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FDA Suggests Radiation Industry Changes for Safer CT Scans


The U.S. Food and Drug Administration (FDA) has sent a letter to the Medical Imaging and Technology Alliance (MITA) and radiation therapy industry calling on them to make a number of changes in the equipment and training to improve safety and reduce risk of radiation overdose to patients.

The call for these changes come after the FDA’s year long investigation of patients undergoing computed tomography (CT) brain perfusion scans who were accidentally exposed to excess radiation.

The FDA found properly used the CT scanners did not malfunction and the patients did not receive overdoses of radiation. The radiation overdoses more likely resulted from the improper use of the scanners.

During the course of the investigation, the FDA identified a series of steps to enhance the safety of these procedures, reducing the likelihood of radiation overexposure to the patient in the event of improper use of the CT scanners.

Since the investigation began, the FDA is aware of at least 385 patients who received excessive radiation from CT brain perfusion scans, many undergoing the test to confirm the presence of a stroke, performed at five hospitals in California and one in Alabama.

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While unnecessary radiation exposure should be avoided, a medically-needed CT scan has benefits that outweigh the radiation risks. Patients should follow their doctor’s recommendations for receiving CT scans.

The FDA has suggested these changes be made:

  1. A console notification to alert the operator of a high radiation dose;
  2. Providing particular information and training on brain-perfusion protocols to all facilities that receiving base CT equipment, whether or not the facilities purchase the related software enabling quantitative analysis of cerebral hemodynamics;
  3. Clarification of parameters affecting dose, along with clear instructions on how to appropriately set those parameters; and
  4. Organization of all dose-related information into one section of each user manual, in a dedicated dose manual, or indexed comprehensively in a concordance covering all manuals.

This is just one part of the FDS’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging.

“Improving patient safety is part of our public health mission,” said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. “Patients should not have to worry that a device designed to diagnose an illness exposes them to unnecessary risks.”

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Food and Drug Administration