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Product Comparison
Anesthesia Units
UMDNS information
This Product Comparison covers the following device term and product code as listed in ECRIs Universal Medical Device
Nomenclature System (UMDNS):
9 Anesthesia Units [10-134]
Table of Contents
Scope of this Product Comparison ...............................................................................................................................3
Purpose..........................................................................................................................................................................3
Principles of operation..................................................................................................................................................3
Gas supply and control ............................................................................................................................................4
Vaporizers ................................................................................................................................................................4
Ventilation................................................................................................................................................................5
Breathing circuits ....................................................................................................................................................6
Scavenging system...................................................................................................................................................7
Monitors and alarms................................................................................................................................................7
Automated anesthesia record keepers/anesthesia information management systems ........................................8
Reported problems........................................................................................................................................................9
Purchase considerations.............................................................................................................................................11
ECRI recommendations.........................................................................................................................................11
Other considerations..............................................................................................................................................12
Cost containment ...................................................................................................................................................13
Stage of development..................................................................................................................................................14
Bibliography................................................................................................................................................................14
Standards and guidelines...........................................................................................................................................15
Anesthesia breathing circuits................................................................................................................................15
Anesthesia equipment ...........................................................................................................................................15
Anesthesia unit vaporizers....................................................................................................................................17
Anesthesia ventilators ...........................................................................................................................................17
Anesthetic reservoir bags ......................................................................................................................................18
Medical gas piping .................................................................................................................................................18
Scavenging systems ...............................................................................................................................................18
Citations from other ECRI publications ....................................................................................................................19
Supplier information ..................................................................................................................................................21
About the chart specifications....................................................................................................................................27
Product Comparison Chart ........................................................................................................................................30
Anesthesia Units
Policy Statement
The Healthcare Product Comparison System (HPCS) is published by ECRI, a nonprofit health
services research agency established in 1955. HPCS provides comprehensive information to help
healthcare professionals select and purchase diagnostic and therapeutic capital equipment more
effectively in support of improved patient care.
The information in Product Comparisons comes from a number of sources: medical and biomedical
engineering literature, correspondence and discussion with manufacturers and distributors,
specifications from product literature, and ECRIs Problem Reporting System. While these data are
reviewed by qualified health professionals, they have not been tested by ECRIs clinical and
engineering personnel and are largely unconfirmed. The Healthcare Product Comparison System and
ECRI are not responsible for the quality or validity of information derived from outside sources or for
any adverse consequences of acting on such information.
The appearance or listing of any item, or the use of a photograph thereof, in the Healthcare
Product Comparison System does not constitute the endorsement or approval of the products
quality, performance, or value, or of claims made for it by the manufacturer. The information and
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Many of the words or model descriptions appearing in the Healthcare Product Comparison System
are proprietary names (e.g., trademarks), even though no reference to this fact may be made. The
appearance of any name without designation as proprietary should not be regarded as a
representation that is not the subject of proprietary rights.
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Healthcare Product Comparison System accepts no advertising and has no obligations to any
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from the medical device industry, nor do they own stock in medical device companies. Employees
engage in no private consulting work for the medical device industry.
About ECRI
ECRI (formerly the Emergency Care Research Institute) is a nonprofit health services research
agency. Its mission is to improve the safety, quality, and cost-effectiveness of healthcare. It is widely
recognized as one of the worlds leading independent organizations committed to advancing the
quality of healthcare.
ECRIs focus is healthcare technology, healthcare risk and quality management, and healthcare
environmental management. It provides information services and technical assistance to more than
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voluntary sector organizations, associations, and accrediting agencies worldwide. Its more than 30
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the healthcare community.
ECRIs services alert readers to technology-related hazards; disseminate the results of medical
product evaluations and technology assessments; provide expert advice on technology acquisitions,
staffing, and management; report on hazardous materials management policy and practices; and
supply authoritative information on risk control in healthcare facilities and clinical practice
guidelines and standards.
December 2005
Anesthesia Units
Scope of this Product Comparison
This Product Comparison covers anesthesia systems that can have the following components:
mainframes, hanger yokes and gauges, flowmeters, vaporizers, flush valves, carbon dioxide (CO2)
absorbers, ventilators, scavenging systems, monitors, and alarms. Not included are separate
analyzers designed to measure concentrations of halogenated anesthetics and gases supplied to the
unit or to detect levels present in the operating room; also not included are separate stand-alone
physiologic monitoring systems. For information on these devices, see the following Product
Comparisons:
Halogenated Anesthetics Analyzers
Multiple Medical Gas Monitors, Respired/Anesthetic
Oxygen Monitors
Physiologic Monitoring Systems, Acute Care; Neonatal; ECG Monitors
Pressure Monitors, Airway
These units are also called: anesthesia
machines.
Purpose
Anesthesia units dispense a mixture of gases
and vapors and vary the proportions to control a
patients level of consciousness and/or analgesia
during surgical procedures. Basically, anesthesia
units perform the following four functions:
Provide oxygen (O2) to the patient
Blend gas mixtures, in addition to O2,
that can include an anesthetic vapor,
nitrous oxide (N2O), other medical
gases, and air
Facilitate spontaneous, controlled, or
assisted ventilation with these gas
mixtures
Reduce, if not eliminate, anesthesia-
related risks to the patient and
clinical staff
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. Because normal
breathing is routinely depressed by anesthetic
agents and by muscle relaxants administered in
conjunction with them, respiratory assistanceeither with an automatic ventilator or by manual
compression of the reservoir bagis usually necessary to deliver the breathing gas to the patient.
