FDA seeks safeguards for radiation-based medical scans

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 yesterday 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. 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 reports of acute overdoses from CT scanning at Cedars-Sinai Medical Center in Los Angeles. More than 250 patients were exposed to excessive radiation. Many reported hair loss and skin redness. 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. But they carry a higher risk. One CT chest scan is said to carry as much radiation as nearly 400 chest X-rays.