FDA increasing oversight of radiology

The federal Food and Drug Administration (FDA) in Washington, DC, announced recently that it will strengthen its oversight of three of the most potent forms of medical radiation, including computed tomography (CT) scans.

The announcement came after an FDA investigation into why more than 200 patients in four hospitals received excessive radiation exposure from CT scans used to detect strokes over an 18-month period. Patients at Cedars-Sinai Medical Center in Los Angeles, where the overdoses first came to light in 2009, received up to eight times as much radiation as intended. No one knew the patients had received such high radiation exposure until some patients lost their hair.

The FDA said in its announcement that it hoped to reduce unnecessary radiation exposure from three of the most popular medical imaging procedures: CT scans, nuclear medicine studies, and fluoroscopies. (For more information on the FDA initiative, go to http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm199904.htm )

"These types of imaging exams expose patients to ionizing radiation, a type of radiation that can increase a person's lifetime cancer risk," the FDA said. "Accidental exposure to very high amounts of radiation also can cause injuries, such as skin burns, hair loss and cataracts."

The agency said it is considering several moves to reduce the risk. For starters, the FDA may require manufacturers of CT scanners and fluoroscopic devices to incorporate new safeguards into the design of their machines that would prevent incorrect radiation settings or alert the user to an input error. Medical personnel training might have to be improved, and the FDA may require that devices capture and transmit radiation dose information to a patient's electronic medical record and to national dose registries.

The changes will have teeth. The FDA is planning to ally with the Centers for Medicare & Medicaid Services (CMS) to incorporate new safety practices into the accreditation process of imaging facilities and hospitals.

Much of the radiology community supports the enhanced oversight and safety improvements. The Medical Imaging and Technology Alliance, an association of manufacturers of radiological equipment based in Arlington, VA, issued a statement supporting the FDA action. The group went on to endorse mandatory accreditation of advanced imaging facilities and minimum standards for personnel who perform medical imaging exams and deliver radiation therapy treatments. The American Society for Radiation Oncology in Fairfax, VA, called for a central database for the reporting of radiation errors.