Volume 7, Issue 1

Winter 2000

In This Issue...

Full Field Digital Mammography Approved for Use in MQSA-Certified Facilities

On January 28, 2000, FDA approved the Senographe 2000D Full Field Digital Mammography (FFDM) system for marketing. and immediate use in facilities that are MQSA screen-film certified. [Correction: Only facilities that are screen-film certified AND have specific FDA approval to use digital mammography on patients may lawfully use an FFDM system. If you plan to purchase or install an FFDM system, please refer to http://www.fda.gov/cdrh/mammography/digital.html to find out how to extend your MQSA certification to include FFDM]. Developed by General Electric, this is the first approved full field mammography system that produces digital images using a solid-state receptor, in contrast to analog images currently produced on radiographic film. "Digital technology may enhance a woman's mammography experience by reducing the need for additional exposures and allowing for easy transfer of images-a real benefit to highly mobile patients," noted DMQRP Director John McCrohan.

Mammography Matters Goes Digital!

This is the last issue of Mammography Matters that FDA will print and distribute. Starting with the Spring 2000 issue, FDA will publish this electronic version of the newsletter. You may also join FDA's Mammography e-mail ListServ to receive newsletter highlights and other notices.

From Alaska to Virginia:
Interpreting Physicians' MQSA and Clinical Experiences

Interpreting physicians Hans Tschersich, M.D., and Leora Sachs, M.D, share a common profession but have widely different day-to-day experiences-largely defined by the location of their facilities. Tschersich, a native of Germany, lives and works on Alaska's Kodiak Island, where he reads roughly 600 mammograms a year at Providence Kodiak Island Hospital. Although that number is "rapidly increasing," Tschersich reports, it is far below the high-volume 3,500 mammograms that Sachs, a native New Yorker, reads annually at Kaiser Permanente in suburban Falls Church, Virginia.

MQSA Information Available on Website

FDA recently upgraded its Mammography Program website (www. fda.gov/cdrh/mammography) to increase its usefulness to mammography facilities and the general public.

A core element of the website is the Policy Guidance Help System (PGHS) - a multi-document search engine providing FDA's current thinking on the final regulations that implement the Mammography Quality Standards Act (MQSA). The PGHS is regularly updated to incorporate newly approved guidance documents.