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Federal Register: Device Improvements to Reduce the Number of Under-Doses, Over-Doses, and Misaligned Exposures From Therapeutic Radiation; Public Meeting; Request for Comment...

Thu, 05/13/2010 - 10:38am
U.S. Food & Drug Administration

[Federal Register: May 7, 2010 (Volume 75, Number 88)]

[Notices]

[Page 25279-25281]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr07my10-119]

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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:

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

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