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

Posted Sep 20 2011 12:00am

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 www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/ucm200086.htm

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

This workshop will be 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

FDA Campus Information (includes directions & parking):
http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation
/ucm241740.htm

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.

Webcast

This workshop will also be webcast. Persons interested in viewing the webcast must register online by 5 p.m. on October 11, 2011. Early registration is recommended because webcast connections are limited. Organizations are requested to register all participants, but view using one connection per location. Webcast participants will be sent technical system requirements after registration, and will be sent connection access information after October 20th. If you have never attended a Connect Pro event before, we advise you to test your connection in advance of the meeting at: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm . To get a quick overview of the Connect Pro program, visit: http://www.adobe.com/go/connectpro_overview FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites.

Requests for oral presentations

Requests for Oral Presentations: This workshop includes public comment and topic-focused roundtable sessions. During on-line registration you may indicate if you wish to present in person during a public comment session or participate in a roundtable session, and which topics you wish to address. FDA will do its best to accommodate requests to make public comment. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the roundtable. Following the close of registration, FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify roundtable participants. All requests to make oral presentations must be received by the close of registration on October 4, 2011. If selected for presentation, any presentation materials must be sent by email to the Contact Person no later than October 11, 2011. No commercial promotional material will be permitted to be presented or distributed at the workshop.

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 .

Food and beverages

Food and beverages will be available for purchase by participants during the workshop breaks.

Day One - 10/25

General MR Safety

8:30- 8:45 AM

Structure of the Day and Logistics

8:45-9:00 AM

Introduction: MRI Safety Workshop

9:00-9:10 AM

Day 1 Introduction: General MRI Safety, Ferromagnetic Detectors, and Innovation

9:10-10:15 AM

Session #1: Public Comment on MRI Safety

10:15-10:30 AM

Break

10:30-11:45 AM

Session #2: Public Comment on Ferromagnetic Detectors

11:45 AM -1:00 PM

Lunch

1:00-2:15 PM

Session #3: Public Comment on the Impact of Innovation on MR Safety Concerns

2:15-2:30 PM

Break

2:30-4:30 PM

Roundtable#1: MRI Safety, Ferromagnetic Detectors, and the Impact of Innovation on MR Safety Concerns

4:30-4:45 PM

Summary of Day One

4:45 PM

Adjourn

Day Two - 10/26

Implants and accessory devices and equipment in the MR environment

8:30 -8:45 AM

Structure of the Day and Logistics

8:45-9:00 AM

Day 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”

10:15-10:30 AM

Break

10:30 – 11:45 AM

Roundtable #2: Scanning patients with implanted medical devices

11:45 AM - 1:00 PM

Lunch

1:00 -2:30 PM

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

2:30 – 2:45PM

Break

2:45- 3:45 PM

Roundtable #3: Accessory medical devices in the MR environment

3:45 - 4 PM

Summary, Closing Remarks and Adjournment

4PM

Adjourn

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. If you wish to attend this Workshop, you must register by 5 pm EDT on October 4, 2011. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, on-site registration on the day of the public workshop will be provided beginning at 7:30 a.m.

To register for the public workshop, Please select either the In-Person Workshop Attendance registration, or the Online Webcast Viewing registration on the form below. Please provide complete contact information for each attendee, including name, title, affiliation, email address, and telephone number. For those without Internet access, please call the Contact Person to register. Registrants will receive confirmation once they have been accepted. You will be notified if you are on a waitlist.

Please indicate all of the topics that you want to make public comment on, and for which you want to participate in a roundtable discussion. You will receive separate notification following the close of registration if you have been scheduled to present a public comment or participate in a roundtable discussion. Due to the limited number of slots available, scheduling will attempt to reflect input from stakeholders from a range of areas, including industry, consumers, and health care providers.

Request to Speak and participation in Roundtable Discussions are only available to In-Person Attendees.

Please be advised that as soon as a transcript is available, it will be 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. A link to the transcripts and an archived file of the webcast will also be available on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select this public workshop from the posted events list), approximately 45 days after the public workshop.

For information regarding registration and special accommodations, contact:

Cynthia Garris
Office of Communication, Education, and Radiation Programs
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue, Bldg 66
Silver Spring, MD 20993
Phone: 301-796-5861
Email: Cynthia.Garris@fda.hhs.gov

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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