FDA MedWatch - Mammograms at Boston Diagnostic Imaging in Orlanda, Florida: FDA Safety Communication - Quality Problems

Mammograms at Boston Diagnostic Imaging in Orlanda, Florida: FDA Safety Communication - Quality Problems

AUDIENCE: Family Practice, OBGYN, Oncology, Radiology, Patient

ISSUE: FDA is alerting patients who had mammograms at Boston Diagnostic Imaging located in Orlando, Florida, anytime on or after May 13, 2013, about possible problems with the quality of their mammograms.

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 FDA suspended the facility’s Mammography Quality Standards Act (MQSA) certificate on August 13, 2015, and 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. This does not mean that the results of the mammograms were inaccurate, but it does mean that the patients should consider having their mammograms re-evaluated at a MQSA-certified facility to determine if the 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.

BACKGROUND: Under the 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 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.

RECOMMENDATION: The FDA recommends the following for patients who had a mammogram at Boston Diagnostic Imaging any time on or after May 13, 2013:

• If you have had a more recent mammogram at a MQSA-certified facility since then, you should follow the recommendations from that facility.
• If you have not had a mammogram at an 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 to ensure quality and accuracy. A database of MQSA-certified facilities in your area is available online or by calling the National Cancer Institute’s (NCI) information number at 1-800-422-6237.
• If you need a repeat mammogram and your health insurance will not pay for it, you can call the National Cancer Institute’s (NCI) information number at 1-800-422-6237. Experts at this number may be able to identify a facility near you that provides free or low-cost mammograms.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including the link to the Safety Communication: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm458677.htm