The law that charges the U.S. Food and Drug Administration with maintaining quality of mammographythe National Mammography Quality Standards Actwill be up for reauthorization in 2007. The reauthorization has provided Congress and the FDA with the opportunity to take a close look at areas that could use some improvementor a complete makeover.
Congress asked the Institute of Medicine, part of the National Academies, to examine current mammography practices and to make recommendations for future improvements. In September, the FDA's National Mammography Quality Standards Act Advisory Committee met with agency staff to discuss the recommendations IOM made in its report, Improving Breast Imaging Quality Standards, which was released in May. Almost all of the 14 members of the FDA committee have a professional stake in mammography services, so their fall meeting was an opportunity to hear from the breast imaging provider community for its take on the recommendations.
IOM recommendations dealing strictly with technical matters generally drew little fire from panelists. None of them, for example, found fault with requiring FDA to set a minimal luminance level for the lighted view boxes that are used in the evaluation of mammograms. Nor did panelists quarrel with the report's authors recommending that the agency develop a uniform set of quality-control tests and test criteria for its regulation of digital mammography.
Still, some panelists disagreed with parts of the IOM recommendations. For example, one of the report's suggestions would have the regulations for the Medical Quality Standards Act mandate a revision of the medical outcomes audits that facilities conduct already to standardize and expand on the information they collect. Although the report argues that this would ease the ambiguous data problem and could help radiologists become more proficient at correctly reading mammograms, those panelists who spoke up on the matter were opposed to these changes in methodology. E. Scott Ferguson, M.D, a West Memphis, Ark., radiologist, was one of these critics: "[The changes] would be a burden on the system," he said. "I dont know what good they would do."
Establishing a data and statistical center that would, among other things, electronically collect and analyze information about patients and their tumors (according to their size, type, and stage, for instance) from pathology reports was another IOM suggestion that the panel did not wholly endorse. Radiologists on the panel thought the project would be more trouble than it was worth. "It's hard for me as a practicing radiologist to see ... [how] it would improve patient outcomes," said Debra Monticciolo, M.D., of the Scott and White Clinic in Temple, Texas.
Also unpopular with some on the panel were several steps the IOM plan says could be taken to ensure that access to mammography services is readily available despite a looming shortage of radiologists willing to specialize in breast imaging in some parts of the United States.
The suggestion that a corps of radiologist assistants (as distinct from radiologic technologists) could ease the shortage and enable more mammograms to be double readthus reducing the chances of missing tumors (or mistakenly finding them)was high on this disapproval list. Again, it was the panel's radiologists who led the charge. As Monticciolo put it, "unless radiologist assistants were willing to take on the medicallegal burden (that radiologists face), not many radiologists in this country would be willing to accept them (as colleagues)."
Meanwhile, the use of ultrasound and magnetic resonance imaging as supplements to film and digital mammography is growing. And more surgery, though not all, for the localization or sampling of tumors is being done stereotacticallyi.e., under concomitant x-ray mammography guidance. Accordingly, the question for FDA and Congress is whether these relatively new modalities and procedures should be federally regulated and, if so, to what extent and by what means.
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"Regulation of breast ultrasound and breast MRI are also mandates that are likely to result in improved technical quality," Carol H. Lee, M.D., chair of the American College of Radiology Commission on Breast Imaging, said in her presentation to the FDA panel. "Unfortunately, this is not yet feasible for breast MRI because the accreditation program has not been established, and also, the hardware and software is still in development in terms of technique for breast MRI."
Summary of IOM Recommendations To Improve Breast Imaging Quality
Source: Improving Breast Imaging Quality Standards (Institute of Medicine 2005), access at http://www.iom.edu/report.asp?id=27028.
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