On August 17, the Food and Drug Administration (FDA) issued a safety communication alerting patients to possible quality problems with mammograms done at Boston Diagnostic Imaging in Orlando, Florida on or after May 13, 2013.
The FDA notes possible problems with the quality of mammograms done on or after May 13, 2013. The agency explains that the alert does not mean that the mammogram results are inaccurate but patients should consider having mammograms done at Boston Diagnostic Imaging re-evaluated at a facility that is certified under the Mammography Quality Standards Act (MQSA) to determine if they 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.
The FDA explains that a mammogram is a safe, low-dose X-ray picture of the breast. Currently, a mammogram is the most effective method of detecting breast cancer in its earliest, most treatable stages.
After deficiencies were noted in the clinical cases Boston Diagnostic Imagine submitted with the facility’s accreditation renewal application, 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. As a result of the review, the ACR revoked the facility’s application for mammography accreditation effective July 29, 2015 and the facility’s MQSA certificate was suspended on August 13, 2015.
The FDA ordered the facility to cease performing mammography. On August 13, 2015, the FDA directed the Boston Diagnostic Imaging to notify all patients who received mammograms at the Orlando facility any time on or after May 13, 2013, and their referring health care providers, about the problems with the mammography quality at the facility.
MQSA was enacted in 1992 and under its provisions, all mammography facilities must meet certain baseline quality standards and be certified to legally operate in the United States. Boston Diagnostic Imaging in Orlando does not meet standards for mammography quality under MQSA and at this time may no longer legally perform mammography.
If a patient had a mammogram at Boston Diagnostic Imaging any time on or after May 13, 2013 and has not had a mammogram at an MQSA-certified facility since then, the FDA recommends that the patient speak with a 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. If a repeat mammogram is required, the patient should be sure to have the procedure done at an MQSA-certified facility to ensure quality and accuracy.
To find an MQSA-certified imaging facility, contact the National Cancer Institute 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.