[Federal Register Volume 75, Number 88 (Friday, May 7, 2010)]
[Notices]
[Pages 25279-25281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10754]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0217]
Device Improvements to Reduce the Number of Under-Doses, Over-
Doses, and Misaligned Exposures From Therapeutic Radiation; Public
Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; requests for comments.
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The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``Device Improvements to Reduce the Number of Under-
doses, Over-doses, and Misaligned Exposures from Therapeutic
Radiation.'' The purpose of this meeting is to discuss steps that could
be taken by manufacturers of linear accelerators, radiation therapy
treatment planning systems, and radiation therapy simulators to help
reduce misadministration and misaligned exposures. FDA is seeking input
on this topic and requests comments on a number of related questions.
Date and Time: The public meeting will be held on June 9 and 10,
2010, from 8 a.m. to 5 p.m.
Location: The public meeting will be held at the Hilton Hotel
Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD
20877.
Contact Person: Simon Choi, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 5400, Silver Spring, MD 20993, 301-796-5426; e-mail:
[email protected].
Registration and Requests for Oral Presentations: Persons
interested in attending the public meeting must register by May 15,
2010. If you wish to attend the public meeting, you must register by e-
mail at [email protected] or by contacting Simon Choi
(see Contact Person). Provide complete contact information for each
attendee, including name, title, company or organization,
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address, telephone number, and e-mail (if appropriate).
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 wish to make an oral presentation during any of the sessions
at the meeting (see section I of this document, Public Meeting), you
must indicate this at the time of registration. FDA has included
specific questions for comment in section II 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 round-
table discussions (see section I 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 radiation
therapy devices. FDA is seeking participants interested in engaging in
one of four round-table discussions related to the presentations given
during each of the earlier sessions of the meeting. Each round-table
discussion will include no more than 10 non-FDA 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 round-table
discussion.
If you need special accommodations due to a disability, please
contact Simon Choi (see Contact Person) 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 radiation
therapy devices could take to help reduce over-doses, under-doses, or
misaligned exposures from therapeutic radiation. The deadline for
submitting comments related to this public meeting is May 15, 2010, by
5 p.m. EST.
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 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.
SUPPLEMENTARY INFORMATION:
I. Public Meeting
The objective of this public meeting is to discuss steps that could
be taken by manufacturers of linear accelerators, radiation therapy
treatment planning systems, and radiation therapy simulators to help
reduce misadministration and misaligned exposures. FDA is seeking input
on this topic and requests comments on a number of related questions.
The public 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 radiation therapy
devices (morning session) and software (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 (QA) at medical facilities (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 II 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 and Requests for Oral Presentations).
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 round-table
discussion between FDA staff and selected participants representing a
range of constituencies (for more information about participating in
the round-table discussion, see Registration and Requests for Oral
Presentations). The participants in each round-table 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. Round-table 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 round-table discussion.
In advance of the public 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).
II. Questions for Comment
A. Device Improvements and Reporting
1. Describe issues with misadministrations and your suggestions to
address the safety issues.
2. Are there any hardware and software features that manufacturers
can build into radiation therapy devices to reduce underexposures,
overexposures, or misaligned exposures to ionizing radiation during
radiation therapy?
3. What techniques do you recommend for improving therapists
attention (e.g. a dead-man switch to assure operator attention). Should
efforts to improve device safety features include: incorporation of
access controls and audit capabilities into equipment to identify the
specific user(s) of the device during any particular treatment? If so,
why, and what access controls and audit
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capabilities should be incorporated? If not, why not?
4. If certain changes are desirable as additional safeguards for
the devices, how feasible is it to retrofit existing units in the
field?
5. Should manufacturers standardize their display format to ensure
that treatment settings, protocols, and collimator positions are
displayed taking human factors into consideration and are recorded for
physician review?
6. Should manufacturers submit more data to FDA as part of their
premarket submissions for approval or clearance of devices, related to
the safety of these devices? If so, why, and what data should be
submitted? If not, why not?
7. Should there be a mandatory ``time-out'' built into the
equipment, similar to what already has been implemented for surgical
procedures, to confirm that all settings for the equipment are correct
and allow adequate time for QA? If not, why not?
8. Should manufacturers provide better instructions and specifics
(i.e. QA methodology) for acceptance testing and/or commissioning due
to new and/or unique features/capabilities? If so, why and what should
be included?
9. Other than requiring a facility to report to FDA, how can FDA
ensure that facilities report to FDA significant under-doses and over-
doses? Should there be a quantitative metric used to define a medical
event similar to that used by the Nuclear Regulatory Commission (e.g.
+[sol]- 20% variation from intended dose)?
10. What prevents users from participating in voluntary reporting?
11. How can FDA encourage reporting and prevent workarounds even
when no clinically significant adverse event occurs?
B. User Training
1. Should manufacturers provide training to ensure equipment users
have adequate understanding of equipment capabilities, operating
principles for the technology, general information about patient dose,
and specific dose-related 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? In your response, please consider dosimetrists, physicists,
radiation therapists or technologists in other specialties and
departmental administrators as well as physicians in all medical
specialties who may operate radiation therapeutic equipment.
3. If manufacturers provide such training, what is the most
effective timing for a new installation and how frequently should it be
repeated for optimum implementation? Should manufacturers recommend an
internal training program for use by the facility to insure continued
staff competence?
4. For software patches and upgrades, how is the software tested
for hazard analysis, verification and validation? Should manufacturers
perform additional testing to adequately test software patches?
5. Would standardizing terminology and standardizing design of
control panels facilitate safe use of the equipment?
6. Should custom-tailored educational material, such as pamphlets,
pocket cards, videos etc. that highlight unique features of the
equipment, be provided with new equipment?
C. Quality Assurance Measures
1. Is there a model QA program that exists which is widely
accepted? If so, please describe.
2. What types of QA should be the responsibility of the facility,
the physicist, the operator, others?
3. Should manufacturers provide QA procedures to medical facilities
and users of radiation therapy devices? If so, why, and what
instructions should be provided? If not, why not? How extensive should
they be?
4. Should manufacturers provide training on QA practices? If so,
why, what type of training should be provided, and to which personnel?
If not, why not and who should?
III. Transcripts
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.
Dated: May 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10754 Filed 5-6-10; 8:45 am]
BILLING CODE 4160-01-S