Radiation-Emitting Products

Quality Assurance Program

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900.12(d): Quality Assurance — general. Each facility shall establish and maintain a quality assurance program to ensure the safety, reliability, clarity, and accuracy of mammography services performed at the facility.

  1. Why hasn't FDA specified the protocols for performing QC tests?
  2. How often must the densitometer and sensitometer be calibrated?
  3. When performing a physics survey or equipment evaluation on a unit with multiple target/filter combinations, what tests or measurements must be performed for each combination?
  4. I have been following the ACR manual and have used an optical density range of 0.7-0.8 when doing my screen-film contact test. The film manufacturer recommends that I use a higher optical density. What should I use under the final regulations?
  5. If there are several acceptable methods for testing performance of a QC requirement and the item being tested passes by one, but not all, the methods, does the item still meet the requirement?
  6. A facility is using more than one type of screen-film combination. Must it perform the QC tests separately for each combination used?
  7. How should facilities document performance of the required QC tests to comply with the regulations?
  8. Our facility has multiple mammographic units and uses several different screen-film combinations. What QC tests are we required to perform?


Page Last Updated: 08/08/2014
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