FDA Says Safer CT Scans Can Help Avoid Radiation Overdose

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Since the 1970s, Computed Tomography (CT) scans have revolutionized medicine. As a diagnostic tool, CT scans have aided doctors in diagnosing disease and assessing internal injuries. An estimated 30 million CT scans are performed in the United States annually. However, this technology has recently come under scrutiny. In 2009, the Food and Drug Administration (FDA) launched an investigation into CT scanners following hundreds of reports of excessive radiation exposure during perfusion CT imaging. Last month, the FDA released its findings and now recommends that manufacturers of CT scanners make changes in order to ensure patient safety.

The FDA reviewed radiation overdose reports from the years 2008 and 2009 linked to CT brain perfusion scans. These tests are key diagnostic tools for determining whether a patient has cardiac issues. The agency found that many patients had confirmed hair loss, memory loss, dizziness and other symptoms. While the full extent of patient injury might not be known, these patients could face long-term risks for brain damage and cancer, according to experts.

To prevent hospital errors and unnecessary medical negligence, the FDA concluded that manufacturers and hospitals need to better train and educate technicians using CT equipment and that special warnings need to be given to operators about the dangerously high doses of radiation they are about to administer. The FDA recommendations are not inconsistent with the position of the American College of Radiology, which has encouraged medical imaging professionals use CT scans only in cases where the medical benefit outweighs associated risk.

Experts acknowledge that CT scans and other medical imaging exams have contributed to declines in cancer mortality and improved the life expectancy of many. However, increased use of this diagnostic tool has resulted in higher radiation exposure for patients. The FDA, with the mission of assuring the safety of medical devices and those products that emit radiation, has taken its public health charge to the next level. With the cooperation of the Medical Imaging Technology Alliance and its member manufacturers, greater patient safety will become more of a reality and less of an expectation.