[Federal Register Volume 75, Number 36 (Wednesday, February 24, 2010)]
[Notices]
[Pages 8375-8377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-3674]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0080]
Device Improvements to Reduce Unnecessary Radiation Exposure From
Medical Imaging; Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
meeting entitled: ``Device Improvements to Reduce Unnecessary Radiation
Exposure From Medical Imaging.'' The purpose of this meeting is to
discuss steps that could be taken by manufacturers of devices used in
computed tomography (CT) and in fluoroscopy that would help reduce
unnecessary patient exposure to ionizing radiation during CT and
fluoroscopic procedures. FDA is seeking input on this topic and
requests comments on a number of related questions.
Dates and Time: The public meeting will be held on March 30 and 31,
2010, from 8 a.m. to 5 p.m. Persons interested in attending and/or
participating in the meeting must register by 5 p.m. on March 15, 2010.
Submit written or electronic comments by April 15, 2010.
Location: The public meeting will be held at the Holiday Inn
Gaithersburg, 2 Montgomery Village Ave., Gaithersburg, MD 20879. The
meeting will not be videotaped or webcast.
Contact Person: Simon Choi, Food and Drug Administration, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, rm. 5400, Silver Spring, MD 20993-
0002, 301-796-5426, e-mail: [email protected].
Registration: If you wish to attend the public meeting, you must
register by e-mailing [email protected]. Provide
complete contact information for each attendee, including name, title,
company or organization, address, e-mail, and telephone number.
Registration requests must be received by March 15, 2010.
If you wish to make an oral presentation during any of the sessions
at the meeting (see section II of this document, Public Meeting), you
must indicate this at the time of registration. FDA has included
specific questions for comment in section III of this document,
Questions for Comment. You should also identify the session(s) during
which you would like to present, as well as the question(s) you would
like to address in each session. In order to keep each session focused
on the topic at hand, presentations given during each session should
address only the topic specified for that session. FDA will do its best
to accommodate requests to speak. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and to request time for a joint presentation. FDA will
determine the amount of time allotted to each presenter and the
approximate time that each oral presentation is scheduled to begin.
If you would like to participate in any of the four planned
roundtable discussions (see section II of this document, Public
Meeting), you must indicate this interest at the time of registration,
and also submit a brief statement that describes your experience with
CT or fluoroscopic devices. FDA is seeking participants interested in
engaging in one of four wrap-up roundtable discussions related to the
presentations given during each of the earlier sessions of the meeting.
Each roundtable discussion will include no more than 10 nonFDA
participants. Only one participant from an organization or company will
be assigned to each discussion group. FDA will attempt to have a range
of constituencies represented in each discussion group. Others in
attendance at the public meeting will have an opportunity to listen to
each roundtable discussion.
Registration is free and will be on a first-come, first-served
basis. Early registration is recommended because seating is limited.
FDA may limit the number of participants from each organization based
on space limitations. Registrants will receive confirmation once they
have been accepted. Onsite registration on the day of the public
meeting will be provided on a space-available basis beginning at 7 a.m.
If you need special accommodations due to a disability, please
contact Simon Choi at 301-796-5426, [email protected] at least 7
days in advance of the meeting.
Comments: FDA is holding this public meeting to obtain information
on a number of questions regarding steps manufacturers of CT and
fluoroscopic devices could take to help reduce unnecessary patient
exposure to ionizing radiation from these medical imaging modalities.
The deadline for submitting comments related to this public meeting is
April 15, 2010.
Regardless of attendance at the public meeting, 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. Submit a
single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified with the docket number found in brackets in the
heading of this document. In addition, when
[[Page 8376]]
responding to specific questions as outlined in section III 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.
SUPPLEMENTARY INFORMATION:
I. Background
Like all medical procedures, medical imaging that uses ionizing
radiation presents both benefits and risks. Medical imaging has led to
improvements in the diagnosis and treatment of numerous medical
conditions. At the same time, exposure to ionizing radiation may
elevate patients' lifetime risk of developing cancer. Overexposure to
ionizing radiation can also cause injuries in the short-term such as
skin burns and hair loss. In an effort to reduce these risks, FDA's
Center for Devices and Radiological Health (CDRH) recently announced
the Initiative to Reduce Unnecessary Radiation Exposure from Medical
Imaging (see http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/UCM199904 for more information).
