The FDA unveiled an initiative to reduce unnecessary radiation exposure from CT scans, nuclear medicine studies and fluoroscopy, the three procedures that are the greatest contributors to radiation exposure in the U.S., according to an FDA press release.
The initiative will include new requirements for manufacturers of CT and fluoroscopic devices to incorporate safeguards into the design of their products, to develop safer technologies, and to provide training for practitioners using the machines. The FDA plans to hold a public meeting March 30-31 to get feedback on what to include in the requirements.
Among the possible examples are requirements that devices display, record and report equipment settings and radiation dose; alerts for users when the dose exceeds a reference level; user training; and a requirement that devices be able to capture and transmit radiation dose information to a patient's electronic medical record and national dose registries, according to the FDA.
The FDA is also collaborating with CMS to incorporate quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals, according to the FDA release. The FDA also recommended that healthcare professional organizations work with the agency to develop diagnostic radiation reference levels for medical imaging procedures and develop national registries for radiation doses.
"The goal of FDA's initiative is to support the benefits associated with medical imaging while minimizing the risks," said Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, in the press release.
Read the FDA's press release on the radiation exposure safety initiative.