Section 0400-20-06-.06 - VETERINARY X-RAY INSTALLATIONS(1) General requirements.(a) Equipment 1. The primary beam for diagnostic purposes in radiography and fluoroscopy shall not be larger than clinically necessary. Cones, diaphragms, or adjustable collimators capable of restricting the primary beam to the area of clinical interest shall be used and shall provide the same degree of protection as is required in the tube housing. See parts (2)(a)1. and 13. and (2)(c)2. and 7. of Rule 0400-20-06-.05 for minimum acceptable criteria for cones, diaphragms, or adjustable collimators.2. Filtration (i) The aluminum equivalent of the total filtration (inherent plus added), permanently in the useful beam shall not be less than that shown in Table RHS 3-1.(ii) If the thickness of the filter in the x-ray apparatus cannot be determined visually or the total filtration is unknown, it may be assumed that the requirements of subpart (i) of this part are met if the half-value layer is not less than that shown in Table RHS 3-2.3. The x-ray tube housing shall be of diagnostic type.4. The effectiveness of protective equipment shall not be impaired.5. A timer shall be provided that will terminate the exposure after a preset time.6. The exposure switch shall be of a dead-man type.7. If the operator is required to be in the room during exposures, the registrant shall require the operator to stand at least 2 meters from the animal for all exposures and outside the primary beam.8. Hand or head held fluoroscopic screens shall not be used.(b) Operation of equipment1. Animal or film holding.(i) Except where clinically contraindicated restraining devices or mechanical supporting devices shall be used.(ii) No individual under 18 years of age and no pregnant women will be used.(iii) No individual shall be used on a consistent or routine basis.(iv) Protective gloves and aprons with at least 0.25 millimeter of lead equivalency shall be provided and their use required of each individual used for this purpose.(v) No part of the body of the individual utilized, for this purpose shall be in the primary beam unless protected by 0.5 millimeter lead equivalent material.(vi) If occupationally exposed persons are utilized their exposure shall be monitored with the monitoring device place on the collar outside the leaded apron.(vii) A record shall be maintained listing the name of the individual holding the film or animal and shall include the date of the examination and it shall be possible to determine the procedure for which the animal or film was held.(2) Specific requirements (a) The following requirements apply to any veterinary intraoral dental radiographic equipment designed to be operated as a hand-held device:71. The registrant shall provide and require individual personnel monitoring of external occupational dose via a whole body dosimeter and extremity dosimeters for both the right and left hands to all persons who may operate the hand-held device. The registrant may be relieved of the requirement of this subpart after one year of personnel monitoring if the results of the personnel monitoring demonstrate that the operator of the hand-held device is not likely to receive a dose in excess of 10 percent of the limits in Rule 0400-20-05-.50, as outlined in Rule 0400-20-05-.71. The registrant shall maintain records of doses received by all individuals for whom monitoring was required pursuant to Rule 0400-20-05-.71 and 0400-20-05-.135.2. Registrants shall implement security and accountability procedures to prevent unauthorized use, misuse, or unauthorized removal of the hand-held device from its storage location. Immediately after learning of an incident of unauthorized use, misuse, or unauthorized removal from its storage location, a registrant shall report the incident to the Division at the contact point identified in part (3)(a)1. of Rule 0400-20-05-.141. The registrant shall maintain records of the security and accountability procedures described in this part. Said records shall be made available for review by the Division.3. The registrant shall ensure that: (i) The operator prevents bystanders within a radius of at least six feet from the patient being examined with the hand-held device; and(ii) Hand-held intraoral dental radiographic devices are not used for patient examinations in areas not designated as examination areas.4. The registrant shall incorporate specific information regarding hand-held devices into any initial and recurring training provided to the facility staff. The training shall contain, at a minimum, the following: (i) Training on the proper operation of the hand-held device;(ii) The requirements listed in parts 1. through 3. of this subparagraph; and(iii) Instructions provided by the manufacturer in regard to equipment with unique features as required under 21 CFR 1020.30(h)(1)(i).85. The registrant shall maintain records of the initial and recurring training provided to the facility staff described in part 4. of this subparagraph. Training records shall be made available for review by the Division and include:(i) The date the training was provided;(ii) The name of each individual trained (printed) and their signature;(iii) The name and dated signature of the individual providing the training;(iv) The topics covered in the training (or an attachment of the training material); and(v) The duration of the training.(b) Fluoroscopic installations1. Target to tabletop distance shall not be less than 30.5 centimeters.2. Equipment installed or reinstalled after July 1, 1972, shall be so constructed that the entire cross-section of the useful beam is attenuated by a primary barrier permanently incorporated into the equipment. The tube mounting and the barrier shall be so linked together that the barrier always intercepts the beam. This barrier is usually the viewing device, either a conventional fluoroscopic screen or an image intensification mechanism.3. The required lead equivalent of the primary barrier shall be at least 1.5 millimeters for 100 kVp, 1.8 millimeters for 125 kVp, and 2.0 millimeters for 150 kVp.4. Collimators shall be provided to restrict the size of the useful beam to less than the area of the primary barrier. For conventional fluoroscopes, this requirement is met if, when the adjustable diaphragm is opened to its fullest extent, an unilluminated margin is left on the fluorescent screen with the screen properly5. For fluoroscopy, the radiation exposure as measured at the minimum target to skin distance shall be as low as practicable and shall not exceed 10 roentgens per minute except when clinically indicated.6. The registrant shall provide and require the use of a curtain of 0.25 millimeter lead equivalent that will hang from the screen and between the animal and fluoroscopist in both horizontal and vertical fluoroscopy, but it shall not substitute for the wearing of a protective apron.7. The registrant shall provide protective aprons, and shall require their use by the veterinarian, assistant and for all other persons within the fluoroscopic room.8. The registrant shall provide protective gloves, and shall require their use by the fluoroscopist during any examination in which the fluoroscopist may be required to approach the primary beam with his hand or hands.9. Conventional fluoroscopic screens shall not be used with mobile fluoroscopic equipment. Image intensification shall always be provided, and in the absence of a table top or panel, a cone or spacer frame shall limit the target to skin distance to not less than 30.5 centimeters.10. A shielding device of at least 0.25 millimeter lead equivalent for covering the bucky slot during fluoroscopy shall be provided. 7 This part is intended to apply to intraoral radiographic units that are hand-held. Any unit designed to be hand-held but operated as a fixed unit shall be subject to the requirements outlined in paragraph (3) of Rule 0400-20-06-.05.
8 "A unit that is hand-held constitutes a unique feature that requires manufacturers to describe any safety procedures and precautions necessary to reduce operator exposure." (See Guidance for Industry and FDA Staff - Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use, December 24, 2008, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Diagnostic Devices Branch, Division of Mammography Quality and Radiation Programs, Office of Communication, Education, and Radiation Programs) centered in the beam at a distance of 38 centimeters from the panel or tabletop. For image intensifiers, the useful beam shall be centered on the input phosphor and during fluoroscopy or cine-recording it should not exceed the diameter of the input phosphor.
Tenn. Comp. R. & Regs. 0400-20-06-.06
Original rule filed February 22, 2012; effective May 22, 2012. Amendments filed September 10, 2019; effective 12/9/2019.Authority: T.C.A. §§ 4-5-201, et seq. and 68-202-101, et seq.