No. 43253 (Amendment): Section R313-28-31. General and Administrative Requirements

(Amendment)

DAR File No.: 43253
Filed: 10/11/2018 12:24:21 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

X-ray inspectors from the Division are finding x-ray equipment being used in medical facilities in Utah that have been purchased from oversees sources. In some cases, this equipment does not meet the safety requirements set forth in this rule making the use of the equipment a potential hazard to the health of the operator and the patient. In all cases, it has been determined that the equipment was not certified and identified as being approved by the federal Food and Drug Administration (FDA) for use in the United States. The purpose of this amendment is to clarify that x-ray equipment purchased for use in Utah must be certified and identified as meeting requirements set by the FDA for x-ray equipment being used in the United States as required by 21 CFR 1010.2 and 1010.3.

Summary of the rule or change:

Subsection R315-28-31(a) is being added to this rule. The subsection clarifies that x-ray equipment purchased for use in Utah shall be FDA approved for use in the United States and shall be certified and identified in accordance with 21 CFR 1010.2 and 1010.3.

Statutory or constitutional authorization for this rule:

• Section 19-3-104
• Section 19-6-104

Anticipated cost or savings to:

the state budget:

There will be no cost or savings to the state due to this amendment because this amendment does not add any new requirements or remove any existing requirements. X-ray equipment manufactured and sold for use in the United States is already required by the federal FDA to be certified and identified as approved for use in the United States. This amendment simply places this requirement in state rules.

local governments:

There will be no cost or savings to local governments due to this amendment because this amendment does not add any new requirements or remove any existing requirements. X-ray equipment manufactured and sold for use in the United States is already required by the federal FDA to be certified and identified as approved for use in the United States. This amendment simply places this requirement in state rules.

small businesses:

There will be no cost or savings to small businesses due to this amendment because this amendment does not add any new requirements or remove any existing requirements. X-ray equipment manufactured and sold for use in the United States is already required by the federal FDA to be certified and identified as approved for use in the United States. This amendment simply places this requirement in state rules.

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 due to this amendment because this amendment does not add any new requirements or remove any existing requirements. X-ray equipment manufactured and sold for use in the United States is already required by the federal FDA to be certified and identified as approved for use in the United States. This amendment simply places this requirement in state rules.

Compliance costs for affected persons:

There should be no additional compliance costs for affected persons because federal rule already requires x-ray equipment manufactured and sold for use in the United States to meet FDA requirements. Anyone who has purchased equipment that does not meet these requirements is already in violation of federal rules and should not have purchased the equipment. When an inspector finds this type of equipment in use the facility is informed that they cannot use the equipment and must purchase equipment that meets the requirements. It is unknown how many persons may have purchased equipment that does not meet the requirements so the potential additional cost of compliance is inestimable.

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

It is not anticipated that adoption of this rule amendment will have any fiscal impact on businesses because they should already be in compliance with federal rules. This amendment simply reinforces the fact that the federal rule applies in Utah and provides x-ray inspectors with a Utah rule to cite when they encounter facilities with equipment that does not meet the requirements.

Alan Matheson, Executive Director

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

Environmental Quality
Waste Management and Radiation Control, RadiationRoom Second Floor
195 N 1950 W
SALT LAKE CITY, UT 84116-4880

Direct questions regarding this rule to:

• Rusty Lundberg at the above address, by phone at 801-536-4257, by FAX at 801-536-0222, or by Internet E-mail at [e-mail]
• Thomas Ball at the above address, by phone at 801-536-0251, by FAX at , or by Internet E-mail at [e-mail]

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:

12/03/2018

This rule may become effective on:

12/14/2018

Authorized by:

Scott Anderson, Director

RULE TEXT

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs

FY 2019

FY 2020

FY 2021

State Government

$0

$0

$0

Local Government

$0

$0

$0

Small Businesses

$0

$0

$0

Non-Small Businesses

$0

$0

$0

Other Person

$0

$0

$0

Total Fiscal Costs:

