105 CMR 120.405
Fluoroscopic X-ray Systems
Fluoroscopic X-ray Systems shall be installed and maintained to comply with the Federal
Performance Standard for Fluoroscopic Equipment, 21 CFR 1020.32 and shall also meet the
following requirements except 21 CFR 1020.32 shall prevail should there be a conflict.
(A) Limitation of Useful Beam.
(1) Primary Barrier.
(a) The fluoroscopic imaging assembly shall be provided with a primary protective
barrier which intercepts the entire cross section of the useful beam at any SID.
(b) The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is
in position to intercept the entire useful beam.
(c) Radiation therapy simulation systems shall be exempt from 105 CMR 120.405(A)
provided the systems are intended only for remote control operation.
(2) Fluoroscopic Beam Limitation.
(a) For certified fluoroscopic systems with or without a spot film device, neither the
length nor the width of the x-ray field in the plane of the image receptor shall exceed
that of the visible area of the image receptor by more than 3% of the SID. The sum of
the excess length and the excess width shall be no greater than 4% of the SID.
(b) For uncertified fluoroscopic systems with a spot film device, the x-ray beam with
the shutters fully opened (during fluoroscopy or spot filming) shall be no larger than the
largest spot film size for which the device is designed. Measurements shall be made at
the minimum SID available but at no less than 20 centimeters table top to the film plane
distance.
(c) For uncertified fluoroscopic systems without a spot film device, the requirements
of 120.405(A)(2)(a) apply.
1. Means shall be provided to permit further limitation of the field. Beam-limiting
devices manufactured after May 22, 1979, and incorporated in equipment with a
variable SID and/or a visible area of greater than 300 square centimeters shall be
provided with means for stepless adjustment of the x-ray field;
2. All equipment with a fixed SID and a visible area of 300 square centimeters or
less shall be provided with either stepless adjustment of the x-ray field or with
means to further limit the x-ray field size at the plane of the image receptor to 125
square centimeters or less;
3. If provided, stepless adjustment shall, at the greatest SID, provide continuous
field sizes from the maximum attainable to a field size of five centimeters by five
centimeters or less;
4. For equipment manufactured after February 25, 1978, when the angle between
the image receptor and beam axis is variable, means shall be provided to indicate
when the axis of the x-ray beam is perpendicular to the plane of the image receptor;
and,
5. For rectangular x-ray fields used with circular image receptors, the error in
alignment shall be determined along the length and width dimensions of the x-ray
field which pass through the center of the visible area of the image receptor.
(d) For fluoroscopic equipment manufactured on or after June 10, 2006, other than
radiation simulation systems, the maximum area of the x-ray field in the plane of the
image receptor shall conform with one of the following requirements:
1. When any linear dimension of the visible area of the image receptor measured
through the center of the visible area is less than or equal to 34 cm in any direction,
at least 80% of the area of the x-ray field overlaps the visible area of the image
receptor; or
2. When any linear dimension of the visible area of the image receptor measured
through the center of the visible area is greater than 34 cm in any direction, the x-ray
field measured along the direction of greatest misalignment with the visible area of
the image receptor does not extend beyond the edge of the visible area of the image
receptor by more than two cm.
(3) Spot-film Beam limitation. Spot-film devices shall meet the following requirements:
(a) Means shall be provided between the source and the patient for adjustment of the
x-ray field size in the plane of the film to the size of that portion of the film which has
been selected on the spot film selector. Such adjustment shall be automatically
accomplished except when the x-ray field size in the plane of the film is smaller than
that of the selected portion of the film. For spot film devices manufactured after
June 21, 1979, if the x-ray field size is less than the size of the selected portion of the
film, the means for adjustment of the field size shall be only at the operator's option;
(b) Neither the length nor the width of the x-ray field in the plane of the image receptor
shall differ from the corresponding dimensions of the selected portion of the image
receptor by more than 3% of the SID when adjusted for full coverage of the selected
portion of the image receptor. The sum, without regard to sign, of the length and width
differences shall not exceed 4% of the SID;
(c) It shall be possible to adjust the x-ray field size in the plane of the film to a size
smaller than the selected portion of the film. The minimum field size at the greatest SID
shall be equal to, or less than, five centimeters by five centimeters;
(d) The center of the x-ray field in the plane of the film shall be aligned with the center
of the selected portion of the film to within 2% of the SID; and,
(e) On spot-film devices manufactured after February 25, 1978, if the angle between
the plane of the image receptor and beam axis is variable, means shall be provided to
indicate when the axis of the x-ray beam is perpendicular to the plane of the image
receptor, and compliance shall be determined with the beam axis indicated to be
perpendicular to the plane of the image receptor.
