Written Directives Medical Use of Radioactive Material Prepared by Deborah Steva Office of Environmental Health & Safety August 2007 Medical Use of Radioactive Material
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Medical Use of Radioactive Material
Prepared by Deborah Steva
Office of Environmental Health & Safety
The Nuclear Regulatory Commission (NRC) defines Medical Use as “the intentional internal or external administration of byproduct material, or the radiation from byproduct material, to patients or human research subjects under the supervision of an authorized user.
An Authorized User is defined as…..
a physician, dentist, or podiatrist who meets the training and experience qualifications specified in 10 CFR Part 35.”
Byproduct Material: Radioactive material regulated by the NRC
The Code of Federal Regulations (CFR) is the set of rules and regulations used by the federal government to control (among other things) the use of radioactive materials in the United States.
The section of the CFR that regulates medical use of radioactive materials is
Title 10 CFR Part 35.
Administration of radioactive material(radiopharmaceutical and/or sealed source administration of radiation) can be divided into two categories
A written directive is a prescription for a specific nuclide and administration route.
A written directive is not the prescription prepared by the referring physician
but is the directive that must be prepared by a physician who is an authorized user, i.e. authorized user approved by the NRC or UVa’s Radiation Safety Committee (RSC) to administer the type of materials or treatments ordered.
A written directive must be prepared, dated and signed by an authorized user before the administration of:
All other administrations of radioactive materials can be administered without a specific “written directive”.
The non-written directive administrations (standard diagnostic nuclear medicine studies) can be ordered in the traditional way and the specific dosage for an administration can be referenced from an authorized user approved dose chart. (Examples: Tc-99m, Tl-201, F-18)
The written directive must contain:
For an administration of a therapeutic dosage of unsealed byproduct material other than sodium iodide I-131:
For gamma stereotactic radiosurgery: the total dose, treatment site, and values for the target coordinate settings per treatment for each anatomically distinct treatment site
For teletherapy: the total dose, dose per fraction, number of fractions and treatment site;
For high dose-rate remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions, and total dose; or
For all other brachytherapy, including low, medium, and pulsed dose rate remote afterloaders:
Written procedures must be developed, implemented and maintained to provide high confidence that the written directive is rigorously followed. The procedure must provide assurance that…..
If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive from the authorized user is acceptable. The information contained in the oral directive must be documented as soon as possible in writing in the patient's record.
A written directive must be prepared within 48 hours of the oral directive.
A written revision to an existing written directive may be made if
the revision is dated and signed by an authorized user before the administration of the dosage of unsealed byproduct material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose.
If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive is acceptable.
The oral revision must be documented as soon as possible in the patient's record.
A revised written directive must be signed by the authorized user within 48 hours of the oral revision. “
All Medical Use of Radioactive Materials requires
an “Authorized User”
someone who is working under the supervision of an authorized user
(as defined by 10CFR35)
No one may administer radioactive material to humans without approval.
Medical Use must be under supervision of Authorized User
Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist….
To become an authorized user at UVa…. you must submit an application to EHS and receive approval from the Radiation Safety Committee (RSC)
Must be identified as an authorized user on a NRC or Agreement State license that authorizes the medical use of byproduct material or is designated in writing as an authorized user by the Radiation Safety Committee of a broadscope license
A physician, dentist, or podiatrist who:
There are specific classroom and laboratory training requirements specified in Part 35 for each application, e.g. HDR, iodine therapy, gamma knife, etc. and
Required number of hours/years work experience under supervision of an authorized user
Part 35 on NRC website:
For guidance on required training and documentation to become an authorized user at UVa
Contact the Environmental Health & Safety Office at 2-4911
(formerly known as Misadministration)
If an administration of byproduct material, or the radiation from byproduct material, to patients or human research subjects does not go as planned, you must notify the Radiation Safety Officer in the Office of Environmental Health & Safety. A determination must be made as to whether a “medical event” has occurred.
You must report to the Radiation Safety Officer (2-4911) immediately…
Any event, in which the administration of byproduct material or radiation from byproduct material results in ……
A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage
A dose that exceeds 0.05Sv (5 rem) effective dose equivalent, 0.5 Sv ( 50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of the following:
The RSO must report to the NRC
Any dose to an embryo/fetus or nursing child that is greater than 50 mSv (5 rem) dose equivalent
that is a result of an administration of byproduct material or radiation from byproduct material to a pregnant or breastfeeding individual
Environmental Health & Safety Office
2 - 4911
1. The section of the Code of Federal Regulations that regulates medical use of radioactive material is a. 10CFR Part 50, b.10 CFR Part 35, c. 10 CFR Part 19
2. Any referring physician can prescribe the administration of radioactive material to a patient her at UVa. T or F
3. In accordance with the regulations, a written directive for a dose of radioactive material must be dated and signed by a. the technologist administering the dose b. the pharmacist c. an authorized user
4. A written directive for administration of a therapeutic dosage of unsealed byproduct material (other than sodium iodide I-131) must specify:
a. radioactive drug to be administered b. dosage and route of administration c. both a. and b.
5. A revision to a written directive for administration of a dose of sodium iodine I-131(100 mCi) may be made a. if approved by the authorized user before the administration b. if approved by the authorized user after the administration c. either a. or b.
6. When can an individual work as an authorized user at UVa?
a. after they are board certified b. after they have completed their required training and work experience c. only after they have been approved in writing and designated an authorized user by the Radiation Safety Committee
7. Mrs. Smith received a therapeutic dose of sodium iodide (I-131). A day after administration it is discovered that the wrong Mrs. Smith received the dose and her thyroid received 100 rem. Has a medical event occurred? a. yes b. no
1.b. 10 CFR Part35
2.F. Only a physician who is an authorized user approved by UVa’s Radiation Safety Committee may administer radioactive material at UVa
3.c. The written directive must be signed by the authorized user
4.c. Both a. and b. Must include radioactive drug, dosage and route of administration
5.a. If approved by the authorized user before the administration
6.c.Only after they have been approved in writing and designated an authorized user by the Radiation Safety Committee
7.a. Yes. A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv ( 50 rem) to an organ or tissue resulting from an administration of a dosage to the wrong individual