Stereotactic breast biopsy:
An overview

The Mammography Quality Standards Act of 1992 represented the response of Congress to public concerns about the quality of screening mammography and interventional radiology. The latter includes stereotactic biopsy and image-directed, open surgical biopsy, but not ultrasound-guided biopsy. The law designated the Food and Drug Administration(FDA) as the federal agency responsible for developing regulations.

Only recently have final regulations for screening mammography been developed by the FDA and attention focused on interventional techniques. To emphasize quality of patient care and avoid turf issues, the American College of Surgeons and the American College of Radiology jointly developed and approved a set of guidelines concerning the qualifications of surgeons or radiologists who wish to perform stereotactic breast biopsy. The guidelines were designed to encompass the three major models of stereotactic breast biopsy practiced in the United States. They do not represent final regulations. Based on the complexities of the details and the federal process of public testimony and consensus development, it is likely to take considerable time before stereotactic breast biopsy regulations are published.

In the meantime, patients will continue, on a large-scale basis, to need this procedure. It will be the responsibility of local hospitals and mammography centers to credential individuals who perform stereotactic breast biopsy. Credentialing bodies need to understand that the voluntary accreditation program of the American College of Radiology for the performance of stereotactic breast biopsy was designed by radiologists and in no way represents federal regulations or excludes surgeons from performing the procedure. Stereotactic breast biopsy is currently ``unregulated.'' Local departments of surgery can promulgate surgical credentialing criteria or utilize the joint American College of Surgeons-American College of Radiology guidelines during this interim period.

The continued input from interested surgeons will be valuable as the FDA's process of fine-tuning the regulations proceeds. The American College of Surgeons firmly believes that by virtue of training and experience, the surgeon should continue to act on the patient's behalf in the evaluation and management of diseases of the breast.

Dr. Winchester, Medical Director, ACS Cancer Department, represents the College on the National Mammography Quality Assurance Advisory Committee of the FDA. He is chairman, surgery department, Evanston (IL) Hospital, and professor of surgery, Northwestern University Medical School, Chicago, IL.

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by David P. Winchester, MD,
FACS, Chicago, IL

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Bulletin of the American College of Surgeons
Vol. 82, No.9, September 1997

Advisory Council for General Surgery

Physician qualifications for stereotactic breast biopsy

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