FDA: small risk of implant malfunction from medical scans

Staff Writer
Columbus CEO

WASHINGTON (AP) — Patients with pacemakers, drug pumps and other medical devices face a very small risk of electrical malfunction when undergoing medical scanning, but it shouldn't stop them from getting necessary care, according to health regulators.

The Food and Drug Administration said Friday that the risk of serious health problems due to medical scans is "extremely low" and can be further reduced by using lower doses of X-ray radiation. The agency first flagged the issue to health providers in 2008 and posted an update to its website Friday.

FDA regulators have received a small number of reports of fainting, dizziness and seizures among patients with drug pumps who underwent scanning. While there is no evidence of "direct causation," FDA regulators say the X-rays used in CT scans could interfere with circuitry in some medical devices, including both implants and wearable devices.

Despite this risk, the FDA stressed that the potential harm is "greatly outweighed by the clinical benefit of a medically-indicated CT examination."

CT scans use a series of X-ray images from different angles to create a multi-perspective image of bones, blood vessels, organs and other parts of the body. They are often used to screen for internal injuries following accidents or to plan surgeries and radiation treatments.

The FDA recommends patients with electronic medical devices notify their physician before underdgoing a CT scan. Patients with insulin pumps, which administer a protein for treating diabetes, should bring the controller for their device and backup insulin, in case of pump problems.

Scanning technicians can take several steps to decrease CT exposure to medical devices, including: scanning around the device — where possible — and using a lower dose of radiation over a longer period of time.