FDA aims to reduce unnecessary radiation exposure with new initiative

The agency will target medical imaging procedures including CT, nuclear medicine studies and fluoroscopy.

In a press release issued yesterday, the FDA announced the launch of a three-part initiative that will help ensure that patients who undergo medical imaging procedures involving radiation receive optimal doses and that the amount of radiation delivered is appropriately justified.

The program aims to promote safe use of medical imaging devices, to support informed clinical decision- making and to increase patient awareness.

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

The announcement comes after the FDA investigated reports last year from more than 200 patients who experienced hair loss and skin redness believed to be caused by excess radiation from CT scanners. High doses of radiation can also cause cataracts and some forms of cancer, the FDA warned, but the agency noted that the amount of radiation patients are exposed to varies from procedure to procedure.

The FDA will focus efforts on reducing unnecessary exposure caused by CT scans, nuclear medicine studies and fluoroscopy because these use much higher radiation doses compared with procedures such as X-rays and mammography, according to officials, and they contribute the most to the total amount of radiation experienced by the U.S. population.

Shuren called for collaboration between the FDA and professional health care organizations, such as the Centers for Medicare and Medicaid Services, to create standards and requirements for both imaging manufacturers and health care providers as well as to encourage better communication between providers and patients about the risks and benefits of these procedures.

The initiative will involve incorporating quality assurance practices into mandatory accreditation processes; creating a national dose registry to help validate diagnostic reference levels, to define levels where they do not yet exist and to provide benchmarks for health care facilities to use when conducting imaging studies; and developing targeted safeguarding requirements for CT and fluoroscopic device manufacturers.

The FDA plans to hold a public meeting March 30 to 31, 2010, to solicit input for such requirements. Examples could include a requirement that these devices display, record and report equipment settings and radiation dose; an alert for users when the dose exceeds a diagnostic reference level; 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, according to the press release.

The FDA is also collaborating with other health organizations to develop and disseminate a patient medical imaging history card. The tool will be available on the FDA’s website and will enable patients to track their own medical imaging history to share with physicians, which officials said may be especially useful if this history is not included in their existing medical record.

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