$0

$0

$0

Fiscal Benefits

State Government

$0

$0

$0

Local Government

$0

$0

$0

Small Businesses

$0

$0

$0

Non-Small Businesses

$0

$0

$0

Other Persons

$0

$0

$0

Total Fiscal Benefits:

$0

$0

$0

Net Fiscal Benefits:

$0

$0

$0

 

*This table only includes fiscal impacts that could be measured. If there are inestimable fiscal impacts, they will not be included in this table. I nestimable impacts for State Government, Local Government, Small Businesses and Other Persons are described in the narrative. Inestimable impacts for Non - Small Businesses are described in Appendix 2.

 

Appendix 2: Regulatory Impact to Non - Small Businesses

This rule change is not expected to have any fiscal impact on non-small businesses revenues or expenditures because any business operating x-ray equipment in Utah must already have equipment that complies with federal FDA requirements that are cited in this rule amendment.

 

The head of Department of Environmental Quality, Alan Matheson, has reviewed and approved this fiscal analysis.

**"Non - small business" means a business employing 50 or more persons; "small business" means a business employing fewer than 50 persons.

 

 

R313. Environmental Quality, Waste Management and Radiation Control, Radiation.

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

R313-28-31. General and Administrative Requirements.

(1) Persons shall not make, sell, lease, transfer, lend, or install x-ray equipment or the accessories used in connection with x-ray equipment unless the accessories and equipment, when properly placed in operation and properly used, will meet the applicable requirements of these rules.

(a) X-ray equipment shall be FDA approved for use in the United States and shall be certified in accordance with 21 CFR 1010.2 and identified in accordance with 21 CFR 1010.3.

(2) The registrant shall be responsible for directing the operation of the x-ray machines which are under the registrant's administrative control. The registrant or registrant's agent shall assure that the requirements of R313-28-31(2)(a) through R313-28-31(2)(i) are met in the operation of the x-ray machines.

(a) An x-ray machine which does not meet the provisions of these rules shall not be operated for diagnostic purposes, when directed by the Director.

(b) Individuals who will be operating the x-ray equipment shall be instructed in the registrant's written radiation safety program and be qualified in the safe use of the equipment. Required operator qualifications are listed in R313-28-350.

(c) The registrant of a facility shall create and make available to x-ray operators written safety procedures, including patient holding and restrictions of the operating technique required for the safe operation of the x-ray systems. Individuals who operate x-ray systems shall be responsible for complying with these rules.

(d) Except for individuals who cannot be moved out of the room and the patient being examined, only the staff and ancillary personnel or other individuals needed for the medical procedure or training shall be present in the room during the radiographic exposure and shall be positioned as follows:

(i) individuals other than the patient shall be positioned so that no part of the body will be struck by the useful beam unless protected by not less than 0.5 mm lead equivalent material;

(ii) the x-ray operator, other staff, ancillary personnel and other individuals needed for the medical procedure shall be protected from primary beam scatter by protective aprons or barriers unless it can be shown that by virtue of distances employed, EXPOSURE levels are reduced to the limits specified in R313-15-201; and

(iii) patients who are not being examined and cannot be removed from the room shall be protected from the primary beam scatter by whole body protective barriers of not less than 0.25 mm lead equivalent material or shall be so positioned that the nearest portion of the body is at least two meters from both the tube head and nearest edge of the image receptor.

(e) For patients who have not passed reproductive age, gonad shielding of not less than 0.5 mm lead equivalent material shall be used during radiographic procedures in which the gonads are in the useful beam, except for cases in which this would interfere with the diagnostic procedure.

(f) Individuals shall be exposed to the useful beam for healing arts purposes only when the exposure has been specifically ordered and authorized by a licensed practitioner of the healing arts after a medical consultation. Deliberate exposures for the following purposes are prohibited:

(i) exposure of an individual for training, demonstration or other non-healing arts purposes; and

(ii) exposure of an individual for the purpose of healing arts screening except as authorized by R313-28-31(2)(i).

