Current through all regulations passed and filed through March 18, 2024
(A) Fluoroscopic
equipment shall meet the following standards:
(1) Unless the United States food and drug
administration (FDA) has granted a variance for specific fluoroscopic equipment, the
source-to-skin distance (SSD) for fluoroscopy
equipment shall not be less than:
(a)
Thirty-eight centimeters on stationary fluoroscopic equipment unless a
particular procedure application prohibits that distance, in which case the SSD
shall not be less than twenty centimeters;
(b) Thirty centimeters on mobile fluoroscopic
equipment unless a particular procedure prohibits that distance, in which case
it shall not be less than twenty centimeters; and
(c) Nineteen centimeters for c-arm type
fluoroscopic equipment having a maximum source-to-image distance (SID) less
than forty-five centimeters unless a particular procedure prohibits that
distance, in which case it shall not be less than ten centimeters. Such systems
shall be used for extremity or dental purposes only;
(2) For c-arm fluoroscopic
equipment equipped with a removable spacer cone, the spacer cone shall be
attached to the x-ray source during use at all times unless it interferes with
the clinical procedure;
(3) 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
and shall prevent further exposures when the primary barrier is not in the path
of the entire x-ray beam;
(4) All
fluoroscopic equipment shall provide intensified imaging. As used in this rule
"intensified imaging" will include the use of digital image receptors;
(5) Fluoroscopic equipment shall meet the
following field limitation specifications:
(a)
For fluoroscopic equipment manufactured before June 10, 2006, the following
applies:
(i) 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 three per cent of the SID. The
sum of the excess length and the excess width shall be no greater than four per
cent of the SID;
and
(ii) 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;
(b) For fluoroscopic equipment
with a circular image receptor manufactured on or after June 10, 2006, the
maximum area of the x-ray field in the plane of the circular image receptor
shall conform with one of the following requirements:
(i)
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 thirty-four centimeters in any
direction, at least eighty per cent of the area of the x-ray field shall
overlap the visible area of the image receptor; or
(ii)
When any linear
dimension of the visible area of the image receptor measured through the center
of the visible area is
greater than thirty-four centimeters in any direction,
the x-ray field measured along the direction of greatest misalignment with the
visible area of the image receptor shall not extend beyond the edge of the
visible area of the image receptor by more than two centimeters;
(c) For fluoroscopic equipment
with a rectangular image receptor manufactured on or after June 10, 2006, the
following applies:
(i) 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 three per cent of
the SID. The sum of the excess length and the excess width shall be no greater
than four per cent of the SID; and
(ii) 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) If the fluoroscopic x-ray field size is
adjusted automatically as the SID or image receptor size is changed, a
capability may be provided for overriding the automatic adjustment in case of
system failure. If it is so provided, a signal visible at the operator's
position shall indicate whenever the automatic field adjustment is overridden.
Each such system failure override switch shall be clearly labeled as follows:
"For X-ray Field Limitation System Failure;"
(e) Beam-limiting devices shall be provided
with a means for stepless adjustment of the x-ray field; and
(f) Stepless adjustment shall, at the
greatest SID, provide continuous field sizes from the maximum obtainable to a
field size of five centimeters by five centimeters or less;
(6) Timers shall meet the
following specifications:
(a) A means shall be
provided to preset the cumulative on-time timer of the fluoroscopic tube. The
maximum cumulative time of the timer shall not exceed five minutes without
resetting;
(b) The timer shall terminate the exposure or
emit a signal audible to the operator when the exposure time reaches a maximum
of five minutes. The signal shall continue to sound while x-rays are produced
until the timer is reset;
(c) For
x-ray controls manufactured on or after June 10, 2006, there shall be provided
for each fluoroscopic tube:
(i) A display of
the fluoroscopic irradiation time at the operator's working position. This
display shall function independently of the audible signal described in
paragraph (A)(6)(c)(ii) of this rule. The following requirements apply:
(a) 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;
(b) The fluoroscopic irradiation time shall
also be displayed within six seconds of termination of an exposure and remain
displayed until reset; and
(c)
