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Date: Monday, October 27, 1997
FOR IMMEDIATE RELEASE
Contact:  FOOD AND DRUG ADMINISTRATION
Sharon Snider:    (301) 827-6242
Broadcast Media:  (301) 827-3434
Consumer Hotline: (800) 532-4440

As part of Breast Cancer Awareness Month, the Food and Drug Administration today announced final regulations that significantly improve the quality and performance of equipment and personnel at all mammography facilities in the United States. The rules expand and strengthen interim regulations in effect since 1994.

"High quality mammograms are essential for early detection of breast cancer," said Health and Human Services Secretary Donna E. Shalala. "FDA's mammography quality program assures women that their mammograms will be done by trained medical personnel at properly equipped facilities and that the resulting images will be of the best possible quality. Our final regulations will help assure that high quality standards will be a reality at virtually all facilities that perform mammography in this country."

The final regulations implement the Mammography Quality Standards Act (MQSA) passed by Congress in 1992 because of concern that not all women were receiving high quality mammography services and worry that breast cancer was being missed in some women.

MQSA requires that all mammography facilities in the United States meet certain stringent quality standards, be accredited by an FDA-approved accreditation body, and be inspected annually.

Over the past three years, the quality of mammography has improved dramatically. Almost all of the nation's 10,000 mammography facilities have been inspected and accredited. Prior to 1992, only about 46 percent of facilities were accredited and many facilities were never inspected.

The regulations require that personnel who perform mammography be adequately trained and qualified to conduct mammography examinations and interpret results; that mammography equipment have appropriate design and performance characteristics; and that doctors and patients be quickly and fully informed of results so that any follow-up testing or treatment can begin immediately.

The final rules toughen the standards for personnel, equipment, quality assurance and quality control, patient notification of results, and accreditation body performance. For example, physicians who interpret mammograms must now 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. They spell out requirements for mammography equipment, including for motion of the tube-image receptor assembly, image receptor sizes, beam limitation and light fields, magnification, focal spot selection, compression, technical factor selection and display, automatic exposure control, x-ray film, lightening, and film masking devices.

The final rules also require more quality control of mobile mammography units and set new standards for imaging breast implants. They also require that each facility have a consumer complaint mechanism. In addition, the rules make it clear that original mammograms must be made available to other medical facilities at the patient's request. This last change is expected to end the difficulty many women experienced under the interim regulations obtaining previous original mammograms for comparison with new mammograms, an essential aid to diagnosis.

The new regulations balance cost with the need for mammography to be accessible; they also balance achievability and flexibility.

Annual inspections to date show that overall the nation's mammography facilities have a very good record of complying with standards. The first year's inspections in 1996 showed that 80 percent of the facilities had either no violations or minor ones, and that only two percent had violations serious enough to warrant a warning letter from the FDA. The second year's inspections have shown further improvement. So far, less than one percent of facilities have been found to have serious problems.

A recent Government Accounting Office report found that adherence to the new standards has had a positive effect on mammography services, and the quality of x-ray is up at mammography facilities across the nation. Before the mammography law took effect, 14 percent of facilities tested were unable to pass image quality tests; now, the nationwide figure is 2 percent.

The names and locations of accredited facilities are available by calling the Cancer Information Service at 1-800-4 CANCER (1-800-422-6237). They are also available on the Internet on FDA's home page at www.fda.gov/cdrh/dmqrp.html.

All accredited facilities receive a certificate from the FDA which they must prominently display stating that they are certified to perform mammography.

The final regulations will be published in the October 28 Federal Register.