WASHINGTON — Federal regulators will require manufacturers of high-grade medical imaging machines to include safety controls that prevent patients from receiving excessive radiation doses.
The proposal announced Tuesday is part of a multipronged effort to address reports of acute injuries as well as reduce lifetime exposure to radiation, which has nearly doubled since 1980.
The Food and Drug Administration push will focus on high-tech machines such as CT scanners, which allow doctors to make lifesaving diagnoses, but also expose patients to high doses of cancer-causing radiation.
FDA officials said manufacturers should install safeguards on their machines that automatically notify operators if they are using a higher-than-recommended dose.
Regulators are also developing best-practice measures that hospitals and imaging centers will have to meet to retain their scanning accreditation.
A public meeting to discuss the proposals with physicians and manufacturers is scheduled for late March.
The average American's total radiation exposure has nearly doubled in the last three decades, largely due to CT scans and other next-generation imaging tests, according to recent studies. Medical radiation now accounts for more than half of the population's total radiation exposure; it used to be just one-sixth.
FDA's initiative comes five months after regulators began looking into reports of acute overdoses from CT scanning at Cedars-Sinai Medical Center in Los Angeles. More than 250 patients there were exposed to excessive radiation, with many reporting losing hair and skin redness. Since then the FDA has launched investigations into similar problems at two other California hospitals.
CT scans became popular because they offer a quick, relatively cheap way to get three-dimensional pictures that give an almost surgical view of the body. Doctors use them to evaluate trauma, belly pain, seizures, chronic headaches and other ailments.
However, they also carry a higher risk than older scans. One CT chest scan carries as much radiation as nearly 400 chest X-rays, according to government officials.
There is some disagreement over the cancer risk associated with medical imaging, though virtually all medical societies recommend minimizing radiation exposure.
The FDA's effort will also try to curb excessive radiation exposure from two other types of imaging: nuclear medicine and fluoroscopy. Nuclear medicine involves injecting nuclear particles into the body to diagnose problems with organs, such as the heart and lungs. Fluoroscopy uses a continuous X-ray beam to view body parts in real time.
Makers of medical scanning equipment include General Electric, Siemens AG and Toshiba Corp.
A spokesman for the industry's trade association was not immediately able to provide comment Tuesday afternoon.
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