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June 1: Mammography Facility Adverse Event and Action Report – 2005

Mammography is a low-dose x-ray of the breasts. Congress enacted the Mammography Quality Standards Act (MQSA) in 1992, marking the first time mammography facilities were required by the federal government to meet strict quality standards. The intent of MQSA is to assure the quality of mammography nationwide. Quality mammography can detect breast cancer in its earliest, most treatable stages. Studies show that widespread use of mammography can reduce deaths from breast cancer by one-third.

Congress charged the Food and Drug Administration (FDA) with implementing and enforcing MQSA. With the help of the National Mammography Quality Assurance Advisory Committee (NMQAAC), FDA developed interim regulations, initiated an inspection program, and issued comprehensive final regulations that became effective on April 28, 1999. The final regulations strengthen the 1994 interim standards for personnel, equipment, quality assurance and quality control activities, and reporting of exam results as well as requirements for the accreditation bodies. To help providers and patients understand how MQSA affects them, FDA developed the Mammography web site.

As of December 31, 2005, there were 8,873 fully certified MQSA mammography facilities operating in the United States.

To gather data for this report, FDA consulted with and received reports from various federal, State, and territorial agencies, as well as the American College of Radiology (ACR).This report also reveals the adverse events and corrective actions taken in 2005.
To Access complete report, please refer the following link http://www.fda.gov/cdrh/mammography/MFAER-05.html

If you have comments regarding this update, please email us at info@mdiconsultants.com

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