A diagnostic imaging facility in Orlando, Boston Diagnostic Imaging, has been ordered to stop performing mammograms due to potential quality issues. According to a safety alert posted on the U.S. Food and Drug Administration’s (FDA’s) website, mammograms performed on or after May 13, 2013 may have quality issues. While the results of these mammograms may not necessarily be incorrect, patients are advised to have their mammograms re-evaluated at a Mammography Quality Standards Act (MQSA)-certified facility. The FDA suspended the facility’s MQSA certificate on August 13th and also ordered Boston Diagnostic Imaging to stop performing mammography.
A clinical review conducted by the American College of Radiology (ACR) between May 13, 2013 and May 13, 2015 identified quality problems with mammograms performed at the facility. The ACR revoked the facility’s mammography accrediation on July 29, 2015.
The FDA instructed the facility to notify all affected patients about the quality issues on August 13th. In order for a mammography facility to operate legally in the United States, it must meet baseline quality standards under the MQSA of 1992. Boston Diagnostic Imaging “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.” the FDA alert stated.
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from Parker Waichman http://www.yourlawyer.com/blog/diagnostic-imaging-facility-in-orlando-has-mammography-certificate-suspended/
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