With growing reports of unnecessary radiation exposure to patients, the Food and Drug Administration has stepped in to require safety controls that will eliminate excessive radiation doses, and also will work to develop best-practice measures.
Examples of the growing problem include patients who weren't told of radiation exposures in California, veterans receiving incorrect doses in Philadelphia, and a 2009 study that shows increasing radiation exposure to patients.
The average American's total radiation exposure has nearly doubled since 1980, largely because of CT scans, according to recent studies, including one by the New England Journal of Medicine. Medical radiation now accounts for more than half of the population's total radiation exposure; it used to be just one-sixth.
Tuesday's announcement comes five months after FDA began looking into reports of problems with CT scanning at Cedars-Sinai Medical Center in Los Angeles that went on for 18 months before being noticed. More than 200 patients were exposed to excess radiation.
The FDA's efforts will extend to other high-dose types of radiation procedures, including 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.
A public hearing is set for March on this initiative, and the FDA will work with CMS to create key quality assurance practices. The FDA will then try to work those practices into the mandatory accreditation and Conditions of Participation processes for imaging facilities and hospitals.
To learn more:
- read this FDA press release