The current status of full-field digital mammography quality control.

U.S. Food and Drug Administration (FDA) regulations require that medical physicists and technologists adhere to the procedures, testing frequencies, and performance criteria outlined in the quality control (QC) manuals provided by the manufacturers of full-field digital mammography (FFDM) systems. As a result of this requirement, QC for digital equipment has become both complicated and inconsistent. The objective of this study was to compare the current QC protocols for the tests to be performed by medical physicists for three commercially available FFDM systems (the Senographe 2000D, the SenoScan, and the Selenia). Although not yet approved by the FDA, the 5000 MA was also included because of its unique design and extensive use in a major ongoing clinical research trial involving the other three FFDM systems. It was found that currently, a high degree of discord exists between the FFDM QC protocols of the early commercial systems, with wide variation in opinion with respect to the minimum performance criteria and testing intervals and with respect to which tests are necessary and what quantities should be measured. Additionally, very few digital detector-specific tests are currently in place. Although technological differences between the early FFDM systems prohibit a strictly uniform set of QC procedures and performance guidelines, a much greater degree of consensus among manufacturers is desirable as FFDM continues to gain clinical presence during the next few years.