Effective October 1, 1994, all mammography facilities (except those of the Department of Veterans Administration) must be certified by FDA as meeting quality standards to continue lawful operation.
Why MQSA? The first and most important reason is breast cancer. In the late 1980's, the incidence of breast cancer (numbers of new cases per year) rose dramatically. This resulted, in part, from the increased use of screening mammography. This meant more otherwise undetectable breast cancer cases were caught early and women were afforded better survival odds. Increased screening only partially explains the rise in numbers of new breast cancer rates. There is still an underlying trend of increasing breast cancer incidence that began in the early 1980's and is still not understood.
Breast cancer is second only to lung cancer in taking women's lives (lung cancer recently surpassed breast cancer as the number one cancer killer). As a result, women who survived breast cancer (and some who eventually did not), along with professional organizations and concerned legislators, all lobbied for MQSA. Women must be assured that their mammograms are produced and interpreted accurately.
Roughly 25 million mammograms were taken in 1992. Most of these were for healthy women undergoing screening. They need protection from risks such as excess radiation or needless biopsy for false positive interpretations. In addition, women with symptoms or otherwise undetectable cancers need to be diagnosed and quickly referred into treatment protocols. These women need the benefits of high quality mammography to diagnose their disease.
For more information on the MQSA check with the FDA Center for Radiological Health MQSA Program.
In Virginia there are approximately 215 facilities that provide mammography services. Virginia has imposed additional requirements on mammography facilities. The federal regulations require federal/state inspectors performing federal inspections to provide advanced notification to the facility prior to the federal survey. However, our State inspectors may conduct an unannounced state inspection. State law also requires mammography facilities to inform their patients if the image quality of the mammogram is not adequate before the patient leaves. If film development is not available or the patent left before the facility could evaluate the quality of the film, the facility has two business days to inform the patient that another mammogram is needed
Radiological Health Program | James Madison Building, 7th Floor | 109 Governor Street, Room 730 | Richmond, VA 23219 | Telephone (804) 864-8150 | Fax: (804) 864-8155