A memo from the Food and Drug Administration has clarified training requirements for medical imaging professionals who operate digital breast tomosynthesis machines. According to the memo, the two currently existing DBT units manufactured by Hologic and GE have been declared unique and separate modalities.
The memo indicates that “Due to the technological differences between the DBT units, as well as their different FDA-approved Indications for Use (IFU), each manufacturer’s DBT system is currently a new mammographic modality.”
Digital training provided as part a general training course is no longer sufficient for personnel who operate DBT units. If an operator received eight hours of training on DBT as a modality prior to August 2014, it is assumed that this training was specific to the Hologic unit, as it was the only DBT system approved at that time. Mammographers must now prove training on the unique features of the specific manufacturer’s DBT system before beginning to independently use that system. This would also apply if they had been trained on one type of DBT unit and began to work with a different type of DBT unit. The training in the unique features of the particular DBT system used may be included in the eight hours of new-modality training, or the training in the unique features may be obtained separately.
For additional information, please refer to The American College of Radiology’s Digital Breast Tomosynthesis (DBT) Initial Training: Frequently Asked Questions.