FDA imaging guidance for patients with electronic medical devices: 4 notes

The FDA has published medical imaging guidance for patients with electronic medical devices after receiving some reports of device interference occurring during CT scans.

The number of reports the FDA has received on this issue is "limited" and the probability of a problem occurring is "extremely low," according to the guidance published Oct. 15 on the agency's website. 

Here are four things to know about the guidance:

  1. Despite the reported issues, CT scans should continue to be the preferred imaging technology for patients with medical devices.

  2. The FDA's current understanding is that interference or damage occurs only when the CT scanner radiation targets the part of the body where the medical device is located.

  3. The likelihood of interference or damage decreases with lower radiation dose and radiation dose rate.

  4. The FDA issued additional patient, physician and radiologist specific guidelines for neurostimulating devices, implantable electronic heart devices and wearable devices.

Read the full guidance here

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