HHS NEWS

P97-35                        FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE         Sharon Snider:    (301) 827-6242
October 27, 1997              
                              Consumer Hotline: (800) 532-4440

 
     FDA ISSUES FINAL STANDARDS FOR MAMMOGRAPHY FACILITIES

     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 to 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.
                         ####