Radiation-Emitting Products

When are "mammography equipment evaluations" required and who must conduct the evaluations?

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Whenever a new unit or processor is installed, or a unit or processor is reassembled, or major components are changed or repaired, an evaluation of the mammography unit or image processor is required. The medical physicist should decide which tests need to be performed following a particular repair, and should explain the rationale behind his or her decision. Examples of major changes or repairs that would call for equipment evaluations are: replacement of an x-ray tube, collimator, AEC unit, AEC sensor, or x-ray filter. For the processor, a total overhaul would be an example of a major repair. Routine preventive maintenance, pump replacement, replacement of the developer or fixer racks, replacement of the control board or changes in chemistry brand are not examples of major changes or repairs and would not require evaluation by a medical physicist.

The mammography equipment evaluation is needed to verify that all functions that may have been affected by the change or repair have been successfully restored even if a full survey had recently been completed. The mammography equipment evaluation must be performed by a qualified medical physicist or by an individual under the direct supervision of the medical physicist. The evaluation will be used to determine whether the new or changed equipment meets the requirements of applicable standards in 900.12(b) and (e). All problems shall be corrected before the new or changed equipment is put into service for examinations or film processing. The facility must maintain (until the next inspection that verifies compliance) the report of the mammography equipment evaluation and all documentation showing that all problems identified in the mammography equipment evaluation were corrected before the equipment was used on patients. 21 C.F.R. 900.12(d)(2). The report should document the date(s) on which the mammography equipment evaluation was performed and who performed the evaluation.

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Page Last Updated: 08/13/2014
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