Feature | Mammography | May 14, 2018

FDA's MQSA Accreditation Bodies Approved for Tomosynthesis Accreditation

Three states and the American College of Radiology are now certified to accredit DBT systems

FDA's MQSA Accreditation Bodies Approved for Tomosynthesis Accreditation

Image courtesy of Fujifilm.

May 14, 2018 — On April 9, 2018, the U.S. Food and Drug Administration (FDA) announced that all four of its Mammography Quality Standards Act (MQSA) accrediting bodies are approved to accredit digital breast tomosynthesis (DBT) systems. This includes the states of Arkansas, Iowa and Texas, and the American College of Radiology (ACR).

In the medical device world, the constant evolution of technology continues to provide new and improved diagnostic and therapeutic tools, and the mammography world is no exception. On Feb. 11, 2011, the fourth generation of mammography technology emerged with FDA’s approval of the first DBT unit for U.S. marketing. At that time, just like when the first full field digital mammography (FFDM) unit was approved for marketing in January 2000, the FDA’s approved accrediting bodies (ABs) did not have standards developed or processes in place to accredit a new technology that was just introduced to the mammography community. Therefore, the FDA had to develop a stop-gap, temporary program — namely the FDA Certificate Extension Program. In the absence of accreditation, this program’s purpose was to provide a temporary way for new technology approved for marketing to be legally used under the MQSA, so that it could benefit patients while accreditation programs were being developed.

The MQSA mandates that facilities be accredited. Once ABs are ready to accredit a new technology, apply to FDA, and are approved, the transition from a certificate extension program to an accreditation program occurs. Such was the case with FFDM in February of 2003 and now again for DBT.

The FDA has worked and continues to work closely with the accrediting bodies to assist facilities with this transition. Individual accrediting bodies have established their own accreditation procedures and transition mechanisms within the confines of the MQSA requirements for accreditation. The FDA continued to accept applications up until April 6, 2018. Any facility granted an extension of its certificate to include the use of a DBT unit to date, or who is granted one on an application received by FDA by April 6, can continue to use its existing DBT unit(s) under that certificate extension while transitioning to being accredited by its accreditation body. If a facility with a current DBT certificate extension adds a new unit and wants to use the DBT modality on the new unit, the facility must now apply to its accreditation body to have that new unit accredited. All other facilities, and those certificate extension facilities that acquire DBT units after the April 6, 2018 cutoff date, must contact their respective ABs to apply for accreditation.

Although housed in a single unit, due to the differences in technology between FFDM and DBT, the FFDM and DBT components of the mammography system need to be accredited as two separate units if the facility uses the DBT component in clinical practice. And even if a facility uses only the DBT component of a mammography system, and not the FFDM mode, both the FFDM and DBT systems must be accredited, as accreditation of the DBT modality relies on documenting the proper functioning of certain aspects of the FFDM system. As when the Certificate Extension Program was in effect, both the FFDM and DBT portions of a unit will each individually require inspection during the annual MQSA inspection process.

To further assist facilities with the DBT accreditation process, the table below summarizes the system components, quality control (QC) tests and new modality training requirements that are evaluated during the accreditation process:

Facility System Facility Intended Use of System Accredit FFDM System? Accredit DBT System? Required Quality Control (QC) Personnel training Requirements
FFDM system with DBT capability FFDM (2-D) ONLY Yes No FFDM QC Only 8 hours of FFDM training only
FFDM (2-D), DBT (3-D) Yes Yes

FFDM OC

DBT QC

8 hours of FFDM training and 8 hours of DBT training
DBT (3-D) ONLY Yes Yes

FFDM QC

DBT QC

8 hours of FFDM training and 8 hours of DBT training
DBT Only System Currently, there are no DBT (3-D) systems approved for U.S. marketing that do not have an FFDM (2-D) component

As noted in the table above, all personnel who perform DBT exams (technologists), interpret DBT images (interpreting physicians) or evaluate DBT units (medical physicists) must have at least 8 hours of training in FFDM and 8 hours of training in DBT. Facilities are required to complete the required quality control testing depending on the clinical use of the unit.

While there was no charge for the temporary FDA Certificate Extension Program, facilities will now incur fees for DBT accreditation, as they do for other types of mammography accreditation. Fees are set by each AB and vary among them. The justifications for each AB’s fees are evaluated and approved by the FDA.