(4) Override. If a means exists to override any of the automatic x-ray field size adjustments
required in 105 CMR 120.405(A)(2), that means:
(a) Shall be designed for use only in the event of system failure;
(b) Shall incorporate a signal visible at the fluoroscopist's position which will indicate
whenever the automatic field size adjustment is overridden; and,
(c) Shall be clearly and durably labeled as follows:
FOR X-RAY FIELD
LIMITATION SYSTEM FAILURE
(B) Activation of the Fluoroscopic Tube. X-ray production in the fluoroscopic mode shall be
controlled by a device which requires continuous pressure by the fluoroscopist for the entire
time of any exposure. When recording serial fluoroscopic images, the fluoroscopist shall be
able to terminate the x-ray exposure(s) at any time, but means may be provided to permit
completion of any single exposure of the series in process.
(C) Air Kerma Rates.
(1) Fluoroscopic Equipment Manufactured Before May 19, 1995.
(a) Fluoroscopic equipment which is provided with automatic exposure rate control
shall not be operable at any combination of tube potential and current which will result
in AKR in excess of 88 mGy per minute (ten roentgens) per minute at the point where
the center of the useful beam enters the patient, except:
1. During recording of fluoroscopic images; or
2. When provided with optional high level control, the equipment shall not be
operable at any combination of tube potential and current which will result in an
AKR in excess of ten roentgens (88 mGy) 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 shall be required. The high level
control shall only be operable when continuous manual activation is provided by the
operator. A continuous signal audible to the fluoroscopist shall indicate that the high
level control is being employed.
(b) Fluoroscopic equipment which is not provided with automatic exposure rate control
shall not be operable at any combination of tube potential and current which will result
in AKR in excess of 44 mGy (five roentgens) per minute at the point where the center
of the useful beam enters the patient, except:
1. During recording of fluoroscopic images; or
2. When an optional high level control is activated. Special means of activation of
high level controls shall be required. The high level control shall only be operable
when continuous manual activation is provided by the operator. A continuous signal
audible to the fluoroscopist shall indicate that the high level control is being
employed.
(c) Fluoroscopic equipment which is provided with both automatic exposure rate
control mode and a manual mode shall not be operable at any combination of tube
potential and current which shall result in an AKR in excess of 88 mGy (ten roentgens)
per minute in either mode at the point where the center of the useful beam enters the
patient, except:
1. During recording of fluoroscopic images; or
2. When the mode or modes have an optional high level control, in which case that
mode or modes shall not be operable at any combination of tube potential and
current which shall result in an AKR in excess of 88 mGy (ten roentgens) per minute
at the point where the center of the useful beam enters the patient, unless high level
control is activated. Special means of activation of high level controls shall be
required. The high level control shall only be operable when continuous manual
activation is provided by the operator. A continuous signal audible to the
fluoroscopist shall indicate that the high level control is being employed.
(2) Fluoroscopic Equipment Manufactured On or After May 19, 1995.
(a) Shall be equipped with automatic exposure rate control if operable at any
combination of tube potential and current that results in an AKR greater than 44 mGy
per minute (five R/min exposure rate) at the measurement point specified in 105 CMR
120.405(C)(3). Provision for manual selection of technique factors may be provided.
