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Committee on Equipment and Facilities has developed
guidelines for determining if an anesthesia machine
is obsolete and therefore not be used.
The following is an abbreviated version of the guidelines.
The complete text is available on the ASA Web site
at <www.ASAhq.org/publicationsAndServices/machineobsolescense.pdf>.
Please share these guidelines with your colleagues
and government and credentialing organizations,
especially those that regulate office surgery.
Guidelines for Determining Anesthesia Machine
Obsolescence
The following guidelines have been developed to
assist anesthesia providers and other health care
personnel, administrators and regulatory bodies
in determining when an anesthesia machine is obsolete.
Anesthesia equipment can become obsolete if essential
components wear out and cannot be replaced. Equipment
also may become obsolete as a result of changes
in medical practices, changes in the training and
experience of anesthesia providers and/or development
of new safety features.
An anesthesia machine should not be considered obsolete
solely because it has reached an arbitrary age.
Furthermore a machine should not be expected to
meet all of the performance and safety requirements
specified in United States or international equipment
standards published after the machine was manufactured.
It is the responsibility of the anesthesia provider
to determine if a machine’s failure to meet
newer standards represents a sufficient threat to
patient safety to render the machine obsolete.
The ASA Standards for Basic Anesthetic Monitoring
<www.ASAhq.org/publicationsAndServices/standards/02.pdf#2>
apply to all anesthesia care. The equipment necessary
to accomplish this monitoring may be integral to
the anesthesia machine or separate from it. The
criteria for defining obsolescence that are described
in this document relate only to the gas and vapor
delivery portion of the machine. Integral monitors
(e.g., electrocardiograph, oxygen monitor, blood
pressure monitor, pulse oximeter, carbon dioxide
monitor) should be considered separately and are
not addressed in these guidelines.
These guidelines apply only to existing machines
and are not intended to unduly restrict the design
of machines in the future. It is recognized that
future machines may incorporate different safety
mechanisms than those in use today to accomplish
the same goals.
The guidelines are divided into absolute and relative
criteria. Only the absolute criteria are presented
here. If any of these criteria are present, the
machine is by definition obsolete. The relative
criteria are related to practice conditions. These
relative criteria and the rationale for all the
criteria can be found on the ASA Web site links
mentioned above. These criteria should be shared
with all component societies and other groups interested
in anesthesia machine safety.
Absolute Criteria
An anesthesia machine shall be considered to be
obsolete if any of the following criteria apply:
I. Lack of essential safety features
A. Minimum oxygen ratio device (O2/N2O proportioning
system) on a machine that can deliver nitrous
oxide;
B. Oxygen failure safety (“fail-safe”)
device;
C. Oxygen supply pressure failure alarm;
D. Vaporizer interlock device;
Note: This does
not apply to an anesthesia machine that allows
only one vaporizer to be mounted at a time.
Note: It may be
possible to add a vaporizer interlock device
to a machine.
E. Pin Index Safety System;
F. Noninterchangeable, gas-specific (e.g., Diameter
Index Safety System [DISS]) connectors on the
gas pipeline inlets.
II. Presence of Unacceptable Features
A. Measured flow (flowmeter-controlled) vaporizers
(e.g., Copper Kettle, Verni-trol);
B. More than one flow control knob for a single
gas delivered to the common gas outlet of the
machine;
Note: This does
not include the flow control knob for an auxiliary
oxygen flowmeter.
C. Vaporizer with rotary concentration dial
such that the anesthetic vapor concentration
increases when the dial is turned clockwise;
Note: It may be
possible to replace an unacceptable vaporizer
without replacing the entire machine.
D. Connection(s) in scavenging system of the
same (i.e., 15-mm or 22-mm) diameter as a breathing
system connection.
Note: It may be
possible to replace an unacceptable scavenging
connection without replacing the entire machine.
III. Adequate Maintenance No Longer Possible
The manufacturer or certified service personnel
will not or cannot service the machine with acceptable
replacement parts so that it performs within the
tolerances to which it was originally designed.
Note: Although a
manufacturer may declare that its own subsidiaries
will no longer service, support or certify a
particular machine, the essential core components
of the machine may still be serviceable.
Note: Obtaining acceptable
replacement parts can be a problem. In some
cases, it may be possible to obtain the parts
from the party who supplied them to the machine
manufacturer. Alternatively such parts may be
obtained from machines that have already been
taken out of service.
Note: When a manufacturer
declares that it will no longer provide support
for a machine, responsibility is typically transferred
to the user (health care facility) and/or the
third party who services the machine.
When it has been determined that a machine is obsolete,
it should not be placed somewhere in the facility
where it might be used clinically (for example,
as an oxygen delivery device). A machine that has
been determined to be obsolete should either be
destroyed or donated to a worthy party (e.g., zoo,
laboratory or developing country). If the latter
course is followed, it would be prudent to obtain
legal advice about potential liability relating
to the donation. Also it is prudent to ensure that
the recipient possesses the infrastructure (e.g.,
electrical power, medical gases), access to drugs
and supplies (e.g., volatile anesthetics, circuits,
replacement parts), technical expertise and training
to safely use the machine.
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Jerry A. Dorsch, M.D., is Associate Professor
Emeritus, Mayo Clinic, Jacksonville, Florida. |
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