Principles of operation
An anesthesia system comprises four basic subsystems: a gas supply and control circuit, a
breathing and ventilation circuit, a scavenging system, and a set of system function and breathing
circuit monitors (e.g., inspired O2 concentration, airway pressure). Also included in some anesthesia
systems are a number of monitors and alarms that 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. To meet the minimum standard of care in the United States,
the American Society of Anesthesiologists (ASA) states that anesthesia systems must continually
monitor the patients oxygenation, ventilation, circulation, expired CO2 levels, and temperature.
Integrated or stand-alone monitors may be used.
Vaporizers
Because the inhaled anesthetic agents, with the exception of N2O, exist as liquids at room
temperature and sea-level ambient pressure, they must be evaporated by a vaporizer. Vaporizers
add a controlled amount of anesthetic vapor to the gas mixture. Some anesthesia units can
accommodate up to three vaporizers. Most units have a lockout mechanism that prevents the use of
more than one vaporizer at a time. There are several types of vaporizers, including variable bypass
C866UN7A-01
Ventilator Bag
Scavenging
To Atmosphere System
(conventional), heated blender, measured flow, and draw-over. Variable bypass vaporizers can be
either mechanically or electronically controlled.
Variable bypass and heated blender vaporizers are concentration calibrated and thus can deliver a
preselected concentration of vapor under varying conditions. In a variable bypass vaporizer, such as
one used for enflurane, isoflurane, halothane, or sevoflurane, a shunt valve divides the gas mixture
entering the vaporizer into two streams; the larger stream passes directly to the outlet of the
vaporizer, while the smaller stream is diverted through an internal chamber in which vapor fills the
space over the relatively volatile liquid anesthetic. The vapor mixes with the gas of the smaller
stream, which then rejoins the larger stream as it exits the vaporizer. In a mechanically-controlled
variable-bypass vaporizer, a bimetallic thermal sensor that regulates the shunt valve to divert more
or less gas through the chamber compensates for temperature changes that affect the equilibrium
vapor pressure above the liquid. Each variable bypass vaporizer is specifically designed and
calibrated for a particular liquid anesthetic.
The heated blender vaporizer was introduced for use with the anesthetic agent desflurane. In this
type of vaporizer, desflurane is heated in a sump chamber. A stream of vapor under pressure flows
out of the sump and blends with the background gas stream flowing through the vaporizer.
Desflurane concentration is controlled by an adjustable, feedback-controlled metering valve in the
vapor stream.
Measured-flow vaporizers (also known as copper kettle or flowmeter-controlled) are not
concentration calibrated; in this type of vaporizer, a measured flow of carrier gas is used to pick up
anesthetic gas. This type of vaporizer has become almost obsolete in the United States since the
adoption of an ASTM International standard that requires all vaporizers to be concentration
calibrated; it may still be in use outside the United States.
Draw-over vaporizers are sometimes used by the military in the field, but they are not typically
used in the United States. They are usually employed in situations or countries in which pressurized
gas sources are unavailable. Such units offer low resistance to gas flow and are relatively simple.
A few anesthesia units now have a liquid-injector type of vaporizer. This vaporizer is electronically
controlled and injects the liquid anesthetic agent directly into the stream of gases.
Ventilation
Manual ventilation, which requires that an operator manually squeeze the reservoir bag for each
patient breath, can be tiring during long procedures and can compete with other tasks; therefore, an
automatic ventilator is generally used to mechanically deliver breaths to the patient. These
ventilators use a bellows or piston in place of the manually-compressed reservoir bag. The ventilator
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Anesthesia Units
forces the anesthesia gas mixture into the patients breathing circuit and lungs and, in a circle
breathing system (discussed below), receives exhaled breath from the patient as well as fresh gas.
The anesthetist can vary the volume of a single breath (tidal volume) and the ventilation rate, either
directly by setting them on the ventilator or indirectly by adjusting parameters such as the duration
of inspiration, the inspiratory flow, and the ratio of inspiratory to expiratory time. The ventilatory
pattern is adjusted to the varying needs of the patient.
Minute ventilation, the total volume inspired or expired during one minute, can be evaluated as
the product of the expired tidal volume and the ventilation rate. It requires careful monitoring, not
only because it is physiologically important to the patient, but also because it can indicate
malfunctions of the ventilation delivery system (e.g., leaks in the breathing circuit). The expired
tidal volume can be measured with a flowmeter, with a spirometer, or with a sensor placed in the
expiratory circuit. Most ventilators are capable of providing controlled ventilation and can maintain
a positive airway pressure during the expiratory phase of the breath (positive end-expiratory
pressure [PEEP]). Many ventilators can be equipped with modes that permit spontaneous breathing
during mechanical ventilation.
Breathing circuits
Fresh Gas Flow
This system, although adaptable to a variety of anesthetic procedures, is used most often in
pediatric anesthesia.
Circle systems offer advantages over T-piece systems in that they conserve a greater proportion of
the anesthetic gases and conserve body heat and moisture from the patient. The advantages of T-
piece systems include a lower circuit compliance, easier circuit sterilization, and a less complex
design requiring fewer valves and no CO2 absorber (although one can be used with it).
Because excess pressure imposed on the patients lungs can cause serious lung damage, either an
APL valve or a valve in the ventilator allows excess gas to escape when a preset pressure is
exceeded. There are two types of APL valves: spring-loaded and needle valves. The spring tension in
spring-loaded APL valves can be adjusted to control the pressure at which the valve will open. At
lower pressures, the valve is closed. The pressure in the breathing system maintained by the needle
valve depends on the flow through the valve. Therefore, when the valve is not fully closed, gas will
always leak from the system. The minimum exhaust pressure required to refill a ventilator bellows
is usually 1 to 2 cm H2O; for maximum pressure, both types of valve are fully closed. Because many
APL valves do not have calibrated markings, the anesthetist must adjust them empirically to give a
desired peak inspired pressure. Circle systems and T-piece systems also include a pressure gauge for
monitoring circuit pressure and setting the APL valve. An electronically controlled, settable, and
calibrated APL valve is available on some anesthesia machines.
