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| Volume 7, Issue 2                                                                                                                                                                                                                                                                                                                                                                                                                                                           |   | Spring 2000 |
| In This Issue...Adding the FFDM System to Your MQSA CertificateMammography Today Update!From the DirectorNew Mammography Program WebsiteEnsuring High-Quality Mammography:  Spotlight on InspectorsInspection Fee Payment ReminderRecognizing Inspectors' ServiceFDA Addresses Consumer IssuesQ&AAccreditation, Certification, and Commercial Products                                                                                                                  | FDA Addresses Consumer Issues

Soon after joining FDA's Mammography Program in October 1999, Deputy Director Helen Barr, M.D., completed a comprehensive review of consumer issues that had been directed to FDA between September 1998 and July 1999.  After hearing consumers' perspectives first-hand in her 12 years as a practicing radiologist, Dr. Barr was interested in understanding the issues consumers were raising at the agency level.

Of the more than 400 messages received by FDA through the Facility Hotline in the 10-month period examined, 41 percent were from consumers, Barr reported.  Twenty-two percent of consumer calls were requests for basic information, including:
- The names and locations of certified facilities within a geographic region,
- Information on contacting the National Cancer Institute for facility referrals and answers to breast cancer inquiries, and
- The website address for the Mammography Program.

An additional 15 percent of consumer calls were questions or complaints about the release of original mammograms, particularly the fees that consumers were being charged for this service.  The remaining 63 percent, Barr noted, covered wide-ranging topics, such as:
- Breast tissue biopsies,
- Alleged misinterpretation of mammograms,
- Digital mammography,
- Ultrasound,
- Lay summaries,
- Pain with compression during mammography,
- Unclean facilities,
- Issues unrelated to mammography (such as chest x-rays), and
- Radiation safety.

Although these issues were brought to FDA's attention through calls placed to its Facility Hotline number, similar consumer messages also were received through e-mails to [email protected], direct calls to DMQRP, or calls forwarded from other FDA consumer lines.

Barr explained that all consumer messages, regardless of how they are received, are forwarded to outreach specialists, who address consumers' questions and concerns.  Although FDA will respond to all consumer inquiries it receives, it encourages consumers to use the Facility Hotline number (1-800-838-7715) to receive a prompt response. Facilities should continue, however, to try to resolve consumer issues themselves or refer consumers to their accrediting body. |
| ***Facility Hotline***Call the facility telephone hotline (1-800-838-7715) or fax (410-290-6351) for more information about FDA certification or inspections.                                                                                                                                                                                                                                                                                                               |
| *Mammography Matters*is a quarterly publication of the Division of Mammography Quality and Radiation Programs (DMQRP), Center for Devices and Radiological Health (CDRH), Food and Drug Administration. Its purpose is to help mammography facilities comply with the requirements of the Mammography Quality Standards Act of 1992. Comments should be addressed to: *Mammography Matters* | FDA/CDRH (HFZ-240) | 1350 Piccard Drive | Rockville, MD 20850Fax 301-594-3306 |