The U.S. Food and Drug Administration (FDA) has issued a safety notification for Medisound, Inc./Digital Radiology Center, in Kissimmee, Fla., which it says was performing mammography without an MQSA certificate.
According to the safety alert, the FDA became aware of problems at the facility while it was working with the American College of Radiology (ACR) on a review of the facility’s accreditation application and request to do business under a new name.
Medisound Inc. had changed its name to Digital Radiology Center after Medisound was the subject of an FDA Safety Notification in August of 2010 for producing poor quality images and possibly unreliable mammography results.
On September 6, the FDA and the Florida Department of Health inspected Digital Radiology Center and found that mammograms had been done at the facility without it having been certified as meeting the baseline quality standards mandated by the Mammography Quality Standards Act (MQSA) of 1992. Furthermore, the FDA stated that Digital Radiology Center had failed to perform required testing on its mammography equipment.
In the safety notification, the FDA recommended that patients who had received a mammogram at the Medisound/Digital Radiology Center facility in Kissimmee, Fla. any time after June 8, 2011, take one of two actions:
- If they had received a mammogram at another facility since their mammogram at Medisound/Digital Radiology Center, they should follow the recommendations from that facility.
- If they had not had a mammogram at another facility since their mammogram at Medisound/Digital Radiology Center, they should ask their primary health care provider if they might need a second mammogram.
Recognizing that for some patients this may be a financial burden as health insurance plans do not typically cover second mammograms, the FDA recommended that patients who will need to pay the full cost of their follow-up testing call the National Cancer Institute’s (NCI) information number at 1-800-422-6237 for a listing of facilities near Kissimmee that provide free or low- cost mammograms.