractions due to ultrasonic


signal-processing circuits holding the last FHR on occasional


signal peaks during noisy signals. Reported complications


of fetal scalp electrode application include


infection, uterine perforation, and soft tissue


injuries; mostly resulting from poor technique.


Some investigators have expressed concern


about the possible risks associated with fetal


exposure to ultrasound.


Use and maintenance
User(s): Physicians, obstetric nurses,


community midwives


Maintenance: Biomedical or clinical engineer/


technician, medical staff, manufacturer/servicer


Training: Initial training by manufacturer,


operator’s manuals, user’s guide


Environment of use
Settings of use: Obstetrics (hospital, OB/GYN


practices), emergency medicine


Requirements: Uninterruptible power source,


battery backup, appropriate transducer/


electrodes/sensors


Product specifi cations
Approx. dimensions (mm): 100 x 150 x 200


Approx. weight (kg): 6


Consumables: Batteries, cables, electrodes/


sensors, gel


Price range (USD): 1,200 - 15,000


Typical product life time (years): 8


Shelf life (consumables): NA


Types and variations
Tabletop, cart, some portable


Fetal monitor
UMDNS GMDN
18339


18340


Monitors, Bedside, Fetal, Antepartum


Monitors, Bedside, Fetal, Intrapartum


43958 Foetal cardiac monitor


Other common names:
Cardiotocographs; fetal electrocardiogram (ECG) monitors; fetal heart rate monitors; ultrasonic fetal monitors; Monitor,
cardiac, fetal; Monitor, heart valve movement, fetal, ultrasonic; Monitor, phonocardiographic, fetal.




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Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
Used to test for and manage diabetes by measuring blood


glucose levels; also used to test for transient high or low glucose


levels (e.g., during surgery); they are also used in sports medicine.


Product description
Handheld device with a display (usually LCD), a keypad to enter


information, and a slot to insert a test strip containing a drop


of blood which is tested for glucose. Some models may have


alarms, memory functions, touchpens, USB ports or wireless


features to transfer data to a computer, and/or a small storage


compartment for test strips.


Principles of operation
In optical BGMs, the blood sample is exposed to a membrane


covering the reagent pad, which is coated with an enzyme


(glucose oxidase, glucose dehydrogenase). The reaction


causes a color change; the intensity of this change is directly


proportional to the amount of glucose in the blood sample.


Light from an LED strikes the pad surface and is refl ected to a


photodiode, which measures the light’s intensity and converts


it to electrical signals. Electrochemical BGMs use an electrode


sensor to measure the current produced when the enzyme


converts glucose to gluconic acid. The resulting current is


directly proportional to the amount of glucose in the sample.


Operating steps
The test strip is inserted into the device either before or after the


addition of blood to the pad; timing begins automatically when


the monitor senses blood on the strip. Within seconds, a reading


is taken and displayed.


Reported problems
Outdated or improperly stored test strips can produce


inaccurate glucose readings. Healthcare personnel who use


BGMs in multiple-patient facilities should be aware of the risk of


exposure to potentially infectious bloodborne pathogens during


testing and cleaning procedures. Cross-contamination can occur


if appropriate infection control measures are not taken. Lancing


devices can cause needlestick injuries.


Use and maintenance
User(s): Patient, clinician, nurse


Maintenance: Patient or clinician


Training: Training manual


Environment of use
Settings of use: Home, hospital, physician


clinic


Requirements: NA (battery-operated


handheld devices do not have special settings


requirements)


Product specifi cations
Approx. dimensions (mm): 90 x 50 x 100


Approx. weight (kg): 0.65


Consumables: Test strips, batteries


Price range (USD): 15 - 1500


Typical product life time (years): 5-7


Shelf life (consumables): Test strips: 6 months


Types and variations
Specialized devices for neonate may be


available; some devices not intended for use


with neonates; some models allow alternate-


site testing (fi ngertip, forearm, palm)


Glucose Analyzer
UMDNS GMDN
16488


15102


Analyzers, Point-of-Care, Whole Blood Glucose


Analyzers, Laboratory, Body Fluid, Glucose


56684


56685


44206


Home-use/point-of-care glucose analyser IVD


Battery-powered Home-use/point-of-care
glucose analyser IVD


Line-powered Laboratory glucose analyser
IVD, automated


Other common names:
Glucometers, glucose meters, glucose monitors, blood sugar meters




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Used to count blood cells. An abnormal red cell count may indicate


polycythemia or anemia, which occurs because of blood loss,


failure of the bone marrow to produce RBCs, vascular hemolysis,


hypersplenism, or defi ciencies of iron, vitamin B12, or folic acid.


Abnormal white cell counts may indicate allergies, bacterial


or viral infections, infl ammatory disorders, tumors, tissue


destruction, toxic metabolic states, leukemia, myeloproliferative


syndromes, parasitic infecitons, or typhoid fever.


Product description
Handheld device or benchtop device, sometimes placed on a


cart, with a display (usually LCD), a keypad to enter information,


and a slot to insert a test strip or sample tube. Some models


may have alarms, memory functions, touchpens, USB ports to


transfer data to a computer, and/or a small storage compartment


for reagents.


Principles of operation
Red blood cell, white blood cell, and platelet counts are obtained


using the volumetric impedance technique, which creates pulses


which are amplifi ed; the magnitude of the pulse is directly


proportional to the volume of the cell. Another method is the


light-scatter technique, which counts and sizes cells by detecting


the amount of light scattered by a stream of hydrodynamically


focused cells. Within minutes of placing the sample into the


analyzer, the sample’s cells have been quantifi ed, and results are


analyzed and displayed.


Operating steps
Whole blood samples are placed in tubes, on reaction cuvettes,


or on test strips, and loaded into the analyzer. The operator may


select the tests being performed on the sample using a keypad


or connected computer.


Reported problems
Operators should be aware of the risk of exposure to potentially


infectious bloodborne pathogens during testing procedures and


should use universal precautions, including wearing gloves, face


shields or masks, and gowns.


Use and maintenance
User(s): Medical staff


Maintenance: Laboratory technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Hospital, patient bedside,


physician offi ce, clinical laboratory, home


Requirements: Battery-operated handheld


devices do not have special settings


requirements; benchtop units require line


power


Product specifi cations
Approx. dimensions (mm): 100 x 300 x 400


Approx. weight (kg): 1-5 for handheld units;


15-25 for benchtop units


Consumables: Reagent cartridges or test


strips, batteries


Price range (USD): 191 - 28,000


Typical product life time (years): 4-6


Shelf life (consumables): Reagents: 1-2 years


Types and variations
Handheld, portable, benchtop


Hematology Point of Care Analyzer
UMDNS GMDN
18513 Analyzers, Point-of-Care, Whole Blood, Hematology 35476 Haematological cell analyser IVD, automated


Other common names:
POC Analyzer, hematology analyzer; Analyser, laboratory, haematology, cell counting, automated




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These devices perform extracorporeal dialysis to replace the


main activity of the kidneys in patients with impaired renal


function, such as those with end-stage renal disease.


Product description
Single-patient hemodialysis systems can be divided into


three major components: the dialysate delivery system, the


extracorporeal blood-delivery circuit, and the dialyzer.


Principles of operation
Single-patient hemodialysis systems can be divided into


three major components: the dialysate delivery system, the


extracorporeal blood-delivery circuit, and the dialyzer. Blood is


taken via the extracorporeal circuit, passed through a dialyzer


for solute and fl uid removal, and returned to the patient. Each


system has its own monitoring and control circuits. The delivery


system prepares dialysate—a solution of purifi ed water with an


electrolyte composition similar to that of blood—and delivers it to


the dialyzer. The external blood-delivery system (extracorporeal


blood circuit) circulates a portion of the patient’s blood through


the dialyzer and returns it to the patient. The dialyzer is a


disposable component in which solute exchange, or clearance,


takes place.


Operating steps
Blood is taken via the extracorporeal circuit, passed through a


dialyzer for solute and fl uid removal, and returned to the patient.


Reported problems
Infections are a leading cause of morbidity and mortality


in chronic hemodialysis patients. For example, HBsAg (an


indicator for the presence of hepatitis B virus) has been


detected on various surfaces in hemodialysis centers. Strict,


specifi c policies and procedures designed to reduce infection


risks should be implemented. These policies should address


issues such as sterilization and disinfection, housekeeping,


laundry, maintenance, waste disposal, isolation precautions, and


universal precautions.


Use and maintenance
User(s): Nurse; dialysis technician


Maintenance: Medical staff; technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Dialysis department at


hospitals; dialysis clinics


Requirements: Stable power source; water


treatment capability (e.g., reverse osmosis,


deionization)


Product specifi cations
Approx. dimensions (mm): 1680 x 510 x 640


Approx. weight (kg): 85


Consumables: Dialysate and administration


sets


Price range (USD): 37,000


Typical product life time (years): 5 to 7


Shelf life (consumables): variable and single


use


Types and variations
Single patient; multiple patient


Hemodialysis Unit
UMDNS GMDN
11218 Hemodialysis Units 34995 Haemodialysis system


Other common names:
Artifi cial Kidneys; Dialysis Machines; Hemodialyzers; Hemodialysis Machines; System, dialysate delivery, sealed; System,
dialysate delivery, sorbent regenerated; Haemodialysis apparatus




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© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Immunoassay analyzers test patient samples for a variety of


substances, including antiarrhythmic, antibiotic, anticonvulsant,


or cardiac glycoside drug concentration determination; infectious


diseases; allergy testing; cardiac markers; endocrine hormone


testing; and protein, viral, or bacterial toxin determinations.


Product description
Laboratory analyzers used to identify and quantify specific


substances, typically using an antibody (e.g., immunoglobulin)


as a reagent to detect the substance (i.e., antigen, hapten) of


interest. These analyzers typically include an autosampler,


a reagent dispenser, a washer, and a detection system.


Configuration and levels of sophistication, as well as available


testing options, vary greatly.


Principles of operation
Labeled molecules are added to patient specimens and passed


through a light of a particular wavelength. If the labeled


molecules bind to the molecules in the patient specimen, the


bound molecules will emit light. This indicates a positive result


that can then be quantified. The light signals are captured by a


detector and analyzed by the system’s computer. Models may


use an enzyme-substrate system, a fluorescent substance (either


a natural substance or a dye), or an acridinium ester or luminol.


Operating steps
The operator loads sample cells into the analyzer; reagents are


already stored in the instrument. Typically, a bar-code scanner


will read the test orders off the label on each test tube. The


analyzer will perform the required test(s), and the results can


be displayed on-screen, printed out, stored in the analyzer’s


internal memory, and/or transferred to a computer.


