Doctors at the Hilo Women’s Imaging Center, part of Hawaii Radiologic Associates Ltd., are notifying patients of possible inaccuracies in thousands of mammograms as the center completes a re-certification process for its imaging equipment.
Certified letters went out last week informing people of the potential for inaccurate mammograms taken between June 30, 2014, and Aug. 24, 2015, on one of the center’s two machines.
About 12,000 mammograms were performed during that period.
The U.S. Food and Drug Administration ordered mammography operations at the center suspended until the re-certification process is complete, which could take up to two months.
Referring physicians also were notified via letter and, in many cases, in person by radiologist Dr. David Camacho, a partner with Hawaii Radiologic Associates.
“It’s not necessarily that there are (errors), but that there could be,” Camacho said Monday. “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.”
The mammography machine in question has since been inspected by the manufacturer and deemed suitable for use, Camacho said.
The FDA retracted the Hilo center’s accreditation after an annual evaluation by the American College of Radiology determined the mammography unit “failed to meet standards,” according to a statement from HRA. Thirty random samples from the 14-month period were used in the evaluation.
“It could be positioning, or when you take a picture it’s a little blurry because the patient moved,” Camacho said of the potential errors. He said it was unlikely that misdiagnoses or a lack of diagnosis occurred during the time frame in question.
“That could happen, but I would pretty much doubt that would happen because we’re a sensitive mammography center,” Camacho said.
The rest of the department’s imaging equipment — such as magnetic resonance imaging (MRI), CT scans, ultrasounds and X-rays — remains accredited. The Hilo center continues to provide these services.
Patients are being asked to check with their physician to see if a re-test is necessary. If that is the case, a new mammogram will be taken at HRA’s Kona center, which is unaffected by Hilo’s decertification. HRA will cover the cost of the mammogram.
“We’re just covering all of the bases,” Camacho said. “We’ll look at everybody and make sure.”
The center was notified in March of the mammography accreditation loss, the first since it opened in 1972.
Camacho said that because mammograms are an annual exam for women age 40 and older, about half of the patients already have been back for evaluations during a period when the machine’s accreditation was not in question.
“That’s the good news out of all this,” he said. “We’ve already looked at more than half of them already.”
Hawaii Radiologic Associates created a hotline at 808-769-5646 for patients and physicians with questions.
Email Ivy Ashe at iashe@hawaiitribune-herald.com.