FDA is currently exploring steps that manufacturers of CT and
fluoroscopic devices could take to reduce unnecessary radiation
exposure through improved product design, enhanced labeling, or
improved instructions and training for equipment use and quality
assurance at medical imaging facilities.
II. Public Meeting
The objective of this public meeting is to receive public input on
steps manufacturers of CT and fluoroscopic devices should take to help
reduce unnecessary patient exposure to ionizing radiation from these
medical imaging modalities.
The meeting will be held over the course of 2 days. Each day will
be divided into two sessions. Day 1 will focus on equipment features
that manufacturers should incorporate into CT scanners (morning
session) and fluoroscopes (afternoon session). Day 2 will focus on
steps manufacturers should take to improve training of individuals who
use these devices (morning session) and steps to improve quality
assurance at medical imaging facilities with respect to these two
modalities (afternoon session).
During each session, members of the public may present oral
comments related to the topic of that session. Specific questions for
comment are listed in section III of this document, Questions for
Comment. Individuals who are interested in giving an oral presentation
during any of the sessions must indicate this interest at the time of
registration and must also identify the session(s) at which they would
like to present (see Registration). In order to keep each session
focused on the topic at hand, each oral presentation should address
only the topic specified for that session. Commentators are free to
submit written comments on any topic(s) to the open docket (see
Comments). FDA will schedule speakers for each session as time permits.
To close each of the four sessions, FDA will hold a roundtable
discussion between FDA staff and selected participants representing a
range of constituencies (for more information about participating in
the roundtable discussion, see Registration). The participants in each
roundtable discussion will remark on the presentations given during the
session, engage in a dialogue with each other and FDA staff, and
provide closing thoughts on the session. Roundtable participants will
not be asked to develop consensus opinions during the discussion, but
rather to provide their individual perspectives. Others in attendance
at the meeting will have an opportunity to listen to each roundtable
discussion.
In advance of the meeting, additional information, including a
meeting agenda with a speakers' schedule for each session, will be made
available on the Internet. This information will be placed on file in
the public docket (docket number found in brackets in the heading of
this document), which is available at http://www.regulations.gov. This
information will also be available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the
appropriate meeting from the list).
III. Questions for Comment
A. Device-Specific Elements: Equipment Features, Labeling, and
Premarket Submission Requirements
Note: The questions in the following paragraphs are relevant to
both CT and fluoroscopic devices. Please clearly indicate in your
response which modality you are discussing. Additionally, while the
questions are worded broadly, please feel free to include elements in
your response that are specific to particular types of procedures
(e.g., multi-phase contrast-enhanced CT examinations, perfusion
studies, etc.) or devices (e.g., multidetector CT devices that allow
very thin slices, etc.).
1. What hardware and software features should manufacturers build
into CT and fluoroscopic devices in order to reduce unnecessary
exposure to ionizing radiation during each imaging exam, and in order
to reduce what may be inappropriate prescription of imaging exams?
Should manufacturers incorporate special provisions for pediatric and
female patients?
2. Should manufacturers incorporate access controls and audit
capabilities into CT and fluoroscopic equipment in order to identify
the user(s) of the device during any particular exam, and to identify
those responsible for creating and changing imaging protocols and
exposure settings? If so, why, and what access controls and audit
capabilities should be incorporated? If not, why not?
3. Should manufacturers incorporate warnings, alerts, lockouts, or
overrides into CT and fluoroscopic equipment that would inform users
and require confirmation or possibly procedure modification during an
imaging session in which the patient could be exposed to high levels of
radiation? If so, why, and what warnings, alerts, lockouts, or
overrides should be incorporated? If not, why not?
4. Should manufacturers set default imaging protocols for CT and
fluoroscopic procedures so that they incorporate the ALARA concept
(maintaining dose As Low As Reasonably Achievable) and utilize or
provide for incorporation of diagnostic reference levels into CT and
fluoroscopic devices? If so, why and how? If not, why not?