The accrediting bodies are the best source of information about the DBT transition to accreditation and the specifics of their DBT accreditation requirements and processes; their links are provided below:

For more information: www.fda.gov

 

Related Content

Table 1. Compared to 2-D mammography, which yields four images per patient, digital breast tomosynthesis (DBT), or 3-D mammography, produces hundreds of images per patient. While this provides more information for clinicians, the exponential increase in data can result in reader fatigue and burnout, which may ultimately affect patient care.

Table 1. Compared to 2-D mammography, which yields four images per patient, digital breast tomosynthesis (DBT), or 3-D mammography, produces hundreds of images per patient. While this provides more information for clinicians, the exponential increase in data can result in reader fatigue and burnout, which may ultimately affect patient care.

Sponsored Content | Case Study | Artificial Intelligence | April 09, 2020
As the largest independent imaging group in Michigan with 10 locations across the state,...
Figure 1. R MLO view from four different years. The skin mole is marked with a circular skin marker (TomoSPOT REF# 782, Beekley Medical) on the far-left image. These images demonstrate the potential for significant variability in location of the skin lesion due to movability of the skin during positioning.

Figure 1. R MLO view from four different years. The skin mole is marked with a circular skin marker (TomoSPOT REF# 782, Beekley Medical) on the far-left image. These images demonstrate the potential for significant variability in location of the skin lesion due to movability of the skin during positioning. 

Sponsored Content | Case Study | Breast Imaging | April 09, 2020
Christina Jacobs, M.D., Director of Breast Imaging (...
A recent study earlier this year in the journal Nature, which included researchers from Google Health London, demonstrated that artificial intelligence (AI) technology outperformed radiologists in diagnosing breast cancer on mammograms
Feature | Breast Imaging | April 06, 2020 | By Samir Parikh
A recent study earlier this year in the journal Nature,
Feature | Breast Density | April 03, 2020 | By Dayna Williams M.D., Shivani Chaudhry, M.D., and Laurie R. Margolies, M.D.
Breast cancer is the most common cance
#COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SARScov2
News | Mammography | March 25, 2020
March 25, 2020 — The...
The 2020 Society of Breast Imaging/American College of Radiology (SBI/ACR) annual symposium has been cancelled, and the event rescheduled for April 8-11, 2020, in Savannah, Ga. #COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SBI20
News | Society of Breast Imaging (SBI) | March 16, 2020
March 16, 2020 — The 2020 Society of Breast Imaging/American College of Radiology (...
DBT, sometimes called 3-D mammography, emerged in the last decade as a powerful tool for breast cancer screening

Images in a 57-year-old woman noted to have "good prognosis" invasive cancer detected at digital breast tomosynthesis (DBT) screening. (a) Craniocaudal view of the left breast obtained with the two-dimensional digital mammography (DM) portion of the DM/DBT screening study demonstrates a subtle area of distortion in the medial left breast. (b) Single-slice image from the left craniocaudal DBT portion of the screening study shows an area of bridging distortion (circle). (c) Electronically enlarged image of the area of concern seen on the left craniocaudal view in a single DBT slice as shown in b. (d) Targeted US scan demonstrates two small adjacent irregular solid masses. US-guided core biopsy yielded an invasive carcinoma of the tubular subtype that was estrogen receptor positive, progesterone receptor positive, and human epidermal growth factor receptor 2 negative. The results of the sentinel node biopsy were negative. Image courtesy of the Radiological Society of North America

News | Breast Imaging | March 11, 2020
March 11, 2020 — A new study published in the journal ...
SoftVue image stacks of sound speed, as shown for cases ranging across the four Breast Imaging Reporting and Data System (BI-RADS) breast density categories

Example: SoftVue image stacks of sound speed, as shown for cases ranging across the four Breast Imaging Reporting and Data System (BI-RADS) breast density categories ((a), fatty; (b), scattered; (c), heterogeneously dense; (d), extremely dense). Note the quantitative scale indicating that absolute measurements are obtained. Image courtesy of MDPI

News | Breast Imaging | March 10, 2020
March 10, 2020 — ...
The study concludes that a combination of Artificial Intelligence algorithms and the interpretations of radiologists could, in the U.S. alone, result in a half million women not having to undergo unnecessary diagnostic tests every year

Researchers who participated in the DM (digital mammography) DREAM Challenge.

News | Mammography | March 07, 2020
March 7, 2020 — The stu...