Means shall be provided to reset the display to zero prior to the beginning of
a new examination or procedure;
(ii) A signal audible to the operator 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;
(7) X-ray production in
the fluoroscopic mode shall be controlled by a device which requires continuous
pressure by the operator for the entire time of any exposure. When recording
serial fluoroscopic images, the operator shall be able to terminate the x-ray
exposure at any time, but means may be provided to permit completion of any
single exposure of the series in progress;
(8) Fluoroscopic systems shall meet the
following air kerma rate limits:
(a)
Fluoroscopic equipment provided with only automatic exposure rate control, or
provided with both automatic exposure rate control and manual mode
capabilities, shall not exceed an air kerma rate of eighty-eight milligray per
minute (ten roentgens per minute exposure rate) in either mode at any
combination of tube potential and current, at the measurement point specified in paragraph (C)(6) of this rule;
(b) Fluoroscopic equipment provided with only
manual mode capabilities shall not exceed an air kerma rate of forty-four
milligray per minute (five roentgens per minute exposure rate) at any
combination of tube potential and current, at the measurement point specified in paragraph (C)(6) of this rule;
and
(c) For fluoroscopic equipment
that is provided with high-level control, and the high-level control is
activated, the air kerma rate shall not exceed one hundred seventy-six
milligray per minute (twenty roentgens per minute exposure rate) at any
combination of tube potential and current, at the measurement point specified in paragraph (C)(6) of this rule;
(i) For all fluoroscopy equipment that is
provided with high-level control, special means of activation of high level
control, such as manual pressure applied continuously by the operator, shall be
required to avoid accidental use; and
(ii) A continuous signal audible to the
operator shall indicate that high level control is being employed;
(9) During fluoroscopy
and cinefluorography the x-ray tube potential and current shall be continuously
indicated;
(10) For
undertable fluoroscopic equipment, a shielding device of at least 0.25
millimeter lead equivalent shall cover the bucky-slot;
(11) For undertable fluoroscopic equipment,
protective drapes, or other devices, at least 0.25 millimeter lead equivalent
shall be provided between the patient and the individual operating the
fluoroscopic equipment to intercept scattered radiation which would otherwise
reach the fluoroscopist and others near the x-ray unit, except when such drapes
or other devices would compromise the sterile field. Such devices shall not
substitute for wearing required protective apparel;
(12) Radiography using the fluoroscopic
imaging assembly shall meet the following specifications:
(a) A means shall be provided between the
source and the patient which will automatically limit the x-ray field at the
time the exposure is initiated to no more than the portion of the image
receptor selected by the operator for spot films or
radiographic images. If the x-ray field size is less than the size of the
selected portion of the image receptor, the field size shall not open
automatically to the size of the selected portion of the image receptor unless
the operator has selected such a mode of operation;
(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 three per cent of the SID when adjusted for full coverage of the selected
portion of the image selector;
(c)
The center of the x-ray field in the plane of the image receptor shall be
aligned with the center of the selected portion of the image receptor to within
two per cent of the SID; and
(d)
Means shall be provided to reduce the x-ray field size in the plane of the
image receptor to a size smaller than the selected portion of the image
receptor. The minimum field size at the greatest SID shall not exceed five
centimeters by five centimeters;
(13) Fluoroscopic equipment manufactured on
or after June 10, 2006, shall display at the operator's working position the
air kerma rate (AKR) and cumulative air kerma in accordance with the following
requirements:
(a) When the x-ray tube is
activated and the number of images produced per unit time is greater than six
images per second, the AKR in milligrays per minute shall be continuously
displayed and updated at least once every second;
(b) The cumulative air kerma in units of
milligrays shall be displayed either within five seconds of termination of an
exposure or displayed continuously and updated at least once every five
seconds;
(c) The
display of the AKR shall be clearly distinguishable from the display of the
cumulative air kerma;
(d) The
AKR and cumulative air kerma shall represent the value for conditions of
free-in-air irradiation at one of the following reference locations specified
according to the type of fluoroscope;
(i) For