5. Should manufacturers incorporate exam referral criteria into CT
and fluoroscopy equipment to allow users to check the appropriateness
of an imaging exam before it is initiated or flag an exam after it is
done? If so, why and how? If not, why not?
6. Should manufacturers incorporate into CT and fluoroscopic
equipment features to ensure that exposure settings, imaging protocols,
and metrics of body dose and peak skin dose are displayed to the
operator(s) of the equipment and recorded for physician review? If so,
why and how? If not, why not?
7. Should manufacturers incorporate features into CT and
fluoroscopic equipment to facilitate transmission of technique
parameters, imaging protocols, and dose metrics to a patient's imaging
record, an electronic health record, or other database? If so, why and
how? If not, why not?
8. Should manufacturers take steps to improve the labeling of CT
and fluoroscopic devices, such as including more information about
radiation exposure, including more information
[[Page 8377]]
about the clinical applications of the device that have been shown to
be safe and effective, improving instructions for use for each distinct
clinical application, and including a comprehensive quality control
manual? If so, why and how? If not, why not?
9. Should manufacturers submit more data to FDA as part of their
premarket submissions for approval or clearance of CT and fluoroscopic
devices, related to the safety and effectiveness of these devices
(e.g., data demonstrating the safety and effectiveness of the device
specific to each distinct clinical indication, or clinical data
demonstrating the benefit of relatively high-dose procedures, for
example, those with peak skin doses exceeding 1 Gy)? If so, why, and
what data should be submitted? If not, why not?
10. Should manufacturers submit technical data to FDA as part of
their premarket submissions for approval or clearance of CT and
fluoroscopic devices, demonstrating dose reduction and image quality
claims? If so, why, and what data should be submitted? If not, why not?
11. In addition to the already-required indications for use
statement, should manufacturers of CT and fluoroscopic devices submit
to FDA as part of their premarket submissions a list of common clinical
applications for which the device could be used (such as those
requiring special software supported by the device) and the appropriate
demographics of the likely patient populations for those exams? If so,
why, and what level of information should be submitted? If not, why
not?
12. What changes should manufacturers make to CT and fluoroscopic
devices currently on the market in order to reduce unnecessary patient
exposure to ionizing radiation?
B. User Training
1. Should manufacturers provide training to medical imaging
equipment users to ensure adequate understanding of equipment
capabilities, operating principles for the technology, general
information about optimizing patient dose and image quality, and
specific dose-reduction equipment features? If so, why, and what
training should be provided? If not, why not?
2. If manufacturers provide such training, which personnel should
receive it to ensure proper use of medical imaging equipment and dose
reduction features? In your response, please consider radiologic
technologists or technologists in other specialties as well as
physicians in all medical specialties who operate fluoroscopic
equipment.
3. If manufacturers provide such training, how, when, and how often
should it be delivered so that it is easily and effectively implemented
at imaging facilities? For example, for software upgrades that affect
dose, should training be performed at each site as well as training at
the time of equipment installation?
C. Quality Assurance Measures
1. Should manufacturers provide quality assurance (QA) instructions
and standard operating procedures to medical imaging facilities and
users of CT and fluoroscopic devices? If so, why, and what instructions
should be provided? If not, why not?
2. Should manufacturers provide training on quality assurance
practices? If so, why, what type of training should be provided, and to
which personnel? If not, why not?
D. Evaluation
1. What tools and metrics should FDA, in collaboration with others
in the Federal Government and the healthcare professional community,
use to evaluate the impact of efforts to reduce unnecessary radiation
exposure from medical imaging?
IV. Transcripts
Transcripts of the public meeting may be requested in writing from
the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public meeting at a cost of 10
cents per page. A transcript of the public meeting will be available on
the Internet at http://www.regulations.gov.
Dated: February 18, 2010.
Jeffrey Shuren,
Director, Center for Devices and Radiological Health.
[FR Doc. 2010-3674 Filed 2-23-10; 8:45 am]
BILLING CODE 4160-01-S