(g) When a patient or film must be provided with auxiliary support during a radiation exposure:

(i) mechanical holding devices shall be used when the technique permits. The written procedures, required by R313-28-31(2)(c), shall list individual projections where mechanical holding devices can be utilized;

(ii) written safety procedures, as required by R313-28-31(2)(c), shall indicate the requirements for selecting an individual to hold patients or films and the procedure that individual shall follow;

(iii) the individual holding patients or films during radiographic examinations shall be instructed in personal radiation safety and protected as required by R313-28-31(2)(d)(i);

(iv) Individuals shall not be used routinely to hold film or patients;

(v) In those cases where the patient must hold the film, except during intraoral examinations, portions of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than 0.5 mm lead equivalent material; and

(vi) Facilities shall have protective aprons and gloves available in sufficient numbers to provide protection to personnel who are involved with x-ray operations and who are otherwise not shielded.

(h) Personnel monitoring. Individuals who are associated with the operation of an x-ray system are subject to the applicable requirements of R313-15.

(i) Healing arts screening. Persons proposing to conduct a healing arts screening program shall not initiate the program without prior approval of the Director. When requesting approval, that person shall submit the information outlined in R313-28-400. If information submitted becomes invalid or outdated, the Director shall be notified immediately.

(3) Maintenance of records and information. The registrant shall maintain at least the following information for each x-ray machine:

(a) model numbers of major components;

(b) record of surveys or calculations to demonstrate compliance with R313-15-302, calibration, maintenance and modifications performed on the x-ray machine; and

(c) a shielding design report for the x-ray suite which states assumed values for workload and use factors and includes a drawing of surrounding areas showing assumed values for occupancy factors.

(4) X-ray records. Facilities shall maintain an x-ray record containing the patient's name, the types of examinations, and the dates the examinations were performed. When the patient or film must be provided with human auxiliary support, the name of the human holder shall be recorded. The registrant shall retain these records for three years after the record is made.

(5) Portable or mobile equipment shall be used only for examinations where it is impractical to transfer the patient to a stationary radiographic installation.

(6) Hand-held medical x-ray systems. X-ray equipment designed to be hand-held shall comply with Section R313-28-31, excluding Subsection R313-28-31(5), and R313-28-52, excluding Subsections R313-28-52(8)(b)(i) and (ii).

(a) When operating hand-held equipment for which it is not possible for the operator to remain at least six feet from the x-ray machine during x-ray exposure, protective aprons of at least 0.5 millimeter lead equivalence shall be provided for the operator to protect the operator's torso and gonads from backscatter radiation;

(b) In addition to the dose limits in R313-15-301, operators of hand-held x-ray equipment shall ensure that members of the public that may be exposed to scatter radiation or primary beam transmission from the hand-held device are not exposed above 2 milliroentgen per hour;

(i) Operators will ensure that members of the public likely to be exposed to greater than 2 milliroentgen per hour will be provided protective aprons of at least 0.5 millimeter lead equivalence or are moved to a distance such that the exposure rate to the individual is below 2 milliroentgen per hour; and

(c) In addition to the requirements of Subsection R313-28-350(1), each operator of hand-held x-ray equipment 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.

(7) Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized.

(a) The speed of the screen and film combinations used shall be the fastest speed consistent with the diagnostic objective of the examinations. Film cassettes without intensifying screens shall not be used for routine diagnostic radiological imaging, with the exception of standard film packets for intra-oral use in dental radiography. If the requirements of R313-28-31(6)(a) cannot be met, an exemption may be requested pursuant to R313-12-55.

(b) The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality.

(c) X-ray systems, other than fluoroscopic, computed tomography, dental or veterinary units, shall not be utilized in procedures where the source to patient distance is less than 30 centimeters.

 

KEY: dental, X-rays, mammography, beam limitation

Date of Enactment or Last Substantive Amendment: [March 24, 2015]2018

Notice of Continuation: July 1, 2016

Authorizing, and Implemented or Interpreted Law: 19-3-104; 19-6-107

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