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U.S. Department of Health and Human Services

Medical Devices

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Public Workshop Magnetic Resonance Imaging Safety, October 25-26, 2011#

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.

Date, Time and Location

This workshop was held October 25-26, 2011, beginning at 8:30 am. EDT each day at the following location:

FDA White Oak Campus
10903 New Hampshire Ave
The Great Room (Room 1503), White Oak Conference Center, Bldg 31
Silver Spring, MD, 20903

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.

Workshop Details

Written or electronic comments

FDA is holding this public workshop to obtain information on a number of questions regarding factors affecting MRI safe use. The deadline for submitting written comments related to this public workshop is November 22, 2011. Regardless of attendance at the public workshop, interested persons may submit written or electronic comments. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. It is necessary to send only one set of comments. Please identify written comments with the docket number FDA-2011-N-0640. In addition, when responding to specific questions, please identify the question you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday and will be posted to the docket at http://www.regulations.gov.

Agenda        

Day One - 10/25General MR Safety
8:30 am-8:35 amWelcome and Intro
8:35-8:45 AMStructure of the Day and Logistics
8:45-9:00 AMIntroduction : MRI Safety Workshop
9:00-9:10 AMDay 1 Introduction : General MRI Safety, Ferromagnetic Detectors, and Innovation
9:10-10:15 AM

Session #1 : Public Comment on MRI Safety, Ferromagnetic Detectors, and Impact of Innovation on MR Safety Concerns

10:15-10:30 AMBreak
10:30-11:45 AM

Session #2 : Public Comment on MRI Safety, Ferromagnetic Detectors, and Impact of Innovation on MR Safety Concerns

11:45 AM-1:00 PMLunch
1:00-2:15 PM

Session #3 : Public Comment on MRI Safety, Ferromagnetic Detectors, and Impact of Innovation on MR Safety Concerns

2:15-2:30 PMBreak
2:30-4:30 PMRoundtable #1 : MRI Safety, Ferromagnetic Detectors, and the Impact of Innovation on MR Safety Concerns
4:30-4:45 PMSummary of Day One
4:45 PMAdjourn
Day Two - 10/26 Implants and accessory devices and equipment in the MR environment
8:30-8:45 AMStructure of the Day and Logistics
8:45-9:00 AMDay 2 Introduction : Implanted and accessory medical devices in the MR environment
9:00-10:15 AM

Session #4 : Public Comment on scanning patients with implanted medical devices, including devices labelled as “MR Conditional”

*Slides are combined

10:15-10:30 AMBreak
10:30-11:45 AMRoundtable #2 : Scanning patients with implanted medical devices
11:45 AM-1:00 PMLunch
1:00 -2:30 PM

Session #5 : Public Comment on use of accessory medical devices in the MR environment

2:30-2:45PMBreak
2:45-3:45 PMRoundtable #3 : Accessory medical devices in the MR environment
3:45-4 PMSummary, Closing Remarks and Adjournment
4PMAdjourn

Transcripts and Archived Webcast

Transcripts are currently available:

A transcript is also accessible at http://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.

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