Radiation Injuries Subject Of FDA Proposals
Patients have been receiving sometimes fatal radiation overdoses during medical treatments. Our Atlanta medical malpractice attorneys have been aware of this problem for years. The issue was recently highlighted by the news media in several articles. Now, federal regulators are taking note and proposing regulations which will begin requiring manufacturers of high-grade medical imaging machines to include safety controls that prevent patients from receiving excessive radiation doses.
The Food and Drug Administration action 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. The proposed new regulations are 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.
One new proposal will require manufacturers to install safeguards on machines that automatically notify operators if they are using a higher-than-recommended dose. The FDA is also developing best-practice measures that hospitals and imaging centers will have to meet to retain their scanning accreditation.
According to the FDA, the average American's total radiation exposure has nearly doubled in the last three decades, largely due to CT scans and other imaging tests. Medical radiation now accounts for more than half of the population's total radiation exposure.
The FDA action follows investigations of 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 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, CT scans carry a higher risk than older scans. One CT chest scan carries as much radiation as nearly 400 chest X-rays.
The FDA's effort will also be directed at 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. Fluoroscopy uses a continuous X-ray beam to view body parts in real time, such as when giving epidural injections..