Current through Register Vol. 48, No. 39, March 25, 2024
Subpart 1.
Applicability.
All fluoroscopic systems must meet the requirements in this
chapter and the applicable performance standards of nationally recognized
standards, such as:
A. Code of Federal
Regulations, title 21, section 1020.32;
B. the manufacturer's specifications;
or
C. part
4732.1100.
Subp. 2.
Fluoroscopic training
requirements.
Except licensed practitioners of the healing arts, any
individual activating the fluoroscopic system must be trained in the aspects of
fluoroscopic equipment use listed in items A to J. The topics to be covered and
documented are:
A. x-ray generation
and control;
B. x-ray
dosimetry;
C. image
formation;
D. image
acquisition;
E. image processing
and management;
F. radiation
effects;
G. patient dose-management
fundamentals;
H. staff radiation
safety;
I. professional standards
and regulatory requirements; and
J.
other miscellaneous items appropriate to site-specific use.
Subp. 3.
Registrant
requirements.
The registrant must ensure that:
A. the written safety procedures provide
precautionary measures to be adhered to when image intensified fluoroscopes are
used for specific surgical applications;
B. portable fluoroscopic equipment must have
spacer cones and the spacer cones must remain with the portable fluoroscopic
equipment at all times. Appropriate spacer cones must be placed on the portable
fluoroscopic equipment that is used outside of the surgical setting;
C. any individual who is in the room during a
fluoroscopic procedure must wear a protective garment of not less than 0.5
millimeter lead equivalence; and
D.
all fluoroscopic x-ray equipment must be provided with a bucky-slot cover
panel, if applicable, and either lead drapes attached to the intensifying tower
or self-supporting shields of not less than 0.5 millimeter lead equivalent
material.
Subp. 4.
Limitation of useful beam x-ray field.
A. All fluoroscopic systems must be provided
with image intensification equipment to view the fluoroscopic images.
B. Spot-film devices must meet the field
limitation and alignment requirements in Code of Federal Regulations, title 21,
section 1020.31.
Subp.
5.
Entrance exposure rate allowable limits.
Fluoroscopic systems must meet requirements in Code of
Federal Regulations, title 21, section 1020.32.
A. Fluoroscopic equipment with automatic
exposure rate control (AERC) must not be operable at any combination of tube
potential and current that results in an air kerma rate in excess of ten
roentgens per minute or 2.58 x 10-3 C/kg per minute
at the point where the center of the useful beam enters the patient, except:
(1) during recording of fluoroscopic images
when using photographic film; or
(2) when an optional high-level control is
provided. When so provided, the equipment must not be operable at any
combination of tube potential and current that results in an air kerma rate in
excess of five R/min (1.29 x 10-3 C/kg per minute)
at the point where the center of the useful beam enters the patient, unless the
high-level control is activated. Special means of activation of high-level
controls is required. The high-level control must be operable only when the
operator provides continuous manual activation. A continuous signal audible to
the fluoroscopist must indicate that the high-level control is being
employed.
B.
Fluoroscopic equipment without AERC (manual mode) must not be operable at any
combination of tube potential and current that results in an air kerma rate in
excess of five R/min (1.29 x 10-3 C/kg per minute)
at the point where the center of the useful beam enters the patient:
(1) during the recording of fluoroscopic
images; or
(2) when an optional
high-level control is activated. Special means of activation of high-level
controls is required. The high-level control must be operable only when the
operator provides continuous manual activation. A continuous signal audible to
the fluoroscopist must indicate that the high-level control is being
employed.
C.
Fluoroscopic equipment with both an AERC mode and a manual mode must not be
operable at any combination of tube potential and current that results in an
air kerma rate in excess of ten R/min (2.58 x 10-3
C/kg per minute) in either mode at the point where the center of the useful
beam enters the patient, except:
(1) during
the recording of fluoroscopic images when using photographic film; or
(2) when the mode or modes have an optional
high-level control, in which case that mode or modes must not be operable at
any combination of tube potential and current that results in an air kerma rate
in excess of five R/min (1.29 x 10-3 C/kg per
minute) at the point where the center of the useful beam enters the patient,
unless the high-level control is activated. Special means of activation of
high-level controls is required. The high-level control must be operable only
when the operator provides continuous manual activation.
