New Inspection Procedures

On May 15, 2006, the Food and Drug Administration (FDA) released a new version of the procedures used to inspect mammography facilities. The most significant change in the new version is the elimination of all x-ray unit tests as reflected in the following list. MQSA inspectors will discontinue performing the equipment tests listed below:

• Collimation (x-ray field/image receptor and compression paddle alignment)
• Exposure measurements for dose determination
• Exposure reproducibility, and
• Beam quality (half value layer)

FDA decided to eliminate these tests from MQSA inspections since there haven’t been any failures in meeting the patient dose requirement for several years and only a very small percentage of units fail to meet the remaining equipment tests. Your medical physicist is still required to perform the equipment tests listed above during the facility's annual mammography physics survey. FDA believes this testing will assure that mammography units continue to comply with the equipment requirements. MQSA inspectors will continue to review the physicist's survey report and check that all tests were performed, and that any problems found by the medical physicist have been corrected.

Inspectors will continue to perform the phantom image evaluation. The phantom image test, along with tests on the processor and evaluation of the darkroom, remain part of mammography facility inspections.

Note: Mammography inspections performed under your State regulations may still include some or all of the equipment tests listed above. If you have any questions about this, please contact your State Radiation Program.

Facility's phantom is used during MQSA annual inspection

In February 2006, FDA made another change to MQSA inspections regarding the phantom image evaluation test. MQSA inspectors now use your facility’s phantom for the phantom image test. Because there were certain problems encountered when using the FDA-supplied phantom for evaluating full-field digital mammography (FFDM) units, FDA changed from the long-established use of its phantom to using the facility’s phantom for both FFDM and screen-film units. Even for those facilities that have only screen-film units, the MQSA inspector will use your facility's phantom for the phantom image test. By MQSA inspectors using solely the facility's phantom for the phantom image evaluation test, the problems have been alleviated.

If you have questions, you may contact the MQSA facility hotline at 1-800-838-7715 or by e-mail at MQSAhotline@hcmsllc.com.

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