Scavenging system
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. Vacuum scavengers use the suction from an operating room vacuum
wall outlet or a dedicated vacuum system. To prevent positive or negative pressure in the vacuum
system from affecting the pressure in the patient circuit, manifold-type vacuum scavengers use one
or more positive or negative pressure-relief valves in an interface with the anesthesia system. In
contrast, open-type vacuum scavengers have vacuum ports that are open to the atmosphere through
some type of reservoir; such units do not require valves for pressure relief.
Passive-exhaust scavengers can vent into a hospital ventilation system (if the system is the
nonrecirculating type) or, preferably, into a dedicated exhaust system. The slight pressure of the
waste-gas discharge from the anesthesia machine forces gas through large-bore tubing and into the
disposal system or directly into the atmosphere.
Anesthesia systems incorporate a set of equipment-related monitors, including those for airway
pressure, expiratory volume, and inspired O2 concentration. They can also include exhaled gas
monitors, such as those for CO2 concentration, N2O concentration, and agent concentration, or
physiologic monitors such as those for blood O2 saturation by pulse oximetry, electrocardiogram,
invasive and noninvasive blood pressure, and temperature.
Anesthesia systems are typically configured with respect to their monitors in one of two ways: as
modular systems or as preconfigured systems. In the modular approach, an anesthesia machine with
a basic set of equipment monitors (usually airway pressure, inspired O2 concentration, and expired
volume) is used as a physical platform for the system. Additional physiologic monitors, individually
or in a monitoring system (with its own display and alarms), along with other devices as needed, are
obtained separately and added to the system. The preconfigured approach involves a more
completely integrated, manufacturer-assembled system that already includes all physiologic and
equipment monitors and displays in a turnkey unit.
Some units may have methods of integrating, analyzing, displaying, and recording the
information generated by the monitors sensors and alarms. Microprocessors have been incorporated
into the systems to implement these functions. Stand-alone microprocessor-controlled data collection
and display units have been used to integrate modular anesthesia systems. These units can also be
Automated anesthesia record keepers (AARKs) are available either as an option on some
anesthesia units or from third-party suppliers. They are used for collecting data from electronic
ventilation and monitoring equipment that has appropriate outputs. Vital signs such as blood
pressure, heart rate, end-tidal CO2, and oximeter values are recorded at specific intervals and
plotted in graph form. Drug dosages, lab data, intraoperative events, and gas delivery rates are
entered into the system either manually or by some semiautomated means; comments can also be
entered directly onto the record. An AARK produces a formatted hard copy of the anesthesia record
for the patients files. Gathering and storing such data can expedite individual patient management
and billing, quality assurance, critical incident analysis, and teaching. However, automated record
keeping has not achieved wide acceptance, in part because of many clinicians concerns about
misleading artifacts being entered into the record, hospital personnels resistance to change, and the
cost of implementing an automated record keeper.
An AIMS can receive, analyze, store, and distribute information relating to the clinical and
administrative management of anesthesia. Information can be collected from numerous sources
associated both directly with anesthesia administration (e.g., an AARK system) and indirectly with
the surgical procedure (e.g., preoperative evaluation, laboratory, and pharmacy records). Long-term
storage capabilities aid in quality assurance and anesthesiology research. Some systems may also
incorporate administrative management tools such as room scheduling and patient billing. (For
further information, see the Product Comparison titled DATA MANAGEMENT SYSTEMS, ANESTHESIA.)
Reported problems
Problems have been reported in all areas of anesthesia systems. Because patients under general
anesthesia depend entirely on others for life support, errors caused by machine failure, faulty
adjustments, or the operator can be critical. Pre-use checklists, regular inspections, and preventive
maintenance are critical to minimizing anesthesia unit hazards.
One of the greatest dangers of general anesthesia is a lack of O2 delivered to the patient (hypoxia),
which can result in brain damage or death. Conversely, the administration of O2 in a concentration
of 100%, even for a short duration, may be toxic. Inhalation of 100% O2 may cause resorption
atelectasis. The danger of inhaling 100% O2 is particularly acute in neonatal anesthesia, during
which retrolental fibroplasia and bronchopulmonary dysplasia can be caused by inhalation of 100%
O2 even for a very short duration. Inadequate O2 delivery can be caused by any number of conditions,
including disconnection of the patient from the breathing circuit; accidental movement of the O2,
N2O, or other gas flow control setting knobs; changes in the patients lung compliance; and gas leaks.
One common safety measure is the inclusion of an O2 monitor and a CO2 monitor or an expired
volume alarm (in an anesthesia unit with an ascending bellows or piston) in the anesthesia system.
An O2 monitor warns of inadequate O2 concentration in the inspiratory limb. A CO2 monitor or a
spirometer alarm (in an anesthesia unit with an ascending bellows) in the breathing circuit can alert
the anesthetist to inadequate ventilation such as that caused by a disconnection.
