Increase in Violations of FDA Mammography Standards Reported

An increase in serious and moderate violations of the U.S. Food and Drug Administration mammography standards occurred during the past year, according to the FDA's annual report.

Violations resulted in revocation of at least two facility accreditations by the American College of Radiology during 2000 and one mammography technician is under criminal prosecution by the FDA. Two facilities have been closed in California and one each in New York, South Carolina and Texas, according to the report.

A total of 18 incidents were listed in the FDA document, ranging from failure to perform quality checks to technicians operating without a license.

Under federal regulations put into place in 1992, all mammography facilities are required to meet strict quality standards including certification. Currently, 9,407 facilities out of 9,725 have become fully certified with the remainder earning provisional certification as they complete the process of becoming accredited.

"We are confident that the number of citations will decrease as all of us in the mammography community become more familiar with requirements under the final regulations," said Capt. John McCrohan, director of the agency's mammography division and author of the report.

Other sources: FDA