16 Del. Admin. Code § 4465-F-15.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 4465-F-15.0 - Dual-Energy X-ray Absorptiometry (DXA) (Bone Densitometry)

15.1 DXA systems shall be:

15.1.1 Certified by the manufacturer pursuant to the Medical Device Act and Subchapter C - Electronic Product Radiation Control (EPRC) of Chapter V of the Federal Food, Drug and Cosmetic Act;

15.1.2 Registered in accordance with Part B of these regulations; and

15.1.3 At a minimum, maintained and operated in accordance with the manufacturer's specifications.

15.2 Operator Requirements. In addition to the minimum qualifications outlined in these regulations, operators shall complete training specific to patient positioning and the operation of the DXA system.

15.3 During the operation of any DXA system:

15.3.1 In the absence of a survey performed by or under the supervision of a QMP (QE) determining the minimum distance the operator may be from the patient and radiation source, the operator, ancillary personnel, and members of the general public shall be positioned at least two meters from the patient and DXA system during the examination, or alternatively, work shall be performed using protective lead aprons and/or a portable shield.

15.4 Reserved.

15.5 Quality Assurance. In addition to the applicable requirements in Part F, subsection 3.2.1, a facility performing DXA shall:

15.5.1 Conform to the DXA system manufacturer recommendations and recommendations of recognized professional societies such as the International Society for Clinical Densitometry or the American College of Radiology;

15.6 Records. The registrant shall keep the following records for a minimum of 3 years:

15.6.1 The maintenance and QC tests as prescribed by Part F, subsection 15.1.3 and Part F, subsection 15.5.

16 Del. Admin. Code § 4465-F-15.0

16 DE Reg. 1274 (6/1/2013)
22 DE Reg. 401 (11/1/2018) (Final)