The National Mammography Quality Assurance Advisory Committee has advised the U.S. Food and Drug Administration (FDA) to expand the Mammography Quality Standards Act (MQSA) program to cover stereotactic breast biopsy.
Stereotactic breast biopsy had been exempt from MQSA rules, but at the November 5 meeting, nine out of 14 committee members voted in favor of regulating stereotactic breast biopsy facilities, citing current variable quality, lack of voluntary participation in existing accreditation programs, and dose concerns.
Members voting against the proposal cited access issues, no scientifically documented need, and that MQSA did not intend to address interventional procedures.
Dr. David Dershaw of the American College of Radiology (ACR) Breast Imaging Government Relations Committee, and Dr. Carol Lee, president of the Society of Breast Imaging (SBI) and chair of the ACR Breast Imaging Commission, urged the FDA to include stereotactic breast biopsy under the MQSA regulations so they will apply to all physicians performing the procedure.
By AuntMinnie.com staff writers
November 6, 2007
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