HILO » Doctors are warning patients that there could be inaccuracies in thousands of mammograms taken in a Hilo imaging center while it was using a faulty machine.
The Hawaii Tribune-Herald reported Hilo Women’s Imaging Center, part of Hawaii Radiologic Associates Ltd., is telling patients one of the center’s two machines was problematic from June 30, 2014 and Aug. 24, 2015, when 12,000 mammograms were performed.
The U.S. Food and Drug Administration retracted the Hilo center’s accreditation after an annual evaluation by the American College of Radiology determined the mammography unit “failed to meet standards.”
Dr. David Camacho, a partner with Hawaii Radiologic Associates, said it isn’t that there necessarily are errors with the images, but that there could be.
“We (were) accredited from August 2015 until now . they want us to go back and look at those mammograms . (from) the time that we were having trouble with the one machine,” he said.
Camacho said the errors could be something minor such as positioning, or a patient moving when the image was taken. He said it is unlikely that misdiagnoses or a lack of diagnosis occurred.
“We’re just covering all of the bases,” Camacho said. “We’ll look at everybody and make sure.”
The FDA has ordered the center to stop performing mammograms while it completes a re-certification process for its imaging equipment.
Camacho said since mammograms are an annual exam for women over the age of 40 about half of the affected patients have already been back for evaluations that were not affected by the imaging issues.