FDA Launches Initiative to Reduce Radiation Exposure

The U.S. Food and Drug Administration (FDA) announced in February an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy.

These types of imaging exams expose patients to ionizing radiation, a type of radiation that can increase a person’s lifetime cancer risk. Accidental exposure to very high amounts of radiation also can cause injuries, such as skin burns, hair loss, and cataracts.

“The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “The goal of the FDA’s initiative is to support the benefits associated with medical imaging while minimizing the risks.”

A new study from the National Council on Radiation Protection & Measurement (NCRP) concludes Americans were exposed to seven times more radiation from medical procedures in 2006 than in the early 1980s, reports FierceHealthcare.

Through the Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, the FDA is taking steps to:

  1. Promote safe use of medical imaging devices;
  2. Support informed clinical decision making; and
  3. Increase patient awareness.

The FDA says it intend to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate safeguards into the design of their machines. Examples might require these devices to display, record, and report equipment settings and radiation dose, to alert users when the dose exceeds a diagnostic reference level, to train users, and to capture and transmit radiation dose information to a patient’s electronic medical record (EMR) and to national dose registries.

The FDA and the Centers for Medicare & Medicaid Services (CMS) are reportedly collaborating to incorporate key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals.

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