[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]
BILLING CODE 7590-01-M