Digital mammography struggles with PACS compatibility glitches

August 4, 2008 Digital mammography struggles with PACS compatibility glitches H. A. Abella -------------------------------------------------------------------------------- A recent advisory by the FDA urging breast imaging facilities to ensure compatibility between full-field digital mammography systems and PACS exposed an ongoing problem: Interoperability issues persist as some vendors fail to comply with healthcare digital imaging standards. The FDA learned that image quality from a number of FFDM units was being compromised when displayed on some third-party PACS. According to the agency: The image identification information quadrant by some PACS may obscure breast tissue on hard-copy images in violation of regulation 21 CFR 900.12(c)(5). The view and laterality may not always appear near the axillary portion of the breast in either of these PACS's soft- or hard-copy images as required by regulation 21 CFR 900.12(c)(5)(iii). These issues could lead radiologists to overlook or misplace suspicious lesions, a problem that escalates when images end up at facilities unfamiliar with the configuration of equipment originally used to perform the mammogram. The FDA thus recommended July 29 that all facilities check to ensure that image-identifying information is correctly displayed on both soft- and hard-copy FFDM images.

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