Document ID: FDA-2010-N-0217-0001
Agency: fda
Document Type: Notice
Title: Device Improvements to Reduce the Number of Under-Doses, Over-Doses, and Misaligned Exposures From Therapeutic Radiation
Posted Date: 2010-05-07T04:00Z

[Federal Register Volume 75, Number 88 (Friday, May 7, 2010)]
[Notices]
[Pages 25279-25281]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10754]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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: 
simon.choi@fda.hhs.gov.
    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 CDRHRadiationTherapy@fda.hhs.gov or by contacting Simon Choi 
(see Contact Person). Provide complete contact information for each 
attendee, including name, title, company or organization,

[[Page 25280]]

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

[[Page 25281]]

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