fluoroscopes with x-ray source below the x-ray table, x-ray source above the
table, or of lateral type, the reference location shall be the respective
locations specified in paragraph (C)(6)(a), (C)(6)(b) or (C)(6)(d) of this
rule;
or
(ii) For C-arm
fluoroscopes, the reference location shall be fifteen centimeters from the
isocenter toward the x-ray source along the beam axis. Alternatively, the
reference location shall be at a point specified by the manufacturer to
represent the location of the intersection of the x-ray beam with the patient's
skin;
(e) Means shall be provided to reset to zero
the display of cumulative air kerma prior to the commencement of a new
examination or procedure; and
(f)
The displayed AKR and cumulative air kerma shall not deviate from the actual
values by more than plus or minus thirty-five per cent;
(14)
Fluoroscopic equipment manufactured on or after June 10,
2006 shall be equipped with means to display a last image hold (LIH) image
following termination of the fluoroscopic exposure:
(a)
For a LIH image
obtained by retaining pre-termination fluoroscopic images, if the number of
images and method of combining images are selectable by the user, the selection
shall be indicated prior to initiation of the fluoroscopic
exposure;
(b)
For a LIH image obtained by initiating a separate
radiographic exposure at termination of the fluoroscopic imaging, the technique
factors for the LIH image shall be selectable prior to the fluoroscopic
exposure, and the combination selected shall be indicated prior to initiation
of the fluoroscopic exposure; and
(c)
Means shall be
provided to clearly indicate to the user whether a displayed image is the LIH
radiograph or fluoroscopy. Display of the LIH radiograph shall be replaced by
the fluoroscopic image concurrently with re-initiation of the fluoroscopic
exposure unless separate displays are provided.
(B) In addition to other
applicable radiation safety rules adopted pursuant to Chapter 3748. of the
Revised Code, handlers of fluoroscopic radiation-generating equipment shall
comply with the following:
(1) Any individual
who is in the room during the fluoroscopic procedure shall be adequately
protected by standing behind a whole body protective barrier or shall be
required to wear a protective lead apron of not less than 0.25 millimeter lead
equivalent;
(2)
Protective lead or lead equivalent gloves shall be used by individuals who are
required to have their hands in or near the useful beam; and
(3) Handlers of
fluoroscopic equipment used for interventional or cardiac procedures or on
pediatric or pregnant patients shall maintain a record of:
(a) Cumulative air kerma or dose area product
used for each examination, if the display of either is available on the
fluoroscopic equipment; or
(b) The
following items if the cumulative air kerma or dose area product is not
displayed on the fluoroscopic equipment:
(i)
Mode of operation such as high-level or pulsed mode;
(ii) Cumulative fluoroscopic exposure time;
and
(iii) Number of radiographs and
number of acquisitions.
(C) In addition to other applicable quality
assurance requirements of Chapter 3701:1-66 of the Administrative Code,
handlers of fluoroscopic equipment shall comply with the following:
(1) Handlers shall designate and utilize a
radiation expert who shall develop in writing and perform fluoroscopic image
quality evaluations appropriate for the fluoroscopic equipment including
written procedures to include time intervals and system conditions for the
evaluation of image quality;
(2) On
new installations or reinstallations of existing equipment prior to patient
exposure, handlers shall utilize a radiation expert to perform the following:
(a) Radiographic device tests to determine
compliance with allowable limits as specified in paragraph (A)(12) of this
rule;
(b) Fluoroscopic image
quality evaluations as specified in paragraph (C)(1) of this rule;
(c) Air kerma rate tests as specified in
paragraph (C)(6) of this rule;
(d)
High contrast and low contrast resolution evaluations
in both fluoroscopic and radiographic modes;
(e)
Five minute timer
evaluations; and
(f)
Evaluation of the accuracy of technique factor
indicators and integrated radiation dose displays;
(3) After initial evaluations of fluoroscopic
equipment have been performed, the test and evaluations in paragraph (C)(2) of
this rule shall be performed by a radiation expert annually
;
(4) After repair or replacement of any
component of the fluoroscopic equipment which may alter the radiation output or
image quality, prior to patient use, a radiation expert shall perform and
document measurements of air kerma rates as specified in paragraph (C)(6) of
this rule and image quality as specified in paragraph (C)(1) of this rule
unless in the documented determination of a radiation expert, the repair or
replacement will not cause a significant change in radiation output or
significant degradation of image quality as specified in the quality assurance
