The FDA moves to quell fears of medical radiation overexposure with an initiative that tackles CT, fluoroscopy and nuclear medicine, they announced on Tuesday.

The ambitious multi-part plan aims to ensure that all radiological scans in these modalities are justified by medical criteria and that the lowest needed dose is used in each procedure, the FDA said.

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

The FDA's plan would encourage health care organizations to help establish set reference levels for dose exposure, as well as national dose registries where all radiological scans across the country could be logged. The agency also hopes to pressure medical device makers into including safety features in future radiography machines. And ultimately, the FDA hopes to give patients lifetime electronic records cataloging all radiological exposures.

And with the Centers for Medicare and Medicaid, the agency wants to add quality assurance practices to shore up the now required accreditation process of imaging centers.

ON TARGET

To start, the FDA aims to convene a public meeting on March 30-31 to receive comments on how best to get manufacturers of CT scans and fluoroscopy devices to include improvements that would improve safety.

Suggestions the FDA mentions include built-in dose displays, alerts that sound whenever a dose exceeds a standard level for the procedure, or the ability to capture and transmit radiation doses to the patient's electronic health record or a national dose registry.

This latter possibility would fit nicely with the FDA's most radical goal: the creation of patient medical imaging records that would be hosted on the FDA's website and which a patient could use to keep track of all radiation doses and to share with doctors.

The nation's main radiology group, the American College of Radiology, welcomes the idea. "We're in favor of the concept of an electronic dose record card," Shawn Farley, a spokesman for the ACR, tells DOTmed News. Farley notes that ACR currently hands out a "low tech" paper version of the dose record that resembles the immunization card given to children.

While the FDA doesn't name the health care organizations they're working with to establish diagnostic reference levels or national dose registries, the ACR has worked in both areas, and is currently devising its own dose registry. Farley says the ACR supports the FDA's proposals, and hopes to help. "We look forward to working with them in trying to carry this out," he says.

Still, Farley believes accreditation - required by the CMS for imaging facilities billing certain procedures by the beginning of 2012 - is the first step.

"We feel the main way of going about this is the accreditation. If nothing else, it will provide a baseline of care to try to make sure things are uniform nationwide," Farley says.

In January, CMS named ACR one of its first accrediting bodies for assessing imaging facilities.