In an effort to make sure that kids don’t get too much radiation during medical tests, the U.S. Food and Drug Administration proposed guidelines for manufacturers of medical imaging devices to make new equipment that takes children’s safety into account.
The agency is urging manufacturers to include instructions on how to safely use their devices in pediatric settings. If device makers can’t prove their machines are safe and effective for use on children, they should warn against using them. The devices targeted by the FDA include those used for CT scans, X-rays (including dental), angiography and several others.
The guidance document, which will be opened for public comment on May 10, is part of a larger effort by the FDA, the medical imaging community and the Alliance for Radiation Safety in Pediatric Imaging to prevent unnecessary exposure to radiation during diagnostic testing.
“The FDA is especially worried about radiation exposure in younger patients,” said Jana Delfino, a biomedical engineer at the FDA’s Center for Devices and Radiological Health. “Children are more radiation sensitive, have a longer expected lifetime and most importantly, equipment that is optimized for adults may result in excessive radiation exposures.”
Because children will most likely live longer than adults, any radiation effects have a longer time to manifest themselves.
Among those effects, according to the American Cancer Society, are numerous types of cancer, including lung cancer, skin cancer, breast cancer and multiple myeloma.
Despite the potential dangers of radiation, the number of children who receive CT scans, one of the most common diagnostic tests, has increased exponentially.
A 2011 study found that the number of visits to pediatric emergency rooms that involved a CT scan between 1995 and 2008 increased from .33 to 1.65 million, a fivefold increase.
“Over the past 20 years or so, there has been a vast increase in the number of CT scanners available, and technology has improved to the point where they are much more efficient than they used to be, factors that contribute directly to the accessibility of CT imaging and the number of examinations performed each year,” said Dr. Lawrence Tanenbaum, director of magnetic resonance imaging and computerized tomography at Mount Sinai Medical Center in New York,
CT scans, he explained, offer a reliable way to diagnose problems without the need for less informative and/or potentially more invasive procedures.
“Radiologists practice in a way that uses the minimum amount of radiation in all circumstances because that’s prudent,” he said. He added that with children, that often means the image quality will be a bit lower but still highly acceptable.
The FDA’s guidelines offer some suggested features manufacturers can add to their new devices to make them safer for children, such as preset control settings, procedures, labeling and protocol that can minimize exposure while producing acceptable-quality images and an interface that will remind device users about pediatric concerns.
“These changes are reasonable and are easy to achieve,” said Tanenbaum.
After the guidance document is released, the public will be invited to comment. The FDA will hold a public meeting on July 16 and after that, will issue a final guidance.