Section 1611. Fluoroscopic equipment

A. The provisions of this section apply to equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, except computed tomography x-ray systems manufactured on or after November 29, 1984.

B. Primary protective barrier.

1. Limitation of useful beam. The fluoroscopic imaging assembly shall be provided with a primary protective barrier that intercepts the entire cross section of the useful beam at any SID. The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in position to intercept the entire useful beam. The AKR due to transmission through the barrier with the attenuation block in the useful beam combined with radiation from the fluoroscopic imaging receptor shall not exceed 3.34x10^-3% of the entrance AKR, at a distance of 10 cm from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor. Radiation therapy simulation systems shall be exempt from this requirement provided the systems are intended only for remote control operation.

2. Measuring compliance. The AKR shall be measured in accordance with subsection E of this section. The AKR due to transmission through the primary barrier combined with radiation from the fluoroscopic image receptor shall be determined by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm. If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 cm above the tabletop. 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 cm. Movable grids and compression devices shall be removed from the useful beam during the measurement. For all measurements, the attenuation block shall be positioned in the useful beam 10 cm from the point of measurement of entrance AKR and between this point and the input surface of the fluoroscopic imaging assembly.

C. Field limitation.

1. Angulation. For fluoroscopic equipment manufactured after February 25, 1978, when the angle between the image receptor and the beam axis of the x-ray beam 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. Compliance with subdivisions 4 and 5 of this subsection shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.

2. Further means for limitation. Means shall be provided to permit further limitation of the x-ray field to sizes smaller than the limits of subdivisions 4 and 5 of this subsection. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID or capability of a visible area of greater than 300 square cm, shall be provided with means for stepless adjustment of the x-ray field. Equipment with a fixed SID and the capability of a visible area of no greater than 300 square cm shall be provided with either stepless adjustment of the x-ray field or with a means to further limit the x-ray field size at the plane of the image receptor to 125 square cm or less. Stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size containable in a square of five cm by five cm. This paragraph does not apply to non-image-intensified fluoroscopy.

3. Non-image-intensified fluoroscopy. The x-ray field produced by non-image-intensified fluoroscopic equipment shall not extend beyond the entire visible area of the image receptor. Means shall be provided for stepless adjustment of field size. The minimum field size, at the greatest SID, shall be containable in a square of five cm by five cm.

4. Fluoroscopy and radiography using the fluoroscopic imaging assembly with inherently circular image receptors.

a. For fluoroscopic equipment manufactured before June 10, 2006, other than radiation therapy simulation systems, the following applies:

(1) Neither the length nor 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 3.0% of the SID. The sum of the excess length and the excess width shall be no greater than 4.0% of the SID.

(2) 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 that pass through the center of the visible area of the image receptor.

b. 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.

5. Fluoroscopy and radiography using fluoroscopic imaging assembly with inherently rectangular image receptors. For x-ray systems manufactured on or after June 10, 2006, the following applies:

a. Neither the length nor 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 3.0% of the SID. The sum of the excess length and the excess width shall be no greater than 4.0% of the SID.

b. The error in alignment shall be determined along the length and width dimensions of the x-ray field that pass through the center of the visible area of the image receptor.

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 fluoroscopist'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"

D. Activation of tube. X-ray production in the fluoroscopic mode shall be controlled by a device that requires continuous pressure by the operator for the entire time of any exposure. When recording serial radiographic images from the fluoroscopic image receptor, the operator shall be able to terminate the x-ray exposure or exposures at any time, but means may be provided to permit completion of any single exposure of the series in process.

E. Air kerma rates. For fluoroscopic equipment, the following requirements apply:

1. Fluoroscopic equipment manufactured before May 19, 1995.

a. Equipment provided with automatic exposure rate control (AERC) 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 (10 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection, except as specified in subdivision 1 e of this subsection.

b. Equipment provided without AERC shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 44 mGy per minute (5 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection, except as specified in subdivision 1 e of this subsection.

c. Equipment provided with both an AERC mode and a manual mode 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 (10 R/min exposure rate) in either mode at the measurement point specified in subdivision 3 of this subsection, except as specified in subdivision 1 e of this subsection.

d. Equipment may be modified in accordance with this part to comply with subdivision 2 of this subsection. When the equipment is modified, it shall bear a label indicating the date of the modification and the statement:

"Modified to comply with 21 CFR 1020.32(h)(2)"

e. Exceptions:

(1) During recording of fluoroscopic images; or

(2) When a mode of operation has an optional high-level control, in which case that mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of any of the rates specified in subdivisions 1 a, b, and c of this subsection at the measurement point specified in subdivision 3 of this subsection, unless the high-level control is activated. 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 being employed.

