Surgical Suite
Use of Medical Lasers
Employees are exposed to lasers used in healthcare facilities during diagnostic, cosmetic, preventive, and therapeutic applications. Lasers
used in these applications are incorporated into an apparatus, which includes:
- a delivery system to direct the
output of the laser,
- a power supply with laser control and
calibration functions,
- mechanical housing with interlocks,
and
- associated liquids and gases if
required for the operation of the laser.
Although there are hundreds of different types of lasers, only
about a dozen laser systems are found in
everyday clinical use. Nearly all treatment
laser products used in surgery are Class 4 as
they are designed to deliver laser radiation
for the purpose of altering biological tissue.
The following provides information
regarding the use of lasers:
The Food and Drug Administration
regulates all medical lasers under regulations
issued under the Medical Device Amendments to the Food
and Drug Act [21
CFR Parts 800-1299 Note: Enter terms in the search boxes], and the Federal Laser Product
Performance Standard [21
CFR Part 1040].
For additional information on Potential Hazards and
Possible Solutions, see
Surgical Suite - Laser Hazards.
Note: Class 2 and higher
must have the
laser
radiation warning label. |
Federal regulations
require manufacturers to classify medical
laser systems based primarily on their
ability to cause damage to the eye and
skin. This classification must be indicated
on the laser system’s label.
Class 1
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A Class 1
laser system is considered to be
incapable of producing damaging
radiation levels during normal operation,
and is exempt from any control measures
or other forms of surveillance.
Although some Class 1 lasers emit
very weak, non-hazardous beams, most
Class 1 laser systems incorporate
"embedded" higher-power lasers,
which can be accessed only if
important safety features such as
interlocks are defeated or
deliberately bypassed as is sometimes
done during servicing. In this case,
the system temporarily reverts back
to the original laser classification
(requiring special safety
procedures). NOTE: Products which
have been previously classified as
Class 2a should be treated the same
as Class 1.
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Class 1M
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A Class 1M
laser system is considered to be
incapable of producing hazardous
exposure conditions during normal
operation unless the beam is viewed
with an optical instrument such as
an eye-loupe (diverging beam) or a
telescope (collimated beam), and is
exempt from any control measures
other than to prevent potentially
hazardous optically aided viewing;
and is exempt from other forms of
surveillance.
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Class 2 |
A Class 2
laser system emits in the visible
portion of the spectrum (400-700
nm), and eye protection is normally
afforded by the aversion
response. The aversion response is
the closure of the eyelid, eye
movement, pupillary constriction, or
movement of the head to avoid an
exposure to a bright light
stimulant. The aversion response to
a bright visible laser source is
assumed to limit the exposure of the
retina to 0.25 seconds or less.
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Class 2M |
A Class 2M
laser system emits in the visible
portion of the spectrum (400-700
nm), and eye protection is normally
afforded by the human aversion
response for unaided viewing.
However, Class 2M is potentially
hazardous if viewed with certain
optical aids.
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Class 3R
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A Class 3R
laser system is potentially
hazardous under some direct and
specular reflection (shiny or mirror-like) viewing
conditions if the eye is
appropriately focused and stable,
but the probability of an actual
injury is small. This laser will not
pose either a fire hazard or diffuse
reflection hazard. NOTE: Products
which have been previously
classified as Class 3a should be
treated the same as Class 3R.
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Class 3B
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A Class 3B
laser system may be hazardous under
direct and specular viewing
conditions, but is normally not a
diffuse reflection or fire hazard.
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Class 4
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A Class 4
laser system is a hazard to the eye
and skin from the direct beam, and
may pose a diffuse reflection or
fire hazard, and may also produce
laser-generated airborne
contaminants and hazardous plasma
radiation. |
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Laser-Generated Airborne
Contaminants (LGAC)
In operations using
lasers that vaporize tissue through disruption of cells, laser generated
airborne contaminants (LGAC) result as an airborne hazard requiring appropriate
management. Analysis of these contaminants produced during laser surgical
procedures has shown the presence of:
- gaseous toxic compounds.
- bio-aerosols.
- dead and live cellular material.
- viruses.
In orthopedics,
dentistry, plastic surgery and other fields, it
is also possible to generate particulates and
metal fumes. At certain concentrations some of
the LGAC may cause ocular and upper respiratory
tract irritation, have unpleasant odors, create
visual problems for the user, and have been
shown to have mutagenic and carcinogenic
potential. It has been shown that laser smoke
production is a function of increased irradiance
levels. Therefore, laser surgical procedures
requiring high irradiance levels are more likely
to produce LGAC.
Possible Solutions
-
Airborne contaminants should be controlled by the use of local exhaust
ventilation, respiratory protection or a combination of both. [ANSI Z136.3]
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Detailed training in
laser safety should be provided for those healthcare personnel using, or
working in the presence of, Class 3B and Class 4 health care laser
systems. All training activities should be documented and retained on
file. Laser safety training should be presented to the following
healthcare personnel: [ANSI Z136.3]
- Laser Safety Officer (LSO)
- Users
- Laser technical support staff
- Nurses and allied health personnel
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Each medical specialty has evolved
its own procedures for bringing in new
techniques and new surgical procedures. In all
cases, the laser user should use the laser for
its intended purpose within the user's scope of
practice, training and experience. All
credentialing processes must require training
in the safe clinical use of the laser, as well
as the maintenance of a safe environment in
compliance with defined standards, and local,
state and Federal requirements.
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