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U.S. Department of Health and Human Services

Radiation-Emitting Products

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We are an FFDM certified facility but have now decided to have our mammography examinations read off-site at another already certified facility. This process entails the use of a review workstation and laser printer (accessory components) that are new to our facility. We know that we have to perform a Mammography Equipment Evaluation (MEE) on these accessory components prior to clinical use. ...

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... However, since the accessory components have already undergone an MEE and are currently being used at the other facility, do they have to undergo a new MEE or can we use their original MEE or a subsequent annual physics survey instead?

 

For MEE tests that are specific to the accessory component, such as the SMPTE pattern, monitor luminance, and room illumination for the review workstation, the SMPTE pattern for the laser printer, and other component-specific tests that may be listed in the component’s QC manual, you can use the test results from previous annual physics surveys or MEEs as long as those tests were performed within the last 14 months. For those MEE tests that evaluate the performance of the whole imaging chain and help to ensure that all the system components are compatible with one another, such as the phantom image and other tests that may be listed in the FFDM manufacturer’s or accessory component’s QC manual, FDA interprets 21 CFR 900.12(e)(10) to mean that you cannot use prior tests. The medical physicist must perform these MEE tests on the accessory components prior to using the components in patient examinations.

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