FDA Announces Plan to Reduce Patient Radiation Errors at Medical Facilities

February 9, 2010

The U.S. Food and Drug Administration (FDA) today announced an initiative to prevent patients from receiving unnecessary radiation exposure during computed tomography (CT), nuclear medicine studies and fluoroscopy medical imaging procedures.

These types of medical imaging expose patients to a significantly larger dose of radiation than standard X-rays, dental X-rays or mammography. For example, the radiation dose associated with a CT abdomen scan is the same as the dose from approximately 400 chest X-rays. In comparison, a dental X-ray calls for approximately one-half the radiation dose of one chest X-ray.

Accidental exposure to high doses this type of radiation, called ionizing radiation, causes injuries such as skin and tissue burns, hair loss and cataracts. It can also increase a patient’s lifetime cancer risk.

“The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The goal of FDA’s initiative is to support the benefits associated with medical imaging while minimizing the risks.”

Radiation errors have made big headlines in the news recently. In October 2009, Cedars-Sinai Medical Center admitted that over an 18-month period from February 2008 until August 2009, 206 patients at the facility received radiation doses that were approximately eight times the expected level. http://newyorkcity.injuryboard.com/fda-and-prescription-drugs/fda-fears-patient-radiation-overexposure-from-ct-brain-perfusion-scans-widespread.aspx?googleid=272758

Just last month, a New York Times investigation found 621 mistakes involving radiation treatment errors from 2001 to 2008 at hospitals in New York State. http://www.nytimes.com/2010/01/24/health/24radiation.html

Through the FDA’s regulatory oversight of medical imaging devices and through collaboration with other federal agencies and health care professional groups, the FDA is advocating the adoption of two principles of radiation protection: appropriate justification of the radiation procedure and optimization of the radiation dose used during each procedure.

The FDA will require manufacturers of CT and fluoroscopic devices to incorporate important safeguards into the design of their machines, develop safer technologies and to provide appropriate training to technicians operating the machines. The FDA could require devices to display, record, and report equipment settings and radiation dose; an alert for users when the dose exceeds a diagnostic reference level (the optimal dose for most patients); training for users and a requirement that devices be able to capture and transmit radiation dose information to a patient’s electronic medical record and to national dose registries.