Radiation-Emitting Products

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?

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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?

No to both questions. First, if the system was designed to have the plate remain flat and parallel, then the situation you describe would not meet the intent of the regulation and the worn part(s) must be repaired or replaced. Second, the regulations do not currently cover interventional procedures so accessory devices used solely for such procedures, even when they are used on accredited units, are not required to meet the regulations. 

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Page Last Updated: 07/15/2014
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