NEWS
12/14/1993
Clinton Amends the 1992 Mammography Quality Standards Act
P93-45 Sharon Snider
FOR IMMEDIATE RELEASE Office 301 443-3285
President Clinton today signed an amendment to the 1992
Mammography Quality Standards Act authorizing the Food and Drug
Administration to immediately publish improved mammography
standards that are essential for early diagnosis of breast cancer.
The new FDA regulations, which will be published shortly in
the Federal Register, establish quality control standards and a
certification system for more than l0,000 U.S. medical facilities
that perform and interpret mammography tests.
"These measures can make an important difference in the lives
of thousands of American women," said Donna E. Shalala, Secretary
of Health and Human Services. "The purpose of the regulations is to
make every mammogram count in the fight against breast cancer. As
the new standards go into effect, women can be sure that their
mammograms are of top quality.
"I expect the mammography facilities to act with the same
determination shown by President Clinton, who has given the new
quality standards a high priority," Secretary Shalala added. "And
I wish to express my appreciation to Congress for providing FDA
with the authority to implement this program. Without the hard work
and commitment of Sen. Barbara Mikulski, Reps. John Dingell and
Henry Waxman, and members of the Congressional Caucus for Women's
Issues, we would not be where we are today."
-MORE-
Page 2, P93-45, Mammography
By Oct. 1, 1994, every facility that performs mammography will
have to be certified by FDA to continue to operate legally. Even
facilities that do not perform mammography but only interpret
mammograms will have to be certified that they meet FDA's
standards.
The rules cover equipment, personnel and practices at
mammography facilities. They also set standards for approval of
accrediting bodies.
The new rules implement the Mammography Quality Standards Act,
which was enacted in 1992 following reports that some poorly
conducted and misread mammography tests had been responsible for
delayed diagnoses of breast cancer and deaths.
The new interim regulations require that:
* personnel who perform mammography and physicians who
interpret the mammograms be certified or licensed and have adequate
training and experience;
* all certified facilities be inspected annually by federal
inspectors or state inspectors working under contract to FDA;
* mammography units be monitored closely to ensure proper
radiation levels;
* facilities set up quality assurance programs to ensure that
mammograms are as clear as possible, and that positive results are
followed up properly; and
* mammography and other patient records be retained for five
years.
-MORE-
Page 3, P93-45, Mammography
The new rules require that mammography facilities be certified
by an accrediting body approved by FDA. Nearly 60 percent of all
mammography facilities are currently accredited by the American
College of Radiology. ACR standards are substantially in
compliance with FDA's new, tough standards. With some minor
modifications, ACR should be able to apply and receive FDA approval
as an accrediting body. Some state agencies may also be able to
meet FDA standards with minor modifications.
The new accreditation and certification process is the first
part of the plan to upgrade the nation's mammography system. In
the coming year, FDA will establish a new advisory panel--the
National Mammography Quality Assurance Advisory Committee--to help
FDA develop final mammography standards. The committee will also
report new developments in breast imaging and investigate whether
there is a shortage of rural mammography facilities and health
professionals.
The new rules, which are being implemented through an
accelerated process, will become effective 60 days after they are
published in the Federal Register.
####