The FDA has ordered Miami-based North Shore Medical Center to halt mammogram services over quality issues that may have led to inaccurate results, according to a letter obtained by the Miami Herald.
The FDA ordered the hospital, part of Dallas-based Steward Health Care, to stop performing mammograms March 14 after it determined the hospital "failed to meet the clinical image quality standards" set by the American College of Radiology, the facility's FDA-approved accreditation body for mammography services. The potentially inaccurate screenings were completed from March 14, 2022, to March 14, 2024.
"There is a serious concern about the quality of the mammography that our facility performed," Terri Noe, MD, lead interpreting physician at the hospital, wrote in a letter to patients, according to the news outlet. "This does not necessarily mean that the results you and your healthcare provider(s) were given are wrong," the letter states. "However, most patients will need to have their mammogram(s) performed at our facility reviewed to determine whether a repeat mammogram at another facility is needed."
Both the hospital and FDA declined to answer the Herald's questions surrounding how many patients were affected or why the mammograms didn't meet image quality standards.
According to Cathy Pague, a spokesperson for North Shore Medical Center, the hospital has contacted affected patients and their physicians. The facility is also "voluntarily covering the costs for reevaluation of individual mammograms and offering new screenings for all those who have not had subsequent screenings," she told the news outlet.
It's unclear if or when the hospital plans to resume mammograms. The FDA has said it is "not able to discuss details of possible or ongoing regulatory actions."
The service stoppage marks the latest in a series of cutbacks at the hospital. In March, NSMC began conducting layoffs as part of cuts to some of its programs. So far this year, the hospital has shuttered its neonatal intensive care, obstetrics and behavioral health units. Steward, the hospital's parent company, filed for Chapter 11 bankruptcy in May and is in the process of selling all 31 of its hospitals through auctions.
Becker's has reached out to NSMC and will update the report if more information becomes available.