NEWS 12/14/1993
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. ####