ECRI has investigated incidents of patient exposure to carbon monoxide (CO) during the
administration of inhaled anesthetics through semiclosed circle anesthesia systems. Once in the
blood, CO binds tightly with hemoglobin, forming carboxyhemoglobin and diminishing the ability of
hemoglobin to transport and release O2. A reaction between halogenated anesthetic agents and
commonly used CO2 absorbents can produce CO if the CO2 absorbent is excessively dry. Drying out
can occur when (1) an anesthesia machine has been idle (e.g., over a weekend), and (2) there is a
continuous flow of medical gas (which is very dry) through the CO2 absorber. When dry, the
absorbent becomes highly reactive in the presence of certain halogenated agents, resulting in the
production of CO as the agent flows through the machines CO2 absorber. ECRI recommends that the
absorbent material in both canisters of an absorber be replaced whenever there is reason to believe
that a machine has been left idle with gas flowing for an undetermined time. Fresh absorbent
materials are sufficiently hydrated and normally remain hydrated by exhaled water vapor in the
circle system, thereby preventing reaction with halogenated agents. For more information, please see
the Health Devices citation in this report.
Some anesthesia system malfunctions can cause delivery of gas with excessive CO2 concentration,
an inadequate or excessive amount of anesthetic agent, or dangerously high pressure.
Hypoventilation, compromised cardiac output, air in the pleural cavity (pneumothorax), and
asphyxiation are possible consequences of such problems.
Improperly calibrated vaporizers can result in the delivery of the wrong concentration of
anesthetic agent to the patient. Removing some vaporizers from the anesthesia machine and
transporting them can disturb their calibration and could eventually cause delivery of too much or
too little anesthetic. However, many tip-proof vaporizers have been released to reduce calibration
errors. The output of an anesthesia vaporizer should be tested each time the vaporizer is removed
from a system and each time it is returned to service. Each vaporizer should be inspected and the
calibration verified at least twice a year.
Contamination of any part of the anesthesia breathing circuit, including the breathing tubes, Y-
connector, face mask, and reservoir bag, may lead to nosocomial infections. Reported cases include
infections of the upper respiratory tract or the lungs and, in one instance in Australia, transmission
of hepatitis C. The Centers for Disease Control and Prevention (CDC) and the American Association
of Nurse Anesthetists recommend single use of disposables or high-level disinfection of reusables or
disposables between patients to prevent cross-contamination. There has been some controversy
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9
Anesthesia Units
concerning the use of disposable bacteria filters to prevent patient cross-infections (Berry and Nolte
1991, Brooks et al. 1991, Dorsch and Dorsch 1998, Hogarth 1996, Komesaroff 1996, Snowdon 1994).
CDC has not made a definitive recommendation concerning the use of bacterial filters with
anesthesia machines. Possible hazards, such as the increased impedance to gas flows and obstruction
of the circuit, are associated with these filters. Also, because many viruses are difficult to culture,
the efficacy of viral filters that attempt to reduce viral contamination of breathing systems is not
established. Frequent replacement of disposable filters can prevent inadequate gas delivery due to
clogging and some filters can be sterilized and reused.
The piping connections for O2 and N2O within the hospital walls can be accidentally interchanged
during installation or repair of medical gas systems, potentially for causing patient injury or death.
After any such work, careful inspection and testing with an O2 analyzer are vital. Gas lines should
also be checked for liquid, gaseous, solid particulate, and microorganism contamination after
installation or repair and periodically thereafter.
In the United States, a diameter index safety system (DISS) is used to prevent the connection of
gas hoses from the machine to the wrong wall outlet, and a pin index safety system is used to
prevent the connection of the wrong cylinders to the yokes in the anesthesia machine. The pin index
safety system employs pins protruding from the yoke that correspond to holes in a specific type of
gas cylinder post. Only a cylinder post with the corresponding holes can fit properly onto the yoke.
Countries outside the United States have similar requirements to ensure the proper connection of all
medical gas hoses to the anesthesia machine. ECRI has seen instances of improper connections in
which damaged pins allowed users to force the wrong cylinder into place. ECRI recommends that
damaged indexing components should never be used.
Faulty or inoperative scavenging systems are responsible for most anesthetic gas pollution in the
operating room; other causes include improper anesthesia administration technique and leaks in
anesthesia equipment. Common sources of leaks include hose connectors, the CO2 absorber, the APL
valve, and the endotracheal tube or mask. Current scientific and epidemiologic studies have shown
that exposure to trace levels of anesthetic gases continually present in the operating room can cause
adverse health effects in operating room personnel, such as an increased incidence of spontaneous
abortion and congenital anomalies in offspring. In addition, trace gas levels in the air may have a
slight anesthetizing effect on the anesthetist and surgeon.
The increased interest in low-flow anesthesia to reduce costs has increased the potential danger
associated with leaks in the anesthesia unit. Because low-flow anesthesia requires very little fresh
gas flow, a leak in the equipment can result in inadequate delivery of O2 and anesthetic gases.
Regular testing of the anesthesia equipment using standard leak tests should minimize the risk of
leaks during the administration of anesthesia.
Inadequate evacuation of some scavenging systems can cause pressure to build up in the
breathing circuit, with the potential for pneumothorax.
Another common problem is circuit obstruction due to the presence of a foreign object (e.g., needle
caps) or a manufacturing defect. This problem occurs most often when a pre-use check is omitted.
As mentioned previously, anesthesia units that lack integrated monitors and alarms can cause
confusion by sounding numerous alarms simultaneously. While integrated monitors and alarms are
becoming more widespread, both modular and integrated systems are subject to the confusion caused
by false alarms. A false alarm, caused by accidental patient movement or other nonphysiological
reasons, can confuse operating room staff and possibly draw attention away from other alarms that
may truly indicate a change in the patients physiologic condition. Ensuring that the alarm limits are
properly set and positioning sensors and electrodes in such a way as to minimize artifacts can reduce
the incidence of false alarms. Also, ECRI recommends that users do not set physiologic alarm limits
below normal values in order to reduce nuisance alarms.
