QC, Cushion Pads and the FDA

The facility that I work at does not use cushion pads when performing exams. We tried them many years ago and for many different reasons chose not to use them. Every once in awhile a patient will ask if we use them and occasionally a vendor will stop by to entice us into using them on our patients. 

When I was reading the recent updates for mammography from the FDA, there were some interesting points brought up about the use of cushion pads and quality control.  Since we don't use the pads, I have never thought about their use in regards to quality control.

Prior to full-field digital mammography (FFDM), it seems that if you routinely used the cushion pads on most of your patients, the FDA required you  to perform your weekly phantom and the annual phantom and dose QC tests with the cushion. This was done to simulate your typical clinical conditions.

With the widespread use of FFDM, the FDA had to reexamine this rule. The FDA has changed their wording and intent slightly on this issue now. The FDA still recommends that the phantom test be done under clinical conditions, but they only require the pad be used if the manufacturer of your mammography unit requires that it be used during the quality control testing. In other words, the quality control testing, like phantom imaging, is tested in the manner that your image receptor manufacturer recommends. 

For many of us mammographers, this change will not affect our quality control process because we do not use the cushion pads.  If you routinely use these pads make sure you read the updates on the FDA website, and consult your physicist and vendor if you still have questions.