D.C. Mun. Regs. tit. 22, r. 22-B10855

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10855 - FLUOROSCOPIC EQUIPMENT

10855.1

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.

10855.2

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. 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 image receptor shall not exceed 3.34 x 10<-3> percent of the entrance AKR, at a distance of ten centimeters (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 and the manufacturer sets forth instructions for assemblers with respect to control location as part of the information required in § 10853.14. Additionally, the manufacturer shall provide to users, under § 10853.15(a)(1), precautions concerning the importance of remote control operation.

10855.3

The AKR shall be measured in accordance with § 10855.12. 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 one hundred square centimeters (100 cm²) with no linear dimension greater than twenty centimeters (20 cm). If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned thirty centimeters (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 thirty centimeters (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 ten centimeters (10 cm) from the point of measurement of entrance AKR and between this point and the input surface of the fluoroscopic imaging assembly.

10855.4

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 § 10855.7 through 10855.9 shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.

10855.5

Means shall be provided to permit further limitation of the x-ray field to sizes smaller than the limits of § 10855.7 through 10855.9. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID or the capability of a visible area of greater than three hundred square centimeters (300 cm²), 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 three hundred square centimeters (300 cm²) 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 one hundred twenty five square centimeters (125 cm²) 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 centimeters by five centimeters (5 cm x 5 cm). This paragraph does not apply to non-image-intensified fluoroscopy.

10855.6

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 centimeters by five centimeters (5 cm x 5 cm).

10855.7

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

(a) 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 percent (3%) of the SID. The sum of the excess length and the excess width shall be no greater than four percent (4%) of the SID; and

(b) 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.

10855.8

For fluoroscopic equipment manufactured on or after June 10, 2006, other than radiation therapy simulation systems, the maximum area of the x-ray field in the plane of the image receptor shall conform with one (1) of the following requirements:

(a) 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 (34 cm) in any direction, at least eighty percent (80%) of the area of the x-ray field overlaps the visible area of the image receptor; or

(b) 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 (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 centimeters (2 cm).

10855.9

For x-ray systems manufactured on or after June 10, 2006, the following applies:

(b) 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.

10855.10

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".

10855.11

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 radiographic images from the fluoroscopic image receptor, the operator 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.

10855.12

For fluoroscopic equipment, the following requirements apply:

(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 eighty-eight milligray (88 mGy) per minute (vice ten roentgen per minute (10 R/min.) exposure rate) at the measurement point specified in § 10855.15, except as specified in § 10855.12(e);

(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 forty four milligray (44 mGy) per minute (vice five roentgen per minute (5 R/min.) exposure rate) at the measurement point specified in § 10855.15, except as specified in § 10855.12(e);

(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 eighty-eight milligray (88 mGy) per minute (vice ten roentgen per minute (10 R/min.) exposure rate) in either mode at the measurement point specified in § 10855.15, except as specified in § 10855.12(e);

(d) Equipment may be modified in accordance with § 10853.31 to comply with § 10855.13. When the equipment is modified, it shall bear a label indicating the date of the modification and the statement:

"Modified to comply with 22 DCMR B § 10855.23 ".

(e) Exceptions to the § 10855.12 requirements for fluoroscopic equipment are as follows:

(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 the rates specified in § 10855.12(a), (b), or (c) at the measurement point specified in § 10855.15, 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.

10855.13

Fluoroscopic equipment manufactured on or after May 19, 1995:

(a) Shall be equipped with AERC if operable at any combination of tube potential and current that results in an AKR greater than forty-four milligray (44 mGy) per minute (vice five roentgen per minute (5 R/min.) exposure rate) at the measurement point specified in § 10855.15. Provision for manual selection of technique factors may be provided; and

(b) Shall not be operable at any combination of tube potential and current that will result in an AKR in excess of eighty-eight milligray (88 mGy) per minute (vice ten roentgen per minute (10 R/min.) exposure rate) at the measurement point specified in § 10855.15, except as specified in § 10855.14.

10855.14

Exceptions to the § 10855 requirements for fluoroscopic equipment are as follows:

(a) 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;

(b) 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; and

(c) 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 one hundred seventy-six milligray (176 mGy) per minute (vice twenty roentgen per minute (20 R/min.) exposure rate) at the measurement point specified in § 10855.15. 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.