program;
(a) The radiation expert may designate
qualified individuals to perform and document the measurements specified in
paragraphs (C)(6) and (C)(1) of this rule;
(b) The radiation expert shall provide the
criteria for qualifying these designees in the quality assurance program;
and
(c) The radiation expert's
approval of the designee's test results shall be
documented within thirty days;
(5) The results of all tests performed in
accordance with paragraphs (C)(2) to (C)(4) of this rule shall:
(a) Include the technique factors used in
determining such results;
(b)
Include the name of the individual performing the measurements;
(c) Include the date the measurements were
performed; and
(d) Be maintained by
the IRRP between inspections for review by the department;
(6) Compliance with air kerma rate
allowable limits in paragraph (A)(8) of this rule shall be determined as
follows:
(a) If the source is below the x-ray
table, the air kerma rate shall be measured at one centimeter above the
tabletop or cradle;
(b) If
the source is above the x-ray table, the air kerma rate shall be measured at
thirty 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 c-arm type fluoroscopic equipment,
the air kerma rate shall be measured at thirty centimeters from the input
surface of the image receptor with the source positioned at any SID;
(d) For fixed SID lateral fluoroscopes
attached to the x-ray table, the maximum air kerma rate shall be measured at a
point fifteen 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
table top is moveable, 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 fifteen centimeters to the centerline of the table;
(e) For c-arm type fluoroscopic equipment
having a SID less than forty-five centimeters, the air kerma rate shall be
determined at the minimum SSD; and
(f)
The maximum air kerma rate shall be determined with the kVp, mA and/ or other
selectable parameters adjusted to those settings which give the maximum air
kerma rate. X-ray systems that incorporate automatic exposure control shall
have sufficient attenuative material placed in the useful beam to produce the
maximum exposure rate of the system.
(D) Handlers of mobile fluoroscopic equipment
shall not be required to comply with the requirements of paragraphs (A)(10),
and (A)(11) of this rule and paragraph (H) of rule
3701:1-66-02
of the Administrative Code.
(E)
Handlers of c-arm fluoroscopic equipment having a maximum SID less than
forty-five centimeters shall not be required to comply with the requirements of
paragraphs (A) (5)(e), (A)(5)(f), (A)(10), (A)(11), and (A)(12) of this rule
and paragraph (H) of rule
3701:1-66-02
of the Administrative Code. In addition, if a radiation expert has specified in
the registrant's quality assurance program that an individual is unlikely to
receive a total effective dose equivalent of greater than two millirem in any
one hour or one hundred millirem in a year, the handler shall not be required
to comply with the requirements of paragraph (B)(1) of this rule.
(F) All individuals operating fluoroscopic
equipment, and individuals likely to receive an annual effective dose
equivalent in excess of one millisievert (one hundred millirem) from
participating in fluoroscopic procedures, shall receive at least two hours of
radiation protection training specific to fluoroscopy in addition to the
training required by rule
3701:1-38-10
of the Administrative Code prior to performing or participating in fluoroscopic
procedures. Additionally, each individual shall receive one hour of re-training
whenever the individual receives in excess of thirty per cent of the allowable
occupational dose measured over one calendar year.
(G) The training required by paragraph (F) of
this rule shall be approved by the registrant's designated radiation expert,
and be specific to the type of fluoroscopic equipment used. Documentation of
receiving the training required by paragraph (F) of this rule shall be retained
by the registrant and be available for review upon inspection. At a minimum,
training topics shall include, but not be limited to:
(1) Principles and operation of the
fluoroscopic equipment to be used;
(2) Fluoroscopic and
radiographic outputs of each mode of
operation, including high level control options
clinically used;
(3) Dose management,
including dose reduction techniques for fluoroscopic equipment;
(4)
Safe operating procedures of
each piece of fluoroscopic equipment that may be used by each
individual.
(5)
Units of measurement and dose, including dose-area
product values and air kerma;
(6)
Radiation
protection methods for patient and staff;
(7)
Basic properties
of radiation; and
(8)
Biological effects of radiation.
(H) Fluoroscopic equipment used
for radiation therapy procedures is regulated pursuant to rule
3701:1-67-09
of the Administrative Code.
(I)
Computed tomography scanners equipped with fluoroscopic capabilities are
regulated pursuant to rule
3701:1-66-10
of the Administrative Code.