The magnetic fields created by magnetic resonance imaging (MRI) equipment may interfere with
the function of conventional anesthesia units and electronic monitoring equipment when used in
proximity to such equipment. Conversely, magnetic materials and electronic monitors may interfere
with MRI scanner function and degrade image quality. Also, anesthesia machines are designed to be
compatible with MRI units when used in accordance with the instructions and precautions contained
in the operation manual and on the unit itself. If the instructions are not followed, the anesthesia
units could be attracted to MRI units, potentially causing user or patient injury. Many MRI-
compatible anesthesia machines have restrictions or limitations to their use in the MRI
environment. If they are not used in accordance with these restrictions/limitations, MRI-compatible
devices can pose the same types of hazards in the MRI environment as devices that are not MRI
compatible. For instance, if some MRI-compatible devices are positioned closer to the MRI unit than
is specified by the device supplier, they can become airborne and crash into the magnet. Also, some
MRI-compatible devices that come into physical contact with a patient, if used inappropriately, can
cause burns (or the sensation of heat) to a patient. The hazards posed by the inappropriate use of
MRI-compatible devices in the MRI environment can cause injury to the patient or staff and/or
damage to equipment (e.g., the MRI-compatible device or the MRI unit itself). A few suppliers offer
MRI-compatible anesthesia machines, and a line of MRI-compatible monitors is available.
Users should be careful not to hang any extraneous materials (e.g., polyethylene garbage bags) or
equipment from anesthesia units. If accidentally bumped, the hanging objects may compromise the
anesthesia units stability and be sucked into the receiving end of the anesthesia unit. This could
cause the full negative pressure to be transmitted to the patient breathing system, collapsing the
reservoir bag.
Purchase considerations
ECRI recommendations
Included in the accompanying comparison chart are ECRIs recommendations for minimum
performance requirements for anesthesia units. The recommendations are listed in two categories:
basic and high performance.
ECRI considers certain minimum safety measures necessary for all anesthesia units. Among these
measures are O2 fail-safe and hypoxic mixture fail-safe systems, gas cylinder yokes for O2 in case
central supplies fail, and an internal battery (for units with automatic ventilators) capable of
powering the unit for at least 30 minutes.
An anesthesia unit should consist of a gas supply and control circuit, a breathing and ventilation
circuit, and a scavenging system (not required on basic systems). The unit must be able to measure
O2 concentration, airway pressure, and either the volume of expired gas or the concentration of
expired CO2 (ETCO2). (Note: ASA recommends monitoring of ETCO2 in all intubated patients; this
can be accomplished by the anesthesia unit or by a separate device [e.g., capnograph, multigas
monitor].)
Gas cylinders should be attached through hanger yokes with the proper pin index safety system
and check valves. Each pipeline gas cylinder supply should have a pressure gauge with scale
numbers large enough to be easily read. Gas hoses and machine receptacles should use DISS fittings
to prevent misconnection.
It is advantageous if the anesthesia unit accepts medical-air input to allow delivery of either air
and/or N2O as the gas carrier. In the event of a partial or complete loss of O2 supply, an undefeatable
audible alarm should activate and the flow of N2O gases should automatically shut off or decrease
proportionately to the flow of O2 to prevent a hypoxic condition. Also, flows and the mixture ratios
determined from flowmeter settings should be accurate to within 10% of set values. Anesthetic vapor
concentration delivered to the common gas outlet should be accurate to within 0.2% vapor
concentration of agent or 10% of the set value (whichever is greater) at any gas flow. It is preferable
that ventilation rate and PEEP values be monitored. It should not be possible to silence or disable a
ventilator monitor alarm for longer than two minutes.
Line-powered units should have a power-loss alarm and battery-powered units should have an
automatic low-battery alarm. All line-powered units should include a backup battery to guard
against power loss. The anesthesia unit should automatically switch to the internal battery if line
power is interrupted; also, the loss of line power should be accompanied by an alarm. The battery
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Anesthesia Units
should also operate the anesthesia unit and integral monitors for at least 30 minutes. A low-battery
alarm should visually and audibly indicate when the battery voltage falls to a level below which the
unit may fail to perform satisfactorily. If the battery is rechargeable, it should not require more than
16 hours to recharge after depletion.
High-performance systems are distinguished largely by their ability to serve a wide range of
patients and to operate with little or no supplemental equipment. Features that make this possible
include ventilator modes and tidal volume ranges suitable for neonates and adults, as well as
integrated gas and sometimes physiologic monitoring. High-perfomance units generally include more
automated features, including storage of trends and self-tests at the beginning of each procedure.
Basic systems include only the most vital monitoring capabilities (i.e., O2 and CO2 volumes or
pressures) and have only one or two automatic ventilator modes. When equipped with appropriate
stand-alone monitors, these units are adequate for treatment of most patients but may remain ill-
suited for use on neonates and very sick patients, as well as for monitoring-intensive procedures
(e.g., certain types of cardiac surgery). These fundamental systems may also include units designed
for military or field use, which often lack ventilators and pipeline gas inlets.
Other considerations
Some anesthesia units require stand-alone physiologic monitors (modular approach) and/or
anesthetic agent monitors, while others have integrated monitors (preconfigured approach). The
advantages of preconfigured monitoring include convenience and electronically integrated displays
and prioritized alarms. Modular systems can be less expensive than preconfigured systems,
especially if the facility already owns the monitors.
Hospitals can purchase customized modular systems assembled from standard components, or
they can assemble their own modular systems. These systems must meet all national and regional
safety standards. Advantages of the modular approach include flexibility in choosing and upgrading
monitors and ease of service; drawbacks include assembling a system that may not be successfully
integrated and thus has multiple alarms and/or multiple displays.
