Mammography procedures at the Hilo Women’s Imaging Center are on track to resume in the coming weeks.
Mammography procedures at the Hilo Women’s Imaging Center are on track to resume in the coming weeks.
Procedures were suspended two months ago after the center’s mammography services were decertified by the U.S. Food and Drug Administration. The FDA decision came after one of the center’s two mammography machines did not receive its annual accreditation from the American College of Radiology. A random sampling of 30 images taken between June 30, 2014, and Aug. 24, 2015, did not meet quality standards.
“There are a lot of quality issues with mammograms (so) it’s highly regulated,” said Dr. David Camacho, a partner and co-owner of Hawaii Radiologic Associates Ltd., which operates the Hilo Women’s Imaging Center in addition to a clinic in Kona.
Mammogram quality is affected by factors such as how technicians set up the image, whether a woman accidentally moves during the procedure and the performance of the machine itself. One machine had been “giving us trouble kind of intermittently,” Camacho said.
“You’re tweaking it all the time,” he said.
Both mammogram machines were accredited last week by the ACR, which reported the results to the FDA.
“We passed everything again,” Camacho said. “So, we’re waiting for the FDA to now certify us.”
The accreditation loss was the first since the Hilo center opened in 1972. The facility’s other imaging equipment, such as its MRI machine, was unaffected and has remained in operation.
As required by the FDA, the center sent out 12,000 certified letters in early April to patients who had received a mammogram during the period when inaccurate images might have been made.
Referring physicians also were notified. Patients were asked to check with their physician regarding whether they needed their mammograms re-reviewed.
Certified mail must be signed for and picked up in person at the post office, leading to days of long lines after women were notified of their letters.
As of Thursday, 3,750 people had called their physicians or the center asking for a new review. The FDA requested that patients call physicians first, not the center.
Given the volume of extra calls they have fielded, the physicians have been “totally helpful and understanding,” Camacho said. “I was really nervous about that, but they told me ‘Don’t worry, we’ll take of it’… I think the main focus of the community has been for the patients.”
So far, 350 of the 3,750 mammograms have been checked, and three women have been asked to come back for a re-screening. That screening comes free of charge.
“If it’s not exact, we’re calling (them) back,” Camacho said. The center also hired MagView, a Maryland-based company that specializes in mammography information services, to write a software program for reading the remaining images.
The remaining mammograms will be reviewed by the end of the month.
Still, not all patients went to pick up their letters.
About 3,500 letters, or just under one-third of the total, had to be re-sent via regular mail to ensure patients were notified. Those letters went out Friday, Camacho said.
The suspension of procedures in Hilo also has led to a substantial backup of appointments. Appointments made before the March suspension had to be rescheduled.
Camacho estimated about 2,500 patients were waiting for the center to reopen so they could have their regular appointments. The center typically performs 250 mammograms a week, he said.
“A few are driving to Kona,” he said. Most preferred to wait for the reopening so they would not have to drive across the island. Mammograms are an annual exam for women age 40 and older.
“It’s hard enough actually bringing people in to have this done as an exam,” Camacho said.
When the recertification is complete, the Hilo center will be open seven days a week in order to address the appointment backlog.
For more information about the recertification process, visit www.hirad.com/mammo.html
Email Ivy Ashe at iashe@hawaiitribune-herald.com.