Improving Health Through Medical Physics


Richard Martin, JD | Alexandria, VA

AAPM Newsletter — Volume 43 No. 4 — July | August 2018

At Government Relations Forum State Inspectors Ask: Where Are the CT Phantoms?

Bette Blankenship, Chair of the Government and Regulatory Affairs Committee (GRAC), and Richard Martin updated attendees on AAPM advocacy activities at the Conference of Radiation Control Program Directors (CRCPD) 50th National Conference on Radiation Control held in May. The presentation included a discussion of AAPM's work in support of radiation safety, our advocacy for low dose research legislation, and our efforts to maintain medical access to beneficial isotopes.

The conference provided a forum for professional organizations and state regulators to address radiation safety concerns. One of the concerns raised by state regulators was the availability of Cone Beam Computed Tomography (CBCT) quality assurance phantoms. Under federal performance standard on computed tomography (CT), 21 CFR 1020.33(d), the manufacturer is required to provide a phantom with each CT system. That phantom should be the property of the facility and readily accessed as needed. Under 1020.33(d), the phantom must be "capable of providing an indication of contrast scale, noise, nominal tomographic section thickness, the spatial resolution capability of the system for low and high contrast objects and measuring the mean CT number of water or a reference material."

The CRCPD has been addressing this issue with the Food & Drug Administration (FDA). If you are having issues with manufacturers providing phantoms with their CT systems, please advise Laurel Burk, PhD, at the FDA regarding the issues you are addressing. In addition, copy Richard Martin on your correspondence to the FDA so we can follow-up to ensure resolution of any problems.

If you have any questions or would like additional information on this issue, please contact Richard Martin, JD, AAPM Government Relations Program Manager.

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