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FDA Warns of Mammogram Quality Problems at Orlando Imaging Facility

Aug 18, 2015

The U.S. Food and Drug Administration (FDA) is notifying patients of potential mammogram quality issues at a facility in Orlando. According to a safety alert posted on the agency's website on August 17th, mammograms that were performed at Boston Diagnostic Imaging on or after May 13, 2013 may have issues with quality. The agency states that the results may not necessarily be inaccurate, but affected patients should consider having their mammograms re-evaluated at a Mammography Quality Standards Act (MQSA)-certified facility to determine if another mammogram or additional follow-up is necessary.

The American College of Radiology (ACR) conducted a review of mammograms performed at Boston Diagnostic Imaging after finding issues with clinical cases submitted with the facility's renewal application, the FDA said in the alert. The clinical image review was conducted between May 13, 2013 and May 13, 2015. On July 29, 2015, the ACR revoked the facility's mammography accrediation. The facility had its MQSA certificate suspended by the FDA on August 13, 2015; the agency ordered Boston Diagnostic Imaging to stop performing mammography.

The FDA instructed the facility to inform all affected patients about the quality issues on August 13th. In order for a mammography facility to operate legally in the United States, it must meet baseline quality standards under the MQSA of 1992. Boston Diagnostic Imaging "did not meet standards for mammography quality under the Act. The facility may no longer legally perform mammography at this time due to the suspension of its MQSA certificate." the FDA alert stated.

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