News | Mammography | July 30, 2018

FDA Approves New Tomosynthesis Quality Control Tests for ACR Digital Mammography QC Manual

Approval will help streamline digital breast tomosynthesis quality control procedures for mammography facilities

FDA Approves New Tomosynthesis Quality Control Tests for ACR Digital Mammography QC Manual

July 30, 2018 — The U.S. Food and Drug Administration (FDA) recently approved the American College of Radiology’s (ACR’s) amendment to the 2016 Alternative Standard #24 to the “Quality control tests--other modalities” requirement. This FDA review and approval of the ACR Digital Breast Tomosynthesis (DBT) quality control (QC) test procedures enables the college to incorporate DBT into the 2016 ACR Digital Mammography Quality Control Manual.

The FDA requires digital mammography facilities with DBT to perform QC for approved imaging systems, according to their respective manufacturers’ quality control manuals. Approval of this amendment 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.

“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 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 PDF of the manual. Medical physicists associated with ACR-accredited facilities may also obtain the link to the manual from their facility to download a free version.

The full amended FDA alternative standard approval can be viewed here.

For more information: www.acraccreditation.org

Related Content

This is an example of 3-D ultrasound imaging on a breast, designed to help increase efficiency and diagnostic accuracy in any practice. Image courtesy of Hologic.

This is an example of TriVu ultrasound imaging on a breast, designed to help increase efficiency and diagnostic accuracy in any practice. Image courtesy of Hologic.

Feature | Breast Imaging | September 15, 2021 | By Jennifer Meade
The...
While the Mammography Quality Standards Act (MQSA) and the introduction of EQUIP (Enhancing Quality Using the Inspection Program) have been successful in standardizing and enhancing mammographic imaging quality, inadequate breast positioning can dramatically impact the ability of radiologists and technicians to quickly and accurately detect breast cancer and potentially malignant lesions in their patients

Getty Images

Feature | Mammography | September 15, 2021 | By Christopher Austin, M.D. and Randy D. Hicks, M.D., MBA
Plan to attend RSNA21 at McCormick Place Chicago, Nov. 28 – Dec. 2, 2021

Getty Images

News | RSNA | September 13, 2021
September 13, 2021 — The Radiological Society of North America (RSNA) today announced highlights of the Technical Exh
According to ARRS’ American Journal of Roentgenology (AJR), immediately reading screening mammograms during the coronavirus disease (COVID-19) pandemic promises a new and improved paradigm—reducing care disparities, while increasing the speed of diagnostic workup.

Flow Chart of Patient Selection

News | Breast Imaging | September 09, 2021
September 9, 202
Laws designed to help women with increased risk for missed breast cancer diagnoses may help catch the disease earlier, according to Penn State College of Medicine researchers.

Getty Images | AleksandarNakic

News | Breast Imaging | September 09, 2021
September 9, 2021 — Laws designed to help women with increased risk for...
At the recent 2021 AAPM Meeting in July, Sun Nuclear Corporation featured its comprehensive portfolio of independent, integrated quality management solutions for radiation therapy and diagnostic imaging.
News | Quality Assurance (QA) | September 02, 2021
September 2, 2021 — At the recent 2021 AAPM Meeting
The researchers say there is currently a lack of good quality evidence to support a policy of replacing human radiologists with artificial intelligence (AI) technology when screening for breast cancer.

Getty Images

News | Artificial Intelligence | September 02, 2021
September 2, 2021 — Humans still seem to be better than technology when it comes to the accuracy of spotting possible