Reported problems
Operators should be aware of the risk of exposure to potentially


infectious bloodborne pathogens during testing procedures and


should use universal precautions, including wearing gloves, face


shields or masks, and gowns.


Use and maintenance
User(s): Laboratory technician


Maintenance: Laboratory technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Clinical laboratory


Requirements: Adequate benchtop or floor


space, water supply, line power, biohazard


disposal


Product specifications
Approx. dimensions (mm): 600 x 750 x 1,000


Approx. weight (kg): 10-60


Consumables: Reagents (cartridges, test


strips, etc.), reaction cuvettes


Price range (USD): 4,278 - 339,000


Typical product life time (years): 5-7


Shelf life (consumables): Reagents: 1-2 years


Types and variations
Enzyme, fluorescence, or chemiluminescence


methodolgies; some models can be interfaced


to an automated chemistry analyzer to


decrease operator intervention and possibly


improve workflow.


Immunoassay Analyzer
UMDNS GMDN
18625 Analyzers, Laboratory, Immunoassay 56724 Multichannel immunoassay analyser IVD,


automated


Other common names:
IA analyzer, EIA analyzer, FIA analyzer, CIA analyzer, enzyme photometric analyzer, immunofluorescence analyzer,
luminescent analyzer




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Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
At birth, an infant’s core and skin temperatures tend to drop


signifi cantly because of heat loss from conduction, convection,


radiation, and water evaporation. Prolonged cold stress


in neonates can cause oxygen deprivation, hypoglycemia,


metabolic acidosis, and rapid depletion of glycogen stores.


Product description
Bassinets enclosed in plastic with climate controlled equipment


and hand-access ports with doors that are intended to keep


infants warm and limit their exposure to germs.


Principles of operation
These devices provide a closed, controlled environment that


warms an infant by circulating heated air over the skin. The heat


is then absorbed into the body by tissue conduction and blood


convection. Ideally, both the skin and core temperatures should


be maintained with only minor variations.


Operating steps
The neonate lies on a mattress in the infant compartment,


which is enclosed by a clear plastic hood. Incubators have hand-


access ports with doors that permit the infant to be handled


while limiting the introduction of cool room air. The clinician can


raise or remove the plastic hood or open a panel to gain greater


access to the infant.


Reported problems
Deaths and injuries to neonates in incubators have been linked


to thermostat failure that caused incubator overheating and


infant hyperthermia and to malfunctions or design defects that


produced fi res and electric shock hazards. Inadequate control


over the amount of oxygen delivered in an incubator can cause


hyperoxia or hypoxia.


Use and maintenance
User(s): Nursing staff


Maintenance: Medical staff; technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Hospital (primary care,


intermediate care, intensive care areas);


transport units used in ambulances


Requirements: Stable power source


Product specifi cations
Approx. dimensions (mm): 1326 x 1040 x 750


Approx. weight (kg): 93


Consumables: NA


Price range (USD): 13,000 - 43,000


Typical product life time (years): 7 to 10


Shelf life (consumables): NA


Types and variations
Incubator; incubator/warmer; transport;


mobile


Incubator, Infant
UMDNS GMDN
12113


17432


12114


Incubators, Infant


Incubators, Infant, Mobile


Incubators, Infant, Transport


35121


36025


Transport infant incubator


Conventional infant incubator


Other common names:
Beds, Infant; Combination Incubator/Warmers; Infant Incubators; Infant Warmers; Neonatal Care Stations; Transport
Incubators; Warmers; Thermostated transportable incubator; Incubator, neonatal transport




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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The CO2 laser is applied extensively in gynecology, genitourinary,


plastic, dental, hepatic, orthopedic, and cardiovascular surgery


and are considered the mainstay of laser neurosurgery. They are


used for cutting, dissection, and coagulation of a wide range of


tissues.


Product description
Devices that typically consist of a laser tube, a laser pump, a


cooling system, an aiming laser, and a delivery system. A typical


CO2 laser delivery system consists of a hollow articulated arm


with mirrors set in each rotating joint so that the handpiece can


aim the beam in any direction. The handpiece has a focusing


lens to control spot size and focal length.


Principles of operation
CO2 lasers have two main modes of operation: continuous wave


(CW) and pulsatile (e.g., superpulse, pulser). In the CW mode,


the laser continuously delivers energy as long as the footpedal


is depressed. This mode releases the highest average power, but


it is the least precise of the operating modes. Pulsatile modes


allow the laser to fi re much shorter pulses than the CW mode.


Superpulse emits pulses that are 200 to 1,000 microseconds


(μsec) long; it is used when precise control is necessary. Pulser,
a second type of pulsatile mode, emits energy for 2 to 25


milliseconds (msec). A newer, highly developed type of pulsatile


mode is ultrapulse; the peak energy of each pulse in this mode


lasts longer than that of superpulse, subjecting tissue to a


substantially greater amount of energy per pulse.


Operating steps
These devices are intended to create surgical incisions, to


excise or vaporize deeper tissues (e.g., to remove tumors) after


incisions, to coagulate very small bleeding vessels, to vaporize


surface anomalies (e.g., warts), and to excise or vaporize tissue


accessible by both rigid and fl exible endoscopes.


Reported problems
Serious eye injuries have resulted from exposure to direct or


refl ected laser light; many of these injuries occurred because


eye protection was inappropriate. Fire is a risk, particularly


during laser surgery in the area of the head and neck. Oxygen


and nitrous oxide can enter the surgical site or collect in the


otopharyngeal cavity and increase the fl ammability of nearby


materials. Other risks include excessive bleeding resulting from


the CO2 laser’s inability to effectively coagulate blood vessels.


Use and maintenance
User(s): Surgeon


Maintenance: Medical staff; technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Hospital; clinic; physician


offi ce


Requirements: Stable power source; smoke


evacuation


Product specifi cations
Approx. dimensions (mm): 350 x 400 x 1190


Approx. weight (kg): 49


Consumables: CO2 compressed gas


Price range (USD): 13,019-75,000


Typical product life time (years): 7


Shelf life (consumables): Variable


Types and variations
Free-fl owing tube; sealed tube


Laser, CO2
UMDNS GMDN
18203


18204


16942


Lasers, Carbon Dioxide


Lasers, Carbon Dioxide, Dental


Lasers, Carbon Dioxide, Surgical/Dermatologic


35939


47878


Surgical/dermatological carbon dioxide laser
system


Dental carbon dioxide laser system


Other common names:
Carbon Dioxide Lasers; Laser, ENT, microsurgical carbon dioxide; Laser, surgical, carbon dioxide, general-purpose;
Laser, surgical, carbon dioxide, speciality




http://www.who.int/medical_devices/en/index.html
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Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


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Health problem addressed
Devices used to coagulate abnormal vascular tissue in the retina.


Proliferation of such tissue (diabetic retinopathy) may lead to


blindness. They may create highly localized perforations in the


iris or in the trabecular meshwork to relieve excessive intraocular


pressure (glaucoma). They can also be used to reshape the


cornea to correct vision problems.


Product description
Most ophthalmic laser systems consist of a laser module—a


laser medium, laser pump, laser cavity, and cooling system that


is typically coupled to a slit-lamp biomicroscope by a flexible


fiberoptic cable. Other laser-energy delivery systems include


indirect ophthalmoscopes, intraocular probes, and interfaces for


operating microscopes.


Principles of operation
These devices are grouped into three main types:


photocoagulating lasers, photodisrupting lasers, and


photoablating lasers. Some ophthalmic lasers are also used for


photodynamic therapy. For photocoagulation ophthalmologists


use argon, dye, krypton, diode, and frequency-doubled Nd:YAG


lasers to coagulate abnormal vascular tissue in the retina. Dye


and diode lasers are being used in the photodynamic treatment


of intraocular tumors. Q-switched Nd:YAG ophthalmic lasers


are used for microsurgery in the anterior portions of the eye.


Excimer lasers are used in phototherapeutic keratectomy to


smooth over corneal scarring and remove calcification plaques,


in photorefractive keratectomy to shape the cornea to correct


myopia, and in automated lamellar keratoplasty to correct both


myopia and hyperopia.


Operating steps
The ophthalmologist views the structures within the patient’s


eye and aims and focuses the laser through the optics of the


slit lamp; when the laser is fired, the energy is delivered through


these optics or through coaxial optics.


Reported problems
Adverse outcomes include hemorrhage in and behind the retina,


retinal membrane contraction, atrophy of the iris, corneal edema


and neovascularization, loss of blue vision, changes in corneal


epithelial cell density, and increased intraocular pressure. Using


an Nd:YAG laser in the presence of an IOL can pit the lens,


affecting visual acuity.


Use and maintenance
User(s): Surgeon


Maintenance: Medical staff; technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals; supervised training with experienced


surgeons


Environment of use
Settings of use: Hospital; clinic


Requirements: Stable power source


Product specifications
Approx. dimensions (mm): 130 x 220 x 250


Approx. weight (kg): 47


Consumables: NA


Price range (USD): 75,000


Typical product life time (years): 7


Shelf life (consumables): NA


Types and variations
With integrated slit lamp; without integrated


slit lamp


Laser, Ophthalmic
UMDNS GMDN
16945


17773


17808


17481


18224


17702


18227


16946


16947


Lasers, Argon, Ophthalmic


Lasers, Argon/Krypton, Ophthalmic


Lasers, Diode, Ophthalmic


Lasers, Dye, Ophthalmic


Lasers, Er:YAG, Ophthalmic


Lasers, Excimer, Ophthalmic


Lasers, Excimer/Ho:YAG, Ophthalmic


Lasers, Krypton, Ophthalmic


Lasers, Nd:YAG, Ophthalmic


16945


36171


44731



17481


17702


36532


16947


Ophthalmic argon laser system


Ophthalmic argon/krypton laser system


Ophthalmic diode-pumped solid-state laser
system


Ophthalmic dye laser system


Ophthalmic excimer laser system


Ophthalmic krypton laser system


Ophthalmic Nd:YAG laser system


Other common names:
Coagulators, Laser, Ophthalmic; Coagulators, Optical; Laser Coagulators, Ophthalmic; Photocauteries; Photocoagulation
Lasers; Photocoagulators; Semiconductor laser therapy equipment; Diode-pumped solid-state (DPSS) laser




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Mammographic radiographic units use x-rays to produce images


of the breast—a mammogram—that provide information about


breast morphology, normal anatomy, and gross pathology.