10855.15

Compliance with § 10855.12 shall be determined as follows:

(a) If the source is below the x-ray table, the AKR shall be measured at one centimeter (1 cm) above the tabletop or cradle;

(b) If the source is above the x-ray table, the AKR shall be measured at thirty centimeters (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 thirty centimeter (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 thirty centimeters (30 cm) from the input surface of the fluoroscopic imaging assembly;

(d) In a C-arm type of fluoroscope having an SID less than forty-five centimeters (45 cm), the AKR shall be measured at the minimum SSD; and

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

10855.16

Fluoroscopic radiation therapy simulation systems are exempt from the requirements set forth in § 10855.12.

10855.17

RESERVED

10855.18

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 values shall not exceed the maximum deviation as stated by the manufacturer in accordance with § 10853.17.

10855.19

Means shall be provided to limit the source-skin distance to not less than thirty-eight centimeters (38 cm) on stationary fluoroscopes and to not less than thirty centimeters (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 section, provisions may be made for operation at shorter source-skin distances but in no case less than twenty centimeters (20 cm). When provided, the manufacturer must set forth precautions with respect to the optional means of spacing, in addition to other information as required in § 10853.15.

10855.20

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 forty-five centimeters (45 cm), means shall be provided to limit the source-skin distance to not less than nineteen centimeters (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 distances specified in this subsection, provisions may be made for operation at shorter source-skin distances but in no case less than ten centimeters (10 cm). When provided, the manufacturer must set forth precautions with respect to the optional means of spacing, in addition to other information as required in § 10853.17.

10855.21

Fluoroscopic equipment manufactured before June 10, 2006, 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 (5) 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 § 10853.31 and 10853.32 to comply with the requirements of § 10853.23. When the equipment is modified, it shall bear a label indicating the statement:

"Modified to comply with 22 DCMR B § 10853.23 ".

10855.22

As an alternative to the requirements of this section, 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.

10855.23

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 § 10855.24. 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 (6) seconds;

(2) The fluoroscopic irradiation time shall also be displayed within six (6) seconds of termination of an exposure and remain displayed until reset; and

(3) Means shall be provided to reset the display to zero (0) prior to the beginning of a new examination or procedure.

10855.24

A signal audible to the fluoroscopist shall sound for each passage of five (5) 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 (2) seconds.

10855.25

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

10855.26

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

10855.27

For an 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.

10855.28

For an LIH image obtained by initiating a separate radiographic-like exposure at the termination of fluoroscopic imaging, the techniques 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.

10855.29

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.

10855.30

The predetermined or selectable options for producing the LIH radiograph shall be described in the information required by § 10853.17. The information shall include a description of any technique factors applicable for the selected option and the impact of the selectable options on image characteristics and the magnitude of radiation emissions.

10855.31

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:

(a) When the x-ray tube is activated and the number of images produced per unit time is greater than six (6) images per second, the AKR in milligram per minute shall be continuously displayed and updated at least once every second;

(b) The cumulative air kerma in units of milligram shall be displayed either within five (5) seconds of termination of an exposure or displayed continuously and updated at least once every five (5) seconds;

(c) The display of the AKR shall be clearly distinguishable from the display of the cumulative air kerma; and

(d) The AKR and cumulative air kerma shall represent the value for conditions of free-in-air irradiation at one (1) of the following reference locations specified according to the type of fluoroscope. The reference location shall be identified and described specifically in the information provided to users according to § 10853.20(c).

10855.32

For fluoroscopes with x-ray source below the x-ray table, x-ray source above the table, or of lateral type, the reference locations shall be the respective locations specified in § 10855.15(a), (b), or (e) for measuring compliance with air kerma rate limits.

10855.33

For C-arm fluoroscopes, the reference location shall be fifteen centimeters (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.

10855.34

Means shall be provided to reset to zero (0) the display of cumulative air kerma prior to the commencement of a new examination or procedure.

10855.35

The displayed AKR and cumulative air kerma shall not deviate from the actual values by more than plus or minus thirty-five percent (35%) over the range of six milligray per minute (6 mGy/min.) and one hundred milligray (100 mGy) to the maximum indication of AKR and cumulative air kerma, respectively. Compliance shall be determined with an irradiation time greater than three (3) seconds.

D.C. Mun. Regs. tit. 22, r. 22-B10855

Final Rulemaking published at 60 DCR 10252 (July 12, 2013)

Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor's Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor's Order 98-88, dated May 29, 1998.