FDA approves ACR DBT quality control test procedures

The U.S. Food and Drug Administration (FDA) has approved the American College of Radiology’s (ACR) digital breast tomosynthesis (DBT) quality control test procedures, enabling the procedures to be incorporated into the 2016 ACR Digital Mammography Quality Control Manual.

The FDA requires radiology departments and imaging centers to perform quality control for DBT modalities according to manufacturers’ quality control manuals. The FDA approval as an amendment to ACR’s 2016 Alternative Standard #24 will enable mammography QC technologists and medical physicists to use the updated ACR manual in lieu of manufacturers’ quality control manuals when it becomes available. An FDA press release said the agency has determined that the ACR's quality control manual is, as required in § 900.18(a)(1): Alternative Requirements, “at least as effective in assuring quality mammography” as following the manufacturers’ QC manuals.

“The new DBT QC procedures in the updated ACR manual will promote uniformity of quality control since it will allow facilities to follow one manual, instead of the dozens of different manuals that are mandated for the varying manufacturers and models of digital mammography equipment with DBT,” said Eric Berns, Ph.D., lead author and chair of the ACR Subcommittee on Mammography Quality Assurance. “The new manual focuses on tests that are clinically relevant for high-quality imaging and provides the structure for a thorough and complete quality control program.”

The ACR stated in a press release that the updated manual is currently undergoing preparation for publication and should be available in the fall of 2018. ACR-accredited mammography facilities (and those applying for accreditation) will be invited to download a free copy of the manual. Medical physicists associated with ACR-accredited facilities may also obtain a free copy.