Mammography is used primarily to detect and diagnose breast


cancer and to evaluate palpable masses and nonpalpable breast


lesions.


Product description
A complete mammographic radiographic system includes


an x-ray generator, an x-ray tube and gantry, and a recording


medium. The x-ray generator modifies incoming voltage to


provide the x-ray tube with the power necessary to produce


an x-ray beam. They also include a “paddle” for compression


and placement of the breasts during imaging. Screen-film


systems consist of a high-resolution phosphorescent screen


with phosphor crystals that emit light when exposed to x-rays.


Digital mammographic computed radiography (CR) uses a


“digital” cassette to replace the traditional film cassette and


digital cassette reader, producing a digital image from the


cassette instead of developing film through a film processor.


Principles of operation
Low energy X-rays are produced by the x-ray tube (an evacuated


tube with an anode and a cathode) when a stream of electrons,


accelerated to high velocities by a high-voltage supply from the


generator, collides with the tube’s target anode. The cathode


contains a wire filament that, when heated, provides the electron


source. The target anode is struck by the impinging electrons.


X-rays exit the tube through a port window of beryllium.


Additional filters are placed in the path of the x-ray beam to


modify the x-ray spectrum. The x-rays that pass through the


filter are shaped by either a collimator or cone apertures and


then directed through the breast.


Operating steps
The mammography technician positions the patient, aligns


the X-ray tube for projection, compresses the patient’s breast


with the compression paddles, and then steps away to avoid


X-ray exposure before initiating the exposure to the patient.


Developed images are typically sent to a view box or work


station for viewing.


Reported problems
Historically, the most common problems associated with


mammography have not involved the units themselves but rather


are related to radiation exposure risks to patients. Inadequate


compression of the breast can cause poor image quality on


mammograms. Sagging of the breast during mediolateral oblique


and 90° lateral views, underexposure of the thick posterior part


of the breast and overexposure of the thin anterior part, blurring


of calcifications, and uneven exposure of fibroglandular tissue


can result if compression is not properly applied during imaging.


Use and maintenance
User(s): Radiology/mammography technican,


radiologist


Maintenance: Biomedical or clinical engineer/


technician, radilogy staff, manufacturer/


servicer


Training: Initial training by manufacturer,


operator’s manuals, user’s guide


Environment of use
Settings of use: Radiology departments,


mammography clinics, stand-alone imaging


centers, mobile (i.e., trailer- or truck-based)


units


Requirements: Stable power source;


appropriate shielding; imaging workstations


or X-ray viewboxes


Product specifications
Approx. dimensions (mm): 1000 x 750 x 1000


Approx. weight (kg): 300


Consumables: NA


Price range (USD): 30,000-240,000


Typical product life time (years): 8-10


Shelf life (consumables): NA


Types and variations
Digital, film


Mammography unit
UMDNS GMDN
12425
18432


Radiographic Units, Mammography;
Radiographic Systems, Digital, Mammography


37672 Stationary mammographic x-ray system,
digital


Other common names:
Mammo units; X-ray system, diagnostic, mammographic, stationary, digital




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EEG monitors are used for observing and diagnosing a variety


of neurologic conditions, including epilepsy, related convulsive


disorders, and brain death. They can also be used to evaluate


psychiatric disorders and differentiate among various psychiatric


and neurologic conditions. In addition, electroencephalographic


studies with EEG monitors can assist in localizing tumors or


lesions on or near the surface of the brain.


Product description
EEG monitors use electrodes placed on a patient’s scalp to


measure, amplify, display in graphic form, and record the weak


electrical signals generated by the brain. They continuously


display processed EEG signals in graphic form over a period


of time so that waveform and pattern changes can be readily


detected. EEG monitors use computers to analyze and generate


large amounts of electroencephalographic data (as in Fourier


analysis), which are processed and displayed in various formats.


Many systems can produce and display certain types of EPs


or event-related potentials, a specific type of EEG signal that


occurs in response to a periodically applied external stimulus.


Principles of operation
Low-amplitude (microvolt range) EPs believed to be generated


by large numbers of nerve cells known as pyramidal cells, which


are located in the outer layer (cortex) of the brain, polarize


and depolarize in response to various stimuli, creating the EEG


waveform. These fluctuating electrical potentials are detected


by electrodes placed on the scalp and are displayed and/or


recorded on the EEG. Each EEG channel amplifies a signal from


a pair of electrodes, and these amplified signals can be printed


on a chart recorder and/or displayed on a monitor.


Operating steps
Scalp electrodes are usually affixed by a technician with a conductive


adhesive or paste. Cup, or disk, electrodes are affixed to the scalp


with a special adhesive called collodion or with a conductive paste.


Regardless of the electrode-placement procedure used, patients


usually lie down, remain awake, and keep their eyes closed during an


EEG recording; however, sleep EEG recordings (polysomnography)


are also common. The set of electrode pairs that the technician


selects for recording is called a montage.


Reported problems
The most common problem is improper electrode application.


Avoiding this problem requires use of proper technique during skin


preparation and electrode attachment, in addition to positioning


the electrodes in the correct system configurations. Poor electrode


contact with the scalp can distort the results of EEG recordings.


A recurring difficulty with electroencephalography is the failure of


EEG monitors to filter out artifacts, which can result in an incorrect


signal interpretation or inability to analyze the EEG signal.


Use and maintenance
User(s): Neurologists, neurosurgeons, or


other physicians, EEG technicians, sleep lab


technicians, nurses, anesthesiologists, OR


technicians,


Maintenance: Biomedical or clinical engineer/


technician, medical staff, manufacturer/


servicer


Training: Initial training by manufacturer,


operator’s manuals, user’s guide


Environment of use
Settings of use: ICUs, OR, sleep lab, EEG lab,


neurology clinics


Requirements: Uninterruptible power source,


battery backup, good lead/cable connections,


conductive gel


Product specifications
Approx. dimensions (mm): 350 x 50 x 390


Approx. weight (kg): 8


Consumables: Electrodes, conductive gel


Price range (USD): 1,750 - 113,000


Typical product life time (years): 8-10


Shelf life (consumables): NA


Types and variations
Computer laptop, mobile console, or monitor


Monitor, Bedside, Electroencephalography
UMDNS GMDN
12602 Monitors, Bedside, Electroencephalography 38736 Electroencephalographic monitoring system,


portable


Other common names:
Cerebral function monitors; EEG recorders; electroencephalographs; monitors, bedside, electroencephalography,
spectral




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Continuous monitoring is a valuable tool that helps provide


additional information to the medical and nursing staff about


the physiologic condition of the patient. Using this information,


the clinical staff can better evaluate a patient’s condition and


make appropriate treatment decisions and is used to treat a


wide range of patient conditions.


Product description
Depending on their confi guration, central monitors include


modules to measure varios parameters, including ECG,


respiratory rate, NIBP and IBP, body temperature, SpO2, SvO2,


cardiac output, ETCO2, intracranial pressure, and airway gas


concentrations. They include computing capabilities and


additional displays to observe trend information; some also


include full-disclosure capabilities. They do not replace bedside


monitors.


Principles of operation
Physiologic monitors can be confi gured, modular, or both.


Confi gured monitors have all their capabilities already built-in.


Modular systems feature individual modules for each monitoring


parameter or group of parameters; these modules can be used in


any combination with each bedside monitor or be interchanged


from monitor to monitor. Some physiologic monitoring systems


have the capabilities of both modular and confi gured systems.


With these monitors, frequently used parameters (e.g., ECG)


are confi gured to the monitor, but modules As monitoring data


is collected, some central stations are beginning to send the


information to the patient’s electronic medical record (EMR).


Operating steps
Receivers are connected to a bedside monitor and/or central


station monitor. Some central station monitors can be networked


so that a patient’s waveform can be simultaneously displayed


at multiple locations within a hospital. Some telemetry systems


allow receivers to be connected to a bedside monitor or to be


used on the same central station network as hardwired bedside


monitors. This allows the clinician to view a patient’s ECG and


other monitored information at the bedside and at the central


station.


Reported problems
Central monitors may tempt hospital personnel to pay more


attention to the equipment than to the patient connected to it.


Even monitors that are functioning reliably cannot substitute for


frequent direct observation. Frequent false positive alarms can


cause alarm fatigue and result in clinical staff missing critical


patient events like low oxygen saturation levels.


1. 99


2. 105


3. 66


TELEMETRY
CENTRAL STATION


Use and maintenance
User(s): Physicians, nurses, other medical staff


Maintenance: Biomedical or clinical engineer/


technician, medical staff, manufacturer/


servicer


Training: Initial training by manufacturer,


operator’s manuals, user’s guide


Environment of use
Settings of use: General medical and surgical


areas, intermediate care/step down units,


cardiac rehab, telemetry units


Requirements: Uninterruptible power source,


redundant data backups


Product specifi cations
Approx. dimensions (mm): Varies by


confi guration selected


Approx. weight (kg): Varies by confi guration


selected


Consumables: None


Price range (USD): 4,500 - 40,000


Typical product life time (years): 7-10


Shelf life (consumables): NA


Types and variations
Desk mounted, bedside mounted


Monitor, Central Station
UMDNS GMDN
20179 Monitors, Central Station 38470 Patient monitoring system central station


monitor


Other common names:
Central station monitors, central monitoring, alarm monitoring center, alarm monitoring station; Monitoring central




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Health problem addressed
Continuous monitoring is a valuable tool that helps provide


additional information to the medical and nursing staff about


the physiologic condition of the patient. Using this information,


the clinical staff can better evaluate a patient’s condition and


make appropriate treatment decisions.


Product description
These systems usually include a central station monitor that


receives, consolidates, and displays the information and a set of


monitors that are deployed near the patient (bedside monitors)


to provide the required data from each patient (ECG, respiratory


rate, noninvasive blood pressure (NIBP) and invasive blood


pressure (IBP) (systolic, diastolic, and mean), body temperature,


(SpO2), mixed venous oxygenation (SvO2), cardiac output,


(ETCO2), intracranial pressure, and airway gas concentrations).


Principles of operation
Physiologic monitors can be confi gured, modular, or both.


Confi gured monitors have all their capabilities already built-


in. Modular systems feature individual modules for each


monitoring parameter or group of parameters; these modules


can be used in any combination with each bedside monitor or


be interchanged from monitor to monitor. Some devices have


the capabilities of both modular and confi gured systems. Many


physiologic monitoring systems include a central station capable


of displaying ECG waveforms and other information from any


bedside within the system, and many are equipped with alarms


that are coordinated with those at the bedside monitor.


