FDA Warns of Quality Problems with Mammograms at Florida Facility

FDA Warns of Quality Problems with Mammograms at Florida Facility

The Food and Drug Administration (FDA) is alerting patients about possible quality problems with mammograms done at Boston Diagnostic Imaging in Orlando, Florida on or after May 13, 2013.

The FDA says there are possible problems with the quality of mammograms done on or after May 13, 2013 at the Orlando facility. This does not mean that the mammogram results are inaccurate but patients should consider having their mammograms re-evaluated at a facility that is certified under the Mammography Quality Standards Act (MQSA) to determine if  patients need a repeat mammogram or additional medical follow-up. Patients have the right to request their mammogram and copies of their medical reports from Boston Diagnostic Imaging, according to the FDA.A mammogram is a safe, low-dose X-ray picture of the breast. It is currently the most effective method of detecting breast cancer in its earliest, most treatable stages, the FDA explains.

The American College of Radiology (ACR) conducted a clinical image review of mammograms performed by Boston Diagnostic Imaging between May 13, 2013, and May 13, 2015. The review was conducted after deficiencies were noted in the clinical cases that were submitted with the facility’s accreditation renewal application. The ACR revoked the facility’s application for mammography accreditation effective July 29, 2015. The facility’s MQSA certification was suspended on August 13, 2015, and the FDA directed the facility to cease performing mammography.

On August 13, 2015, the FDA directed the facility to notify all patients who received mammograms at Boston Diagnostic Imaging any time on or after May 13, 2013, and their referring health care providers, about the problems with the mammography quality at the facility.

Under MQSA, enacted in 1992, the FDA requires all mammography facilities to meet certain baseline quality standards and be certified to legally operate in the United States. Boston Diagnostic Imaging in Orlando did not meet standards for mammography quality under MQSA and at this time may no longer legally perform mammography.

The FDA recommends that patients who had a mammogram at Boston Diagnostic Imaging any time on or after May 13, 2013 and have not had a mammogram at an MQSA-certified facility since then, speak with their health care provider as soon as possible about medical follow-up. These patients may need to have their mammograms re-evaluated, and may need a repeat mammogram and/or further evaluation. Any patient who needs a repeat mammogram should be sure to have the procedure done at an MQSA-certified facility to ensure quality and accuracy.

The National Cancer Institute has a database of MQSA-certified facilities available online or by phone at 1-800-422-6237. Questions about the FDA safety communication may be directed to the MQSA Hotline at 1-800-838-7715, by email to MQSAhotline@hcmsllc.com, or fax to 1-410-290-6351.