Radiation-Emitting Products

As a medical physicist is there anything I need to be aware of regarding laser printer mammography equipment evaluations (MEE)?

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Some medical physicists are not including appropriate testing of the laser printer in their survey/MEE reports to the facility. There seems to be confusion about the required MEE testing of a laser printer: (1) before it is first put into clinical use; (2) following reassembly; or (3) after major repairs vs. the routine quality control QC testing of the laser printer after it is placed into clinical use. In some cases, the medical physicists did not test the laser printer at all, did inappropriate testing, or did appropriate testing but did not include documentation of the tests in the facility survey/MEE report. Therefore, FDA is clarifying the applicable MQSA requirements.

The regulations at 21 CFR 900.12(e)(6) require that all test procedures be conducted as specified in the QC manual of the FFDM system manufacturer. Some of these QC manuals specify both periodic QC (daily, weekly, or annual) and MEE testing for the laser printer while others do not address the subject and refer the user to the laser printer manufacturer’s QC manual. 

A table summarizing the laser printer test procedures in the current FFDM manufacturer QC manuals is available on the following webpage: 

http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Guidance/ucm219622.htm

Some of FFDM QC manuals do not specifically address the laser printer MEE testing requirements when first installed, reassembled, or after having undergone a major repair. They instead instruct operators to follow the applicable printer QC manual.  Hence, the facility or medical physicist has to obtain this information from the laser printer manufacturer. In some cases, the QC manuals only address the interface between the FFDM unit and the laser printer. They do not address the basic requirement that the laser printer, before it is used clinically for mammography, has to be operating as designed by the laser printer manufacturer. Because the MEE requires that both the interface and basic requirements be checked, the medical physicist may have to consult both the FFDM manufacturer’s QC manual and the laser printer QC or operator’s manual to determine which tests are required to assure that the laser printer is functioning properly before being used clinically.

Some medical physicists incorrectly assume that simply scoring a laser printed phantom image satisfies all the requirements of the laser printer MEE. However, in most cases, simply scoring a phantom would be unacceptable under the applicable manual(s). To avoid unnecessary follow-ups by MQSA inspectors or facility citations, we urge all medical physicists to review the FFDM manufacturer’s QC manual and, where necessary, the laser printer QC or operator’s manual to determine the appropriate testing. Medical physicists must clearly document the testing of the laser printer in their reports.

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Page Last Updated: 06/23/2014
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