Operating steps
Once patients are attached to the appropriate monitoring


electrodes/pads, the cables are connected to the physiologic


monitor. Then the monitor allows patients’ physiologic


parameters to be continuously monitored so that changes can be


identifi ed and, if necessary, treated. The monitored parameters


can be seen at the bedside and (if desired) shared with a central


station. System suppliers offer different monitoring options to


meet a variety of applications (such as critical care, the operating


room, or transport).


Reported problems
Poor electrode preparation and attachment are most commonly


reported. Cables and lead wires should be periodically inspected


for breaks and cracks. Loss of patient alarms, misleading alarms,


and parameter errors have been the causes of most monitor


recalls. Even monitors that are functioning reliably cannot


substitute for frequent direct observation. Many devices


produce frequent “false alarms” which can lead to alarm fatigue


and missed critical events.


Use and maintenance
User(s): Physicians, nurses, other medical staff


Maintenance: Biomedical or clinical engineer/


technician, medical staff, manufacturer/


servicer


Training: Initial training by manufacturer,


operator’s manuals, user’s guide


Environment of use
Settings of use: Hospital, inter- and intra-


hospital transport; mostly in intermediate


care/step down units and in general medical


and surgical areas


Requirements: Uninterruptible power source,


battery backup, good lead/pad/cable


connections


Product specifi cations
Approx. dimensions (mm): 375 x 275 x 238


Approx. weight (kg): 10


Consumables: Batteries, cables, sensors/


electrodes, cuffs


Price range (USD): 3,000 - 50,000


Typical product life time (years): 7-10


Shelf life (consumables): NA


Types and variations
Bedside mounted, pole mounted, wall


mounted, transport, handle


Monitoring System, Physiologic
UMDNS GMDN
12636 Monitoring Systems, Physiologic 33586


36872


35569


Physiologic monitoring system, single-patient


Transportable physiologic monitoring system


Neonatal physiologic monitoring system


Other common names:
Operating room (OR) monitors, acute care monitoring systems, vital signs monitors, neonatal monitors, physiologic
monitors; Single-patient monitoring system and related equipment; Measuring/monitoring system, biophenomena;
Monitoring, bedside unit; Single patient monitoring system; Monitor, patient transport; Physiologic monitoring system,
acute care, battery-powered; physiologic monitoring system, neonatal




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Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


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Health problem addressed
Continuous monitoring is a valuable tool that helps provide


additional information to the medical and nursing staff about


the physiologic condition of the patient. Using this information,


the clinical staff can better evaluate a patient’s condition and


make appropriate treatment decisions. Most commonly used


for treatment of patients with cardiac conditions.


Product description
Telemetric monitors designed for continuous measurement and


transmission of several vital physiologic parameters to a central


station or a bedside monitor. These monitors typically consist


of transmitters and electrodes, an antenna system or access


points, receivers, and a display screen and recorder. Telemetry


systems transmit physiologic parameters like ECG, NIBP, SpO2.


Principles of operation
Telemetric monitoring systems transmit patients’ physiologic


parameters to a central station display and/or a bedside


monitor. Data transfer is done to a remote location by means of


radio waves. Because they use radio-wave transmission, cables


are not required to connect the patient and transmitter to the


display monitor, thereby allowing greater patient mobility.


Operating steps
Appropriate monitoring electroed must be attached to the


patient. The cables are attached to the telemetry transmitter.


The transmitter sends physiologic monitored data to the central


station or bedside monitor that receives, consolidates, and


displays the information collected from one or more patients.


Reported problems
The frequency bands used by wireless medical telemetry


are getting crowded, putting medical telemetry at risk for


interference. Signal fading, during which the ECG signal is


momentarily lost, results in inaccurate ECG signals, false alarms,


and monitoring data loss. To reduce the potential of interference


from noise, hospitals should survey the installation site to ensure


that the antennae are properly placed, that no other equipment


operates at that frequency, and that no outside interference


impede telemetry signals.


Use and maintenance
User(s): Physicians, nurses, other medical staff


Maintenance: Biomedical or clinical engineer/


technician, medical staff, manufacturer/


servicer


Training: Initial training by manufacturer,


operator’s manuals, user’s guide


Environment of use
Settings of use: Hospital; step-down/


intermediate care areas, cardiac rehab,


any area with mobile patients that require


physiologic monitoring


Requirements: Uninterruptible power source,


battery backup, good lead/pad/cable


connections


Product specifications
Approx. dimensions (mm): 124 x 70 x 35


Approx. weight (kg): 0.18


Consumables: Batteries, cables, sensors/


electrodes


Price range (USD): 2,300 - 150,000


Typical product life time (years): 7-10


Shelf life (consumables): NA


Types and variations
Telemetry pack worn by patient (e.g.,


pendant, strapped to arm, garment pouch)


Monitor, Telemetric, Physiologic
UMDNS GMDN
13987 Monitors, Telemetric, Physiologic 31733 Electrocardiography telemetric monitoring


system


Other common names:
Arrhythmia detectors, arrhythmia monitors, cardiac monitors, arrhythmia ECG monitors, telemetric ECG monitors,
electrocardiographic monitors, ECG physiologic telemetry units, telemonitors; ECG telephonic transmission equipment;
Monitor, telemetric, electrocardiography




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These devices are intended to treat renal failure, partially


replacing kidney function by removing metabolic wastes


through selective diffusion across the peritoneum.


Product description
These devices consist of a machine that performs automated


dialysis cycles (for CCPD), a catheter and a sterile disposable


tubing system.


Principles of operation
These devices perform three main types of PD therapy:


continuous ambulatory peritoneal dialysis (CAPD), intermittent


peritoneal dialysis (IPD), and continuous cyclic peritoneal


dialysis (CCPD). The type of therapy indicated depends on the


physician’s preference and profi ciency in the required aseptic


technique as well as on the patient’s condition. The most


commonly used type of therapy is CAPD, in which the patient


manually infuses dialysate from a portable plastic bag that is


usually worn until the dialysate is drained several hours later.


CAPD is inexpensive and can be performed almost anywhere if


strict aseptic technique is used. IPD can be performed manually


by the patient, a family member, or a nurse; it can also be


performed automatically with a PD unit.


Operating steps
A typical dialysis cycle consists of fi lling the peritoneal cavity


with a volume of dialysate, letting the dialysate remain within the


cavity for a selected period of time (dwell time) while diffusion


and osmosis occur, and draining the spent dialysate from the


peritoneal cavity.


Reported problems
Peritonitis (infl ammation of the peritoneum) is the most serious


complication of PD therapy. Poor aseptic technique often


introduces bacteria that are present on the hands or on the skin


surrounding the catheter site to the PD tubing, which can result


in peritonitis and catheter-site or tunnel infections. User error


has resulted in the accidental introduction of disinfectant into


the peritoneal cavity. Also, arthritic or very weak patients may


have diffi culty handling the tubing sets and drainage equipment.


Use and maintenance
User(s): Patient


Maintenance: Medical staff; technician;


biomedical or clinical engineer


Training: Initial training by dialysis department


staff


Environment of use
Settings of use: Hospital; dialysis clinic; home


Requirements: Stable power source (if using


continuous cycler-assisted peritoneal dialysis)


Product specifi cations
Approx. dimensions (mm): 215 x 455 x 385


Approx. weight (kg): 17


Consumables: Dialysate and administration


sets


Price range (USD): 7,000 - 13,000


Typical product life time (years): 5 -7


Shelf life (consumables): variable and single


use


Types and variations
Continuous ambulatory peritoneal dialysis


(CAPD); continuous cycler-assisted peritoneal


dialysis (CCPD)


Peritoneal Dialysis Unit
UMDNS GMDN
11226 Peritoneal Dialysis Units 11226 Peritoneal dialysis system


Other common names:
Artifi cial Kidney Machines; Cyclers, Peritoneal Dialysis; Dialysis Machines; Dialysis Units; Kidney Machines; Peritoneal
Dialysis Cyclers; PD Cyclers; Peritoneal Dialysis Drainage Systems; Automated peritoneal dialysis apparatus; System,
peritoneal, automatic delivery; Dialysis system, peritoneal




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Pulmonary function analyzers measure the performance of


a patient’s respiratory system, especially for outpatient or


presurgical screening. These systems measure the ventilation,


diffusion, and distribution of gases in the lungs. They are used


to help assess patients with conditions like chronic obstructive


pulmonary disorder (COPD).


Product description
Pulmonary function analyzers are designed to assess the


volume, airfl ow, and derived parameters through the respiratory


tract of adults and older children. These devices typically


include a spirometry instrument (e.g., pneumotachometer,


bellows, rolling-seal-type spirometer), a computer, a gas


analyzer, and an electronic unit with computerized capabilities


and appropriate software. In addition to diagnostic spirometer


measurements, they may measure parameters such as functional


residual capacity, diffusing capacity of the lungs for carbon


monoxide, and airway resistance. The analyzers are intended


to provide a baseline for ventilatory function as well as identify


respiratory impairments. Some systems include a total-body


plethysmograph for measuring lung volume and Raw.


Principles of operation
Spirometry instruments measure the volume of gases exhaled


by the patient (i.e., volume changes of the lungs) either by


volume displacement or fl ow sensing methods. Spirometers


measure the volume directly; these devices include water-seal


bellows and rolling-seal spirometers, or the fl ow of gas that


is integrated to yield volume. Such fl ow sensing instruments


can employ a pneumotachometer, a hot-wire anemometer, or


a turbinometer. Some analyzers incorporate computers with


software that permits customized reports or the inclusion of


specialized predictive equations for normal function.


Operating steps
The operator selects the desired parameters to be measured or


follows a procedure protocol; a spirometry instrument is held to


the patient’s mouth in order to measure exhaled breath. Results


are displayed onscreen and may be stored or printed out.


Reported problems
Computer software can be a signifi cant source of error, and a


manufacturer should be able to document the computational


algorithms of its software and demonstrate its accuracy.


Problems related to equipment failures of spirometers are


uncommon; some may result from misuse of a properly


functioning analyzer. The mouthpiece or tubing on a spirometry


instrument can provide a warm, moist environment favorable to


the growth and transmittal of disease-causing microorganisms.


