FDA Initiative Addresses Unnecessary Radiation Exposure
With recent news of excessive, harmful radiation from medical imaging procedures, the U.S. Food & Drug Administration announced on February 9, 2010 an initiative to decrease unnecessary exposure from computed tomography (CT) scans, nuclear medicine studies, and fluoroscopy. These contribute substantially to total radiation exposure, with much higher radiation than standard and dental X-rays, and mammography. FDA officials acknowledged that overall, public exposure to radiation from imaging has risen dramatically in the past 20 years. Health risks from overexposure include increased incidences of cancer, burns, cataracts, and hair loss. Eight patients at one medical center received eight times the normal radiation level from CT scans, which deliver higher and more variable doses than previously thought, according to two new studies. FDA plans to require dosage safeguards for equipment, mandate accreditation of imaging providers, and establish a dosage information registry with benchmarks of appropriate levels for particular procedures. FDA is also working with CMS (the Centers for Medicare & Medicaid Services) to add quality assurance practices to the accreditation and conditions of participation requirements for hospitals and imaging facilities. A public hearing on elements of the initiative is scheduled for March 30-31. More information can be found on the FDA website.
Eileen Shannon Carlson, RN, JD
Tags: Centers for Medicare & Medicaid Services, CMS, FDA, February 2010, Food & Drug Administration, medical imaging, radiation