(b) Shall not be operable at any combination of tube potential and current that will
result in an AKR in excess of 88 mGy per minute (ten R/min exposure rate) at the
measurement point specified in 105 CMR 120.405(C)(3).
(c) Exceptions:
1. For equipment manufactured prior to June 10, 2006, during the recording of
images from a fluoroscopic image receptor using photographic film or a video
camera when the x-ray source is operated in a pulsed mode.
2. For equipment manufactured on or after June 10, 2006, during the recording of
images from the fluoroscopic image receptor for the purpose of providing the user
with a recorded image(s) after termination of the exposure. Such recording does not
include images resulting from a last-image-hold feature that are not recorded.
3. When a mode of operation has an optional high-level control and the control is
activated, in which case the equipment shall not be operable at any combination of
tube potential and current that will result in an AKR in excess of 176 mGy per
minute (20 R/min exposure rate) at the measurement point specified in 105 CMR
120.405(C)(3). Special means of activation of high-level controls shall be required.
The high-level control shall be operable only when continuous manual activation is
provided by the operator. A continuous signal audible to the fluoroscopist shall
indicate that the high-level control is employed.
(3) Compliance with the requirements of 105 CMR 120.405(C) shall be determined as
follows:
(a) If the source is below the table, the AKR shall be measured one centimeter above
the tabletop or cradle.
(b) If the source is above the table, the AKR shall be measured at 30 centimeters above
the tabletop with the end of the beam-limiting device or spacer positioned as closely as
possible to the point of measurement.
(c) For a C-arm type of fluoroscope, the AKR shall be measured 30 centimeters from
the input surface of the fluoroscopic imaging assembly, with the source positioned at any
available SID, provided that the end of the beam-limiting device or spacer is no closer
than 30 centimeters from the input surface of the fluoroscopic imaging assembly;
(d) For a lateral type fluoroscope, the air kerma rate shall be measured at a point 15
centimeters from the centerline of the x-ray table and in the direction of the x-ray source
with the end of the beam-limiting device or spacer positioned as closely as possible to
the point of measurement. If the tabletop is movable, it shall be positioned as closely
as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer
no closer than 15 centimeters to the centerline of the x-ray table.
(e) In a C-arm type of fluoroscope having an SID less than 45 cm, the AKR shall be
measured at the minimum SSD.
(4) The registrant of a facility or responsible person at the facility shall have a qualified
medical physicist perform periodic measurement of AKR for both typical and maximum
values as follows:
(a) Such measurements shall be made annually or after any maintenance of the system
which might affect the AKR;
(b) If the fluoroscope does not display the AKR of the current patient in view of the
operator when the fluoroscopy trigger is depressed, results of these measurements shall
be posted where any fluoroscopist may have ready access to such results while using the
fluoroscope and in the record required in 105 CMR 120.403(A)(2)(b). The
measurement results shall be stated in coulombs per kilogram (roentgens) per minute
and include the technique factors used in determining such results. The name of the
individual performing the measurements and the date the measurements were performed
shall be included in the results;
(c) Conditions of periodic measurement of typical AKR are as follows:
1. The measurement shall be made under the conditions that satisfy the
requirements of 105 CMR 120.405(C)(1)(c);
2. The kVp, mA, and/or other selectable parameters shall be adjusted to those
settings typical of clinical use for an abdominal patient;
3. The x-ray system that incorporates automatic Exposure rate control shall have
sufficient attenuative material placed in the useful beam to produce a milliamperage
and/or kilovoltage to satisfy the conditions of 105 CMR 120.405(C)(1)(e)3.; and
(d) Conditions of periodic measurement of maximum AKR are as follows:
1. The measurement shall be made under the conditions that satisfy the
requirements of 105 CMR 120.405(C)(1)(c);
2. The kVp, mA and/or other selectable parameters shall be adjusted to those
settings which give the maximum AKR;
3. The x-ray system(s) that incorporates automatic exposure rate control shall have
sufficient attentuative material placed in the useful beam to produce the maximum
AKR of the system.
(D) Barrier Transmitted Radiation Rate Limits.
