FDA Wants New Safety Standards for Some X-Rays
Feb. 10, 2010— -- WASHINGTON -- The U.S. Food and Drug Administration (FDA) says it wants to issue new safety requirements for manufactures of computed tomography (CT) and fluoroscopic devices to reduce unnecessary radiation from medical imaging.
The FDA's plan focuses on three procedures with high radiation doses: CT, nuclear medicine studies, and fluoroscopy. These are the greatest contributors to total radiation exposure within the United States population, the FDA said. That's because they require much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography.
"The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a prepared statement. "The goal of FDA's initiative is to support the benefits associated with medical imaging while minimizing the risks."
While the three procedures have led to early diagnosis of disease, they expose patients to ionizing radiation that may increase lifetime cancer risk -- although there is debate within the medical community about the extent of the danger.
Radiologist Dr. Joseph Schoepf, director of Cardiovascular Imaging at the Medical University of South Carolina, lauded the FDA's initiative and said it would restore the public's trust in imaging.
"It is important to note, however, that an increase in cancer mortality [from radiation] has not been observed," added. "On the contrary, cancer mortality has dramatically decreased over the past decades, in step with increased utilization of medical imaging."
The Archives of Internal Medicine recently published results from two studies indicating that CT scans deliver much higher doses of radiation than previously thought. The FDA has noted that a patient would have to get 400 standard chest X-rays to be exposed to the same level of radiation as just one CT abdomen scan.
