Technology changes drive new x-ray standards

August 16, 2006

The National Electrical Manufacturers Association has published two new standards for manufacturers of hard-copy and soft-copy reading devices for full-field digital mammography. The FDA-sanctioned documents should help breast imaging facilities meet their obligations under the Mammography Quality Standards Act.

The National Electrical Manufacturers Association has published two new standards for manufacturers of hard-copy and soft-copy reading devices for full-field digital mammography. The FDA-sanctioned documents should help breast imaging facilities meet their obligations under the Mammography Quality Standards Act.

Upon FFDM's introduction, system manufacturers provided components and an FDA-approved quality control plan to enable mammography facilities to comply with MQSA rules.

The FDA later approved other manufacturers to market hard-copy and soft-copy displays. This move made quality control at these facilities more difficult, since the MQSA requires the facilities to develop quality assurance plans consistent with those recommended by FFDM device manufacturers, said Dr. Charles Finder of the FDA MQSA program.

Quality control plans at individual facilities might not adequately address the needs of components developed by different manufacturers, Finder said.

The FDA asked NEMA's X-ray Imaging Section's mammography group to develop templates that provide a consistent presentation format and a minimum set of quality control tests for manufacturers. NEMA came up with Quality Control XR 22-2006 and XR 23-2006 manuals for hard-copy and soft-copy interpretation devices, respectively, said John Sandrik, chair of the NEMA group.

Display, workstation, and output device manufacturers who follow these templates will have incorporated the essential aspects of quality assurance programs being recommended, said Agfa Healthcare's Ralph Schaetzing, chair of the XR-23 Task Force.

"This will ease the burden of the mammography facility to establish and maintain a quality assurance program substantially the same as the one recommended by the image receptor manufacturer," Schaetzing said.

NEMA reached out to all known manufacturers, the American Association of Physicists in Medicine, and the American College of Radiology in order to achieve consensus.

"These standards will serve an important role until the ACR FFDM QC plan is completed," said Priscilla Butler, ACR's senior director for breast imaging accreditation programs.

Radiologists and imaging facility administrators can download XR 22-2006, Quality control manual template for manufacturers of displays and workstations labeled for final interpretation in full-field digital mammography, and XR 23-2006, Quality control manual template for manufacturers of hardcopy output devices labeled for final interpretation in full-field digital mammography, free of charge.

For more information from the Diagnostic Imaging archives:

Technology advancements spur new MRI test standards

Breast informatics drives health system's quality efforts

Digital mammography wins over lingering skeptics

MQSA historic success becomes regulatory threat