12 Va. Admin. Code § 5-481-1653

Current through Register Vol. 41, No. 9, December 16, 2024

Section 12VAC5-481-1653 - Hand-held radiographic unit

In addition to the applicable provisions found elsewhere in this chapter, the following provisions apply to a hand-held radiographic unit.

1. A hand-held radiograph unit shall be:

a. 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.

b. Registered with the agency in accordance with applicable parts of this chapter.

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

2. For all uses:

a. Operators of a hand-held radiographic unit shall be specifically trained to operate such equipment.

b. When operating a hand-held radiographic unit, operators shall wear dosimetry unless otherwise authorized by the agency.

c. A hand-held radiographic unit shall have the backscatter radiation shield in place to protect the operator during operation.

d. The operator shall ensure there are no bystanders within a radius of at least six feet from the patient being examined with a hand-held radiograph unit.

e. A hand-held radiographic unit shall not be used in hallways or waiting rooms.

12 Va. Admin. Code § 5-481-1653

Derived From Virginia Register Volume 31, Issue 24, eff. 8/27/2015.

Statutory Authority: § 32.1-229 of the Code of Virginia.