The FDA has introduced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures like computed tomography (CT), nuclear medicine studies, and fluoroscopy.
The FDA said that the procedures are the contributors to total radiation exposure within the US population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography.
CT, nuclear medicine, and fluoroscopic imaging have led to early diagnosis of disease, improved treatment planning, and image-guided therapies that help save lives every day. The FDA continues to support a strong dialogue between patients and physicians over the medical necessity and risk associated with these types of imaging studies.
The three types of imaging exams will expose patients to ionizing radiation, a type of radiation that can increase a person’s lifetime cancer risk. Accidental exposure to high amounts of radiation also can cause injuries, such as skin burns, hair loss and cataracts. Health care decisions made by patients and their physicians should include discussions of the medical need and associated risks for each procedure.
The three-pronged initiative that FDA has introduced expects to promote the safe use of medical imaging devices, support informed clinical decision-making, and increase patient awareness of their own exposure.
The FDA intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate safeguards into the design of their machines to develop safer technologies and to provide appropriate training to support safe use by practitioners.
Jeffrey Shuren, director of the Center for Devices and Radiological Health at FDA, said: “The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years. The goal of FDA’s initiative is to support the benefits associated with medical imaging while minimizing the risks.”