The American College of Radiology has reported that the FDA will significantly reduce the scope of their annual Mammography Quality Standards Act (MQSA) inspections by eliminating equipment tests that are already performed annually by a facility's medical physicist.
Beginning May 15, 2006, MQSA inspectors will no longer perform the following tests during the inspection:
* Collimation
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* Dose estimate tests
* Cassette variability
* Exposure reproducibly
* Half-value layer
The MQSA inspector will continue to perform the Sensitometric Testing for Evaluation of Processors (STEP), darkroom fog (screen-film systems only) and phantom image tests.
Lillian Gill, Senior Associate Director, FDA, CDRH, announced these changes at the recent Conference of Radiation Control Program Directors meeting in Detroit, Mich., pointing out that FDA found no dose inspection noncompliances in over 100,000 measurements. In addition, the difference between the inspector-measured doses and those measured by the medical physicist were less than 1%.
Facilities must recognize that some state inspectors may continue to perform these tests under their own state laws. However, states that are FDA-approved MQSA state certifiers (Illinois, Iowa, and South Carolina) may also need to continue these tests under their state certification regulations. For more information, contact your state radiation control agency.
