Food and Drug Administration Calls for Better Controls of Medical Radiation Exposure

On Tuesday, Feb. 9, 2010, the U.S. Food and Drug Administration launched the "Initiative to Reduce Unnecessary Radiation Exposure From Medical Imaging" that targets CT, nuclear medicine and fluoroscopy.

The FDA announced that it will use its regulatory authority and collaborate with others in the federal government and healthcare community to promote safer use of medical imaging devices. The agency is also touting greater support for informed clinical decision making and increased patient awareness.

The agency cited the need to justify ordering and performing each procedure and carefully optimizing the radiation dose during a medical imaging procedure or therapy session.

"When such exams are conducted, patients should be exposed to an optimal radiation dose — no more or less than what is necessary to produce a high-quality image. In other words, each patient should get the right imaging exam, at the right time, with the right radiation dose," the FDA stated in a white paper at http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm199994.htm.

To promote the safe use of medical radiation using its regulatory authority, the FDA has scheduled a public meeting March 30 and 31, 2010, to seek input on requirements. Among the items the FDA is considering are a CT and fluoroscopic device display that will record and report radiation dose or alert users when a dose exceeds a set reference level. The three areas the agency will address are:

1. Establishing requirements for manufacturers of CT and fluoroscopic devices to incorporate additional safeguards into equipment design, labeling and user training.
2. Partnering with the Centers for Medicare and Medicaid Services (CMS) to incorporate key quality assurance practices into accreditation and participation criteria for imaging facilities and hospitals.
3. Recommending that the healthcare professional community collaborate with the FDA to develop diagnostic reference levels for CT, fluoroscopy and nuclear medicine procedures locally and also through a national radiation dose registry.