"It's a reauthorization of the original act," said Robert A. Smith, PhD, director of cancer screening for the American Cancer Society. "Commonly, these appropriations are authorized only for a limited period of time after which Congress and the agencies reassess and determine whether or not to reauthorize the law."

"This essentially gives them the opportunity to, perhaps, alter the legislation and correct some shortcomings or oversights in the original legislation and either increase, let it remain the same, or decrease the funding level," he added.

The regulations require technicians who perform mammograms to be properly trained, mammography equipment to have appropriate design and performance characteristics, and doctors and patients to be quickly and completely informed of results so follow-up testing or treatment can start immediately.

Physicians who interpret mammograms now must have 60 hours training in mammography, technologists must keep their skills current by doing an average of 200 mammograms every two years, and medical physicists who survey mammography equipment and facilities must meet initial and ongoing training requirements.

The regulations better define equipment capabilities needed for high-quality mammography and spell out equipment requirements. The final rules require more quality control of mobile mammography units and set new standards for imaging breast implants. They also require facilities to have a consumer complaint mechanism and make it clear that mammograms must be made available to other medical facilities when a patient requests it. The new regulations also balance cost with the need for mammograms to be accessible to more women.

The original goal of the act, said Dr. Smith, was to assure a high minimum standard of mammography all women could depend upon. The ACS and other organizations had strongly encouraged women to ask if a facility was accredited. As a result, more and more facilities that had not been interested in going through a peer evaluation of their performance suddenly found women were choosing to go only to facilities that had submitted to that scrutiny.

One of the most important points in the reauthorization is the amendment requiring all women receive results of their mammogram directly from the interpreting physician, Dr. Smith said. "This means women will no longer have to operate under the assumption that no news is good news."

Annual inspections show mammography facilities have done a good job of complying with standards. The first year's inspections, in 1996, revealed 80 percent of facilities had either no violations or minor ones. Only two percent had violations serious enough to warrant a warning letter from the US Food and Drug Administration. The second year's inspections showed even more improvement.

Link: FDA Closes Mammography Facility