FDA Safety Communications: Mammogram Quality Problems

Mammograms at Richard D. Adelman M.D. in Raleigh, North Carolina: FDA Safety Communication - Quality Problems

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

ISSUE: FDA is alerting patients who had mammograms at Richard D. Adelman, M.D., Family Medicine practice located in Raleigh, North Carolina, any time after August 24, 2012, about possible problems with the quality of their mammograms. The American College of Radiology (ACR) did a review of mammograms performed by the Richard D. Adelman, M.D., Family Medicine practice between August 25, 2012, and August 25, 2014 and identified problems with the quality of the mammograms. ACR revoked the facility's accreditation on November 5, 2014. On November 18, 2014, the FDA required the facility to notify all patients who received mammograms at its facility any time after August 24, 2012 about these problems, and to stop performing mammography.

This does not necessarily mean that the results of the mammograms were inaccurate, but patients should have their mammograms reviewed at an Mammography Quality Standards Act (MQSA)-certified facility to determine if they need a repeat mammogram or additional medical follow-up. Patients have the right to request their original mammogram and copies of their medical reports from Richard D. Adelman, M.D, Family Medicine practice.

BACKGROUND: 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 did not meet standards for mammography quality under the Act. The facility may not perform mammography due to the revocation of its accreditation by the ACR and its MQSA certification being no longer in effect until the accreditation is reinstated.

RECOMMENDATION: The FDA recommends the following for patients who had a mammogram at Richard D. Adelman M.D., Family Medicine practice any time after August 24, 2012:

• If you have had a more recent mammogram at an 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:
• Consider requesting your mammogram and copies of your medical reports from Richard D. Adelman, M.D, Family Medicine practice and have your mammogram reviewed at an MQSA-certified facility to determine whether a repeat mammogram or additional medical follow-up is needed. 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 NCI information service at 1-800-422-6237 for a listing of MQSA-certified facilities near you that provide free or low-cost mammograms.
• If you have questions about this communication, please contact the MQSA Hotline at 1-800-838-7715, email your question to MQSAhotline@hcmsllc.com or fax to 1-410-290-6351.

Read the MedWatch safety alert, including a link to the FDA Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm439723.htm

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