Radiation-Emitting Products

Frequently Asked Questions about DBT and MQSA Training Requirements

Mammographic Modalities and MQSA Training Requirements

Q. Is digital breast tomosynthesis (DBT) a mammographic modality under MQSA?

A. Under MQSA, there are currently not one, but three different DBT modalities. MQSA defines a mammographic modality as “a technology for radiography of the breast.” As of April 2015, three DBT systems have been approved for marketing in the United States: Hologic Selenia Dimensions, GE SenoClaire, and Siemens Mammomat Inspiration. Due to the technological differences between these DBT systems, and differences in their FDA-approved Indications for Use (IFU), each manufacturer’s DBT system is currently treated as a separate mammographic modality under the MQSA definition. Facilities that perform mammography using any of these DBT modalities are subject to MQSA requirements.

Q. How do the MQSA “new modality” training requirements apply to DBT?

A. Under MQSA, personnel need to receive 8 hours of initial training prior to independently using any new mammographic modality, defined as a modality in which the person has not previously been trained. However, the FDA’s Division of Mammography Quality Standards (DMQS) recognizes that there are many features which are common to different DBT systems, while some features are unique to each specific system. Therefore, training must include both the common features of DBT and the unique features of the particular DBT system, but these two aspects of the training may be obtained either in a single training program or in separate settings. Once personnel have received training in the common features of DBT, they do not need to repeat this portion of the training when receiving training in the unique features of a particular system. For further details and sample training scenarios, please see below.

Q. Do the modality training requirements apply to recently graduated radiology residents, fellows, radiologists providing locum tenens services, consulting medical physicists, and mammography technologists providing per diem services?

A. Yes. For residents and fellows, the training can be obtained during residency or fellowship. The documentation of initial DBT training provided by a residency or fellowship program must also specify the particular DBT system(s) whose unique features were included in the training. Please see DMQS’s sample residency letter.

Q. Must the training be provided by the manufacturer?

A. No. Under MQSA, the new modality training, including the training on the unique features (the technological differences and the IFU) of a particular DBT system, does not need to be provided by the manufacturer. The individual providing the training must be a qualified instructor, defined as “an individual whose training and experience adequately prepare him or her to carry out specified training assignments.” Each of the currently approved manufacturers, Hologic, GE, and Siemens, offers training on its own system; however, third-party training courses as well as informal training can also satisfy the requirement for new mammographic modality training under MQSA. For example, peer training by a qualified peer who has previously met the training requirement is permitted. DMQS will accept signed attestation, using DMQS’s recommended form or a form with similar elements, to document that personnel received training in the unique features of a particular manufacturer's DBT system.

Training in Common Features and Unique Features

Q. Do personnel who have received 8 hours of DBT training specific to one manufacturer’s system meet the requirements for the initial 8 hours of DBT training for another manufacturer’s system?

A. No, not completely. Personnel need to have acceptable documentation of a total of 8 hours of training in the new mammographic modality, that is, in the specific manufacturer’s DBT system which the personnel will use and in which they have not yet been trained. DMQS recognizes that there are many features which are common to different DBT systems, while some features are unique to each system, so training must include both the common features of DBT and the unique features of the particular DBT system. These two aspects of the training may be obtained either in a single training program or in separate settings. Once personnel have received training in the common features of DBT, they do not need to repeat this portion of the training when receiving training in the unique features of a particular system. Supplemental training on the unique features of a particular DBT system can typically be offered in less than 8 hours. Thus:

  • Personnel who have already received 8 hours of general DBT training also need documentation of training in the unique features of the particular DBT system they will use.
  • Personnel who have received 8 hours of training on one specific DBT system which they will use also need documentation that specifies the system whose unique features were included in the training.
  • Personnel who have received 8 hours of training on any one DBT system also need documentation of training on the unique features of another DBT system prior to independently using that other system.
Q. What are the “unique features” of a particular DBT system?

A. The unique features of a specific DBT system will typically include its particular technological features of image acquisition, processing, and/or display, the quality control tests recommended by the system’s manufacturer, and the system’s unique FDA-approved Indications for Use (IFU), such as the particular combination of views approved for screening mammography using that DBT system. Training intended for an interpreting physician, a medical physicist, or a radiologic technologist should emphasize those unique features of the system that fall into the person’s respective area of responsibility.

Q. Does the DBT system manufacturer determine the unique features?

A. No, the qualified trainer determines the unique features. As noted above, the training should be designed for an intended audience—interpreting physicians, medical physicists, or radiologic technologists—since it should emphasize those unique features of the system that fall into the area of responsibility of the intended audience.

Q. How much training is required on the unique features of the particular DBT system?

A. Currently, DMQS has not specified the number of hours of training needed on the unique features of the particular DBT system. Personnel who have already received training in the common features of DBT may receive supplemental training in the unique features of the particular DBT system they will use; this supplemental training can typically be offered in less than 8 hours.

Status of Prior Training

Q. What is the status of training received prior to the FDA approval of the GE and Siemens DBT systems?

A. From February 11, 2011, to August 26, 2014, Hologic was the only DBT system approved for marketing in the United States. Therefore, if 8 hours of new modality training in DBT were obtained between February 18, 2011, and August 26, 2014, DMQS will accept that such training included the unique features of the Hologic system, even if that is not stated explicitly on the training certificate.

Q. A training provider offered a DBT course in January 2014, when Hologic was the only DBT system approved for marketing in the United States. DMQS will accept that the course included the unique features of the Hologic system, even if that is not stated explicitly on the training certificate. The training provider then repeated the identical course in September 2014, after FDA approval of GE DBT, but the certificate does not specify that the course included the unique features of Hologic DBT. Will the September 2014 course remain acceptable for Hologic training, since it is the same course? If so, how should this training be documented?

A. Yes, the September 2014 course remains acceptable for Hologic training. To document their training in the unique features of the Hologic system, attendees of the September 2014 course should complete and sign an attestation, usingDMQS’s recommended form or a form with similar elements.

Documentation of Training

Q. How must I document training in the common features of DBT and in the unique features of a particular manufacturer’s DBT system?

A. Eight hours of general training in DBT, or 8 hours of training in a particular manufacturer’s DBT system, counts toward the training in common DBT features for any approved DBT system, but personnel also need to document that they received training in the unique features of whichever DBT system they will use. For documentation of training in the unique features of a particular manufacturer's DBT system, DMQS will accept:

  • A course certificate or letter that clearly indicates that the training included the unique features of a particular system, or 
  • A signed attestation, using DMQS’s recommended form or a form with similar elements, to document training in the unique features

For Further Questions

Q. I have additional questions on these requirements. Whom should I contact?

A. Contact the FDA Mammography Facility Hotline at 1-800-838-7715 or MQSAhotline@hcmsllc.com.
 

Page Last Updated: 05/22/2015
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