1. A. A bone densitometry system shall be:

   1. 1. Certified by the manufacturer pursuant to 21 CFR Part 803, Medical Device Reporting of the Federal Food and Drug Administration Modernization Act of 1997; 21 USC Chapter 9, Subchapter V, Part C – Electronic Product Radiation Control (EPRC) (§ 360hh et seq.) of the Federal Food, Drug and Cosmetic Act; and 21 CFR 1020.30, Diagnostic x-ray systems and their major components.
   2. 2. Registered with the agency in accordance with applicable parts of this chapter.
   3. 3. Maintained and operated in accordance with the manufacturer's specifications.
2. B. Equipment requirements. A system 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 2.0% of the SID.

3. C. Operators of a bone densitometry system shall meet one of the following:

   1. 1. Be certified by the American Registry of Radiologic Technologists (ARRT);
   2. 2. Be licensed by the Virginia Department of Health Professions, Board of Medicine as a radiologic technologist or a limited radiologic technologist for bone density operation;
   3. 3. Be licensed by the Virginia Department of Health Professions, Board of Medicine as a practitioner of the healing arts; or
   4. 4. Be in an accredited program for radiologic technology and under the supervision of an individual who meets one of the criteria listed in subdivision 1, 2, or 3 of this subsection.

4. D. During the operation of any bone densitometry system:

   1. 1. The operator, ancillary personnel, and members of the general public shall be positioned at least one meter from the patient and bone densitometry system during the examination.
   2. 2. The operator shall advise the patient that the bone densitometry examination is a type of x-ray procedure.
5. E. The registrant shall keep maintenance records for bone densitometry systems as prescribed by subdivision A 3 of this section. These records shall be maintained for inspection by the agency.

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

   1. 1. Under a prescription of an individual licensed by the Virginia Department of Health Professions, Board of Medicine as a practitioner of the healing arts; or
   2. 2. Under a screening program approved by the agency.

Statutory Authority

§ 32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.