DAR File No. 37867

Environmental Quality, Radiation Control

Section R313-28-80

Intraoral Dental Radiographic Systems

Notice of Proposed Rule

(Amendment)

DAR File No.: 37867
Filed: 07/30/2013 12:53:15 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The reason for the change is to allow registrants (owners of X-ray systems) the ability to acquire and use hand-held portable dental X-ray systems, without the need for an exemption.

Summary of the rule or change:

The change adds Subsection R313-28-80(12). The added subsection requires that hand-held portable dental X-ray systems be compliant with Section R313-28-31, excluding Subsection R313-28-31(5), and with Section R313-28-80, excluding Subsections R313-28-80(7)(b) and R313-28-80(11)(b). The change specifies shielding requirements for the operator of the X-ray unit to protect the operator's torso, hands, face, and gonads from backscatter radiation. The change states that portable radiation machines designed to be hand-held are exempt from Subsection R313-28-35(7), shall be held by the tube housing support or handle, and shall be used in accordance with the manufacturer's operating procedures. The rule requires operators to be trained and records of training to be maintained on file for examination by an authorized representative of the Director.

State statutory or constitutional authorization for this rule:

• Section 19-3-104
• Section 19-3-108

Anticipated cost or savings to:

the state budget:

It is not believed that there will be any anticipated cost or savings to the state budget. This is because certain hand-held portable dental X-ray systems are already registered by the Division of Radiation Control through an exemption previously granted by the Radiation Control Board. This rule change eliminates the exemption.

local governments:

There will be no cost or savings to local government because there are no local government agencies with hand-held portable dental X-ray systems. If a local government agency should obtain such a system, the registration cost will be the same as all other X-ray tubes and the inspection fee will remain the same as for other dental X-ray units.

small businesses:

Dental practice facilities, as small businesses, may see a savings because a hand-held portable dental X-ray system may be moved from room to room. Portable systems may eliminate the need for a wall-mounted X-ray system to be installed in each examination room. It is not possible to estimate the amount of this savings, because any savings will be dependent on the size of the dental practice.

persons other than small businesses, businesses, or local governmental entities:

There will be no cost or savings to persons other than small businesses, businesses, or local government entities; because if a person obtains a hand-held portable dental X-ray system, the registration cost will be the same as all other X-ray tubes and the inspection fee will remain the same as for other dental X-ray units.

Compliance costs for affected persons:

The compliance costs for affected persons are expected to be minimal, likely less than $500 per facility using a hand-held portable dental X-ray system. The costs will be predominately related to any need to obtain a lead apron for operators to wear and the need to store training records for operators. Affected persons may obtain operator training through information manuals provided by the manufacturer or though onsite instruction. It is not possible to estimate the cost for onsite instruction because of the many variables associated with this option.

Comments by the department head on the fiscal impact the rule may have on businesses:

This rule does not change the X-ray tube registration cost or the inspection fee for a hand-held portable dental X-ray system. Some regulated facilities may see a cost savings because portable dental X-ray systems may eliminate the need for a wall mounted X-ray unit to be installed in each examination room. The compliance costs are expected to be minimal, likely less than $500 per facility that chooses to use a hand-held portable dental X-ray system.

Amanda Smith, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Environmental Quality
Radiation ControlRoom Third Floor
195 N 1950 W
SALT LAKE CITY, UT 84116-3085

Direct questions regarding this rule to:

• Craig Jones at the above address, by phone at 801-536-4264, by FAX at 801-533-4097, or by Internet E-mail at cwjones@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

09/16/2013

This rule may become effective on:

10/15/2013

Authorized by:

Rusty Lundberg, Director

R313. Environmental Quality, Radiation Control.

R313-28. Use of X-Rays in the Healing Arts.

R313-28-80. Intraoral Dental Radiographic Systems.

In addition to the provisions of R313-28-31, R313-28-32 and R313-28-35, the requirements of this section apply to x-ray equipment and associated facilities used for dental radiography. Criteria for extraoral dental radiographic systems are covered in R313-28-51, R313-28-52 and R313-28-53. Intraoral dental radiographic systems used must meet the requirements of R313-28-80.

(1) Source-to-Skin distance (SSD). X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit source-to-skin distance to not less than:

(a) 18 centimeters if operable above 50 kilovolts peak, or

(b) 10 centimeters if not operable above 50 kilovolts peak.

(2) Field limitation. Radiographic systems designed for use with an intraoral image receptor shall be provided with means to limit the x-ray field so that:

(a) if the minimum source-to-skin distance (SSD) is 18 centimeters or more, the x-ray field, at the minimum SSD, shall be containable in a circle having a diameter of no more than seven centimeters; and

(b) if the minimum SSD is less than 18 centimeters, the x-ray field, at the minimum SSD, shall be containable in a circle having a diameter of no more than six centimeters.

