THIS HOWEVER is up to date the results of something that started back in 94 and culminates in new standards and guidelines set by FDA. Clinicians will love the clarity and security of performing MRI mammograms in complete safety from hazardous xrays.. check it out..
.S. HHS: FDA issues final standards for
mammography facilities
( M2 PressWIRE )
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.
CONTACT: Sharon Snider
Tel: +1 301 827-6242
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