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NRC REVISES REGULATIONS ON MEDICAL USES OF RADIOACTIVE MATERIAL
Coutesy of MedHP-Sec Listserver
No. 02-048
April 17, 2002
NRC REVISES REGULATIONS ON MEDICAL USES OF RADIOACTIVE MATERIAL
The Nuclear Regulatory Commission has revised its regulations on the
medical uses of radioactive material. The regulations also respond to
a petition for rulemaking filed by the University of Cincinnati.
The agency currently regulates the use of certain radioactive
materials in medical diagnosis and treatment, as well as research,
for about eleven million patients a year.
The revisions, designed to be both risk-informed and more performance-
based, focus the regulations on the medical procedures that pose
higher risks to workers, patients and the public from a radiation
safety aspect. The regulations also eliminate some of the previous
detailed requirements of those who perform lower risk diagnostic
medical procedures such as bone or thyroid scans.
Licensees have six months to implement the new requirements.
Highlights of the revised rule are:
(1) Patient notification/reportable events --
Under the revised regulations, the term "medical event," referring to
the administration of radioactive materials in a manner that differs
substantially from the physician's direction, replaces the previous
term "misadministration." The regulations continue to require that,
when a medical event occurs, the licensee must notify the NRC, the
referring physician and the affected patient, unless the referring
physician personally informs the licensee either that he will inform
the individual or that, based on medical judgment, telling the
individual would be harmful. Previously, the licensee was required to
provide a written description of the medical event regardless of
whether it was requested. Under the revision, the patient must be
informed that such a description can be obtained from the licensee.
Also, under the revision, if the physician is not the licensee, the
licensee must provide a copy of the medical event record to the
referring physician.
(2) Radiation Safety Committee --
Under the revised regulations, the Radiation Safety Committee is
responsible for broad oversight of the uses of certain radioactive
materials. However, the current specific responsibilities of the
Radiation Safety Committee have been transferred from the Committee
to licensee management. A Committee is still required for certain
medical licensees performing two or more higher risk activities such
as those used in the treatment of cancer. The regulations specify
radiation safety goals or objectives for the Committee, but allow
licensee management flexibility in implementing those goals.
(3) Physician's written directions --
Detailed requirements for a medical licensee to have a quality
management program have been deleted. Instead, the revised
regulations require that licensees have written procedures for those
activities involving higher risk. Licensees must develop and maintain
procedures to provide high confidence that the right patient receives
the correct dose at the correct treatment site, consistent with the
physician's written instructions.
(4) Training and experience --
Some of the training requirements for individuals performing
diagnostic procedures using radioactive materials in unsealed form
have been reduced, consistent with the lower risk associated with
these procedures. However, the revised regulations retain the current
training requirements for individuals using sealed sources of
radioactive material for therapeutic administrations because of the
higher risk associated with using these types of material. The
training and experience requirements contained in Subpart J of the
current regulation are also being retained for a two-year period
from the effective date of the revised rule. Training and experience
were the primary concerns expressed by commenters during development
of the final rule.
In addition, the revised rule adds a requirement for reporting
unintended medical radiation exposure of an embryo, fetus, or nursing
child.
The revised rule also addresses a petition for rulemaking filed by
the University of Cincinnati. The petition requested a 500-millirem
radiation dose limit for certain individuals visiting patients who
are required to be confined to the hospital while receiving radiation
treatment, where the visitors are determined by the physician to be
necessary for the patient's physical or emotional support. The
response to the petition, incorporated into the rule, allows
physicians the discretion to permit visitors to receive up to 500
millirem from exposure to a hospitalized patient. A millirem is a
unit of measurement used to determine the effect of radiation on the
body (for instance, a round-trip, cross-country flight is equal to
about 5 millirem). The current limit of 100 millirem per year for
visitors is the same as for members of the public under other
circumstances. The agency believes the emotional benefit to the
patient and the visitor outweighs any small increase in radiation
risk to the visitor, and, accordingly, physicians should be provided
the flexibility to make decisions regarding patients' visitors.
A proposed rule on the medical uses of radioactive material was
published in the Federal Register for comment on August 13, 1998. The
NRC staff held meetings and workshops since then in San Francisco,
Kansas City and Washington, D.C., that included participation by the
general public, state regulators, medical professional societies, and
medical boards. Also, the Commission was briefed by the Advisory
Committee on the Medical Uses of Isotopes (ACMUI) and various
stakeholders during public meetings. Issues regarding the rule were
also discussed with the ACMUI at public meetings.
Over 600 comments were received during development of the rule, which
were considered in development of the final version.
The agency has also revised its medical policy statement on the
medical uses of radioactive material. Highlights of the policy
statement were announced separately.
This regulation becomes effective six months after publication of a
Federal Register Notice on this subject, expected shortly.
Documents related to this rulemaking may be examined at the NRC
Public Document Room, One White Flint North, 11555 Rockville Pike,
Room O-1 F23, Rockville, MD 20852. Documents will also be available
through the NRC's Agencywide Document Access and Management System
(ADAMS). Help in using ADAMS is available by contacting NRC's Public
Document Room staff at 1-800-397-4209, 301-415-4737 or by sending an
email message to pdr@nrc.gov.
For more information on the final rule, contact Roger W. Broseus at
301-415-7608, or by email at RWB@nrc.gov.
The above may be viewed on the NRC Web site at URL:
http://www.nrc.gov/reading-rm/doc-collections/news/archive/02048.html
-------------------------------------------------
Sandy Perle
Director, Technical
ICN Worldwide Dosimetry Service
ICN Plaza, 3300 Hyland Avenue
Costa Mesa, CA 92626
Tel:(714) 545-0100 / (800) 548-5100 Extension 2306
Fax:(714) 668-3149
E-Mail: sandyfl@earthlink.net
E-Mail: sperle@icnpharm.com
Personal Website: http://sandy-travels.com
ICN Worldwide Dosimetry Website: http://www.dosimetry.com
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