FDA Workshop Covers MRI Safety Enhancements

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MRI safety was the topic of a two-day public workshop held earlier this week by the Food and Drug Administration (FDA) on its White Oak campus in Silver Spring, Maryland.

Experts present at the workshop discussed means of improving MRI safety, including the use of a screening process to ensure that patients with such implants as pacemakers do not undergo scans.

“The MRI’s strong magnetic field can affect devices, and many patients don’t know what type of implants they have,” Ellen Lipman, director of professional development, American Society of Radiology Technologists, said during the workshop. Lipman noted that manufacturers should provide to patients the name and the model of any implanted device and indicate whether it is safe for imaging.

The same information should also be incorporated into patients’ electronic health records (EHRs) if at all possible, she added.

Training and education for MRI technologists was also covered as part of the workshop. “Technologists must be educated, licensed, and certified,” said Charles Stanley, president of the Section for Magnetic Resonance Technologists.

One expert deemed patient training equally imperative to improved MRI safety.

“We need to train radiologists, and patients need to be trained as well,” said Carolyn Roth, chief executive officer of Imaging Education Associates, Berwyn, Pennsylvania. “Patients get their information from Hollywood. They watch an episode of House and think they understand MRI safety.”

The FDA says it will use the comments from the workshop to heighten overall awareness of safety issues that may occur in the MRI environment, and to identify regulatory, policy, and system-oriented solutions for mitigating risk.