Use and maintenance
User(s): Physicians, nurses, other medical staff


Maintenance: Biomedical or clinical engineer/


technician, medical staff, manufacturer/


servicer


Training: Initial training by manufacturer,


operator’s manuals, user’s guide


Environment of use
Settings of use: Pulmonary medicine,


respiratory therapy, or general medicine


departments


Requirements: Uninterruptible power source,


battery backup, appropriate masks and tubing


Product specifi cations
Approx. dimensions (mm): 350 x 600 x 1,000


Approx. weight (kg): 50


Consumables: Tubing, masks


Price range (USD): 1,800 - 60,000


Typical product life time (years): 8


Shelf life (consumables): NA


Types and variations
Portable, cart, desktop, tabletop


Pulmonary function analyzer
UMDNS GMDN
13182 Analyzers, Physiologic, Respiratory Function


Mechanics, Adult
35282 Pulmonary function analysis system, adult


Other common names:
Respiratory function analyzers; respiratory function mechanics analyzers; Calculator, pulmonary function laboratory




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This technology is effective in arthrography, bronchography,


gastrointestinal and biliary tree studies, hysterosalpingography,


intravenous and retrograde pyelography, myelography, and


sialography. Other applications include locating ingested foreign


materials; localizing lesions for needle aspiration or biopsy;


highlighting congenital anatomic abnormalities; diagnosing


congestive heart failure; and evaluating chest pain.


Product description
These devices consist of a combination of a patient support unit


(usually a table base and a movable tabletop), an under-table


x-ray tube and holder, x-ray generators, a power-assisted spot-


fi lm device, an image intensifi er, radiation shields, a Bucky fi lm


tray, an overhead x-ray tube and ceiling support for follow-up


radiography, and a control panel.


Principles of operation
Most R/F systems allow spot fi lming of the image to produce


an x-ray fi lm for later detailed study by the radiologist and for


fi lm archiving. For routine radiography and follow-up x-ray


scans after studies that use contrast media (e.g., gastrointestinal


studies), most systems include an under-table Bucky tray for use


with an overhead x-ray tube.


Operating steps
Patients are positioned on the x-ray table and a catheter


inserted (procedure-dependent). The x-ray scanner will be used


to produce fl uoroscopic images. Depending on the procedure,


a dye or contrast substance may be injected into the patient via


an IV line in order to better visualize the organs or structures


being studied. After the procedure is complete the IV line will


be removed.


Reported problems
Typical problems include mechanical issues; unexpected failures


of safety features; overexposure or unexpected exposure to


radiation; breakage or weakening of mechanical supports;


overheating in drive motors; table misalignments; inadequate


radiation shielding; and noncompliance with regulatory codes.


Use and maintenance
User(s): Radiologic technician


Maintenance: Medical staff; technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Hospitals; private practices;


clinics; stand-alone imaging centers


Requirements: Radiation shielding (room,


mobile, or overhead); stable power source


Product specifi cations
Approx. dimensions (mm): Confi gurable


Approx. weight (kg): Confi gurable


Consumables: NA


Price range (USD): 415,000 - 1,150,000


Typical product life time (years): 10


Shelf life (consumables): NA


Types and variations
Over- or under-table x-ray tube; C-arm;


remote control; direct control


Radiographic, Fluoroscopic System
UMDNS GMDN
16885 Radiographic/Fluoroscopic Systems, General-


Purpose
37645 Stationary basic diagnostic x-raysystem, digital


Other common names:
General-Purpose Radiographic/Fluoroscopic Systems; Radiographic/Fluoroscopic Units, General-Purpose; Tables,
Radiographic/Fluoroscopic; Direct-Controlled Radiographic/Fluoroscopic Systems; Remote-Controlled Radiographic/
Fluoroscopic Systems




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These systems are used mainly for treatment of cancer and


related diseases.


Product description
Computer workstations that typically consist of a computer,


software for dosage calculation, and input and output devices


(e.g., keyboards, monitors, printers) for graphic and alphanumeric


data. These systems use x-ray image data and dosimetric data


to help clinicians determine the optimum treatment parameters


to match the prescribed dose and constraints. Planning systems


are available for all types of radiation treatment delivery.


Principles of operation
Various computer algorithms are used to model the interactions


between the radiation beam and the patient’s anatomy to


determine the spatial distribution of the radiation dose. Different


algorithms are necessary to account for the different types


of radiation and computational complexity. With the increase


in computational performance available today, improved


algorithms are being developed. All treatment planning systems


use x-ray based image data since the x-ray data is necessary


for the dosimetry calculations. Most treatment planning systems


today use inverse planning, which works backwards from the


prescribed treatment volume to determine the optimum beam


angles and collimation.


Operating steps
The fi rst step in treatment planning is to identify the planning


target volume and the organs at risk. This is done by the


oncologist using the contouring tools available on the planning


system. Automatic contouring tools can help in outlining organs


or regions of bulk density. Depending on the type of lesion, it


may be necessary to use multiple images from different sources.


Alignment can be achieved using either implanted fi ducial


markers or anatomic structures. Dose calculation is central to all


treatment planning systems.


Reported problems
Several issues have been reported involving treatment delivery


errors due to incorrect calibration among third-party equipment,


treatment planning systems, and treatment delivery equipment.


These errors can affect multiple patients. Therefore, all those


involved in radiation oncology should be alert to any anomalies.


Use and maintenance
User(s): Medical physicists


Maintenance: Medical staff; technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Hospitals; private practices;


clinics; stand-alone imaging centers


Requirements: Stable power source


Product specifi cations
Approx. dimensions (mm): NA


Approx. weight (kg): NA


Consumables: NA


Price range (USD): 50,000 - 230,000


Typical product life time (years): 5 to 7


Shelf life (consumables): NA


Types and variations
Radiosurgery planning systems;


brachytherapy planning systems


Radiotherapy Planning System
UMDNS GMDN
21955 Workstations, Radiotherapy Planning 40996 Radiation therapy treatment planning system


Other common names:
Computers, Radiotherapy Planning System; Computers, Radiotherapy Treatment Planning; Computers, Radiotherapy,
Planning; Radiotherapy Planning Workstations; Radiotherapy Treatment Planning Systems; Treatment Planning
Systems;Radiotherapy, dose planning system; System, planning, radiation therapy treatment.




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Linear accelerators (linacs) and cobalt radiotherapy units are


used in external-beam radiation therapy to treat cancer. Cobalt


units and low-energy linacs are used primarily to treat bone


cancer and tumors of the head, neck, and breast. High-energy


linacs are used to treat deep-seated neoplasms and tumors of


the pelvis and thorax. Radiation is used to treat at least 50% of


all cancer cases. It can be either curative or palliative, depending


on the stage and prognosis of the disease.


Product description
Linacs emit a well-defined beam of uniformly intense x-ray


photon radiation of different energies, depending on the


accelerator. Some linacs also produce electron beams. Cobalt


radiotherapy units use a man-made radioisotope, cobalt-60,


to produce gamma-ray photons. Linacs consist of four major


components—a modulator, an electron gun, a radio-frequency


(RF) power source, and an accelerator guide. The electron beam


produced by a linac can be used for treatment or can be directed


toward a metallic target to produce x-rays. Linacs are classified


according to their energy levels, low, medium, and high.


Principles of operation
Linear accelerators accelerate electrons that collide with a heavy


metal target, scattering high-energy x-rays. A portion of these


x-rays is collected and shaped to form a beam that matches the


patient’s tumor. The beam comes out of a gantry which rotates


around the patient. The patient lies on a moveable treatment


couch and lasers are used to make sure the patient is in the


proper position. Radiation can be delivered to the tumor from


any angle by rotating the gantry and moving the treatment


couch.


Operating steps
A radiation therapist positions the patient on the unit’s table and


carefully aligns the patient with positioning lasers and fiducial


tattoos. Additional beam shaping elements are attached to the


collimator or are adjusted on the collimator. The therapist then


leaves the room and controls the delivery of radiation from a


separate control room.


Reported problems
Most radiation therapy-related errors and incidents have been


reported to be caused by use error. This can result in significant


under-dose or over-dose in the delivery of radiation. Errors can


also occur at the planning stage or in equipment calibration.


Missed clinical information at the planning stage has caused


severe (even fatal) radiation injury, and poor calibration can


lead to serious medical errors. Also, in several reported cases,


electromagnetic interference from a linear accelerator caused


infusion-pump failure when the pumps were being used on


patients undergoing radiation therapy.


Use and maintenance
User(s): Medical physicists; radiation therapy


technicians


Maintenance: Medical physicists; radiation


therapy staff; technicians; biomedical or


clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Radiation therapy department


or centers


Requirements: Stable power source; shielded


room and control room


Product specifications
Approx. dimensions (mm): 6500 x 7000 x


3200 (room size); 2500 x 500 (treatment


couch)


Approx. weight (kg): Variable


Consumables: NA


Price range (USD): 1,500,000-4,500,000


Typical product life time (years): 8-10


Shelf life (consumables): NA


Types and variations
Linear accelerators; Cobalt radiotherapy units


Radiotherapy Systems
UMDNS GMDN
16972
12364


Radiotherapy Systems, Cobalt;
Linear Accelerator


38297
35159


Teletherapy radionuclide system; Linear
accelerator system


Other common names:
Radotherapy systems, external beam radiation therapy systems, radiation therapy systems, LINAC; Cobalt radiotherapy
machine; Radioisotope teletherapy equipment; Radiotherapy unit, cobalt; Radionuclide system, therapeutic, teletherapy;
Medical linear accelerator




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© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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These devices are most commonly used in conjunction with


external-beam radiotherapy, surgery, or chemotherapy to treat


endometrial, cervical, prostate, or pancreatic cancer; they are


also the primary treatment for soft-tissue sarcomas, vaginal


and rectal cancers, early-stage lip and tongue cancers, and


endobronchial carcinomas.


Product description
These systems are typically radioisotope delivery units (i.e.,


afterload unit) with a source-drive mechanism (usually a


computer-controlled stepper motor with drive rollers or belts),


applicators, a control console, and a computerized planning unit.


Principles of operation
Remote afterloading brachytherapy systems automatically


administer a radioisotope directly to cancerous tissue,


thereby minimizing the radiation dose to surrounding tissue


and eliminating the radiation exposure to hospital staff. The


amount of the radiation dose varies with the brachytherapy


method chosen for treatment delivery: low-dose-rate (LDR)


brachytherapy uses an implanted source that delivers a dose


of 40 to 60 centigrays (cGy) per hour over several days; high-


dose-rate (HDR) brachytherapy uses a traveling (stepping)


source that delivers a dose greater than 100 cGy per minute for


5 to 30 minutes; pulsed-dose-rate (PDR) brachytherapy uses a


cable-driven source delivering a dose of up to about 300 cGy


per hour for 10 to 30 minutes, repeated over several days.


