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

VolparaDensity With Tyrer-Cuzick Model Improves Breast Cancer Risk Stratification
News | Breast Density | May 22, 2019
Research has demonstrated use of Volpara Solutions' VolparaDensity software in combination with the Tyrer-Cuzick Breast...
Partial Breast Irradiation Effective, Convenient Treatment Option for Low-Risk Breast Cancer
News | Radiation Therapy | May 20, 2019
Partial breast irradiation produces similar long-term survival rates and risk for recurrence compared with whole breast...
Managing Architectural Distortion on Mammography Based on MR Enhancement
News | Mammography | May 15, 2019
High negative predictive values (NPV) in mammography architectural distortion (AD) without ultrasonographic (US)...
Screening MRI Detects BI-RADS 3 Breast Cancer in High-risk Patients
News | MRI Breast | May 09, 2019
When appropriate, short-interval follow-up magnetic resonance imaging (MRI) can be used to identify early-stage breast...
Novel Artificial Intelligence Method Predicts Future Risk of Breast Cancer
News | Artificial Intelligence | May 08, 2019
Researchers from two major institutions have developed a new tool with advanced artificial intelligence (AI) methods to...
Georgia Becomes 38th State With Breast Density Inform Law
News | Breast Density | May 06, 2019
Georgia Gov. Brian Kemp signed breast density inform bill HB62 into law May 3, 2019. The law, which becomes effective...
American Society of Breast Surgeons Issues Risk-based Screening Mammography Guidelines
News | Mammography | May 03, 2019
The American Society of Breast Surgeons (ASBrS) has released the first screening mammography guidelines based on a...
Hologic Launches Trident HD Specimen Radiography System
Technology | Breast Biopsy Systems | April 26, 2019
Hologic Inc. announced global commercial availability of the Trident HD specimen radiography system. The next-...
California Protons Cancer Therapy Center Begins Breast Cancer Study Enrollment
News | Proton Therapy | April 25, 2019
California Protons Cancer Therapy Center announced two major efforts representing significant steps forward in breast...
Women With Coronary Artery Wall Thickness at Risk for Heart Disease
News | Cardiac Imaging | April 25, 2019
The thickness of the coronary artery wall as measured by magnetic resonance imaging (MRI) is an independent marker for...