Radiation-Emitting Products

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.

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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?

What follows is the recommended procedure for the inspector. The inspector:

1. asks the technologist to expose the phantom and produce an image. The inspector scores the phantom image on the acquisition work station (AWS) and, if the image passes, enters the information into the inspection software and closes out the inspection. If the image does not pass, the inspector:

2. asks the technologist to expose the phantom a second time to produce another image. The inspector scores this second phantom image on the AWS and if the image passes, closes out the inspection as in step #1 above. If the image does not pass, the inspector asks the satellite facility to send both phantom images to the hospital. Hospital personnel are instructed to print a hardcopy of both images and mail the images to the inspector. The inspector scores the images. This process should be accomplished within 5 days. The completed inspection is then downloaded to the FDA and a summary report is sent to the facility.

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Page Last Updated: 06/17/2014
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