Current through March 20, 2024
Fluoroscopic x-ray systems must meet the machine performance
standards of
21 CFR §
1020.32. Use of non-image intensified
fluoroscopic equipment is prohibited. The provisions of this chapter apply to
equipment for fluoroscopic imaging or for recording images from the
fluoroscopic image receptor, except computed tomography (CT) x-ray systems
manufactured on or after November 29, 1984.
005.01 PERIODIC MEASUREMENT OF
AIR KERMA RATE (AKR). A periodic measurement of air kerma rate
(AKR) must be performed as follows.
005.01(A) MEASUREMENTS OF AIR
KERMA RATE (AKR). Measurements must be made for both typical and
maximum values of the air kerma rate (AKR), materials may be placed in the
useful beam to protect the imaging system when performing the periodic
measurements.
005.01(A)(i)
Measurements must be made annually or after any maintenance of the system which
might affect the air kerma rate (AKR.
005.01(A)(ii) For
units manufactured before June 10, 2006, results of the measurements must be
posted where a fluoroscopist may have access to those results while using the
fluoroscope.
005.01(B)
RECORDS OF MEASUREMENTS OF AIR KERMA RATE (AKR).The measurement
results may be stated in roentgens per minute (R/min) or milliGray per minute
(mGy/min). The results must include the technique factors used to determining
the results, the name of the individual that performed the measurements, and
the date the measurements were performed.
005.01(C)
CONDITIONS OF PERIODIC
MEASUREMENT OF TYPICAL AIR KERMA RATE (AKR). The following
conditions apply to the periodic measurement of the typical Air Kerma Rate
(AKR):
(i) The measurement must be made under
the conditions that satisfy the requirements of
21 CFR §
1020.32(d)(3);
(ii) Fluoroscopic systems that do not
incorporate automatic exposure rate control (AERC) must use a milliamperage
(mA) and kilovolt peak (kVp) typical of clinical use of the fluoroscopic
system; and
(iii) Fluoroscopic
systems that incorporate automatic exposure rate control (AERC) must have
sufficient material placed in the useful beam to produce a milliamperage (mA)
and kilovolt peak (kVp) typical of the clinical use of the fluoroscopic system.
005.01(D)
CONDITIONS OF PERIODIC MEASUREMENT OF MAXIMUM AIR KERMA RATE (AKR).
The following conditions apply to the periodic measurement of the
maximum air kerma rate (AKR):
(i) The
measurement must be made under the conditions that satisfy the requirements of
21 CFR §
1020.32(d)(3);
(ii) Fluoroscopic systems that do not
incorporate automatic exposure rate control (AERC) must be adjusted to those
settings which give the maximum air kerma rate (AKR); and
(iii) Fluoroscopic systems that incorporate
automatic exposure rate control (AERC) must have sufficient material placed in
the useful beam to produce the maximum air kerma rate (AKR) of the system.
005.02 CONTROL OF SCATTERED
RADIATION. The following requirements apply to controlling the
scatter of radiation.
005.02(A)
FLUOROSCOPIC TABLE DESIGNS. Fluoroscopic table designs, when
combined with the procedures performed at the registrant's facility, must
ensure that no unprotected part of any staff or ancillary individual's body is
exposed to unattenuated scattered radiation that originates from under the
table. The attenuation provided must be not less than 0.25 millimeter lead
equivalent.
005.02(B)
EQUIPMENT CONFIGURATION. Equipment configuration, when combined
with procedures performed at the registrant's facility, must ensure that no
portion of any staff or ancillary individual's body, except the extremities, is
exposed to the unattenuated scattered radiation that originates from above the
tabletop unless:
(i) That individual is 120
centimeters from the center of the useful beam; or
(ii) The radiation has passed through not
less than 0.25 millimeter lead equivalent material including, but not limited
to, drapes, bucky-slot cover panel, or self-supporting curtains. This
requirement is in addition to any lead equivalency provided by the protective
apron specified in 180 NAC 003.08.
005.02(C)
EXEMPTIONS TO THE USE
OF PROTECTIVE BARRIERS. When a sterile field will not permit the
use of the normal protective barriers or drapes, the shielding required by 180
NAC
6-005.02(B) must
be maintained to the degree possible under the clinical conditions.
005.03 FLUOROSCOPIC
RADIATION THERAPY SIMULATION SYSTEMS. Fluoroscopic radiation
therapy simulation systems are exempt from the requirements of 180 NAC
6-005.01. In addition, these systems are exempt from the requirements of
21 CFR §
1020.32(a) provided these
systems are designed and used in a manner that no individual other than the
patient is in the x-ray room during the time the system is producing
x-rays.
005.04
EQUIPMENT OPERATION. The following requirements apply to the
operation of fluoroscopic equipment.
005.04(A) Images formed by the use of
fluoroscopic x-ray systems must be under the direction of and interpreted by a
licensed practitioner of the healing arts.
005.04(B) Only a licensed practitioner may
perform interpretative fluoroscopic procedures.
005.04(C) Fluoroscopy must not be used as a
positioning tool for general purpose radiographic examinations.
005.04(D) Operators must be competent in the
standard operating procedures of the unit in use.
005.04(E) Registrants must maintain a record
of the cumulative fluoroscopic exposure time used and the number of
fluorographic images recorded for each examination. This record must include
patient identification, type and date of examination, the fluoroscopic system
used, and operator's name.
