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FDA Preliminary Public Health Notification

The FDA has issued a preliminary public health notification regarding the possible malfunction of electronic medical devices caused by computed tomography (CT) scanning. According to the notification, preliminary public health notifications are intended to quickly share device-related safety information with healthcare providers when the available information and understanding of an issue are still evolving and are updated if and when new information on the subject becomes available.

The notification indicates that while most patients with electronic medical devices undergo CT scans without any adverse consequences, there have been a small number of reports of CT interference with pacemakers, defibrillators, neurostimulators and implanted or external drug infusion pumps. The notification indicates that the adverse events were most likely due to x-rays during the CT scan.

Hearing aids are not specifically named in the FDA notification as devices that could theoretically be affected by CT x-rays. The list includes: cardiac pacemakers, implantable cardiac defibrillators, neurostimulators, drug infusion pumps, including insulin pumps, retinal implants and cochlear implants.

The notification further states that no reports of CT interference with cochlear implants and retinal implants have been received to date, although it is theoretically possible.

The notification provides further information about the adverse events, recommendations for CT operators and wearers of electronic devices, reporting, and contact information.

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