Community hospital issues fix after FDA declares mammography services ‘serious risk to human health’
An Oklahoma hospital is resuming breast imaging services this week after the Food and Drug Administration recently raised red flags about the quality of its mammography services.
It was back on March 3 that the American College of Radiology first revoked Wagoner Community Hospital’s accreditation. Around that time, ACR noted “serious deficiencies” with the provider’s imaging quality, alerting federal officials to the issue.
FDA responded by declaring breast imaging delivered at the hospital a “serious risk to human health,” according to an update shared Monday.
Wagoner has now alerted constituents to the issue and is beginning to resume services, Director of Quality Brandy Moore, RN, told Radiology Business Tuesday. She said previous issues of grainy image quality stemmed from the use of outdated imaging equipment, and they’ve since made an upgrade that rectified the issue.
“Most of the deficiencies were based on that antiquated 2D technology that we had, which is why we bought a new 3D system,” she said. “We’re looking forward to utilizing it in the future.”
She added that the problem likely would have been solved sooner, but “COVID definitely put us behind in notification and communication with the FDA.”
The agency first initiated the call for additional mammography review in October after a previous inspection found quality control deficiencies. Wagoner’s accreditation was reinstated in late May following its corrective actions, according to the announcement.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.