[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
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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