Operating steps
After the treatment parameters have been tested, the source


drive mechanism, usually a computer-controlled stepper motor


with drive rollers or belts, advances the source from the shielded


safe through the guide tubes and into the treatment applicators.


The source guide tubes, also called transfer tubes, ensure


accurate source placement in the applicators. The indexer, which


typically provides 18 to 24 channels, facilitates source entry and


transfer for complex treatments requiring multiple applicators.


Reported problems
Most of the problems associated with brachytherapy are side


effects of radiation. Patients may develop localized irritation,


soft-tissue ulcerations, osteonecrosis, small-bowel perforations,


radiation mucositis, and abdominal fi stulas from implanted


radioactive sources. There have also been reports of dose


miscalculations and improper handling of source wires and


seeds by physicians, nurses, and medical physicists during


brachytherapy treatment.


Use and maintenance
User(s): Radiation physicist; licensed


dosimetrist (supervised by radiation


physicist); radiation oncologist


Maintenance: Medical staff; technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Hospital radiation oncology


department


Requirements: Stable power source; shielding


for treatment room and control room


Product specifi cations
Approx. dimensions (mm): 1330 x 540 x 790


Approx. weight (kg): 92


Consumables: NA


Price range (USD): 255,000 - 485,124


Typical product life time (years): 8 to 10


Shelf life (consumables): NA


Types and variations
High-dose-rate (HDR) brachytherapy; low-


dose-rate (LDR) brachytherapy; pulsed-dose-


rate (PDR) brachytherapy systems


Remote-afterloading brachytherapy system
UMDNS GMDN
20352


17517


Brachytherapy Systems


Brachytherapy Systems, Remote Afterloading


38300 Remote-afterloading brachytherapy system


Other common names:
Curietherapy Systems; Endocurietherapy Systems; Radiotherapy Units; Remote Afterloaders; Radionuclide system,
therapeutic, brachytherapy, remote afterloading; System, applicator, radionuclide, remote-controlled




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© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
These scanners are used for a wide variety of diagnostic


procedures, including spine and head injuries, lesions, and


abdominal and pelvic malignancies; to examine the cerebral


ventricles, the chest wall, and the large blood vessels; and to


assess musculoskeletal degeneration.


Product description
Devices that consist of an x-ray subsystem, a gantry, a patient


table, and a controlling computer. A high-voltage x-ray generator


supplies electric power to the x-ray tube, which usually has a


rotating anode and is capable of withstanding the high heat


loads generated during rapid multiple-slice acquisition. The


gantry houses the x-ray tube, x-ray generator, detector system,


collimators, and rotational frame.


Principles of operation
CT scanners use slip-ring technology, which was introduced in


1989. Slip-ring scanners can perform helical CT scanning, in which


the x-ray tube and detector rotate around the patient’s body,


continuously acquiring data while the patient moves through


the gantry. The acquired volume of data can be reconstructed


at any point during the scan. All modern CT scanners are


multislice. Inside the gantry, an x-ray tube projects a fan-shaped


x-ray beam through the patient to the detector array. As the


x-ray tube and detector rotate, x-rays are detected continuously


through the patient. The computer mathematically reconstructs


data from each full rotation to produce an image of one slice.


Operating steps
During a CT scan, the table moves the patient into the gantry


and the x-ray tube rotates around the patient. As x-rays pass


through the patient to the detectors, the computer acquires and


processes data to form an image.


Reported problems
Controlling the radiation dose is the most signifi cant concern


facing all CT users. Also, unnecessary testing could cause an


overexposure to radiation. System problems and communication


breakdowns can result in repeat CT scans, and so, facilities need


to provide extensive training for these systems to eradicate


confusion when using the equipment.


Use and maintenance
User(s): Computed tomography scanning


technician


Maintenance: Medical staff; technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Hospitals; private practices;


clinics; stand-alone imaging centers


Requirements: Stable power source; shielded


room and control room


Product specifi cations
Approx. dimensions (mm): 1882 x 2225 x 1006


Approx. weight (kg): 1906


Consumables: NA


Price range (USD): 329,900-3,200,000


Typical product life time (years): 8 to 10


Shelf life (consumables): NA


Types and variations
Multislice; 3-D CTA; 4-D imaging


Scanning System, CT
UMDNS GMDN
13469 Scanning Systems, Computed Tomography 37618 Full-body CT system


Other common names:
Computed Tomography Scanners; Computed Tomography Scanning Systems; Computed X-Ray Tomography Scanners;
Computer-Assisted Tomography Scanners; Computerized Tomographs; CT Scanners; CT Scanners, Mobile; CT Scanning
Systems; CT Slice Scanners; Multislice Scanners, Computer Tomography; Scanners, Computed Axial Tomography;
Scanners, Computed Tomography; Scanners; Computer Tomography, Mobile; Scanners, Computed Tomography, X-Ray;
Scanner, computed tomography, full-body; Whole body x-ray CT scanner




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© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
MRI is primarily used to identify diseases of the central nervous


system, brain, and spine and to detect musculoskeletal disorders.


It is also used to view cartilage, tendons, and ligaments. MRI


can also be used to image the eyes and the sinuses. MRI can be


used to help diagnose infectious diseases; to detect metastatic


liver disease; to display heart-wall structure; to stage prostate,


bladder, and uterine cancer; to evaluate kidney transplant


viability; and to study marrow diseases.


Product description
An MRI unit consists of a magnet, shimming magnets, an RF


transmitter/receiver system with an antenna coil, a gradient


system, a patient table, a computer, display monitors, and an


operator console. They typically have static magnetic fi elds


ranging from 0.064 to 3.0 T (as measured in the center of


the magnet bore). For comparison, the earth’s magnetic fi eld


is approximately 0.00006 T. Three basic magnet designs


are available for diagnostic MRI applications: the permanent


magnet, the resistive magnet, and the superconducting magnet.


Most systems today use a superconducting magnet. A standard


MRI suite comprises three main rooms: the procedure room, the


equipment room, and the control room.


Principles of operation
MRI units use strong electromagnetic fi elds and radio-frequency


radiation to translate the distribution of hydrogen nuclei in body


tissue into computer-generated images of anatomic structures.


MRI depends on the magnetic spin properties of certain atomic


nuclei in body tissue and fl uids and their behavior in the applied


magnetic fi eld. These nuclei are normally aligned randomly in


tissue until an external magnetic fi eld is applied and the nuclei


align themselves with that fi eld.


Operating steps
During an MRI scan the patient is moved into the bore of the MRI


magnet while the operator adjusts the controls depending on the


section(s) of the anatomy being scanned. Before the procedure


begins patients are checked for metal jewelry or other metal


objects which can distort the image or cause injury. Images are


processed by the MRI system’s computer and are generated for


viewing and diagnosis. Images are typically transferred to a


picture archiving and communication system.


Reported problems
Although the number of adverse incidents is relatively low,


numerous reports of injuries in MRI centers and a few reports


of deaths. Most of these incidents can be attributed to the


presence of ferromagnetic devices and equipment (including


implants) in the MR environment. Ferromagnetic objects have


become projectiles and injured or killed


patients. Several incidents have occurred


in which patients undergoing MRI studies


sustained second- and third-degree burns


when their skin contacted surface coils or


monitoring cables.


Use and maintenance
User(s): Radiologists, MRI technicians


Maintenance: Medical staff; technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: MRI suite or clinic; operating


room


Requirements: Stable power source; shielded


room and control room


Product specifi cations
Approx. dimensions (mm): 2500 x 2500 x


2500


Approx. weight (kg): 5,500


Consumables: NA


Price range (USD): 150,000 - 3,100,000


Typical product life time (years): 8-10


Shelf life (consumables): NA


Types and variations
Extremity, full body, mammographic,


neurosurgical; various fi eld strength systems;


open or closed


Scanning System, Magnetic Resonance Imaging, Full-Body
UMDNS GMDN
18108 Scanning Systems, Magnetic Resonance Imaging,


Full-Body
37652


37653


37654


Full-body MRI system, permanent magnet


Full-body MRI system, resistive magnet


Full-body MRI system, superconducting
magnet


Other common names:
MRI systems; MRI scanners, MR scanners, magnetic resonance scanners




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
These devices are used primarily for abdominal and OB/GYN


scanning. Some systems include additional transducers to


facilitate more specialized diagnostic procedures, such as


cardiac, vascular, endovaginal, endorectal, or small-parts (e.g.,


thyroid, breast, scrotum, prostate) scanning.


Product description
General-purpose ultrasonic scanning systems provide two-


dimensional (2-D) images of most soft tissues without subjecting


patients to ionizing radiation. These systems typically consist of


a beamformer, a central processing unit, a user interface (e.g.,


keyboard, control panel, trackball), several probes (transducers


or scanheads), one or more video displays, some type of


recording device, and a power system.


Principles of operation
Ultrasound refers to sound waves emitted at frequencies


above the range of human hearing. For diagnostic imaging,


frequencies ranging from 2 to 15 megahertz (MHz) are typically


used. Ultrasonic probes contain one or more elements made of


piezoelectric materials (materials that convert electrical energy


into acoustic energy and vice versa). When the ultrasonic


energy emitted from the probe is refl ected from the tissue, the


transducer receives some of these refl ections and reconverts


them into electrical signals. These signals are processed and


converted into an image. Lower sound frequencies provide


decreased resolution but greater tissue penetration, while


higher frequencies improve resolution when deep penetration


is not necessary.


Operating steps
To perform ultrasonic imaging, a probe is either placed on the


skin (after an acoustic coupling gel is applied) or inserted into a


body cavity. Scanned structures can be measured by ultrasound


technicians using digital calipers (i.e., cursors electronically


superimposed over the scanned cross-sectional image that


calculate the size of the scanned structure). The caliper system


can also be used by technicians to plot and measure the area,


circumference, or volume of a structure. A data-entry keyboard


permits information such as patient name, date, and type of


study to be entered and displayed along with the scanned image.


Reported problems
Ultrasound diagnostic imaging appears to be risk-free when used


properly. Ultrasound transducers should be handled carefully


to avoid damage. Electromechanical problems, such as cracks


in piezoelectric elements, can alter beam width and/or spatial


pulse length, thereby affecting lateral and axial resolution. Errors


in distance measurements can cause incorrect calculations.


