FDA issues FFDM and third-party PACS advisory
The obscuration is in violation of regulation 21 CFR 900.12(c)(5), or the view and laterality may not always appear near the axillary portion of the breast in either the soft or hard copy images, which may result in pathology being overlooked or incorrectly localized, according to the agency.
The FDA said the situation is especially important if the images are sent to another facility that is unfamiliar with the configuration of equipment being used at the facility performing the mammogram.
Therefore, the FDA is recommending that “all facilities check to ensure that all image-identifying information is correctly displayed on all their soft and hard copy mammography images.”
The agency noted that this advisory is intended to aid medical physicists, who conduct mammography equipment evaluations and surveys on mammography units, accreditation bodies that evaluate facility documentation for accreditation of a new unit, as well as Mammography Quality Standards Act inspectors, who review the documentation during inspections.