News | Magnetic Resonance Imaging (MRI) | August 01, 2019 | Jeff Zagoudis, Associate Editor

FDA Issues Draft Guidance on Medical Device Safety in MRI Environment

Draft guidance document, available for public comment for 60 days, provides suggested standards for testing and labeling of medical devices meant to function in an MRI environment

FDA Issues Draft Guidance on Medical Device Safety in MRI Environment

August 1, 2019 — The U.S. Food and Drug Administration (FDA) issued a new draft guidance titled Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.

The MR environment presents unique safety hazards for patients and other persons with medical devices near or inside an MR system. This draft guidance, when finalized, is intended to:

  • Provide recommendations on testing for assessing the safety and compatibility of medical devices in the MR environment;
  • Identify test methods that address specific hazards and provide recommended format for MRI Safety Information in medical device labeling; and
  • Submit comments on the draft guidance.

According to the FDA, the guidance document “applies to all implanted medical devices, external medical devices that are fastened to or carried by a patient, and all medical devices that are intended to enter the MR environment.” Contents include recommendations on MR safety and compatibility assessments, as well as key information the agency says should be included in any FDA submissions for the affected devices. The guidance does not apply to the MRI scanner systems themselves. 

In the document, the FDA recommends that the safety and performance of a medical device should be assessed for all of the magnetic field strengths to which that device may potentially be exposed. Some of the potential safety issues covered in the document include: 

  • Magnetically induced displacement force and/or torque (unwanted movement of the device caused by the magnetic field); 
  • Heating of the medical device and/or surrounding tissue, by radiofrequency (RF) induction or switching magnetic field gradients;
  • Gradient induced vibration of the medical device;
  • Unintended stimulation of the device by switching gradient pulses;
  • Medical device malfunction; and
  • Image artifacts.

The FDA explains that all devices should be labeled as either MR-conditional (demonstrated safety in the MR environment within defined conditions), MR safe (poses no known hazards resulting from exposure to any MR environment) or MR unsafe (poses unacceptable risks to the patient,medical staff or other persons within the MR environment). 

This draft guidance will be open for public comments for 60 days at www.Regulations.gov under docket number FDA-2019-D-2837.

Read the full draft guidance document.

For more information: www.fda.gov

Related MRI Safety Content

Closing the Loopholes in MRI Safety

VIDEO: New App Improves MRI Safety For Implantable Devices

The Changing Relationship Between MRIs and Pacemakers

How To Manage Risk in the MR Suite

Related Content

Radiographer Apollo Exconde with his Lego concept open MRI for patient education.

Radiographer Apollo Exconde with his Lego concept open MRI for patient education.

News | Patient Engagement | November 11, 2019
November 11, 2019 — Radiographer Apollo Exconde...
Unlike other technologies for imaging the placenta, pCASL MRI can distinguish maternal blood from fetal blood

Image courtesy of Pixabay

News | Clinical Trials | November 07, 2019
November 7, 2019 — A new imaging technique to track
The introduction of liquid helium free, high-end MRI systems by MR Solutions substantially reduces the environmental impact
News | Magnetic Resonance Imaging (MRI) | November 05, 2019
November 5, 2019 — Environmental impact is becoming a significant factor in the selection of suppliers even in precli
MRI control room at Centra DuPage Hospital
News | Magnetic Resonance Imaging (MRI) | November 04, 2019
November 4, 2019 — Traditional image-guided procedures remained restricted to the limitation of physicians referring
The Neuroreader software program quantifies brain volume in study participants with TBI

The Neuroreader software program quantifies brain volume in study participants with TBI. Image courtesy of UCLA Health.

News | Clinical Trials | October 29, 2019
October 29, 2019 — A UCLA-led...
An example of a semitruck trailer-based mobile MRI suite.

An example of a semitruck trailer-based mobile MRI suite, similar to the one involved in the accident.

Feature | Magnetic Resonance Imaging (MRI) | October 25, 2019 | Dave Fornell
A radiology nurse was seriously injured Oct. 23 at Sunderby Hospital in Luleå, located in northern Sweden, when caught...
NVIDIA and King's College London Debut First Privacy-preserving Federated Learning System

Image courtesy of NVIDIA

News | Artificial Intelligence | October 23, 2019
To help advance medical research while preserving data privacy and improving patient outcomes for brain tumor...
Greater Left Ventricular Mass Increases Risk of Heart Failure
News | Cardiac Imaging | October 21, 2019
Elevated left ventricular mass, known as left-ventricular hypertrophy, is a stronger predictor of coronary artery...
The Revolution Apex intelligent computed tomography (CT) scanner

The Revolution Apex intelligent computed tomography (CT) scanner. Image courtesy of GE Healthcare.

News | RSNA | October 18, 2019
At the 2019 annual meeting of the Radiological Society of North America (RSNA 2019), Dec. 1-6 in Chicago, GE Healthcare...
Guerbet Signs Agreement With Icometrix for Exclusive Distribution of Icobrain
News | Neuro Imaging | October 16, 2019
Guerbet announced it has signed an exclusive agreement with Icometrix for the distribution in France, Italy and Brazil...