216 R.I. Code R. 216-RICR-40-20-4.5

Current through October 15, 2024

Section 216-RICR-40-20-4.5 - Fluoroscopic Equipment

4.5.1Applicability

A. The provisions of § 4.5 of this Part apply to equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor. X-ray systems subject to § 4.5 of this Part shall also meet the requirements of § 4.4 of this Part.

B. Only image-intensified or direct-digital receptor fluoroscopic equipment shall be used for fluoroscopy.

4.5.2Primary Protective Barrier

A. Limitation of Useful Beam. 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 air kerma rate [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 3.34 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.

B. Measuring Compliance. The AKR shall be measured in accordance with §4.5.6 of this Part. 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.

4.5.3Equipment Operation

A. All fluoroscopic images shall be viewed, directly or indirectly, and interpreted by a licensed practitioner of the healing arts.

B. The operation of mobile or portable fluoroscopic X-ray systems, by radiologic technologists, for positioning purposes only, shall be performed under the direct supervision of a licensed practitioner of the healing arts who meets the requirements of §4.3.3(C) of this Part.

C. A medical resident or radiologic technology student in training shall not be allowed to operate fluoroscopic X-ray systems unless in the physical presence of a licensed practitioner of the healing arts and a radiologic technologist, as specified in §4.3.3(C) of this Part.

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

E. Operators shall be competent in the standard operating procedures of the unit in use, including the use of available dose-saving features, and the relative radiation output rates of the various modes of operation.

F. Procedure planning for fluoroscopic procedures on pregnant patients shall include feasible modifications to minimize the dose to the conceptus.

G. Procedure planning for fluoroscopic procedures on pediatric patients shall include feasible modifications to minimize dose.

H. The registrant shall use all methods available on the fluoroscopy system to monitor dose during a fluoroscopic procedure.

I. The facility shall establish a written policy regarding patient dose management in fluoroscopically guided procedures in conformance with the ACR-AAPM Technical Standard for Management of the Use of Radiation in Fluoroscopic Procedures (2021) incorporated above at §4.1.1(B) of this Part or NCRP Report 168 Radiation Dose Management for Fluoroscopically-Guided Interventional Medical Procedures incorporated above at §4.1.1(C) of this Part.

4.5.4Field Limitation

A. 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 §§4.5.4(C) and (D) of this Part shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.

B. Further Means for Limitation. Means shall be provided to permit further limitation of the X-ray field to sizes smaller than the limits of §§4.5.4(C) and (D) of this Part. Beam-limiting devices manufactured after May 22,1979 and incorporated in equipment with a variable SID and/or 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 (5 cm) by five centimeters (5 cm).

C. Fluoroscopy and Radiography Using the Fluoroscopic Imaging Assembly with Inherently Circular Image Receptors

1. For fluoroscopic equipment manufactured before June 10, 2006, other than radiation therapy simulation systems, 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 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.

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.

2. 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).

D. 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:

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 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.

2. 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.

E. Override Capability. 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.

4.5.5Activation of the Tube

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 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.

4.5.6Air Kerma Rates (AKR)

A. 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 eighty-eight (88) mGy per minute (ten (10) R/min) exposure rate at the measurement point specified in 21 C.F.R. § 1020.32(d)(3), except as specified in §4.5.6(A)(1)(e) of this Part.

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 (44) mGy per minute (five (5) R/min exposure rate) at the measurement point specified in 21 C.F.R. § 1020.32(d)(3), except as specified in §4.5.6(A)(1)(e) of this Part.

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 (88) mGy per minute (ten (10) R/min exposure rate) in either mode at the measurement point specified in 21 C.F.R. § 1020.32(d)(3), except as specified in §4.5.6(A)(1)(e) of this Part.

d. Equipment may be modified in accordance with §4.4.7(F) of this Part to comply with §4.5.6(A)(2) of this Part. When the equipment is modified, it shall bear a label indicating the date of the modification and the statement: MODIFIED TO COMPLY WITH 21 C.F.R. § 1020.32(H)(2).

e. Exceptions:

(1) During recording of fluoroscopic images.

2. 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 (44) mGy per minute (five (5) R/min exposure rate) at the measurement point specified in 21 C.F.R. § 1020.32(d)(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 eighty-eight (88) mGy per minute (ten (10) R/min exposure rate) at the measurement point specified in 21 C.F.R. § 1020.32(d)(3), except as specified in §4.5.6(A)(2)(c) of this Part.

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 lastimage-hold feature that are not recorded.

(3) Fluoroscopy equipment with optional high-level control. When high-level control is selected 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 (176) mGy per minute (twenty (20) R/min exposure rate) at the measurement point specified in 21 C.F.R. § 1020.32(d)(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 operator shall indicate that the high-level control is employed.

4.5.7Measurement of Entrance AKR

A. Compliance with §4.5.6 of this Part shall be determined as follows:

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

2. 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.

3. In a C-arm type of fluoroscope, the AKR shall be measured at thirty centimeters (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.

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

5. In a lateral type of fluoroscope, the AKR 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.

4.5.8Indication of Potential and Current

During fluoroscopy and cinefluorography, the 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.

4.5.9Source-Skin Distance

A. 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 paragraph, provisions may be made for operating at shorter source-skin distances but in no case less than twenty centimeters (20 cm).

B. 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 sourceskin distance specified in this paragraph, provisions may be made for operation at shorter source-skin distances but in no case less than ten centimeters (10 cm).

