FDA Mammography Inspection Training Video

FDA has issued a training video to help mammography facilities and their staffs better understand new Mammography Quality Standards Act inspection review questions dealing with mammography image quality. CDRH Division of Mammography Quality Standards director Helen Barr says in her introduction to the video’s mock inspection scenario that image quality issues led to about half of the additional mammography reviews last year. She says that with modern mammography technology, problems are usually not machine-related, but rather are due to image issues often caused by problems with patient positioning and compression.

The video explains the agency’s EQUIP (Enhancing Quality Using Inspection Program) effort. It includes discussion of the responsibility of interpreting physicians and lead interpreting physicians regarding image quality. It stresses that EQUIP does not involve any new regulations, but rather a new emphasis in the existing inspection protocol.