Q. Is Digital Breast Tomosynthesis (DBT) a mammographic modality under MQSA?
A. MQSA defines a mammographic modality as “a technology for radiography of the breast.” Under MQSA, DBT is considered a mammographic modality. As of January 2017, four DBT systems have been approved for marketing in the United States: Hologic Selenia Dimensions, GE SenoClaire, Siemens Mammomat Inspiration, and the Fujifilm ASPIRE Cristalle. While there are technological differences between these DBT systems, and differences in their FDA-approved Indications for Use, these systems are now treated under MQSA, like full field digital mammography units, as a single mammographic modality. Facilities that perform mammography using any of these DBT units 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. While the FDA’s Division of Mammography Quality Standards (DMQS) recognizes there are some features that are unique to each specific DBT system, personnel need only obtain training on one DBT system, or general DBT training, to meet the new modality training requirement.
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. Yes. Personnel need to have acceptable documentation of a total of 8 hours of training in the new mammographic modality. While the FDA’s Division of Mammography Quality Standards (DMQS) recognizes there are some features that are unique to each specific DBT system, personnel need only to obtain training on one DBT system, or general DBT training, to meet the new modality training requirement. Nevertheless, personnel are encouraged to pursue additional training on the unique features of their unit(s) and providers of DBT modality training are encouraged to discuss the similarities and differences between DBT systems.
Q. Must the training be provided by the manufacturer?
A. No. Under MQSA, the new modality training 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, Siemens, and Fuji, offers training on its own system; however, third-party training courses as well as certain 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 8 hours of DBT new modality training requirement is permitted.
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. The new modality requirement applies to all mammography personnel types listed above. For residents and fellows, the training can be obtained during residency or fellowship and should be documented in the residency or fellowship letter. Please see DMQS’s sample residency letter.
Q. How must I document initial new modality training on a DBT system?
A. Eight hours of general training in DBT, or 8 hours of training on a particular manufacturer’s DBT system, both count towards the new mammographic modality training requirement. Documentation may include: letters, certificates or other documents from manufacturer’s or other formal training courses, confirming letter from a Continuing Education Unit granting organization, or an attestation about experience with investigational units using DMQS’s recommended form.
For Further Questions
Q. I have additional questions on these requirements. Who should I contact?
A. Contact the FDA Mammography Facility Hotline at 1-800-838-7715 or MQSAhotline@versatechinc.com.