By: Helen Barr, M.D.
Mammography has been widely used as a screening tool to detect early-stage breast cancer since the mid-1960s.
As the use of the technology expanded it became clear that there were wide variations in the quality of the mammograms and the dose being delivered to patients.
Following a series of hearings, Congress stepped in and enacted the Mammography Quality Standards Act of 1992 (MQSA).
This week we celebrate the 25th anniversary of this important law that gave the FDA authority to improve the quality of mammography services by setting standards for image quality, radiation dose, personnel qualifications, and record retention and reporting requirements, among others. The MQSA also requires that each facility be accredited by an FDA-approved body and hold an active MQSA certificate to legally practice mammography.
The goal of the MQSA was to ensure that mammography facilities – regardless of their location – adhere to uniform standards that consistently ensure high-quality breast images, which are critical to the diagnosis of breast cancer. The program also ensures that patients receive their mammogram results within 30 days (sooner if there are problems) and in plain language they can understand.
Today the nation’s 8,700 -plus mammography facilities are inspected every year, an immense task that is accomplished by both FDA inspectors and our state contracting partners. We recently enhanced the inspection process by creating our Enhancing Quality Using the Inspection Program (EQUIP) initiative, which adds inspection questions related to already existing regulations aimed at image quality. In this way, we can ensure that facilities have processes in place which help them continuously maintain image quality and spot issues early so that they can be rapidly corrected, benefiting both patients and facilities.
In 1995, 30 percent of mammography facilities in the United States were operating in violation of the law. Today I’m happy to report that 99 percent of facilities have no serious violations.
Over the last 25 years, breast imaging technology has moved from screen film technology, to full-field digital mammography (first cleared by FDA for marketing in 2000), to digital breast tomosynthesis, a new technology that takes x-ray “slices” to improve visualization of breast tissue, for which the first unit received FDA’s marketing approval in 2011.
The MQSA program has continued to adapt and evolve along with the technology aided by the dedicated work of my staff. This involves coordinating expertise with our colleagues in other parts of our Center for Devices and Radiological Health and in FDA’s Oncology Center for Excellence.
The advances in mammography technology, combined with FDA’s scientific expertise and regulatory authority in this area, have served the public well. Thanks in large part to early detection of the disease through quality mammography under the MQSA, as well as improved therapies, the five-year survival rate for all women diagnosed with breast cancer in the United States between 2006 to 2012 was 90.8 percent compared to 74.8 percent between 1975 to 1977, the Centers for Disease Control and Prevention reported earlier this year. Moreover, today’s mammograms require very small doses of radiation, far less than was required decades ago.
Helen Barr, M.D., is Director, Division of Mammography Quality Standards, at FDA’s Center for Devices and Radiological Health.
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