(1) The AKR due to transmission through the primary protective barrier with the
attenuation block in the useful beam, combined with radiation from the image intensifier,
if provided, shall not exceed two milliroentgen (0.516 µC/kg) per hour at ten centimeters
from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the
image receptor for each roentgen per minute of AKR.
(2) Measuring Compliance of Barrier Transmission.
(a) The AKR due to transmission through the primary protective barrier combined
with radiation from the image intensifier shall be determined by measurements averaged
over an area of 100 square centimeters with no linear dimension greater than
20 centimeters.
(b) If the source is below the tabletop, the measurement shall be made with the input
surface of the fluoroscopic imaging assembly positioned 30 centimeters above the
tabletop.
(c) If the source is above the tabletop and the SID is variable, the measurement shall
be made with the end of the beam-limiting device or spacer as close to the tabletop as
it can be placed, provided that it shall not be closer than 30 centimeters.
(d) Movable grids and compression devices shall be removed from the useful beam
during the measurement.
(e) The attenuation block shall be positioned in the useful beam ten centimeters from
the point of measurement of AKR and between this point and the input surface of the
fluoroscopic imaging assembly.
(E) Indication of Potential and Current. During fluoroscopy and cinefluorography the kV and
the mA shall be continuously indicated.
(F) Source-to-skin Distance.
(1) Means shall be provided to limit the source-skin distance to not less than 38 cm on
stationary fluoroscopes and to not less than 30 cm on mobile and portable fluoroscopes. In
addition, for fluoroscopes intended for specific surgical application that would be prohibited
at the source-skin distances specified in 105 CMR 120.405(D)(1), provisions may be made
for operating at shorter source-skin distances but in no case less than 20 cm.
(2) For stationary, mobile, or portable C-arm fluoroscopic systems manufactured on or after
June 10, 2006, having a maximum source-image receptor distance of less than 45 cm, means
shall be provided to limit the source-skin distance to not less than 19 cm. Such systems
shall be labeled for extremity use only. In addition, for those systems intended for specific
surgical application that would be prohibited at the source-skin distance specified in
105 CMR 120.405(F)(2), provisions may be made for operation at shorter source-skin
distances but in no case less than ten cm.
(G) Fluoroscopic Timer.
(1) Fluoroscopic Equipment Manufactured Before June 10, 2006:
(a) Means shall be provided to preset the cumulative on-time of the fluoroscopic x-ray
tube. The maximum cumulative time of the timing device shall not exceed five minutes
without resetting.
(b) A signal audible to the fluoroscopist shall indicate the completion of any preset
cumulative on-time. Such signal shall continue to sound while x-rays are produced until
the timing device is reset.
(2) For x-ray controls manufactured on or after June 10, 2006, there shall be provided for
each fluoroscopic tube:
(a) A display of the fluoroscopic irradiation time at the fluoroscopist's working
position. This display shall function independently of the audible signal described in
105 CMR 120.405(G)(2). The following requirements apply:
1. When the x-ray tube is activated, the fluoroscopic irradiation time in minutes and
tenths of minutes shall be continuously displayed and updated at least once every six
seconds.
2. The fluoroscopic irradiation time shall also be displayed within six seconds of
termination of an exposure and remain displayed until reset.
3. Means shall be provided to reset the display to zero prior to the beginning of a
new examination or procedure.
(b) A signal audible to the fluoroscopist shall sound for each passage of five minutes
of fluoroscopic irradiation time during an examination or procedure. The signal shall
sound until manually reset or, if automatically reset, for at least two seconds.
(H) Control of Scattered Radiation.
(1) Fluoroscopic table designs when combined with procedures utilized shall be such that
no unprotected part of any staff or ancillary individual's body shall be exposed to
unattenuated scattered radiation which originates from under the table. The attenuation
required shall be not less than 0.25 millimeter lead equivalent.