(3) Exposure Initiation.

(a) Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, for example, the depression of a switch. Radiation exposure shall not be initiated without a deliberate action; and

(b) It shall not be possible to make an exposure when the timer is set to a "zero" or "off" position if either position is provided.

(4) Exposure Termination.

(a) Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor.

(b) An x-ray exposure control shall be incorporated into x-ray systems so that an exposure of more than 0.5 seconds can be terminated immediately by the operator.

(c) Termination of an exposure shall cause automatic resetting of the timer to its initial setting or to "zero."

(5) Exposure Indication. Means shall be provided for visual indication, observable from the operator's protected position, whenever x-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.

(6) Timer Linearity. For systems having independent selection of exposure time settings, the average ratio of exposure to the indicated milliampere-seconds product obtained at two consecutive timer settings or at two settings not differing by more than a factor of two shall not differ by more than 0.10 times their sum.

(7) Exposure Control Location and Operator Protection.

(a) Stationary x-ray systems shall be required to have the x-ray exposure control mounted in a protected area or a means to allow the operator to be at least 2.7 meters (9.0 feet) from the tube housing assembly while making exposures; and

(b) Mobile and portable x-ray systems which are:

(i) used for greater than one week in the same location, for example, a room or suite, shall meet the requirements of R313-28-80(7)(a); or

(ii) used for less than one week in the same location shall be provided with either a protective barrier at least two meters high for operator protection, or means to allow the operator to be at least 2.7 meters (nine feet) from the tube housing assembly while making exposures.

(8) Exposure Reproducibility. When all technique factors are held constant, the coefficient of variation of exposure shall not exceed 0.05 for certified x-ray systems or 0.10 for non-certified x-ray systems. This requirement applies to clinically used techniques.

(9) mA/mAs Linearity. The following requirements apply when the equipment is operated on a power supply as specified by the manufacturer for fixed x-ray tube potentials within the range of 40 to 100 percent of the maximum rated potentials.

(a) For equipment having independent selection of x-ray tube current, the average ratios of exposure to the indicated milliampere-seconds product obtained at two consecutive tube current settings or, when the tube current selection is continuous, two settings differing by no more than a factor of two shall not differ by more than 0.10 times their sum.

(b) For equipment having a combined x-ray tube current-exposure time product selector but not a separate tube current selector, the average ratios of exposure to the indicated milliampere-seconds product obtained at two consecutive mAs selector settings, or when the mAs selector provides continuous selection, at two settings differing by no more than a factor of two shall not differ by more than 0.10 times their sum.

(10) Accuracy. Deviation of technique factors from indicated values shall not exceed the limits specified for that system by its manufacturer. In the absence of manufacturer's specifications the deviation shall not exceed ten percent of the indicated value.

(11) Administrative Controls.

(a) Patient and film holding devices shall be used when the technique permits and holding is required.

(b) The x-ray tube housing and the position indicating device shall not be hand-held during an exposure.

(c) The x-ray system shall be operated so that the useful beam at the patient's skin does not exceed the requirements of R313-28-80(2).

(d) Dental fluoroscopy without image intensification shall not be used.

(12) Hand-held Portable Dental X-ray Systems.

(a) X-ray equipment designed to be hand-held shall comply with Section R313-28-31, excluding Subsection R313-28-31(5), and with Section R313-28-80, excluding Subsections R313-28-80(7)(b) and R313-28-80(11)(b).

(b) Protective shielding of at least 0.5 millimeter lead equivalence shall be provided for the operator to protect the operator's torso, hands, face, and gonads from backscatter radiation. If the protective shielding is a backscatter shield attached to the x-ray unit, the shield shall be positioned as close to the patient as possible and the operator shall take care to remain in a protective position.

(c) Portable radiation machines designed to be hand-held are exempt from Subsection R313-28-35(7). The portable radiation machines shall be held by the tube housing support or handle and shall be used in accordance with the manufacturer's operating procedures.

(d) In addition to the requirements of Subsection R313-28-350(1), each operator shall complete the training program supplied by the manufacturer prior to using the x-ray unit. Records of training shall be maintained on file for examination by an authorized representative of the Director.

 

KEY: dental, [x]X-rays, mammography, beam limitation

Date of Enactment or Last Substantive Amendment: [March 16, 2007]2013

Notice of Continuation: September 23, 2011

Authorizing, and Implemented or Interpreted Law: 19-3-104; 19-3-108