FDA to take closer look at medical radiation, devices

The Food and Drug Administration will step up oversight of three forms of medical radiation, including CT scans, in an effort to reduce patients' exposure to unnecessary radiation, The New York Times reports.

The move follows reports last year that patients at four hospitals, including a major Los Angeles medical center, were exposed to excessive doses of radiation during CT scans meant to detect strokes. A "growing movement" to increase the safety of therapeutic and diagnostic medical radiation has coalesced among professional groups, lawmakers and consumer advocates. The FDA measures will target "CT scans, which provide three-dimensional images; nuclear medicine studies, in which patients are given a radioactive substance and doctors watch it move through the body; and fluoroscopies, in which a radiation-emitting device provides a continuous internal image on a monitor" (Bogdanich and Ruiz, 2/9).

"The agency also will promote a personal medical imaging history card that will enable patients to keep track of the number of images, and the amount of radiation, they receive over time, according to a medical imaging safety initiative unveiled Tuesday," the Los Angeles Times reports. In addition, the FDA could require manufacturers to join the safety push. "Equipment might be automatically calibrated to a recommended dose for a given procedure, so that any dosage increase would require an action by the operator. Equipment might also be designed to require identification of the operator as a way of tracking errors" (Zajac and Zarembo, 2/10).

"The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years," a senior FDA official said, according to HealthDay News/Business Week. The FDA hopes to minimize risk - including radiation-related cancers - by ensuring procedures are justified and that minimum necessary doses of radiation are delivered. HealthDay reports, "While the extent of the cancer risk is a topic of debate, most experts agree that exposure to unnecessary radiation from these devices should be reduced" (Reinberg, 2/9).

Also in FDA news, a review of the agency process for approving medical devices is underway, Dow Jones Newswires/The Wall Street Journal reports, prompting device makers to brace "for changes that could make it tougher and more expensive to roll out new products." The agency's "510(k) process is intended for new products that are similar to items already approved. Most medical devices are cleared this way, but the FDA has drawn flak for how it interprets the rules." In September, the agency issued a "self-critical report" regarding the approval process for a specific knee device. The FDA "asked the influential Institute of Medicine to review the 510(k) process. That review is expected to conclude in March next year" (Kamp, 2/9).