Public Workshop – Magnetic Resonance Imaging Safety FDA

The Food and Drug Administration (FDA) is announcing a public workshop entitled: “Magnetic Resonance Imaging (MRI) Safety Public Workshop.” The purpose of the public workshop is to discuss factors affecting the safe use of magnetic resonance imaging (MRI) and approaches to mitigate risks. The overall goal is to discuss strategies to minimize patient and staff risk in the MRI environment. The topics to be discussed are: general MRI safety, ferromagnetic detectors, scanning patients with medical implants, and the impact of innovation on MRI safety concerns. Additional background about Magnetic Resonance Imaging can be found at MRI (Magnetic Resonance Imaging).

The purpose of the workshop is to discuss factors affecting the safe use of magnetic resonance imaging (MRI) devices and approaches to mitigate risks.

 

Background

The number of MRI procedures performed each year continues to rise. At the same time, MRI technology, implanted medical devices and medical device accessories (non-implanted) are becoming more complex. There is increasing demand to scan patients with implanted or accessory medical devices, and the presence of these devices are becoming commonplace in the MRI suite during imaging procedures. While MRI procedures are relatively safe, there are hazards inherent to the MRI environment that must be considered to ensure the safety of patients, healthcare providers and others who enter the MRI suite. The Agency recognizes the need to work with stakeholders to identify hazard reduction strategies that minimize risk in the MRI environment.

Through this effort, FDA and stakeholder groups will take steps to promote the safe use of MRI by increasing awareness of safety issues that may occur in the MRI environment and by identifying regulatory, policy and system-oriented solutions to mitigate risk. FDA can advance these goals by collaborating with medical device and health care industries, and the healthcare provider and consumer communities.

 

Transcripts and Archived Webcast

Please be advised that as soon as a transcript is available, it will be accessible athttp://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857. A link to the transcripts will also be available on this page approximately 45 days after the public workshop.

Archived webcasts are currently available:

Contacts for Additional Information

For information regarding the program, contact:

Carol Krueger
Office of the Center Director
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Bldg 66, Room 5437 br /> Silver Spring, MD 20993
Phone: 301-796-3241
Email: Carol.Krueger@fda.hhs.gov

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