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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Compression Paddle

Policy Guidance Help System logo

Citation:

900.12(b)(8)(ii)(A)(B)(C)(D)(E): Compression Paddle.

(A)  Systems shall be equipped with different sized compression paddles that match the sizes of all full-field image receptors provided for the system. Compression paddles for special purposes, including those smaller than the full size of the image receptor (for "spot compression") may be provided. Such compression paddles for special purposes are not subject to the requirements of paragraphs (b)(8)(ii)(D) and (b)(8)(ii)(E) of this section.

(B) Except as provided in paragraph (b)(8)(ii)(C) of this section, the compression paddle shall be flat and parallel to the breast support table and shall not deflect from parallel by more than 1.0 cm at any point on the surface of the compression paddle when compression is applied.

(C) Equipment intended by the manufacturer’s design to not be flat and parallel to the breast support table during compression shall meet the manufacturer’s design specifications and maintenance requirements.

(D) The chest wall edge of the compression paddle shall be straight and parallel to the edge of the image receptor.

(E) The chest wall edge may be bent upward to allow for patient comfort but shall not appear on the image.

Questions: 

  1. A facility has two identical x-ray units, both of which have the capability to use multiple cassette/image receptor sizes. Would it be permissible to have both equipped with the 18 x 24 cm cassette-grid-compression paddle combination and have only one 24 x 30 cm cassette-grid -compression paddle combination that could be used on either unit on an as-needed basis? Additionally, must the facility provide the "spot compression" paddles referred to in the regulation?
  2. Must the compression paddle remain parallel to the patient support table when no compression is being applied?
  3. First, a facility's mammography unit has a compression paddle on which the plastic plate itself does not flex but the mounting is worn and allows the plate to tilt when under compression. Would this meet the intent of the regulation? Second, in addition to standard mammography, interventional procedures (such as wire placements) are performed using an accredited, conventional mammography x-ray unit. The special paddles provided for this purpose will not meet this requirement. Must the facility purchase new paddles for this application that will meet the specification?
  4. What is the intent of the requirement that these paddles "meet the manufacturer's design and maintenance specifications"?
  5. The chest wall edge of the compression paddle on our system is generally straight but "slightly wavy." Will this meet the requirement?
  6. If the image of the chest wall edge of some of a facility's "spot compression" paddles appears on the mammograms during these special procedures, would this be a violation of the regulations?
  7. Who is responsible for performing the compression paddle deflection test? How often should this test be performed and by what method?
  8. Can a single paddle meet the requirement of being matched to all full-field image receptors provided for the system?
  9. What documentation should facilities have to show that their mammography compression paddles were designed to not be "flat and parallel to the breast support table"?
  10. One of our compression paddles is not perfectly straight. Does it still meet the requirement?