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

Ariz. Admin. Code § R9-7-724

New Section R9-7-724 recodified from R12-1-724at 24 A.A.R. 813, effective March 22, 2018 (Supp. 18-1). Amended by final expedited rulemaking at 25 A.A.R. 3561, effective 12/3/2019.