FDA questions mammography quality at Fla. center

The U.S. Food and Drug Administration (FDA) has released an alert regarding possible issues with the quality of mammograms acquired at Palm Beach Broward Medical Imaging Center in Deerfield Beach, FL, on or after April 2, 2016.

In an annual Mammography Quality Standards Act (MQSA) inspection of the facility in February 2017, the FDA discovered that the facility did not perform the quality control tests recommended by manufacturers of the mammography machines.

The American College of Radiology (ACR) subsequently conducted an Additional Mammography Review (AMR) and determined that mammograms at the facility did not meet clinical image evaluation criteria set by the college. The ACR revoked the facility's accreditation on November 9, 2017, and on November 14 the FDA removed the facility's MQSA certificate and, thus, its legal capacity to offer a mammography exam in the U.S.

The FDA advised several measures for patients who had a mammography exam at the facility on or after April 2, 2016:

  • Schedule a medical follow-up with a healthcare provider for re-evaluation of mammograms taken at the facility.
  • Schedule a repeat mammography exam at an MQSA-certified facility, if the healthcare provider deems a repeat mammogram necessary.
  • Patients who have had a more recent mammogram at a different MQSA-certified facility should follow that facility's protocol.

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