D. The registrant with fluoroscopic systems
manufactured after May 19, 1995, must ensure that the entrance exposure rate
allowable limits in this subpart are met.
(1)
Fluoroscopic equipment operable at any combination of tube potential and
current that results in an air kerma rate greater than five R/min (1.29 x
10-3 C/kg per minute) at the point where the center
of the useful beam enters the patient must be equipped with automatic exposure
rate control. Provision for manual selection of technique factors may be
provided.
(2) Fluoroscopic
equipment must not be operable at any combination of tube potential and current
that results in an exposure rate in excess of ten R/min (2.58 x
10-3 C/kg per minute) at the point where the center
of the useful beam enters the patient, except:
(a) during the recording of images from an
x-ray image-intensifier tube using photographic film; or
(b) when an optional high-level control is
activated, the equipment must not be operable at any combination of tube
potential and current that results in an air kerma rate in excess of 20 R/min
(5.16 x 10-3 C/kg per minute) at the point where the
center of the useful beam enters the patient. Special means of activation of
high-level control is required. The high-level control must only be operable
when the operator provides continuous manual activation. A continuous signal
audible to the fluoroscopist must indicate that the high-level control is being
employed.
Subp.
6.
Indication of kilovoltage and milliamperage.
For fluoroscopic x-ray systems, kilovoltage and the
milliamperage must be continuously indicated.
Subp. 7.
Source-to-skin
distance.
The source-to-skin distance must not be less than:
A. 15 inches (38 centimeters) on stationary
fluoroscopes;
B. 14 inches (35.5
centimeters) on stationary fluoroscopes manufactured prior to August 1,
1974;
C. 11.8 inches (30
centimeters) on all portable fluoroscopes; and
D. 7.9 inches (20 centimeters) for image
intensified fluoroscopes used for specific surgical applications.
Subp. 8.
Control of
scattered radiation.
The procedures in this subpart must be used to control
scattered radiation from all fluoroscopes.
A. When a fluoroscopic table with an under
table x-ray tube is used, the bucky opening must be shielded to attenuate the
scattered radiation by at least 70 percent. Lead drapes must be attached to the
intensifier tower to attenuate scattered radiation by at least 70
percent.
B. For other under table
configurations, provisions must be made through equipment design or radiation
protection measures to ensure that individuals do not receive a dose in excess
of the allowable dose limits listed in parts
4732.0410 to
4732.0430.
C. For single-tube above table combination
radiographic and fluoroscopic x-ray systems used in the fluoroscopic mode,
protective aprons of not less than 0.5 millimeter lead equivalence must be used
to ensure that any individual who is in the room during a fluoroscopic
procedure does not receive a dose greater than the allowable dose limits in
part
4732.0410. In addition, portable
lead shields, barriers, or aprons of not less than 0.5 millimeter lead
equivalence must be used.
D. For
portable C-arm fluoroscopes, provisions must be made through the use of
protective aprons of not less than 0.5 millimeter lead equivalence to ensure
that any individual other than the patient who may be exposed during a
fluoroscopic procedure does not receive a dose in excess of the allowable dose
limits in part
4732.0410.
Subp. 9.
Radiation therapy simulation
systems.
A radiation therapy simulation system is exempt from the
requirements of subpart
3, provided:
A. the system is designed and used so that no
individual other than the patient is in the simulation room when the system is
producing x-rays; and
B. the system
has a means to indicate the cumulative time that an individual patient has been
exposed to x-rays. Procedures must require in such cases that the timer be
reset between examinations.
Subp.
10.
Real-time cabinet fluoroscopic systems.
A real-time cabinet fluoroscopic system used for research
must meet the requirements in part
4732.1040.
Statutory Authority: MS s
144.12