This message is for mammography facilities and for the medical physicists that perform mammography facility surveys.

The Radiation Safety Section is accepting current Food and Drug Administration (FDA) policies regarding application force of mammography compression devices. Specifically:

1. Rule 663(4) of the Ionizing Radiation Rules states "The maximum compression force shall be not less than 25 pounds nor more than 40 pounds in the power drive mode." The Mammography Quality Standards Act (MQSA) regulation 900.12(e)(4)(iii) states "...the maximum compression force for the initial power drive shall be between 111 newtons (25 pounds) and 200 newtons (45 pounds)." WE WILL ACCEPT THE HIGHER MAXIMUM COMPRESSION FORCE OF 45 POUNDS.

2. At least one model of machine, the Planmed Sophie, has a compression device that is intialized via a foot switch that is accessible from both sides of the patient. Compression increases at a "fast pace" until a preset limit is reached. At that point a tone is heard and compression stops. To continue compression, the operator stops pressing the foot switch and then starts again. Compression resumes but now increases at a slower rate than before. The compression paddle speeds and the compression preset limit can be selected prior to imaging from the control panel and compression ranges from 0 to 45 pounds can be achieved. A question arose as to if tapping on the foot pedal after initial compression can result in forces higher than 45 pounds. The FDA has determined that, as long as the preset limit at which the compression rate changes from fast to slow is set in the 25 to 45 pound range, the equipment meets the MQSA compression requirement 900.12(e)(4)(iii). We WILL ACCEPT THE FDA INTERPRETATION OF THIS REQUIREMENT.