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U.S. Department of Health and Human Services

Radiation-Emitting Products

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We are using an FDA cleared single use cushion pad when performing mammograms on some of our patients. Do we have to include the pad when performing the phantom and dose QC tests?

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When performing the weekly and annual phantom and dose tests, you must simulate as closely as possibly your typical clinical conditions. 21 CFR 900.12(e)(2)(i), (e)(5)(vi). Thus, if you are not using a cushion pad for more than half of your screen-film patients, you do not have to include the cushion pads when performing the phantom and dose QC tests. However, if you are using a cushion pad for more than half of your screen-film patients, you must include the cushion pad when performing these QC tests.  If you routinely use the cushion pad on both the bucky and the compression paddle, you must use two layers of the cushion pad when performing the phantom and dose QC tests. While not a regulatory requirement, FDA recommends that the pads also be included when performing AEC testing.

For FFDM units, we recommend that you perform QC tests, such as the phantom test, under clinical conditions. However, we can only REQUIRE that a facility include the pad during the test(s) when the manufacturer’s QC manual specifies a pad be present during QC testing. The unit manufacturer’s QC manual defines the test conditions for the phantom image and other QC tests because, under 21 CFR 900.12(e)(6), “…the quality assurance program shall be substantially the same as the quality assurance program recommended by the image receptor manufacturer.”

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