Imaging Groups Reject Call For FDA Oversight Of CT Scanners

Direct FDA jurisdiction over how CT scanners are used -- including radiation dose requirements -- would be a logistical nightmare because of the numbers and types of scanners in operation, and the variety of imaging services they provide, the American College of Radiology and the Society of Computed Body Tomography and Magnetic Resonance said Tuesday in a joint statement.

Instead, ACR/SCBTMR said that concerns surrounding imaging equipment could be addressed if the federal government required healthcare providers that use imaging equipment to adopt ACR safety standards.

ACR/SCBTMR were responding to a perspective piece published in the June 23 issue of New England Journal of Medicine which suggested that direct FDA oversight of CT scanners and other devices that deliver radiation is needed to control patient exposure brought on by the overuse of imaging equipment by inadequately trained medical staff.

The author, Rebecca Smith-Bindman, MD, a professor of radiology at UC San Francisco's Helen Diller Family Comprehensive Cancer Center, wrote that she and her colleagues had determined that the risk of cancer from a single CT scan could be as high as 1 in 80.

"Yet no professional or governmental organization is responsible for collecting, monitoring, or reporting patients' CT-dose information," Smith-Bindman wrote in NEJM. "The FDA approves CT scanners, but because it has no authority to oversee the way CT tests are used in clinical practice, it collects only limited data on routine doses. Radiologists and other medical specialists determine how CT tests are performed. Studies have consistently shown that physicians know little about radiation doses or cancer risks from medical imaging."

Smith-Bindman wrote that while radiation doses are supposed to be "as low as reasonably achievable," there are no guidelines to indicate what constitute reasonable doses for most types of CT. In addition, she wrote, enforcement and training requirements vary from state to state, and CT technologists often don't receive consistent and comprehensive training.

In their response Tuesday, ACR/SCBTMR said they share Smith-Bindman's concerns about the overuse and improper use of CT scanners, but said her call to put medical imaging directly under FDA oversight would create "narrowly defined regulations (that) may not allow for the flexibility that physicians need to provide the best possible care to their patients."

ACR/SCBTMR said a more effective and immediate path toward addressing radiation doses would be for the federal government to require all imaging providers to meet existing, previously voluntary programs that the ACR has already put in place. Those programs include:

• Computerized exam ordering systems based on ACR criteria that help doctors prescribe the best exam for a patient's given condition, inform them when an exam that does not use radiation may be more appropriate or when no scan may be warranted at all.
• ACR facility accreditation, which requires facilities to maintain image quality, checks radiation dose used, and minimizes the likelihood of adverse events such as those highlighted in recent news reports, by requiring physicians to meet certain education/training standards, scanners to be surveyed regularly by a medical physicist to ensure proper function, and technologists operating scanners to be certified.
• The ACR CT dose index registry, which allows providers to submit radiation dose data so that facilities may compare their CT dose indices against realistic national benchmarks and may re-examine their imaging protocols if necessary.

"Lawmakers and government agencies need to work with the provider community to help ensure that that the next steps to address the very important issues of medical radiation reduction and necessary utilization are the correct steps," ACR/SCBTM said in a media release. "Federally mandating participation in these existing programs can help ensure that medical imaging is safe, effective, and available without removing treatment decisions from doctor's hands, and without further stressing the American healthcare system."