Anesthesia units and patient monitoring systems should be carefully chosen to ensure that all the
essential monitoring functions recommended by the American Society of Anesthesiologists are
obtained and to ensure optimal integration and an adequate standard of care. For legal reasons, the
level-of-monitoring and anesthesia-delivery capabilities for each anesthesia station should be
uniform so that all patients receive the same standard of care for the same surgical procedures.
Integrated anesthesia workstations, along with the gas/vapor dispensing subsystem and
individual physiologic and equipment monitors, may also include a device for automatically
dispensing injectable drugs. Consequently, the anesthesia workstation can be viewed as an
integrated monitoring system that dispenses anesthetic drugs.
Hospitals should also consider the standardization of anesthesia equipment; that is, purchasing
systems that are compatible with equipment already in operating rooms or other areas of the
hospital (e.g., intensive care units). The purpose of standardization is to allow a reduced parts
inventory, minimize the number of suppliers and service personnel, and reduce confusion among the
staff.
Pulse oximetry is considered a standard of care for monitoring arterial O2 saturation in the
operating room during procedures requiring anesthesia and in intensive care units and recovery.
Pulse oximeters noninvasively measure O2 saturation of blood hemoglobin (SpO2) and, along with
O2 monitors and CO2 monitors, are increasingly being required for anesthesia units by state law.
Some U.S. states have specified their own requirements for anesthesia units. Hospitals should check
with their states department of health for any regulations that may apply to their area. Pulse
oximeters provide a spectrophotometric assessment of hemoglobin oxygenation by measuring light
transmitted through a capillary bed, synchronized with the pulse. The detection system consists of
single-wavelength LEDs (light-emitting diodes) and microprocessors located within a sensor. For
more information on pulse oximeters, see the Product Comparison titled OXIMETERS, PULSE.
CO2 monitors measure end-tidal CO2 and can help identify leaks and misconnections as well as
indicate when the trachea has not been properly intubated.
Many features of anesthesia systems are optional, allowing hospitals to choose the ones that best
fit their needs. Among anesthesia units with essentially equivalent mechanical gas/vapor dispensing
subsystems, the monitors included in the system and the ways in which information is integrated
and displayed are often the primary distinguishing features.
Cost containment
Because anesthesia systems entail ongoing maintenance and operational costs, the initial
acquisition cost does not accurately reflect the total cost of ownership. The anesthetic agents are the
biggest ongoing expense associated with anesthesia units. Therefore, a purchase decision should be
based on issues such as life-cycle cost (LCC), local service support, discount rates, and non-price-
related benefits offered by the supplier.
An LCC analysis should be conducted to determine the cost-effectiveness of all the units that meet
the users needs.
Although costs associated with many of the following may be similar for a number of anesthesia
units, they should still be carefully considered to determine the total LCC for budget purposes:
Maintenance, service, and inspection
Accessories, such as monitoring equipment, necessary to comply with standards
Optional accessories
Vaporizers (some have been offered at discounted prices or at no cost upon the
introduction of a new anesthetic agent)
Gases, including O2, N2O, and anesthetic agents
Anesthesia circuits
Recording and storage of anesthesia-related data
Disposables
Utilities
When selecting a vaporizer, consider the type of anesthetic agent required for the hospitals
patient mix in conjunction with the types of procedures being performed. Users should ask the
supplier if the anesthetic gas monitor will be able to identify and measure all anesthetic agents used
(i.e., some models may not recognize sevoflurane).
Hospitals can purchase service contracts or service on a time-and-materials basis from the
supplier. Service may also be available from a third-party organization. The decision to purchase a
service contract should be carefully considered. Most suppliers should provide routine software
updates, which enhance the systems performance, at no charge to service contract customers.
Purchasing a service contract also ensures that preventive maintenance will be performed at regular
intervals, thereby eliminating the possibility of unexpected maintenance costs. Also, many suppliers
do not extend system performance and uptime guarantees beyond the length of the warranty unless
the system is covered by a service contract. Hospitals that plan to service their anesthesia units in-
house should inquire about the availability and cost of service training and the availability and cost
of replacement parts.
ECRI recommends that, to maximize bargaining leverage, hospitals negotiate pricing for service
contracts before the system is purchased. Additional service contract discounts may be negotiable for
multiple-year agreements or for service contracts that are bundled with contracts on other similar
equipment in the department or hospital. Discounts will depend on the hospitals negotiating skills
and knowledge of discounts offered to other customers, the system configuration and model to be
purchased, previous experience with the supplier, and the extent of concessions granted by the
supplier, such as extended warranties, fixed prices for annual service contracts, and guaranteed on-
site service response. Buyers should make sure that applications training and service manuals are
included in the purchase price of the system. Some suppliers offer more extensive on- or off-site
training programs for an additional cost. For customized analyses and purchase decision support,
readers should contact ECRIs SELECT Group.
ECRI. All Rights Reserved.
13
Anesthesia Units
Stage of development
Efforts to improve the design of anesthesia units center on gas supply and proportioning systems,
breathing circuits, gas scavenging and humidification devices, gas monitors, ventilators, vaporizers,
and data-handling (display, processing, and reporting) software. There is also an effort to decrease
the overall size of anesthesia units.
Although anesthesia systems are fundamentally unchanged, manufacturers have made a handful
of improvements. Among them are:
The introduction of low-volume breathing circuits
The increasing availability of ventilation modes
Increasing automation of pre-use checks
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Petty WC. New anesthetic requires new vaporizers for safety. J Clin Monit 1996 Nov;12(6):483.
