Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1007-1-6.11 - Use of dual-energy x-ray absorptiometry (DXA) bone densitometry systems6.11.1 In addition to the provisions of 6.3 and 6.4, the requirements of 6.11 apply to all facilities using DXA machines.6.11.2 DXA Systems shall be: 6.11.2.1 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;6.11.2.2 Registered in accordance with Part 2 of these regulations; and6.11.2.3 At a minimum, maintained and operated in accordance with the manufacturer's specifications6.11.3 Operator requirements. 6.11.3.1 Each operator of a bone densitometry machine shall meet the adequate radiation safety training and experience requirements of Part 2, Section 2.4.5.3, and Part 2, Appendix 2F.6.11.4 During operation of any DXA system: 6.11.4.1 In the absence of a radiation survey performed by or under the supervision of a RMP the operator, ancillary personnel, and members of the general public shall be positioned at least 2 meters (at least 6 feet) from the patient, x-ray tube, and useful beam during the examination.6.11.5 Quality assurance. 6.11.5.1 In addition to the applicable requirements in 6.3.5.1, a facility performing DXA shall: (1) Conform to the DXA system manufacturer recommendations and recommendations of recognized professional societies such as the International Society for Clinical Dosimetry or the American College of Radiology.6.11.6 Records. 6.11.6.1 The registrant shall keep the following records for a minimum of 3 years: (1) The maintenance and QC tests as prescribed by 6.11.2.3 and 6.11.5.1.Colorado Register, Vol 37, No. 14. July 25, 2014, effective 8/14/201438 CR 02, January 25, 2015, effective 2/14/201538 CR 05, March 10, 2015, effective 3/30/201538 CR 12, June 25, 2015, effective 7/15/201538 CR 14, July 25, 2015, effective 8/14/201539 CR 02, January 25, 2016, effective 2/14/201639 CR 16, August 25, 2016, effective 9/14/201639 CR 22, November 25, 2016, effective 12/15/201640 CR 11, June 10, 2017, effective 6/30/201740 CR 20, October 25, 2017, effective 11/14/201742 CR 24, December 25, 2019, effective 1/14/202043 CR 14, July 25, 2020, effective 8/14/202043 CR 18, September 25, 2020, effective 10/15/202044 CR 11, June 10, 2021, effective 7/15/202144 CR 14, July 25, 2021, effective 8/14/202145 CR 22, November 25, 2022, effective 12/15/202247 CR 06, March 25, 2024, effective 4/14/2024