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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Other Modalities Quality Control Tests

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Citation:

900.12(e)(6): Quality Control tests — other modalities. For systems with image receptor modalities other than screen-film, the quality assurance program shall be substantially the same as the quality assurance program recommended by the image receptor manufacturer, except that the maximum allowable dose shall not exceed the maximum allowable dose for screen-film systems in paragraph (e)(5)(vi) of this section.

Questions:
  1. What are the required quality control tests for new mammographic modalities?
  2. Can a facility use printers and monitors that were not specifically approved as part of its FFDM unit?
  3. Can a manufacturer hook up a printer or monitor to its FFDM unit if the printer or monitor were not part of its original Pre-Market Approval (PMA)?
  4. Must a facility perform all the required QC testing on a laser printer even if the facility is using only soft copy for final interpretation and is using the printer only to provide final interpretation quality hard copy images to patients, their representatives, and health-care providers or for retention purposes? If not, is the facility subject to citation during an MQSA inspection?
  5. As a medical physicist is there anything I need to be aware of regarding laser printer mammography equipment evaluations (MEE)?
  6. We do not have a QC manual for our printers or monitors. What QC testing should we perform on our printers and monitors?
  7. An FFDM unit is located in a satellite facility of a main hospital, and the review work station (RWS) and hard copy printer are located at the main hospital. The FFDM manufacturer quality control manual instructions call for making a final decision on whether the phantom image test passes by scoring the image either from the RWS or from a printed image. How can the inspector score the image correctly if the RWS and printer are not onsite during the inspection?

  8. What testing do the various FFDM manufacturers require for a new unit mammography equipment evaluation (MEE)?

  9. Is there a list that shows the laser printers that have been cleared for mammography by the FDA? If not, how can I determine if FDA has cleared a given laser printer for mammography use?

  10. 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.  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?

  11. We are adding an FFDM unit to our already certified digital facility.  We know that we have to perform an MEE on the unit prior to clinical use.  However, since our review workstation and laser printer (accessory components) have already undergone an MEE and are currently being used with our first unit, do they have to undergo a new MEE or can we use their original MEE or a subsequent annual physics survey instead?

  12. We are applying to become a new FFDM certified facility.  We know that we have to perform an MEE on the unit prior to clinical use.  However, we will have our examinations read off-site using a review workstation and laser printer (accessory components) that are currently located at another certified facility. Those accessory components have already undergone an MEE as part of the other facility. Do these accessory components have to undergo a new MEE or can we use their original MEE or a subsequent annual physics survey instead?

  13. Our facility has five FFDM units (not all of the same model or from the same manufacturer), two laser printers (not the same model or from the same manufacturer) and four review workstations (not all of the same model or from the same manufacturer). We run clinical images through all the accessory components interchangeably. Do we have to perform periodic QC testing (e.g., weekly phantom image test) on all possible combinations of units with the printers and review workstations?

  14. We have a screen-film unit that we are converting to FFDM-computed radiography (CR) use. We know that we have to perform a Mammography Equipment Evaluation (MEE) on the CR system prior to clinical use.  However, since the unit underwent an MEE when it was first installed and has had subsequent testing as part of the annual physics survey does it have to undergo a new MEE or can we use its original MEE or a subsequent annual physics survey instead?