N.D. Admin. Code 33.1-10-06-12

Current through Supplement No. 394, October, 2024

Section 33.1-10-06-12 - Bone densitometry

1. Bone densitometry systems shall be:

a. Certified by the manufacturer pursuant to the Medical Device Act and part C - electronic product radiation control (EPRC) of chapter V of the Federal Food, Drug and Cosmetic Act;

b. Registered in accordance with chapter 33.1-10-02 of these regulations; and

c. Maintained and operated in accordance with the manufacturer's specifications.

2. Equipment requirements. Systems with stepless collimators shall be provided with means to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond two percent of the source-image receptor distance.

3. Operators of bone densitometry systems shall complete a training course on the bone densitometry which is acceptable to the department. The training course shall include:

a. Basic radiation protection;

b. Operating procedures for bone densitometry systems, to include use of various system functions, safety, and maintenance; and

c. Patient positioning for the type of examinations performed.

4. During the operation of any bone densitometry system:

a. The operator, ancillary personnel, and members of the general public shall be positioned as far away as practical but not less than two meters from the patient and bone densitometry system during the examination.

b. The operator shall advise the patient that the bone densitometry examination is a type of x-ray procedure.

5. The registrant shall keep maintenance records for bone densitometry systems as prescribed by subdivision b of subsection 1 of section 33.1-10-06-03. These records shall be maintained for inspection by the department.

6. Bone densitometry on human patients shall be conducted only:

a. Under a prescription of a licensed practitioner of the healing arts; or

b. Under a screening program approved by the department.

7. Any person proposing to conduct a bone densitometry screening program shall submit the information outlined in appendix E.

N.D. Admin Code 33.1-10-06-12

Adopted by Administrative Rules Supplement 370, October 2018, effective 1/1/2019.