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:
- Despite the reported issues, CT scans should continue to be the preferred imaging technology for patients with medical devices.
- 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.
- The likelihood of interference or damage decreases with lower radiation dose and radiation dose rate.
- 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.
