It’s a big deal when radiology makes national headlines. And it was a big deal in February when national news media broadcast live the Congressional hearing on controlling radiation dose. The event was sparked by recent FDA investigations into hundreds of cases of potential radiation overexposure during CT studies in California and Alabama, and a series of articles in a national newspaper highlighting issues with excessive or incorrect radiation.
A two-day public FDA meeting in late March was convened to find answers. The meeting kicked off FDA’s campaign aimed at reducing unnecessary radiation exposure in CT, nuclear medicine and fluoroscopy. The three-prong initiative looks to educate physicians in making more informed decisions on ordering imaging studies, increasing patient awareness to the risk of radiation exposure and engaging industry to create safer devices.
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FDA wants vendors to display, record, and report equipment settings and radiation dose on their systems and train clinicians on dose safety. For the installed base, regulators are looking at software upgrades or other fixes. Diagnostic reference levels and quality assurance standards will be developed as will local and national radiation dose registries for longitudinal tracking.
Nationwide exposure to ionizing radiation has increased seven fold since 1980, largely from the modalities FDA is targeting. Altogether, the three modalities account for 26 percent of imaging procedures—but contribute 89 percent of the annual exposure that patients get from medical imaging.
The National Institutes of Health (NIH) has started the trend (with vendor support) of tracking radiation exposure from CT and PET/CT procedures in patients treated in their facilities via an EMR. They hope this will lead to an accurate assessment of whether any cancer risk is associated with radiation dose from imaging tests. NIH also will allow patients to manage their own radiation history. “While these steps themselves are not sufficient to allow population-based assessment of cancer risk from low-dose radiation, they are nonetheless necessary to begin a data set for this determination,” said David A. Bluemke, MD, director of radiology and imaging sciences at the NIH Clinical Center in Bethesda, Md. “We encourage all medical imaging facilities to include similar requirements for radiation-dose reporting outputs from the manufacturers of radiation-producing medical equipment.” Think nationally, act locally.