HHS NEWS

U.S. Department of Health and Human Services


P98-21                      FOOD AND DRUG ADMINISTRATION 
FOR IMMEDIATE RELEASE       Sharon Snider:       301-827-6242
August 12, 1998             
                            Consumer Inquiries:  800-532-4440

MAMMOGRAPHY FACILITY FINED, SHUT DOWN

The Food and Drug Administration today announced that a mammography facility has agreed to pay a $30,000 penalty for performing mammography examinations without proper certification. In addition, the facility and the president of the facility have agreed to remove themselves from the mammography field for five years.

Under the settlement, CMI, of Chicago, and its president, Thomas E. Miller, will jointly pay $25,000. The facility's supervisory radiologist will pay $5,000.

The Mammography Quality Standards Act of 1992 requires that all medical facilities performing mammography in the United States meet certain quality standards. To ensure those standards are met, facilities must be certified by an accrediting body such as the American College of Radiology (ACR). Conducting mammography without certification is a violation of the law. CMI is the first mammography facility to pay a civil money penalty under the new law.

This settlement resulted from enforcement actions taken by FDA in conjunction with the State of Illinois.

"The effectiveness of mammography screening for breast cancer depends on high quality mammograms," said FDA Acting Commissioner Michael A. Friedman, M.D. "The law was passed to make sure all women have access to uniformly high quality mammography services. Mammography facilities need to take seriously their obligation to fully meet standards and get certified."

CMI, which had been operating under provisional certification, was denied accreditation by the ACR after failing to meet standards--primarily due to poor image quality. It nevertheless continued to do mammography even after being notified by FDA to cease operations and get certified.

Breast cancer is a leading cause of death among women in the United States. Because successful treatment often depends on early detection, and because accurate mammograms can detect breast cancer years before the patient or her doctor can feel a lump, high-quality mammography screening can greatly enhance the chances for survival. On the other hand, low-quality screening can result in the failure to detect early lesions, delayed treatment and an increased likelihood of disability and death.

Prior to the enactment of the Mammography Quality Standards Act, there were no national mandatory standards for ensuring uniform, reliable mammography and quality of mammography varied from facility to facility. Today virtually all 10,000 U. S. facilities have fully met standards and are certified to perform mammography.

CMI ceased operations in September 1997. The five year prohibition begins today with the filing of the consent decree.

#### ATTENTION TV BROADCASTERS: Please use open caption for the hearing impaired.