Use and maintenance
User(s): Ultrasound technician


Maintenance: Medical staff; technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Hospital radiology


departments; private physician offi ces


Requirements: Stable power source


Product specifi cations
Approx. dimensions (mm): 1340x420x630


Approx. weight (kg): 75


Consumables: NA


Price range (USD): 25,000 -220,000


Typical product life time (years): 5


Shelf life (consumables): NA


Types and variations
General-purpose; OB/GYN; small parts;


vascular; cardiology; endocavity


Scanning System, Ultrasonic
UMDNS GMDN
15976 Scanning Systems, Ultrasonic, General-Purpose 40761 General-purpose ultrasound imaging system


Other common names:
Abdominal Ultrasound Scanners; Doppler Devices; General-Purpose Ultrasonic Scanners; Metal Detectors; Metal
Detectors, Ultrasonic; Scanners, Ultrasonic, Dedicated Linear Array; Scanners, Ultrasonic, General-Purpose; Scanners,
Ultrasonic, Pediatric; Ultrasound Scanners, Bladder; Ultrasound Scanners, General-Purpose; Ultrasound Scanners,
Urology; Diagnostic imaging equipment, general use




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Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Monitors partial pressure of CO2 at the skin surface of patients


at risk of hypoxia or inadequate ventilation or in whom clinically


signifi cant metabolic changes may be detected as changes in


tcpCO2 (e.g., patients under general anesthesia, patients with


emphysema). Transcutaneous blood gas monitoring can be


used as a supplement—or, in some cases, as an alternative—to


periodically drawing and analyzing arterial blood.


Product description
Rectangular or square device with wires connecting to patient


measurement sensors; additional input/output channels may be


available; display (LED, LCD) indicates patient blood gas levels;


buttons or dials for control settings; may include thermal printer;


sensors are usually small and round, attached to patient’s skin


with adhesive.


Principles of operation
TcpCO2 is monitored by a small sensor, which houses a pH


electrode, a reference electrode, an electrolyte solution, a Tefl on


membrane, and a heating element. An adhesive ring fastens the


sensor to the skin. The heating element warms the skin to 42° to


45°C. The CO2 that diffuses through the stratum corneum by the


warming of the skin passes across the sensor’s semipermeable


membrane and into a diluted bicarbonate solution (electrolyte


solution) in the sensor chamber. Adding CO2 lowers the pH of


the solution (increases acidity); a glass electrode measures the


change. The electrode’s output is converted into a signal, which


the instrument records as tcpCO2.


Operating steps
Sensors are affi xed to patient skin; device is programmed by


operator (i.e., turned on, measured parameters may be chosen);


device takes periodic or continuous blood gas measurements


and alarms if measurements are outside of normal range.


Periodically location of sensor must be changed to a different


place on patient’s skin to avoid irritation or burns, some devices


include a site-change timer.


Reported problems
Varying degrees of burns can result from the sensor’s elevated


temperature. Thin-skinned infants and patients with peripheral


vascular impairment are especially at risk. Frequent sensor


relocation, as recommended by the manufacturer, can help


prevent burns; however, sensor relocation often entails


recalibration.


Use and maintenance
User(s): Medical staff


Maintenance: Biomedical or clinial engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Hospital


Requirements: Line power


Product specifi cations
Approx. dimensions (mm): 100 x 300 x 200


Approx. weight (kg): 0.5-5


Consumables: Sensors, probes, calibration


materials


Price range (USD): 7,225 - 20,000


Typical product life time (years): 8


Shelf life (consumables): Disposable sensor


membranes: 2 weeks; reusable sensors: 2


months


Types and variations
Modular unit (connected to other patient


monitoring devices) or stand-alone;


specialized for adult, pediatric, or neonate;


most measure both tcpCO2 and tcpO2; some


measure tcpCO2 and SpO2; reusable or


disposable sensors


Transcutaneous Blood Gas Monitor
UMDNS GMDN
17996 Monitors, Bedside, Blood Gas, Transcutaneous 36898 Patient monitoring system module, blood gas,


transcutaneous


Other common names:
TcpCO2 monitor, breathing circuit monitor, CO2 monitor




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© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Ventilators provide temporary ventilatory support or respiratory


assistance to patients who cannot breathe on their own or who


require assistance to maintain adequate ventilation because of


illness, trauma, congenital defects, or drugs (e.g., anesthetics).


Product description
Ventilators consist of a fl exible breathing circuit, a control system,


monitors, and alarms. The gas is delivered using a double-limb


breathing circuit. The gas may be heated or humidifi ed using


appropriate devices. The exhalation limb releases the gas to the


ambient air. Intensive care ventilators are usually connected to a


wall gas supply. Most ventilators are microprocessor controlled


and regulate the pressure, volume, and FiO2. Power is supplied


from either an electrical wall outlet or a battery.


Principles of operation
The control mode provides full support to patients who cannot


breathe for themselves. In this mode, the ventilator provides


mandatory breaths at preset time intervals and does not allow


the patient to breathe spontaneously. Assist/control modes


also provide full support by delivering an assisted breath


whenever the ventilator senses a patient’s inspiratory effort and


by delivering mandatory breaths at preset time intervals. With


volume-controlled breaths, a control system is used to ensure


that a set tidal volume is delivered during the inspiratory cycle.


Pressure-controlled breaths regulate fl ow delivery to attain and


sustain a clinician-set inspiratory pressure level for a set time so


that the ventilator delivers controlled or assisted breaths that


are time cycled. Combination modes are also available.


Operating steps
Users fi rst check that the unit is ready for use (e.g., run


performance and calibration checks). They next make sure that


settings (including alarm levels) are correct and appropriate for


the patient type and condition. Once completed, the patient


is connected to the ventilator. When the ventilator-patient


connection is completed, users ensure the patient is being


properly ventilated. While patient is being ventilated, caregivers


monitor/evaluate the patient, and respond promptly to alarms.


Reported problems
Risk of acquiring pneumonia may be minimized by following


proper infection control procedures. Leaks in the breathing


circuit or components may prevent the ventilator from delivering


the appropriate amount of ventilation. Proper maintenance and


avoiding operator errors or machine failures can be critical.


Critical changes in patient conditions can be missed if alarms


are not set properly or are not noted by clinical staff.


Use and maintenance
User(s): Physicians, nurses, respiratory


therapist, other medical staff


Maintenance: Biomedical or clinical engineer/


technician, medical staff, manufacturer/


servicer


Training: Initial training by manufacturer,


operator’s manuals, user’s guide


Environment of use
Settings of use: Intensive care, critical care


settings, surgery


Requirements: Uninterruptible power source,


battery backup, proper tubing/masks


Product specifi cations
Approx. dimensions (mm): 125 x 40 x 62


Approx. weight (kg): 67


Consumables: Batteries, tubing, masks, fi lters


Price range (USD): 9,000 - 60,000


Typical product life time (years): 8, depends


on hours used


Shelf life (consumables): NA


Types and variations
Cart or stand mounted


Ventilator, Intensive Care
UMDNS GMDN
17429 Ventilators, Intensive Care 42411 Intensive-care ventilator, adult/infant


Other common names:
IC ventilators, critical care ventilators, continuous ventilators, positive-pressure ventilators; Adult ventilator; Respirator,
general-purpose




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Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Neonatal intensive care ventilators provide ventilatory support


to preterm and critically ill infants who suffer from respiratory


failure and who generally have low-compliance lungs, small


tidal volumes, high airway resistance, and high respiratory


rates. These mechanical ventilators promote alveolar gas


exchange (oxygenation and carbon dioxide [CO2] elimination)


by generating positive pressure to infl ate the lungs of an infant


who is incapable of adequate independent breathing.


Product description
A typical neonatal ventilator system consists of a breathing


circuit, a humidifi cation system, gas-delivery systems, monitors


and their associated alarms, and gas sources for oxygen (O2)


and compressed air. Ventilators also require an integral or


add-on-oxygen-air proportioner (blender) to deliver a fraction


of inspired FiO2 between 21 and 100%. Controls are used to


determine the operating mode and ventilation variables. Most


ventilators have several operating modes.


Principles of operation
Intensive care ventilators designed for neonatal and/or pediatric


respiratory support are mostly time-cycled pressure-control


devices. CPAP is useful for infants with restrictive lung disease


or decreased lung compliance and alveolar collapse (infants with


hyaline membrane disease); PEEP maintains lung volume and


prevents alveolar collapse. High-frequency ventilation delivers


small tidal volumes around a near-constant mean airway pressure


(MAP) at frequencies higher than those produced during the


fastest possible panting (i.e., above 100 breaths per minute),


thus avoiding both high and low extremes of lung volume.


Operating steps
Users fi rst check that the unit is ready for use (e.g., run


performance and calibration checks). They next make sure that


settings (including alarm levels) are correct and appropriate for


the patient type and condition. Once completed, the patient


is connected to the ventilator. When the ventilator-patient


connection is completed, users ensure the patient is being


properly ventilated. While patient is being ventilated, caregivers


should monitor/evaluate the patient, and respond promptly to


alarms.


Reported problems
Risk of acquiring pneumonia may be minimized by following


proper infection control procedures. Leaks in the breathing


circuit or components may prevent the ventilator from delivering


the appropriate amount of ventilation. Proper maintenance and


avoiding operator errors or machine failures can be critical.


Critical changes in patient conditions can be missed if alarms


are not set properly or are not noted by clinical staff.


Use and maintenance
User(s): Physicians, nurses, respiratory


therapist, other medical staff


Maintenance: Biomedical or clinical engineer/


technician, medical staff, manufacturer/


servicer


Training: Initial training by manufacturer,


operator’s manuals, user’s guide


Environment of use
Settings of use: Neonatal intensive care unit


(NICU), pediatric intensive care unit (PICU),


critical care settings, surgery


Requirements: Uninterruptible power source,


battery backup, proper tubing/masks


Product specifi cations
Approx. dimensions (mm): 29 x 53 x 45


Approx. weight (kg): 27


Consumables: Batteries, tubing, masks, fi lters


Price range (USD): 7,500 - 45,000


Typical product life time (years): 8


Shelf life (consumables): NA


Types and variations
Cart or stand mounted


Ventilator, Intensive Care, Neonatal/Pediatric
UMDNS GMDN
14361 Ventilators, Intensive Care, Neonatal/Pediatric 14361 Intensive-care ventilator, neonatal/paediatric


Other common names:
Continuous ventilators, neonatal ventilators, pediatric ventilators, positive-pressure ventilators, time-cycled ventilators;
Ventilator, infant




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Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Portable ventilators deliver room air or oxygen-enriched gas


into the breathing circuit, where it can be humidifi ed by a heated


humidifi er or a heat and moisture exchanger before delivery to


the patient. They provide long-term support for patients who do


not require complex critical care ventilators. They can be used


for treating patients with conditions like pneumonia or during


mass casualty events.


