[Federal Register Volume 59, Number 212 (Thursday, November 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27250]
[[Page Unknown]]
[Federal Register: November 3, 1994]
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 35
Request for Comments Regarding Potential Modifications of NRC's
Therapy Regulations
AGENCY: Nuclear Regulatory Commission.
ACTION: Request for comments regarding potential modification of NRC's
medical therapy regulations.
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SUMMARY: A major revision of the regulations governing the medical use
of byproduct material, and associated licensing and inspection guidance
is planned, to more easily accommodate changes in current technology
and patterns of medical use. The staff discussed the need for
additional regulations and guidance for brachytherapy (in particular,
high-dose-rate brachytherapy) with NRC's Advisory Committee for the
Medical Uses of Isotopes (ACMUI). The ACMUI advised the staff to
solicit additional information from the regulated community to
sufficiently identify and evaluate the problems and determine what
additional regulations and guidance are necessary to further prevent
errors. The NRC seeks input from the medical community with regard to
the adequacy of existing standards and procedures for brachytherapy and
radiopharmaceutical therapy and would like to discuss the future
direction of guidelines and regulations. As one aspect of these
objectives, NRC is publishing this list of issues and questions for
comment and response by members of the medical community and any other
interested parties.
DATES: Submit comments by March 3, 1995. Comments received after this
date will be considered if it is practical to do so, but the Commission
is able to ensure consideration only for comments received before this
date.
ADDRESSES: Send written comments, responses, or suggestions to the
Chief, Rules Review and Directives Branch, U.S. Nuclear Regulatory
Commission, Washington, DC 20555. Copies of comments received may be
examined at the NRC Public Document Room, 2120 L Street NW. (Lower
Level), Washington, DC.
Obtain individual copies of the list of issues and questions from
Patricia K. Holahan, Office of Nuclear Material Safety and Safeguards,
U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone:
(301) 415-7847.
FOR FURTHER INFORMATION CONTACT:
Patricia K. Holahan, Office of Nuclear Material Safety and Safeguards,
U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone
(301) 415-7847.
SUPPLEMENTARY INFORMATION: Because of several recent incidents, the NRC
has increasingly focussed on the medical use of byproduct material for
manual and remote afterloading brachytherapy and radiopharmaceutical
therapy. The NRC has been notified of brachytherapy errors that have
included computer errors (treatment planning and data entry), misplaced
sources, dislodged sources, patient intervention, and human error. In
particular, several incidents have been reported involving an error in
fractionated doses for brachytherapy and radiopharmaceutical therapy.
In addition, there has been an increased use of beta-emitting
radiopharmaceuticals for therapeutic purposes in both nuclear medicine
and radiation oncology.
This list of issues and questions is being provided to allow the
medical community to voluntarily provide comments and responses
regarding those areas of medical use of byproduct material that are
currently being reviewed by NRC, to determine if additional or revised
regulations are warranted. Any party interested in providing input
regarding these issues may provide a written response to the address
above.
1. What constitutes a significant error, for a given fraction (for
fractionated doses), that would require you to make an adjustment in
the prescribed treatment regimen or that might result in unexpected
clinical consequences?
High-Dose-Rate Brachytherapy
____ 10 percent
____ 20 percent
____ 30 percent
All Other Brachytherapy
____ 10 percent
____ 20 percent
____ 30 percent
Radiopharmaceutical Therapy
____ 10 percent
____ 20 percent
____ 30 percent
2. Should the error tolerance for overdoses be different than that
for underdoses? Please explain.
____ Yes ____ No
3. At your facility, how is the accuracy of your computer treatment
planning system verified?
High-Dose-Rate Brachytherapy
4. NRC regulations require that the written directive for high-
dose-rate remote afterloading (HDR) brachytherapy include the
radioisotope, treatment site, and total dose. What additional
information do you typically include in your written directives and
why?
____ Dose per fraction
____ Number of fractions
____ Treatment volume
____ Other (please specify)
5. If more than one fraction is to be administered, should the
written directive be prepared to include the specifics for the entire
course of therapy or should a written directive be prepared for each
individual fraction?
6. Should there be quality assurance checks and measurements for
remote afterloading brachytherapy devices, in 10 CFR Part 35, as there
are for teletherapy?
____ Yes ____ No
If no, why not?
7. Are there existing standards on calibration of brachytherapy
sources?
____ Yes ____ No
If yes, or yes in part, what are these standards?
8. What types of tests/checks do you perform at source exchange?
9. a. Should there be training and experience criteria established
for brachytherapy physicists involved with HDR treatment planning?
____ Yes ____ No
b. Should there be training and experience criteria established for
brachytherapy physicians performing HDR treatments?
____ Yes ____ No
10. What procedures do you follow to ensure proper placement of
brachytherapy implants (e.g., do you use X-ray films for verification)?
What is the standard of care with respect to proper placement of
brachytherapy implants?
Manual Brachytherapy
11. NRC regulations require that the written directive for all
brachytherapy, other than high-dose-rate remote afterloading
brachytherapy, include: (i) prior to implantation: the radioisotope,
number of sources, and source strengths; and (ii) after implantation,
but prior to completion of the procedure: the radioisotope, treatment
site, and total source strength and exposure time (or equivalently, the
total dose). What additional information do you typically include on
the written directive and why?
Prior to implantation:
After implantation:
12. a. Do you order sources in writing?
____ Yes ____ No, ordered by ______
b. Who usually orders sources at your facility?
13. a. Do you verify the activity of sources:
____ Upon receipt
____ Prior to implantation
____ Not at all
b. If yes, how is the activity verified?
c. Who typically verifies the source activity at your facility?
14. a. What procedures do you follow to ensure proper placement of
brachytherapy implants?
b. What actions do you take to prevent or minimize the likelihood
of brachytherapy sources moving after implantation?
15. Are existing standards and procedures adequate to ensure that
the source is positioned and, consequently, the treatment is in
accordance with the direction of the authorized user?
16. In your experience, what is the most effective means for
accomplishing training of nurses as required in 10 CFR 35.410 and
35.25?
17. Do you believe that all nurses handling brachytherapy patients
at your facility have received adequate training?
____ Yes ____ No
18. For permanent prostate implants, what do you consider to be an
acceptable percentage of implanted seeds outside the target volume?
____ percent
What is the current accepted standard of practice?
Radiopharmaceutical Therapy
19. NRC regulations require that the written directive, for
radiopharmaceutical therapy, include the radiopharmaceutical, dosage,
and route of administration. What additional information do you
typically include in your written directives, and why?
20. If more than one fraction is to be administered, should the
written directive be prepared to include the specifics for the entire
course of therapy or should a written directive be prepared for each
individual fraction?
21. Do you typically prepare separate written directives for
fractionated radiopharmaceutical therapy?
____ Yes ____ No
22. Where would you seek guidance (if needed) on the radiation
safety aspects of radiopharmaceutical therapy (use of unsealed
sources)?
23. Do you have any additional comments or specific issues
regarding NRC's regulation of therapeutic uses of byproduct material?
Dated at Rockville, Maryland, this 28th day of October, 1994.
For the Nuclear Regulatory Commission.
John E. Glenn,
Chief, Medical, Academic, and Commercial Use Safety Branch, Division of
Industrial and Medical Nuclear Safety, Office of Nuclear Material
Safety and Safeguards.
[FR Doc. 94-27250 Filed 11-2-94; 8:45 am]
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