4.5.10Fluoroscopic Irradiation Time, Display and Signal

A. Fluoroscopic equipment manufactured before June 10, 2006:

1. 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 21 C.F.R. § 1020.30(q) to comply with the requirements of §4.5.10 of this Part. When the equipment is modified, it shall bear a label indicating the statement: MODIFIED TO COMPLY WITH 21 C.F.R. § 1020.32(h)(2).

B. For X-ray controls manufactured on or after June 10, 2006, there shall be provided for each fluoroscopic tube:

1. A display of the fluoroscopic irradiation time at the fluoroscopist's working position. This display shall function independently of the audible signal described §4.5.10(B)(2) of this Part. 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 (6) seconds.

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

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

2. 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.

4.5.11[RESERVED]

4.5.12Protection From Scattered Radiation

A. For stationary fluoroscopic systems, ancillary shielding, such as drapes, self supporting curtains, or viewing shields, shall be available and used as supplemental protection for all individuals other than the patient in the room during a fluoroscopy procedure.

B. Where sterile fields or special procedures prohibit the use of normal protective barriers or drapes, all of the following conditions shall be met:

1. Shielding required under §4.5.12(A) of this Part shall be maintained to the degree possible under the clinical conditions;

2. All persons, except the patient, in the room where fluoroscopy is performed shall wear protective garments that provide a lead equivalent shielding of at least twenty-five one hundredths of one millimeter (0.25 mm);

3. The fluoroscopic field size shall be reduced to the minimum required for the procedure being performed (area of clinical interest); and

4. Operating and safety procedures shall reflect the above conditions, and fluoroscopy personnel shall exhibit awareness of situations requiring the use and/or non-use of the protective drapes.

4.5.13Additional Requirements for Facilities Performing Fluoroscopically-Guided Interventional (FGI) Procedures

A. A registrant utilizing fluoroscopically-guided interventional (FGI) procedures shall establish a Radiation Protocol Committee (RPC) in accordance with the following:

1. The registrant may establish a system-wide committee if the registrant has more than one (1) site;

2. Two (2) or more registrants may form a cooperative RPC as long as each facility has a representative on the committee; and

3. If the registrant has already established a radiation safety committee, the requirements of §4.5.13(A) of this Part may be delegated to that committee if the members meet the requirements of §4.5.13(E) of this Part.

B. A quorum of the RPC shall meet as often as necessary, but at intervals not to exceed twelve (12) months.

C. A record of each RPC meeting shall include the date, names of individuals in attendance, minutes of the meeting, and any actions taken. The registrant shall maintain the record for inspection by the Agency for three (3) years.

D. The RPC shall provide an annual report to the radiation safety committee or radiation safety officer, in the absence of a radiation safety committee.

E. Members of the RPC shall include but not be limited to the following individuals:

1. A supervising physician of the healing arts who meets the requirements in § 4.3.3(C) of this Part;

2. A Qualified Medical Physicist;

3. The lead technologist; and

4. Other individuals as deemed necessary by the registrant.

F. The RPC shall establish and implement written FGI procedure protocols, or protocols documented in an electronic report system, that include but are not limited to the following:

1. Identification of individuals who are authorized to use fluoroscopic systems for interventional purposes;

2. A method to be used to monitor patient radiation dose during FGI;

3. Dose notification levels, as appropriate, at which the physician is notified, and appropriate actions are taken for patient safety;

4. Substantial radiation dose level (SRDL) values following nationally recognized standards;

5. Actions to be taken for cases when a SRDL is exceeded which may include patient follow-up; and

6. A review of the established protocols at an interval not to exceed twelve (12) months.

G. A record of each RPC protocol shall be maintained for inspection by the Agency. If the RPC revises a protocol, documentation shall be maintained that includes the justification for the revision and the previous protocol for inspection by the Agency.

H. A record of radiation output information shall be maintained, for three (3) years for inspection by the Agency so the radiation dose to the skin may be estimated in accordance with established protocols. The record shall include, but not be limited to, the following:

1. Patient identification;

2. Type and date of examination;

3. Identification of the fluoroscopic system used; and

4. Peak skin dose, cumulative air kerma or dose area product used if the information is available on the fluoroscopic system. If the peak skin dose, cumulative air kerma or dose area product are not displayed on the fluoroscopic system, records shall include other information necessary to estimate the radiation dose to the skin in accordance with established protocol or the following as necessary:

a. Fluoroscopic mode, such as, high-level or pulsed mode of operation;

b. Cumulative fluoroscopic exposure time; and

c. Number of films or recorded exposures.

4.5.14Radiation Therapy Simulation Systems

A. Radiation therapy simulation systems shall be exempt from the requirements of § 4.5.2(A) of this Part, provided such systems are intended only for remote control operation.

B. Radiation therapy simulation systems shall be exempt from all the requirements of §§4.5.4(C), 4.5.6, and 4.6.12(A)(2) of this Part when used for therapy simulation purposes.

C. As an alternative to the requirements of §4.5.10 of this Part, 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.

4.5.15Display of Last-Image-Hold (LIH)

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

B. 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.

C. 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.

D. 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.

4.5.16Displays of Values of Air Kerma Rate (AKR) and Cumulative Air Kerma

A. 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 (6) 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 (5) seconds of termination of an exposure or displayed continuously and updated at least once every five (5) 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 §§4.5.7(A)(1), (2) or (5) of this Part.

b. For C-arm fluoroscopes, the reference location shall be fifteen (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 (0) 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 ± thirty-five percent (± 35%) over the range of six (6) mGy/min and one hundred (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.

216 R.I. Code R. 216-RICR-40-20-4.5

Adopted effective 1/1/2019
Amended effective 5/25/2022
Amended effective 11/28/2023