FDA OKs ACR's new Digital Mammography QC Manual

The Food and Drug Administration (FDA) approved the American College of Radiology's (ACR's) alternative standard request to allow mammography facilities to use the new Digital Mammography Quality Control (QC) Manual and Digital Mammography QC Phantom in routine QC of digital equipment. The new manual and phantom will aid in ensuring uniformity of QC testing.

The FDA requires digital mammography facilities to perform QC for approved imaging systems, according to their respective manufacturers' quality control manuals. Approval of this alternative standard will enable mammography QC technologists and medical physicists to use the new ACR manual in lieu of manufacturers' quality control manuals when it becomes available. The FDA alternative standard specifies that the new manual may only be used for full-field digital mammography systems without advanced imaging capabilities, such as tomosynthesis or contrast enhancement.

"The new ACR manual will promote uniformity of testing since it will allow facilities with applicable systems to follow one manual instead of the dozens of different manuals that are mandated for the varying manufacturers and models of digital mammography equipment," said Eric Berns, PhD, 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 the structure for a thorough and complete quality control program," he added.

"The evolution of modern digital mammography has improved mammography quality in the United States. This new manual provides simple, user-friendly procedures for technologists and medical physicists to help them maintain this quality of imaging," said Brett Parkinson, MD, chair of the ACR Committee on Mammography Accreditation. He noted that the ACR manual "also contains two optional procedures for radiologists to enable them to self-check system image quality and provide image quality feedback to technologists."