Vote on MQSA oversight of breast biopsy split by specialty

Nov 7, 2007

Earlier this week, the National Mammography Quality Assurance Advisory Committee advised the U.S. Food and Drug Administration (FDA) to expand the Mammography Quality Standards Act (MQSA) program to cover stereotactic breast biopsy. But the vote was not unanimous.

Nine of the 14 committee members voted Monday to the effect that interventions relying on radiology, particularly stereotactic breast biopsies, should be regulated by the FDA, capping an all-day hearing that brought radiologists, surgeons, industry, and consumer representatives to the FDA in Maryland.

While the radiologists argued that the regulation was necessary to ensure that patients receive optimal care, surgeons and industry representatives countered that such regulation would be expensive and cumbersome, and that there was little evidence of a need for it.

But Dr. Carol Lee, president of the Society of Breast Imaging (SBI) disagreed, telling AuntMinnie.com that closer supervision of stereotactic breast biopsy was needed. She said she was pleased with the panel's recommendation.

"The ACR (American College of Radiology) has had a voluntary accreditation program for 11 years, and only 20% of member breast imaging centers are accredited," she said. "The failure rate in voluntary accreditation is 25% initially, with most failures due to incorrect targeting."

"That means poor images and over-radiating people's breasts. We view this as a quality issue," added Lee, who also serves as the chair of the ACR Breast Imaging Commission.

The vote initiates the long process of writing a regulation and bringing it to Congress, said committee member Carol Mount, a radiologic technologist and the supervisor of breast imaging and intervention at the Mayo Clinic in Rochester, MN.

"It may be some time before we see a regulation," Mount said in an interview with AuntMinnie.com. "It wasn't decided what form the regulation should take, whether it would be the ACR standard or a regulation written jointly by surgeons and radiologists."

The American College of Surgeons (ACS) and the American College of Breast Surgeons (ACBS) oppose regulation, saying that it would drive up costs, reduce patient access to care, and instead suggested further study of quality issues.

Regulation is also seen by some as a move by radiologists to protect turf by making it tough for surgeons to perform needle biopsies and other procedures that rely on radiologic images. Mount disagreed with that notion.

"We believe surgeons can do a stereotactic biopsy just as well as radiologists," Mount said. "We want everyone who does this to be accredited."

By Marty Graham
AuntMinnie.com contributing writer
November 8, 2007

FDA MQSA inspection fees to increase, July 17, 2007

ACR's withdrawal from NAPBC draws mixed response, August 30, 2007

Physical, procedural changes boost breast imaging efficiency, December 21, 2005