MITA Statement on FDA CT Investigation

MITA is pleased that the FDA investigation found “no violations of FDA laws and regulations” by manufacturers and that the when the scanners “were used according to the manufacturers’ specifications, they did not result in overexposure.”   Also, MITA agrees with the FDA that manufacturer-defined protocols provide “reasonable and appropriate image quality and dose.” 

MITA supports the FDA’s advocacy for “two principles of radiation protection: appropriate justification for ordering each procedure, and careful optimization of the radiation dose used during each procedure.  As part of our commitment to patient safety, MITA and its members are committed to working with the FDA on MITA’s Dose Check Initiative and the FDA’s recommendations.   We agree wholeheartedly with the FDA that “each patient should get the right imaging exam, at the right time, with the right radiation dose.”

The complete report can be found at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm185898.htm