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FDA Issues Draft Guidance on Medical Device Safety in MRI Environment

Draft guidance document, available for public comment for 60 days, provides suggested standards for testing and labeling of medical devices meant to function in an MRI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FDA Issues Draft Guidance on Medical Device Safety in MRI Environment

August 1, 2019 — The U.S. Food and Drug Administration (FDA) issued a new draft guidance titled Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.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 This draft guidance, when finalized, is intended to: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  • Submit comments on the draft guidance.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

Imaging Biometrics and Medical College of Wisconsin Awarded NIH Grant
News | Neuro Imaging | September 09, 2019
Imaging Biometrics LLC (IB), in collaboration with the Medical College of Wisconsin (MCW), has received a $2.75 million...
ASNC Announces Multisocietal Cardiac Amyloidosis Imaging Consensus
News | Cardiac Imaging | September 09, 2019
September 9, 2019 — The American Society of Nuclear Cardiology (ASNC) published a new expert consensus document along
AJR Publishes Gender Affirmation Surgery Primer for Radiologists. transgender radiology images,

Scout image from contrast-enhanced CT shows erectile implant; stainless steel and silicone anchors (arrow) transfixed to pubic bone are asymmetric.

News | Orthopedic Imaging | September 05, 2019
September 5, 2019 — An ahead-of-print article published in the December issue of the American Journal of Roentgen
Neurological Brain Markers Might Detect Risk for Psychotic Disorders

Researchers at the University of Missouri used MRI scans similar to this photo to find neurological markers in the human brain. These markers can be used to detect people at risk for developing psychotic disorders and to understand when this risk has been successfully treated. Image courtesy of Marquette University/John Kerns.

News | Neuro Imaging | September 04, 2019
Help may be on the way for people who might lose contact with reality through a psychotic disorder, such as...
Medical Imaging Rates Continue to Rise Despite Push to Reduce Their Use
News | Radiology Imaging | September 03, 2019
Despite a broad campaign among physician groups to reduce the amount of medical imaging, use rates of various scans...
High-capacity MRI Scanner Approvals Boosting Innovations in MRI-safe Pulse Oximeters
News | Magnetic Resonance Imaging (MRI) | August 29, 2019
A notable increase in the prevalence of chronic diseases has led to a surge in sales of high-end diagnostic machines,...
Delaware Imaging Network Now Offers NeuroQuant Brain Imaging MRI Software
News | Neuro Imaging | August 29, 2019
Delaware Imaging Network (DIN), Delaware’s largest network of outpatient medical imaging centers, has added NeuroQuant...
Displacement comparison at the end-systolic frame and final frame

Displacement comparison at the end-systolic frame and final frame. The three patients (V6, V10, V16) with different left-ventricle walls are shown. Point-to-surface distance is a measure to estimate the distance of a point from the reference surface. Image courtesy of WMG, University of Warwick

News | Cardiac Imaging | August 28, 2019
A new 3-D magnetic resonance imaging (MRI) computing technique developed by scientists in WMG at the University of...
Smoldering Spots in the Brain May Signal Severe MS

NIH researchers found that dark rimmed spots representing ongoing, “smoldering” inflammation, may be a hallmark of more disabling forms of multiple sclerosis. Image courtesy of Reich lab, NIH/NINDS.

News | Neuro Imaging | August 22, 2019
Aided by a high-powered brain scanner and a 3-D printer, National Institutes of Health (NIH) researchers peered inside...
Vaping Impairs Vascular Function

Image courtesy of the American Heart Association

News | Magnetic Resonance Imaging (MRI) | August 21, 2019
Inhaling a vaporized liquid solution through an e-cigarette, otherwise known as vaping, immediately impacts vascular...