FDA warns of mammo quality performed at Florida facility
The agency said it worked with the American College of Radiology (ACR) as its agents initiated a review of a sample of mammograms performed by Medisound that included images taken between June 10, 2008 through June 12 of this year.
Results from that review included “poor quality mammograms with possibly unreliable results,” according to the FDA.
Under the Mammography Quality Standards Act (MQSA) of 1992, the FDA requires that all mammography facilities meet certain high quality standards. Medisound did not meet standards for mammography quality under MQSA and no longer performs mammography due to a denial of its accreditation by the ACR.
The FDA is alerting patients who had mammograms at this facility between the specified time period about possible problems with the quality of mammograms performed. However, the agency noted that these actions "[do] not mean that the results of all of the exams were inaccurate, [nor] does it mean that patients might need to have their mammograms re-evaluated and possibly repeated.”
The agency said it will continue to monitor this problem and keep the public informed as new information becomes available.