Rogers S, Davies MW. My anaesthetic machines on fire [letter]. Anaesthesia 1997 May;52(5):505.
Sivalingam P, Hyde RA, Easy WR. An unpredictable and possibly dangerous hazard of an
anaesthetic scavenging system [letter]. Anaesthesia 1997 Jun;52(6):609-10.
Snowdon SL. Hygiene standards for breathing systems? [editorial]. Br J Anaesth 1994 Feb;72(2):143-
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Specification for minimum performance and safety requirements for components and systems of
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Anesthesia equipment
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2001).
Medical electrical equipmentpart 1-4: general requirements for safety. Collateral standard:
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Anesthesia ventilators
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Specification for particular requirements for anesthesia workstations and their components
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Canadian Standards Association. Anaesthesia ventilators [standard]. CAN/CSA-Z168.5.1-97(R2001).
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International Organization for Standardization. Breathing tubes intended for use with anaesthetic
apparatus and ventilators [standard]. 4th ed. ISO 5367:2000. 2000.
American Society for Testing and Materials. Specification for anesthesia reservoir bags [standard].
ASTM Committee F29 on Anesthetic and Respiratory Equipment. F1204-88(1998). 1988
(reapproved 1998).
Canadian Standards Association. Low-pressure connecting assemblies for medical gas systems
[standard]. CAN/CSA-Z305.2-M88(R2001). 1988 (reaffirmed 2001).
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Danish Standards Association/European Committee for Standardization. Medical gas pipeline
systemspart 2: anaesthetic gas scavenging disposal systemsbasic requirements [standards].
DS/EN 737-2:1998. 1998.
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anaesthetic gas scavenging systems [draft standard]. EN 737-4:1998. 1998.
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code.
Scavenging systems
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anaesthetic gas scavenging systems [draft standard]. prEN 737-4:1998. 1998.
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2005 Jul;(34(7):23-5.
A5794 The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a
Medical Device Alert notifying healthcare workers that the Association of Anaesthetists of Great
Britain and Ireland (AAGBI) has published an updated version of its guideline "Checking
Anaesthetic Equipment." The document was developed to prevent inadequate pre-use checks of
anesthetic equipment. Use of inadequately checked anesthetic equipment has been associated with
serious patient consequences, such as hypoxic brain damage or death. AAGBI and MHRA
recommend that all U.K. anesthesia practitioners follow the updated AAGBI checklist, which is
available online at http://www.aagbi.org/guidelines.html. Laminated copies of the 2-page checklist
are available from AAGBI and should be attached to every anesthesia unit. Inquiries to AAGBI
should be addressed to the Association of Anaesthetists of Great Britain and Ireland by mail at 21
Portland Place, London W1B 1PY, England; by telephone at (0207) 631 1650; by fax at (0207) 631
4352; or by e-mail at info@aagbi.org. Technical inquiries to MHRA should be addressed to Douglas
McIvor or Nigel Richards, MHRA, by mail at Hannibal House, Elephant and Castle, London SE1
6TQ, England; by telephone at (0207) 972 8193 or 8277, respectively; by fax at (0207) 972 8115; or by
e-mail at douglas.mcivor@mhra.gsi.gov.uk or nigel.richards@mhra.gsi.gov.uk, respectively. Clinical
inquiries to MHRA should be addressed to Dr. Susanne Ludgate, MHRA, by mail at the above
address, by telephone at (0207) 972 8123, by fax at (0207) 972 8111, or by e-mail at
susanne.ludgate@mhra.gsi.gov.uk. All inquiries to MHRA should quote reference no. 20010720.012-
2. Source: Great Britain. Medicines and Healthcare Products Regulatory Agency. Anaesthetic
equipment and associated devices. London: Department of Health; 2004 Jan 15. 5 p. (Medical device
alert; no. MDA/2004/003).
A6015 FDA has designated this Class II Recall No. Z-0192-05 for certain Draeger Medical anesthesia
units. In some cases, the rotary-knob-style APL valve of these anesthesia machines may separate
from the unit. The APL valve is located on the breathing system, and the rotating knob is used to
adjust airway pressure during manual ventilation. If the APL valve separates during use, manual
ventilation will not be possible. Spontaneous and automatic ventilation will not be affected by APL
valve separation. The manufacturer states that the failure rate is approximately 1% and that there
have been no reported injuries resulting from this malfunction. The manufacturer initiated a recall
by letter dated September 15, 2004. Verify that you have received the September 15, 2004, letter
from Draeger. Identify any affected product in your inventory by removing the APL valve from the
breathing system so that you can view the retaining nut, which will have the part number, revision
level, and serial number stamped on the bottom. A DraegerService representative or authorized
service organization will contact you to schedule replacement of affected APL valves. As standard
practice and as referenced in the pre-use check in the operators instruction manual, you should
always have emergency ventilation equipment, such as a manual resuscitator, available for use with
any anesthesia machine. For further information, contact Mike Kelhart, Draeger regulatory affairs,
by telephone at (800) 523-6817, ext. 2349, within the U.S. or at (215) 721-5400 outside the U.S. For
further information regarding replacement of your APL valve, contact Draeger Service technical
support by e-mail at techsupport@draegermed.com or by telephone at (800) 437-2437 (press #3 at the
prompt) within the U.S. Source: FDA Enforcement Rep 2004 Nov 24; letter submitted by
manufacturer.
A6296 FDA has designated this action Class II Recall No. Z-0710-05 for certain Maquet anesthesia
systems. A software update (version 7.0) has been released for these anesthesia systems. The
manufacturer notified U.S. customers by letter dated January 11, 2005. The firm states that all
systems have been updated or returned. No further action is required of customers. Source: FDA
Enforcement Rep 2005 Apr 20; Manufacturer.
