Accuracy of 12,000 mammograms in question after FDA retracts imaging center’s accreditation

Hilo Women’s Imaging Center in Hawaii has begun notifying patients that mammograms taken at the facility between June 30, 2014, and Aug. 24, 2015, may contain inaccuracies after an annual evaluation by the American College of Radiology determined that one of its machines “failed to meet standards,” leading the FDA to retract the center’s accreditation.

Approximately 12,000 mammograms were conducted at the imaging facility, which is part of the part of Hawaii Radiologic Associates Ltd., during that time period, according to an article published online by the Hawaii Tribune-Herald.

“It could be positioning, or when you take a picture it’s a little blurry because the patient moved,” said David Camacho, MD, a partner with the group, adding that it was unlikely that misdiagnoses or a lack of diagnosis occurred. “That could happen, but I would pretty much doubt that would happen because we’re a sensitive mammography center.”

The FDA has ordered the center to suspend all mammography operations until the completion of a re-certification process.