Product description
Ventilators designed to provide support to patients who do


not require complex critical care ventilators. These ventilators


typically consist of a fl exible breathing circuit, a control system,


monitors, and alarms. Some systems may also include specialized


breathing circuits, oxygen accumulators, and heated humidifi ers


or heat and moisture exchangers (HMEs). Most devices use


positive pressure to deliver gas to the lungs at normal breathing


rates and tidal volumes through an endotracheal tube, a


tracheostomy cannula, or a mask. Power is typically supplied


from a power line or from an internal or external battery (e.g., a


car battery). These ventilators are used for long-term respiratory


support in extended care facilities and in the home; they may


also be used in emergency care.


Principles of operation
Portable ventilators deliver room air or O2-enriched gas into


the breathing circuit, where it can be humidifi ed by a heated


humidifi er or an HME before delivery to the patient. Typically,


these ventilators drive air into the breathing circuit with a


motor-driven piston or turbine. In the home setting, O2 is usually


delivered directly into the breathing circuit from a separate


source, such as an O2 tank. Most devices use positive pressure


to deliver gas to the lungs at normal breathing rates and tidal


volumes through an endotracheal tube, a tracheostomy cannula,


or a mask. Portable/home care ventilators may use several


methods of cycling (e.g., volume, time) and several ventilation


modes, including control, assist/control, and synchronized


intermittent mandatory ventilation (SIMV) modes.


Operating steps
Users fi rst check that the unit is ready for use (e.g., run


performance and calibration checks). They then make sure


that settings (including alarms) are correct and appropriate for


the patient type and condition. Once completed, the patient


is connected to the ventilator. When the ventilator-patient


connection is completed, users ensure that the patient is being


properly ventilated. While patient is being ventilated, caregivers


are responsible for monitoring/evaluating the patient, and for


promptly responding to alarms.


Reported problems
Most of the reported problems involving portable ventilators


arise from user error, poorly maintained exhalation valve


assemblies, and the use of poor-quality breathing circuits. Other


issues include disconnection of the breathing


circuit from the device, equipment failure,


disconnection/kinking/bending of tubing,


and extreme environmental conditions. Also,


critical changes in patient conditions can be


missed if alarms are not set properly or are not


noted by clinical staff.


Use and maintenance
User(s): Physicians, nurses, respiratory


therapist, other medical staff


Maintenance: Biomedical or clinical engineer/


technician, medical staff, manufacturer/


servicer


Training: Initial training by manufacturer,


operator’s manuals, user’s guide; clinical staff


to assist family with home care operation


Environment of use
Settings of use: Home care, long-term care


facilities, patient transport vehicles


Requirements: Battery, uninterruptible power


source (for recharging batteries), proper


tubing/masks


Product specifi cations
Approx. dimensions (mm): 150 x 250 x 300


Approx. weight (kg): 7


Consumables: Batteries, tubing, masks, fi lters


Price range (USD): 3,300 - 13,500


Typical product life time (years): 8


Shelf life (consumables): Variable


Types and variations
Portable, carrying case


Ventilator, Portable
UMDNS GMDN
17423 Ventilators, Portable 47083 Portable ventilator, electric


Other common names:
Continuous ventilators; home care ventilators; positive-pressure ventilators; time-cycled ventilators; Continuous,
ventilator, home-use; Portable / home-use ventilator




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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These systems are used for diagnosis and prescription of


medical treatment for patients at remote locations, for remote


clinical consultations between medical professionals, for


education and training of medical staff, and for administrative/


business functions. Telemedicine can be as simple as a telephone


conversation between personnel or a fax transmission, or as


complex as a real-time interactive video examination of a patient


conducted by physicians separated by hundreds of miles.


Product description
Components of a telemedicine videoconferencing system vary,


depending on the confi guration chosen by the buyer. In general,


system components include a codec, viewing monitor(s),


camera(s), control/user interaction devices (e.g., mouse,


keyboard,) input devices (e.g., document scanner, medical


scopes), and output and storage devices (e.g., printers, CD-ROM


drives). Most suppliers offer different confi gurations customized


to the buyer’s needs.


Principles of operation
Telemedicine videoconferencing uses video and


telecommunications technology to transmit medical information


(audio, video, and graphics) between two or more sites.


Operating steps
Patient examinations are conducted using instruments (e.g.,


stethoscopes, ophthalmoscopes) and examining cameras


connected to the telemedicine system, allowing a physician


at a remote site real-time access to the patient and real-time


interaction with the examining physician, physician assistant, or


nurse. A technician or nurse typically operates the instruments


with the patient in an examination room. Images and data


are then transmitted to the remote physician for viewing and


analysis, and interacting with the patient.


Reported problems
The telemedicine system should have some form of security


to avoid problems with data confi dentiality. Electric


fl uctuations can damage computer components, impair system


performance, disrupt program operation, and destroy data.


Preventive measures include installing an online uninterruptible


power supply. A dedicated power line isolated for the central


processing unit may be useful to reduce signal noise. Copying


disks at regular intervals protects stored information.


Use and maintenance
User(s): Physicians, medical professionals,


administrators, students


Maintenance: Technicians; IT staff; biomedical


or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Hospitals; private practices;


clinics; schools


Requirements: Stable power source


Product specifi cations
Approx. dimensions (mm): NA


Approx. weight (kg): NA


Consumables: NA


Price range (USD): 1,495 - 177,000


Typical product life time (years): 5 to 7


Shelf life (consumables): NA


Types and variations
Mobile (rollabout); group (room); desktop


Videoconferencing system, Telemedicine
UMDNS GMDN
18138 Information Systems, Telemedicine,


Videoconferencing
36303 Video conferencing telemedicine system


Other common names:
Teleconferencing Systems, Video; Teleconsultation Systems; Telemedicine Videoconferencing Systems; Video
Teleconferencing Systems; Videoconferencing Systems, Telemedicine




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
These devices are commonly used to provide thermal


support for newborns in the delivery suite, for critically ill


infants who require constant nursing intervention, and for


infants undergoing treatment that prolongs exposure to a


cool environment. Prolonged cold stress can overwork heat-


producing mechanisms, drain energy reserves, and result in


hypoxia, acidosis, hypoglycemia, and, in severe cases, death.


Product description
Infant radiant warmers are overhead heating units. They typically


consist of a heat source, a skin-temperature sensor, an automatic


(servo) control unit, and visual and audible alarms.


Principles of operation
A heating element generates a signifi cant amount of radiant


energy in the far IR wavelength region (longer than three microns


to avoid damaging the infant’s retina and cornea). The radiant


output of the heating unit is also limited to prevent thermal


damage to the infant. The IR energy is readily absorbed by the


infant’s skin; increased blood fl ow in the skin then transfers heat


to the rest of the body by blood convection (heat exchange


between the blood and tissue surfaces) and tissue conduction


(heat transfer between adjacent tissue surfaces).


Operating steps
After birth, infants are placed under a radiant warmer until they


can achieve thermoregulation.


Reported problems
Because warming by IR energy is an effi cient means of energy


transfer, extreme hyperthermia, skin burns, permanent brain


damage, or even death can result.


Use and maintenance
User(s): Nursing staff; physicians


Maintenance: Medical staff; technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Hospital; birthing center


Requirements: Stable power source


Product specifi cations
Approx. dimensions (mm): 2100x1310x750


Approx. weight (kg): 110


Consumables: NA


Price range (USD): 3,250 - 26,000


Typical product life time (years): 8


Shelf life (consumables): NA


Types and variations
Freestanding; modular; permanently-mounted


Warming Unit, Radiant, Infant
UMDNS GMDN
17956


17433


12113


Warming Units, Patient, Radiant, Infant


Warming Units, Patient, Radiant, Infant, Mobile


Incubators, Infant


36812


17433


Infant/regional-body warmer


Infant warmer


Other common names:
Beds, Infant; Combination Incubator/Warmers; Infant Warmers; Mobile Warmers; Transport Warmers; Transport Radiant
Warmers; Warmers, Infant, Radiant, Stationary




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Devices that measure the clotting mechanisms of hemostasis;


used primarily to detect clotting defi ciencies related to


thromboembolytic disease, thrombocytopenia, impaired


liver function, hemophilia, von Willebrand disease, and other


conditions. They are also used to monitor the effect of drugs


such as heparin, oral anticoagulants, and thrombolytic and


antiplatelet agents on whole blood, as well as the effects of


blood component therapy.


Product description
Handheld device or benchtop device, sometimes placed on a


cart, with a display (usually LCD), a keypad to enter information,


and a slot to insert a test strip or sample tube. Some models


may have alarms, memory functions, touchpens, USB ports to


transfer data to a computer, and/or a small storage compartment


for reagents.


Principles of operation
One of three methods may be used: Mechanical impedance


uses blood viscosity changes to determine clotting time.


Instruments using the photometric principle monitor changes


in the specimen’s optical density to detect the beginning of clot


formation. The electromagnetic uses a magnet in the test tube


aligned with a magnetic detector in the cuvette and remains


locked in position with the detector while the test tube rotates.


When a clot forms, it entangles the magnet, breaking the


electromagnetic coupling and allowing the magnet to rotate


with the tube, terminating the test.


Operating steps
Whole blood samples are placed in tubes, on reaction cuvettes,


or on test strips, and loaded into the analyzer. The operator may


select the tests being performed on the sample using a keypad


or connected computer.


Reported problems
Operators should be aware of the risk of exposure to potentially


infectious bloodborne pathogens during testing procedures and


should use universal precautions, including wearing gloves, face


shields or masks, and gowns.


Use and maintenance
User(s): Medical staff


Maintenance: Laboratory technician;


biomedical or clinical engineer


Training: Initial training by manufacturer and


manuals


Environment of use
Settings of use: Hospital, patient bedside,


physician offi ce, clinical laboratory, home


Requirements: Line power, biohazard disposal


Product specifi cations
Approx. dimensions (mm): 200 x 150 x 300


Approx. weight (kg): 1-10


Consumables: Reagents (cartridges, test


strips, etc.), reaction cuvettes


Price range (USD): 648 - 46,000


Typical product life time (years): 5-8


Shelf life (consumables): Reagents: 2 years


Types and variations
Handheld, portable, benchtop; some models


may also test platelet function


Whole Blood Coagulation Analyzer
UMDNS GMDN
16749 Analyzers, Point-of-Care, Whole Blood, Coagulation 56689 Laboratory coagulation analyser IVD,


automated


Other common names:
Thromboelastograph, thrombometer; Analyser, laboratory, haematology, coagulation, automated






Core Medical Equipment




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