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FDA approves ACR's digital mammography quality control manual

por Lauren Dubinsky, Senior Reporter | March 11, 2016
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The American College of Radiology (ACR) announced today that the FDA has approved its new Digital Mammography Quality Control (QC) Manual and Digital Mammography QC Phantom for use in routine QC.

"The new ACR manual provides user-friendly, clinically relevant procedures and presents them with photographs and forms to aid technologists and medical physicists through the QC testing process," Eric Berns, lead author and chair of the ACR Subcommittee on Mammography Quality Assurance, told HCB News.

Dozens of different manuals are mandated from a variety of manufacturers and models of digital mammography systems, but the ACR's goal with the manual and phantom is to standardize QC testing.

The manual provides user-friendly procedures for technologists and medical physicists to help them test the quality of the imaging. It also includes two optional procedures for radiologists so they can self-check system image quality and provide feedback to the technologists.

The FDA requires that facilities with digital mammography systems perform QC according to the manufacturers' QC manuals, but now those facilities will have the option of using the ACR's manual instead. The FDA found that it is "at least as effective in assuring quality mammography as the standard."

However, the ACR manual can only be used for full-field digital mammography systems without advanced imaging capabilities like tomosynthesis and contrast enhancement.

The manual is in the process of being prepared for publication and is expected to be available this spring. Mammography facilities that are accredited by the ACR or applying for accreditation and medical physicists who are affiliated with those facilities will be allowed to download the PDF manual for free.

As more information becomes available, it will be posted on the ACR Mammography Accreditation website.

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