[Federal Register Volume 76, Number 182 (Tuesday, September 20, 2011)]
[Notices]
[Pages 58281-58282]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24030]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0640]


Magnetic Resonance Imaging Safety; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: 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.

DATES: The public workshop will be held on October 25, 2011, from 8:30 
a.m. to 5 p.m. EDT and on October 26, 2011, from 8:30 a.m. to 5 p.m. 
EDT.

ADDRESSES: The public workshop will be held in the Great Room at the 
FDA White Oak Conference Center, Bldg 31, rm. 1503, 10903 New Hampshire 
Ave., Silver Spring, MD, 20993.

FOR FURTHER INFORMATION CONTACT: Carol Krueger, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5437, Silver 
Spring, MD 20993, 301-796-3241, FAX: 301-847-8510, or e-mail: 
Carol.Krueger@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 
    Registration: Registration is free and on a first-come, first-
served basis. Persons interested in attending this workshop must 
register online by 5 p.m. on October 4, 2011. Early registration is 
recommended because facilities are limited; 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. If you need special accommodations due 
to a disability, please contact Cynthia Garris, e-mail: 
Cynthia.Garris@fda.hhs.gov or phone: 301 796-5861 no later than October 
11, 2011.
    To register for the public workshop, please visit the following Web 
site: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm270720.htm (or go the ``FDA Medical Devices 
News & Events--Workshops and Conferences'' calendar and select this 
public workshop from the posted events list). Please provide complete 
contact information for each attendee, including name, title, 
affiliation, address, e-mail, 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.
    Streaming Webcast of the Public Workshop: This workshop will also 
be webcast. Persons interested in viewing the webcast must register 
online by 5 p.m. on October 4, 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 20, 2011. If you have never attended a Connect Pro event 
before, test your connection 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 
after this document publishes in the Federal Register.)
    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 during a public 
comment session or participate in a roundtable session, and which 
topics you wish to address. FDA has included general topics in this 
document. FDA will do its best to accommodate requests to make public 
comment and participate in the roundtable sessions. 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.
    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 found in 
brackets in the heading of this document. In addition, when responding 
to specific questions as outlined in section II of this document, 
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.

I. 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

[[Page 58282]]

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.

II. Topics for Discussion at the Public Workshop

    The public workshop will be organized to discuss the following 
topic areas:

A. General MRI Safety

     Multiple professional organizations, patient safety groups 
and accrediting bodies, i.e. the American College of Radiology (ACR), 
the International Society for Magnetic Resonance in Medicine (ISMRM), 
Emergency Care Research Institute (ECRI Institute), and the Joint 
Commission (TJC), have sponsored MRI safety conferences and published 
recommendations and strategies for MRI safe practices. FDA would like 
public comment on the extent these practices have been adopted, and if 
they have not, what are the reasons for not adopting/implementing these 
practices, and given that FDA does not regulate the practice of 
medicine, what can FDA do to improve adoption.
     FDA would like public comment on the policies and 
procedures individual sites have in place governing the use of non-
implanted medical devices entering the MRI suite.

B. Ferromagnetic Detectors (FD)

     FDA would like public comment on the user experience with 
ferromagnetic detectors (FD) and to gather information on whether these 
devices improve MRI safety. FDA would also like to understand any 
drawbacks to the use of FD and other risk/benefit/cost considerations 
by sites that are considering adopting the technology.
     FDA would also like public comment on the reasons for not 
adopting/implementing use of FD.

C. Scanning Subjects Known To Have Medical Implants

     FDA would like public comment on the clinical scenario and 
the challenges (technical and otherwise) involved in the scanning of 
patients with implanted medical devices. FDA is particularly interested 
in hearing how individual sites make the decision of whether or not to 
scan a patient with an implanted medical device, or any special 
monitoring of the patient's condition or the implanted medical device's 
performance.
     Safely scanning patients with implanted medical devices 
requires coordination between any MRI system and the implanted medical 
device, as not all implants can be safely scanned in all MRI systems. 
Current FDA labeling requirements for ``MR Conditional'' implants 
include the static magnetic field, maximum spatial gradient, and 
maximum specific absorption rate (SAR) under which the device can be 
safely scanned. FDA would like public comment on whether this 
information is or is not sufficient to make an informed decision about 
whether it is safe or is not safe to scan a patient.
     FDA would like public comment on the challenges sites face 
in obtaining the specific conditions of use (i.e. the ``MR 
Conditional'' labeling) for medical implants and what is done when 
information about MRI compatibility is unavailable. For example, when 
presented with a patient with an implanted medical device, how is the 
identity of the implant definitively determined and how is MR labeling 
information obtained to make a decision of whether or not to scan the 
patient? If ``MR Conditional'' labeling cannot be found or the device 
cannot be identified, how is the decision of whether or not to scan a 
patient determined?

D. The Impact of Innovation on MRI Safety Concerns

     FDA would like comment from stakeholders on future 
technical developments and changing clinical practice scenarios that 
may affect the safety profile of MRI.

III. Transcripts

    As soon as the 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 the 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 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.

    Dated: September 13, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-24030 Filed 9-19-11; 8:45 am]
BILLING CODE 4160-01-P