FDA reminds mammography facilities of MQSA-related responsibilities

The FDA has posted a bulletin on its website reminding certified mammography facilities that it is their own responsibility to bring in a qualified medical physicist who can survey their equipment, supervise all equipment-related quality control, and perform mammography equipment evaluations (MEE) on x-ray units and image processors as necessary.

Equipment that is new to the facility, has been reassembled since its last evaluation, or has undergone significant repairs must all be evaluated by the medical physicist at that time.

“It is the facility's responsibility to see that these evaluations are performed by a qualified medical physicist, that reports are complete, and that any issues are addressed in a timely manner,” the statement reads. “It is the facility who will receive citations for any violations identified during an inspection.”

The bulletin details what should be included in all completed Physicist’s Survey reports or MEE reports: a clearly-identified date, the name and signature of all medical physicists involved in the survey or MEE, a summary of the required QC test results and of all tests conducted, a summary of the facility's QC evaluation, and a written justification (by the physicist) of any omitted tests.  

The FDA also reminded facilities that survey reports and MEEs should document serial numbers of all mammography equipment being used.

These requirements are all a part of the FDA’s Mammography Quality Standard Act (MQSA).

The full bulletin, as well as links to previous articles and MQSA insights, can be found on the FDA’s website.