The U.S. Food and Drug Administration (FDA) is warning CT providers and patients that certain implantable and wearable devices such as insulin pumps, pacemakers, defibrillators, and neurostimulators may be adversely affected if scanned directly within the x-ray beam.
The April 4 public health notification emphasized that only a few adverse events have been reported, and that the possibility of harming one of these devices by exposing its circuitry to the x-ray beam is extremely rare. Also, while the possibility of harming the device is real, the potential for harm to a patient is very unlikely, the agency stated.
Even so, the risk can be reduced by using a low-dose scanning protocol, and it can be eliminated completely by avoiding the direct irradiation of the implantable devices, according to the FDA.
The notification updates and replaces the FDA's 2008 public health notification on this topic. More information is available on the agency's website.
