Tuesday, January 22, 2008

FDA Regulating Stereotactic Breast Biopsy

The FDA/MQSA meeting in November of 2007 focused on regulating stereotactic breast biopsy. You can read the entire transcript (@237 pages) which includes comments and presentations on the subject from the panel members and attendees at the FDA Mammograpy website.
There are 2300 units in operation in the United States and only 20% are accredited. The American College of Radiology and the American College of Surgeons each have a voluntary accreditation program in place. The American College of Surgeons has accredited 4 units through its program. The rest are accredited through the American College of Radiology. 25% of the applicants failed the accreditation process on their first attempt due to image quality and dose issues. The representatives from the surgeons aspect of the discussion made pleas for data to be collected to determine if there really is a need for accreditation/regulation and made it quite clear that their stand was aganist mandatory accreditation/regulation. The representatives from the radiologists/technologists aspect of the discussion made it quite clear that there is already data (failed accreditation's, lack of facilities opting for voluntary accreditation) to justify the need for mandatory accreditation/regulation. In the end the panel members voted in favor of the FDA regulating stereotactic breast biopsy.
What are your thoughts? Do you think the FDA should regulate Stereotactic Breast Biopsy?

3 comments:

K. Rush Photography said...

Will this initiative for regulation improve the clinical outcome? What clinical problems have be identified to justify regulations?

Anonymous said...

it's hi time that someone took some action in this area.

Anonymous said...

Anyone who didn't see this coming wasn't paying attention! The only question I have is, why it took so long? The IOM report on the state of mammography pointed to all modalities associated with breast imaging, saying minimum quality standards must be implemented. Look out breast ultrasound and breast MRI you may next. History in this area shows what is voluntary will become mandatory!