(2) Equipment configuration when combined with procedures shall be such that no portion
of any staff or ancillary individual's body, except the extremities, shall be exposed to the
unattenuated scattered radiation emanating from above the tabletop unless that individual:
(a) Is at least 120 centimeters from the center of the useful beam; or
(b) 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, in addition to any lead equivalency provided by the protective apron referred
to in 105 CMR 120.403(A)(1)(e).
(3) The Agency may grant exemptions to 105 CMR 120.405(H)(2) where a sterile field will
not permit the use of the normal protective barriers. Where the use of prefitted sterilized
covers for the barriers is practical, the Agency shall not permit such exemption. See
105 CMR 120.423: Appendix D for a suggested list of fluoroscopic procedures where such
exemptions will be automatically granted.
(I) Radiation Therapy Simulation Systems. Radiation therapy simulation systems shall be
exempt from all the requirements of 105 CMR 120.405(A), (C), (D) and (G) provided that:
(1) Such systems are designed and used in such a manner that no individual other than the
patient is in the x-ray room during periods of time when the system is producing x-rays; and,
(2) Systems which do not meet the requirements of 105 CMR 120.405(G) are provided
with a means of indicating the cumulative time that an individual patient has been exposed
to x-rays. Procedures shall require in such cases that the timer be reset between
examinations.
(J) Spot film Exposure Reproducibility. Fluoroscopic systems equipped with spot film
(radiographic) modes shall meet the exposure reproducibility requirements when operating in
the spot film mode.
(K) Operator Qualifications.
(1) The Registrant of a facility shall ensure that only the following health care providers
shall be allowed to operate fluoroscopic x-ray systems:
(a) Licensed physicians who are board-certified in radiology;
(b) Licensed physicians who are not board-certified in radiology provided that they
have been trained in the following subjects:
1. Principles and operation of the fluoroscopic x-ray system;
2. Biological effects of x-ray;
3. Principles of radiation protection;
4. Fluoroscopic outputs;
5. High level control options;
6. Dose reduction techniques for fluoroscopic x-ray systems; and
7. Application requirements of 105 CMR 120.000.
(c) Radiologic technologists who are licensed in accordance with 105 CMR 125.000
and have been trained in the safe use of fluoroscopic x-ray systems; and
(d) Physician assistants who are licensed in accordance with M.G.L. c. 112, § 9I, and
263 CMR 3.00: Registration of Individual Physician Assistants, and who meet the
requirements of 105 CMR 120.405(K)(2).
(2) The Registrant of a facility shall ensure that a physician assistant delegated the
performance of specified fluoroscopic procedures by a supervising physician has submitted
documentation of the following to the facility:
(a) Successful completion of the education and clinical training specified in 105 CMR
120.405(K)(3) offered by an approved provider;
(b) a passing score on an examination offered by the American Registry of Radiologic
Technologists (ARRT) or equivalent exam approved by the Agency covering the
educational and clinical requirements specified in 105 CMR 120.405(K)(3);
(c) a written and signed statement from the physician assistant's supervising physician,
who meets the requirements of 105 CMR 120.405(K)(1)(a) or (b), verifying the
physician assistant's competency to perform specified fluoroscopic procedures; and
(d) a written practice agreement between the physician assistant and his or her
supervising physician as set forth in regulations of the Board of Registration in Medicine
at 243 CMR 2.08 and of the Board of Registration of Physician Assistants in 263 CMR
5.00: Scope of Practice and Employment of Physician Assistants.
(3) The education and clinical training required by 105 CMR 120.405(K)(2)(a) shall
consist of the following:
(a) Didactic Content
1. Digital image acquisition and display;
2. Contrast media;
3. Fluoroscopic unit operation and safety;
4. Image analysis;
5. Radiation biology;
6. Radiation production and characteristics; and
7. Radiation protection.
(b) Clinical Component
1. Clinical competency requirement: 40 clinical hours performing fluoroscopic
procedures in a fluoroscopic suite under the direct supervision of a physician who
meets the requirements of 105 CMR 120.405(K)(1)(a) or (b), a medical physicist,
or a radiography educator. "Direct supervision," as used in 105 CMR
120.405(K)(3), means physically present where the fluoroscopic procedure is being
performed and immediately available and able to provide assistance and direction
throughout the procedure;
2. Fluoroscopic device orientation: safe and proper manipulation of the
fluoroscopic device.
