The agency said it hopes these measures "will promote the safe use of medical imaging devices, support informed clinical decision-making, and increase patient awareness of their own exposure."
The FDA also plans to require makers of CT and fluoroscopic devices to build safeguards into their machines and to develop safer technology, and to train users of these devices on their proper use. The agency will hold a meeting in late March to get expert opinion on what needs to be done to improve the safety of these devices.
Some suggestions under consideration include requiring the devices to display and record the radiation dose being administered. The FDA said it may also require that the devices record and transmit the radiation dose used to a patient's electronic medical record as well as to a national radiation doses database.
In a cooperative effort, the FDA and the Centers for Medicare and Medicaid Services are going to get hospitals and imaging centers to start using quality-assurance practices to improve the oversight and safe use of these imaging devices. This new program will be part of the accreditation process for these facilities, according to the FDA.
The FDA also wants professional organizations to continue to develop radiation reference levels for medical imaging procedures and to develop one or more national registries for radiation doses.
These registries would collect data from imaging facilities around the country. According to the agency, these data could help "define reference levels where they do not yet exist, validate levels that do exist, and provide benchmarks for health-care facilities to use in individual imaging studies."
In addition, the FDA wants patients to become aware of their radiation expo
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