D6528 FDA has designated this Class II Recall No. Z-1441-04 complete for certain Datascope
anesthesia delivery units. The alternating current (AC) mains switch may fail, resulting in a loss of
AC power. If AC power loss were to occur during device operation, the system would shift to battery
operation to maintain pneumatic ventilation, sound an audible alarm, and display intermittent
alarm messages every 5 minutes to advise of the remaining battery time. The manufacturer initiated
a field correction by a service representative visit in June 2003. The firm states that the field
correction is complete. No further action is required of customers. Source: FDA Enforcement Rep
2004 Sep 22; Manufacturer.
41432 Aldridge J. Leak on Datex Aestiva/5 anaesthetic machine [letter]. Anaesthesia 2005
Apr;60(4):420-1.
Supplier information
Acoma
Acoma Medical Industry Co Ltd [152410]
2-14-14 Hongo Bunkyo-ku
Tokyo 113-0033
Japan
Phone: 81 (3) 38166911 Fax: 81 (3) 38143845
Internet: http://www.acoma.com
E-mail: export@acoma-medical.co.jp
AMS
AMS (Advanced Medical Systems) Ltd [356053]
Kazim Karabekir Cad 95/95 06060 Iskitler
TR-06060 Ankara
Turkey
Phone: 90 (312) 3840520 Fax: 90 (312) 3423307
Internet: http://www.ams.com.tr
E-mail: ams@ams.com.tr
Anmedic
Anmedic AB [397996]
Galgbacksvagen 6
S-186 30 Vallentuna
Sweden
Phone: 46 (8) 51430600 Fax: 46 (8) 51430620
Internet: http://www.anmedic.com
E-mail: mailbox@anmedic.com
Anmedic UK [398001]
PO Box 114
Hayling Island Hampshire PO11 9QN
England
Phone: 44 (239) 2463791 Fax: 44 (239) 2350731
Internet: http://www.anmedic.com
E-mail: mailbox@anmedic.com
Blease
Blease Medical Equipment Ltd [150950]
Beech House Chiltern Court Asheridge Road
Chesham Buckinghamshire HP5 2PX
England
Phone: 44 (1494) 784422 Fax: 44 (1494) 791497
Internet: http://www.blease.com
E-mail: sales@blease.com
Dameca
Dameca A/S [156977]
Islevdalvej 211
DK-2610 Rodovre
Denmark
Phone: 45 44509990 Fax: 45 44509999
Internet: http://www.dameca.com
E-mail: info@dameca.com
Datascope
Datascope Corp, Patient Monitoring Div [101670]
800 MacArthur Blvd PO Box 619
Mahwah, NJ 07430-0619
Phone: (201) 995-8000 (800) 288-2121 Fax: (201) 995-8606
Internet: http://www.datascope.com
E-mail: pm_sales@datascope.com
Datex-Ohmeda/GE Healthcare
Datex-Ohmeda (Finland) [351977]
Kuortaneenkatu 2 Posti Loaero 300
FIN-00031 Helsinki
Finland
Phone: 358 (10) 39411 Fax: 358 (10) 3945566
Internet: http://www.datex-ohmeda.com
E-mail: arto.kontturi@datex-ohmeda.com
D-56291 Leiningen
Germany
Phone: 49 (6746) 1018 Fax: 49 (6746) 8484
Internet: http://www.eku-elektronik.de
E-mail: sales@eku-elektronik.de
F Stephan
F Stephan GmbH Medizintechnik [306280]
Kirchstrasse 19
D-56412 Gackenbach
Germany
Phone: 49 (6439) 91250 Fax: 49 (6439) 912518
Internet: http://www.stephan-gmbh.com
E-mail: info@stephan-gmbh.com
Japan
Phone: 81 (3) 38144061 Fax: 81 (3) 38145304
Internet: http://www.kimura-medical.co.jp
E-mail: tokyo_intl@kimura-medical.co.jp
Medec
Medec [291305]
Lion d'Orweg 19
B-9300 Aalst
Belgium
Phone: 32 (53) 703544 Fax: 32 (53) 703533
Internet: www.medecbenelux.be
Normeca
Normeca A/S [162653]
Postboks 404
N-1471 Skaarer
Norway
Phone: 47 (67) 927600 Fax: 47 (67) 971766
Internet: http://www.normeca.com
E-mail: mobile-hospital@normeca.com
Pneupac
Pneupac Ltd [150970]
Bramingham Business Park Enterprise Way
Luton Bedfordshire LU2 4BU
England
Phone: 44 (1582) 430000 Fax: 44 (1582) 430001
Internet: http://www.pneupac.co.uk
E-mail: info@pneupac.co.uk
Note: The following companies did not provide us with any product information in time for
publication. Their addresses are listed as a service to our readers.
Abbreviations:
The following abbreviations are used in the chart:
ADU Anesthesia delivery unit APL Adjustable pressure-limiting
Note: The data in the charts derive from suppliers specifications and have not been verified
through independent testing by ECRI or any other agency. Because test methods vary, different
products specifications are not always comparable. Moreover, products and specifications are subject
to frequent changes. ECRI is not responsible for the quality or validity of the information presented
or for any adverse consequences of acting on such information.
When reading the charts, keep in mind that, unless otherwise noted, the list price does not reflect
supplier discounts. And although we try to indicate which features and characteristics are standard
and which are not, some may be optional, at additional cost.
For those models whose prices were supplied to us in currencies other than U.S. dollars, we have
also listed the conversion to U.S. dollars to facilitate comparison among models. However, keep in
mind that exchange rates change often.