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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Mobile Units Equipment Quality Control

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Citation:

900.12(e)(7): Mobile Units. The facility shall verify that mammography units used to produce mammograms at more than one location meet the requirements in paragraphs (e)(1) through (e)(6) of this section. In addition, at each examination location, before any examinations are conducted, the facility shall verify satisfactory performance of such units using a test method that establishes the adequacy of the image quality produced by the unit.

Questions:
  1. Does a mobile unit need to include a film processor?
  2. What would represent an appropriate method for repeat analysis for my mobile service that consists of several individually certified facilities? Should there be an independent analysis for each facility or a combined analysis for all of my facilities?
  3. How does a facility demonstrate satisfactory performance for mobile units after they are moved to a new location?
  4. We are a mobile facility with a van that does not have on-board processing. We have a film-changing room on the van where we load and unload cassettes with film during the day. When the van returns to our main office, we batch process the films. Do we have to perform a semiannual test for darkroom fog in this film-changing room?
  5. We use FDA's guidance for mobile facilities where we produce a phantom image after a move of the mobile unit and we monitor the mAs. We then process the phantom image later, prior to processing the mammograms. If we move the mobile unit more than once per week, do we also have to produce a weekly phantom image in addition to the phantom produced after each move?