FDA: Mammo facilities no longer required to maintain printers

The FDA has announced that mammography facilities are no longer required to maintain a printer and/or the ability to print hard-copy images. The decision is now up to each individual facility.

The FDA statement detailed how advances in technology have made the printers less necessary.

“Digital mammography was introduced into clinical use fifteen years ago, and today fewer than 350 screen-film units remain in use in the U.S.,” the FDA’s statement read. “The nearly universal availability of computers for viewing of digital images diminishes the need for a facility to maintain a printer. Another change in current practice was the introduction of digital breast tomosynthesis (DBT) in 2011 and its rapid clinical adoption. DBT images are intended solely for soft-copy interpretation.”

The FDA also noted that any exchanges of images between facilities can be accomplished through whatever format both parties agree on, since there is no specific regulation.

Michael Walter
Michael Walter, Managing Editor

Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.

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