2. Fluoroscopic equipment manufactured on or after May 19, 1995.

a. Equipment shall be equipped with AERC if operable at any combination of tube potential and current that results in an AKR greater than 44 mGy per minute (5 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection. Provision or manual selection of technique factors may be provided.

b. Equipment 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 (10 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection, except as specified in subdivision 2 c of this subsection.

c. Exceptions:

(1) For equipment manufactured prior to June 10, 2006, during the recording of images from the 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 or images 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 subdivision 3 of this subsection. 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. Measuring compliance. Compliance with this subsection shall be determined as follows:

a. If the source is below the x-ray table, the AKR shall be measured at one cm above the tabletop or cradle.

b. If the source is above the x-ray table, the AKR shall be measured at 30 cm above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.

c. In a C-arm type of fluoroscope, the AKR shall be measured at 30 cm 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 cm from the input surface of the fluoroscopic imaging assembly.

d. In a C-arm type of fluoroscope having an SID less than 45 cm, the AKR shall be measured at the minimum SSD.

e. In a lateral type of fluoroscope, the air kerma rate shall be measured at a point 15 cm 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 cm to the centerline of the x-ray table.

4. Exemptions. Fluoroscopic radiation therapy simulation systems are exempt from the requirements set forth in this subsection when used for therapy simulation purposes.

F. (Reserved.)

G. Indication of potential and current. During fluoroscopy and cinefluorography, x-ray tube potential and current shall be continuously indicated. Deviation of x-ray tube potential and current from the indicated value shall not exceed the maximum deviation as stated by the manufacturer.

H. Source-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 this subsection, 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 this subsection, provisions may be made for operation at shorter source-skin distances but in no case less than 10 cm.

I. Fluoroscopic irradiation time, display, and signal.

1. Fluoroscopic equipment manufactured before June 10, 2006.

a. Equipment shall be provided with means to preset the cumulative irradiation time of the fluoroscopic tube. The maximum cumulative time of the timing device shall not exceed five minutes without resetting. A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative irradiation time. Such signal shall continue to sound while x-rays are produced until the timing device is reset. Fluoroscopic equipment may be modified in accordance with 21 CFR 1020.30(q) to comply with the requirements of this subdivision. When the equipment is modified, it shall bear a label indicating the statement:

"Modified to comply with 21 CFR 1020.32(h)(2)"

b. As an alternative to the requirements of this subsection, radiation therapy simulation systems may be provided with a means to indicate the total cumulative exposure time during which x-rays were produced, and which is capable of being reset between x-ray examinations.

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 this subsection. 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.

J. Mobile and portable fluoroscopes. In addition to the other requirements of this subsection, mobile and portable fluoroscopes shall provide an image receptor incorporating more than a simple fluorescent screen.

K. Display of last-image-hold (LIH). Fluoroscopic equipment manufactured on or after June 10, 2006, shall be equipped with means to display LIH image following termination of the fluoroscopic exposure.

1. For an LIH image obtained by retaining pretermination 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.

2. For an LIH image obtained by initiating a separate radiographic-like exposure at the termination of 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.

3. 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 fluoroscopic exposure, unless separate displays are provided for the LIH radiograph and fluoroscopic images.

L. Displays of values of AKR and cumulative air kerma. Fluoroscopic equipment manufactured on or after June 10, 2006, shall display at the fluoroscopist's working position the AKR and cumulative air kerma. The following requirements apply for each x-ray tube used during an examination or procedure:

1. 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 mGy/min shall be continuously displayed and updated at least once every second.

2. The cumulative air kerma in units of mGy shall be displayed either within five seconds of termination of an exposure or displayed continuously and updated at least once every five seconds.

3. The display of the AKR shall be clearly distinguishable from the display of the cumulative air kerma.

4. 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.

a. 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 subdivision E 3 a or E 3 e of this section.

b. For C-arm fluoroscopes, the reference location shall be 15 cm 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.

5. Means shall be provided to reset to zero the display of cumulative air kerma prior to the commencement of a new examination or procedure.

6. The displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ±35% over the range of six mGy/min and 100 mGy to the maximum indication of AKR and cumulative air kerma, respectively. Compliance shall be determined with an irradiation time greater than three seconds.

M. 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 that originates from under the table. The attenuation required shall be not less than 0.25 mm 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 mm 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 12VAC5-481-1591 A 5.

3. The agency may grant exemptions to subdivision 2 of this subsection 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.

N. Operator qualifications. The facility shall ensure that only a licensed practitioner of the healing arts or a radiologic technologist or equivalent be allowed to operate fluoroscopic x-ray systems.

O. Equipment operation.

1. All imaging formed by the use of fluoroscopic x-ray systems shall be viewed, directly or indirectly, and interpreted by a licensed practitioner of the healing arts.

2. The operation of fluoroscopic x-ray systems by radiologic technologists or equivalent shall be performed under the direct supervision of a licensed practitioner of the healing arts.

3. Radiologic technology students shall not be allowed to operate fluoroscopic x-ray systems unless directly supervised by a licensed practitioner of the healing arts or radiologic technologist as specified in subsection N of this section.

4. Overhead fluoroscopy shall not be used as a positioning tool for general purpose radiographic examinations.

5. Facilities shall maintain a record of the cumulative fluoroscopic exposure time used and the number of fluorographic images recorded for each examination. This record shall include patient identification, type and date of examination, the fluoroscopic system used, and operator's name.

P. Surveys. Radiation safety and equipment performance surveys shall be performed annually on all fluoroscopic x-ray systems by or under the direct supervision of a private or state inspector who is physically present at the facility during the inspection in order to assure compliance with these regulations.

Historical Notes

Derived from Volume 31, Issue 24, eff. August 27, 2015.

Statutory Authority

§ 32.1-229 of the Code of Virginia.