Date Issued

January 3, 2018

Audience

• Patients who had mammograms at Palm Beach Broward Medical Imaging Center located in Deerfield Beach, Florida any time on or after April 2, 2016.
• Health care providers who have referred patients to Palm Beach Broward Medical Imaging Center located in Deerfield Beach, Florida, for a mammogram performed on or after April 2, 2016.

Medical Specialty

Primary Care, Family Medicine, Internal Medicine, Obstetrics and Gynecology, Radiation Oncology, Radiology, General Surgery, Breast Surgery

Product

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.

Purpose

The FDA is alerting patients who had mammograms at Palm Beach Broward Medical Imaging Center located in Deerfield Beach, Florida, on or after April 2, 2016, about possible problems with the quality of their mammograms. This does not mean the results of the mammograms were inaccurate, but it does mean that health care providers and patients should consider having these mammograms re-evaluated at a Mammography Quality Standards Act (MQSA)-certified facility to determine if a repeat mammogram or additional medical follow-up is needed. Patients or their representatives have the right to request their mammograms and copies of their medical reports from Palm Beach Broward Medical Imaging Center.

Summary of Problem or Scope

The FDA became aware of problems associated with the quality of mammograms performed at Palm Beach Broward Medical Imaging Center located at the following address:

1500 Hillsboro Blvd.
Deerfield Beach, FL 33441

The results of an annual MQSA inspection of this facility in February 2017 indicated that the manufacturer’s recommended quality control tests were not performed after April 1, 2016. As a result, the FDA notified the facility that it was required to undergo an Additional Mammography Review (AMR) to determine if the overall quality of mammography performed at the facility was compromised due to the failure of the facility to operate in compliance with the MQSA.

The American College of Radiology (ACR) conducted a AMR of mammograms performed by Palm Beach Broward Medial Imaging Center and results indicated the mammograms did not meet the ACR’s clinical image evaluation criteria. On November 9, 2017, the ACR revoked the facility’s accreditation and on November 14, 2017, the FDA placed the facility’s MQSA certificate in a “no longer in effect” status.

Under the Mammography Quality Standards Act (MQSA) of 1992, the FDA requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States. This facility does not meet standards for mammography quality under that Act. This facility must no longer perform mammograms as it does not have an active MQSA certificate.

On November 30, 2017, the FDA directed the facility’s president to notify all patients who received mammograms at Palm Beach Broward Medical Imaging Center on or after April 2, 2016, and their referring health care providers, about the problems with the mammography quality at the facility. To date the facility has not performed the ordered notification.

Recommendations/Actions

The FDA recommends the following for patients who had a mammogram at Palm Beach Broward Medical Imaging Center on or after April 2, 2016:

• If you have had a more recent mammogram at a different MQSA-certified facility since then, you should follow the recommendations from that facility.
• If you have not had a mammogram at a different MQSA-certified facility since then, follow these guidelines:
  • Talk with your health care provider as soon as possible about your medical follow-up. You may need your mammogram re-evaluated, and possibly need a repeat mammogram and/or possible further evaluation.
  • If your health care provider recommends a repeat mammogram, it should be done at an MQSA-certified facility. A database of MQSA-certified facilities in your area is available online, or you can call the National Cancer Institute’s information number at 1-800-422-6237 to find an MQSA-certified facility in your area.

FDA Activities

The FDA will continue to monitor this issue and keep the public informed as new information becomes available.

Contact Information

If you have questions about this communication, please contact the MQSA Hotline by phone: 1-800-838-7715, email: [email protected] or fax: 1-443-285-0689.