The Food and Drug Administration approved the use of digital mammography in the United States in January 2000. With digital mammography, a computerized method of producing electronic X-ray images of the breast, images reside on a computer and can be enhanced, magnified or manipulated. Digital mammography offers an advantage over conventional mammography, in that health care providers can share files over long-distance networks. This makes consultations easier.
Education
Physicians or medical physicists who interpret mammograms, as well as radiologists who work in digital mammography facilities, must meet the educational requirements of the Mammography Quality Standards Act as published by the FDA. At least 8 hours of training in digital mammography is mandated for those who previously worked with conventional mammography equipment.
Mammography Request
A physician must supply a written request for a diagnostic mammography examination, along with sufficient information to explain why the mammography is needed. Relevant information regarding patient history and signs and symptoms must be supplied with the request.
Facility
Digital mammography facilities must have effective quality control programs and keep thorough records. All digital mammography equipment is required to meet the standards specified in the Mammography Quality Standards Act. Equipment must have magnification and spot-compression functions. FDA or state-certified inspectors inspect the digital mammography facility at least once a year.
Mammography Results
The Mammography Quality Standards Act specifies that digital mammography facilities provide a written report to the patient's health care provider as soon as possible after the mammography examination and no later than 30 days after the examination. In cases where abnormalities are detected, the facility must contact the health care provider directly within 3 working days. This act also requires digital mammography facilities to send the patient a written summary in easy-to-understand language within 30 days after the examination. In case of abnormalities, the patient is informed within 3 working days after the results have been interpreted. Actual communication with the patient must be documented.
Radiation Control
All personnel working in the mammography facility endeavor to minimize radiation doses to individual patients as well as staff. An "as low as reasonably achievable" standard applies. Personnel consider a patient's weight and height for every dose of radiation applied. Radiation exposures must be measured and estimated by a medical physicist. The facility follows a quality control program that the digital equipment manufacturer recommends to ensure that quality images are produced without overexposing the patient. Radiation dose for a single image may not exceed 0.3 rad, although the radiation exposure is usually much lower.
Interpretation and Follow-up
The American College of Radiology developed a uniform system, called the BI-RADS, for radiologists to describe mammogram findings. Seven standard categories exist in this system, with follow-up plans to manage the patient's care.
Every digital mammography facility maintains a medical outcomes audit program to follow up mammographic assessments that reveal abnormalities. An annual analysis of this outcomes data must be performed. The goal of the program is to ensure reliability and accuracy in the interpretation of mammograms.
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