(4) The Registrant of the facility and/or responsible person at the facility shall maintain all
records relating to compliance with the education and clinical training requirements for the
current year and the previous four years.
(5) The facility shall establish policies and procedures for limiting the performance of
fluoroscopic procedures to only those health care providers who have met the requirements
of 105 CMR 120.405(K) and who have been granted privileges for the use of fluoroscopy
based on their demonstrated competency in the performance of fluoroscopic procedures.
(6) The Registrant of the facility shall ensure that all physicians who are not board certified
in radiology and who perform fluoroscopic procedures complete two hours of training in
Radiation Safety/Radiation Protection on an annual basis, and that all physicians who are
not board certified in radiology who supervise the performance of fluoroscopic procedures
complete a total of four hours of Radiation Safety/Radiation Protection training on an annual
basis. The facility shall maintain all records relating to compliance with this training
requirement for the current year and the previous four years.
(7) The Registrant of a facility shall ensure that licensed radiologic technologists and
licensed physician assistants who perform fluoroscopic procedures have satisfied all related
continuing education requirements as required by their respective licensing boards, and shall
maintain records documenting completion of such continuing education requirements by
radiologic technologists and physician assistants for five years.
(8) In addition to any other reporting requirements, the facility shall immediately, and no
later than 24 hours after discovery, report to the Agency any incident at the facility involving
fluoroscopic procedures that seriously affects the health and safety of a patient or that causes
serious physical injury to a patient due to radiation exposure.
(9) Nothing in 105 CMR 120.405(K) shall prohibit nurse practitioners from practicing
within their lawful scope of practice, including functioning as first assistants during cardiac
catheterization procedures in accordance with 105 CMR 130.900: Standards for Operation
of Hospital-based Cardiac Catheterization Services, and the Board of Registration in
Nursing Advisory Ruling Number 0201, Nurse Practitioner as First Assistant in Cardiac
Catherization, provided that the physician who is the primary operator, as defined in
105 CMR 130.910, is qualified to operate fluoroscopic x-ray systems pursuant to 105 CMR
120.405(K)(1)(a) or (b).
(L) Patient Dose Evaluation.
(1) Each facility performing fluoroscopically-guided interventional and CT fluoro
procedures shall conduct patient dose evaluation for any procedure that has a reasonable
probability of resulting in a deterministic injury as further defined in 105 CMR
120.405(L)(5).
(2) Records documenting that policies and procedures have been developed to determine
that those procedures that have a potential to result in patient doses exceeding the threshold
for injury have been established to reduce the probability of such exposures and that
appropriate action occurs for patients receiving doses that warrant follow-up.
(3) The facility shall have a patient dose monitoring procedures in place. When the
fluoroscopy unit is equipped with an Air-Kerma dose readout, the recording of this value
shall suffice as a patient dose record.
(4) The facility shall document in the patient’s medical record an estimate of the absorbed
dose to the skin.
(5) Any cumulative absorbed dose to the skin equal to or greater than 2 Gy (200 rads) shall
be noted in the patient’s medical record and reviewed by the Radiation Safety Committee.
(6) Each facility that use fluoroscopic x-ray systems shall maintain a record of the
cumulative fluoroscopic exposure time used and the number of spot films for each
examination. This record shall indicate patient identification, type of examination, date of
examination, and operator’s name. The record shall be maintained for five years.
(M) Equipment Operation.
(1) Radiological technology students shall not be allowed to operate fluoroscopic x-ray
systems unless directly supervised by a licensed practitioner of the healing arts or a licensed
Radiological Technologist.
(2) Overhead fluoroscopy shall not be used as a positioning tool for general purpose
radiographic examinations.
(N)
Mini-C-Arms. 105 CMR 120.405 includes Mini-C-Arms.