Ariz. Admin. Code § R9-7-724 - Surveys after Brachytherapy Source Implant and Removal; Accountability
A. A licensee shall
make a survey to locate and account for all sources that have not been
implanted immediately after implanting sources in a patient or a human research
subject.
B. A licensee shall make a
survey of the patient or the human research subject with a radiation detection
survey instrument immediately after removing the last temporary implant source
to confirm that all sources have been removed.
C. A licensee shall maintain accountability
at all times for all sources in storage or use.
D. A licensee shall return brachytherapy
sources to a secure storage area as soon as possible after removing sources
from a patient or a human research subject.
E. A licensee shall record the procedures
performed in subsections (A) through (D) and retain the records for three years
following completion of the record.
F. A licensee must use only brachytherapy
sources:
1. Approved in the Sealed Source and
Device Registry for manual brachytherapy medical use. The manual brachytherapy
sources may be used for manual brachytherapy uses that are not explicitly
listed in the Sealed Source and Device Registry, but must be used in accordance
with the radiation safety conditions and limitations described in the Sealed
Source and Device Registry; or
2.
In research to deliver therapeutic doses for medical use in accordance with an
active Investigational Device Exemption (IDE) application accepted by the U.S.
Food and Drug Administration, provided the requirements of R9-7-450(A) are
met.
Notes
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