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Compliance with the U.S. Nuclear Regulatory Commission Revised Licensing Guidance for Radioactive Seed Localization

Sheetz, Michael; Steiner, Cynthia1

doi: 10.1097/HP.0000000000000889
OPERATIONAL TOPIC
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The use of radioactive seed localization (RSL) as a reliable alternative to wire localization (WL) for guiding the surgical excision of non-palpable lesions has become more popular because of its demonstrated advantages for both the patient and surgeon. RSL is regulated under 10 CFR 35.1000 (Other Medical Uses) for which the U.S. Nuclear Regulatory Commission (U.S. NRC) issued its original licensing guidance entitled “I-125 and Pd-103 Low Dose Rate Brachytherapy Seeds Used for Localization of Non-palpable Lesions” in 2006. At that time, RSL was performed as an off-label use of the same radioactive 125I seeds used for brachytherapy, so the focus of this initial guidance was to establish the same requirements for RSL as for brachytherapy. Strict compliance with the licensing guidance was burdensome and made it difficult for some licensees to implement an RSL program. In response to a request from the user community and recommendations from an Advisory Committee on the Medical Use of Isotopes (ACMUI) subcommittee, the U.S. NRC formed a working group to consider revisions to its RSL guidance to make it more relevant to the conduct of the procedure. On October 7, 2016, the U.S. NRC issued a revised licensing guidance document titled “Low Activity Radioactive Seeds Used for Localization of Non-Palpable Lesions and Lymph Nodes.” This manuscript highlights the changes in the latest U.S. NRC licensing guidance for RSL, including authorized user training and experience, written directives, surveys, instrumentation, and medical event criteria, and presents practical ways to satisfy the new requirements.

1University of Pittsburgh, Radiation Safety Office, 3500 Fifth Avenue, Suite 400, Pittsburgh, PA 15213.

The authors declare no conflicts of interest.

For correspondence contact: Michael Sheetz is Director of the University of Pittsburgh’s Radiation Safety Office and the Radiation Safety Officer (RSO) for the University and five affiliated University of Pittsburgh Medical Center (UPMC) hospitals. He also has a faculty appointment as Clinical Assistant Professor of Radiology in the University of Pittsburgh’s School of Medicine. Mike holds professional certifications by both the American Board of Health Physics (ABHP) in Comprehensive Health Physics and the American Board of Medical Physics (ABMP) in Medical Health Physics. He received a B.S. Degree in Biological Sciences/Health Planning and Administration from Penn State University and a M.S. Degree in Radiation Health from the University of Pittsburgh’s Graduate School of Public Health. Mike has over 30 years of experience in operational radiation safety and medical health physics at the University of Pittsburgh and UPMC. His email is msheetz@pitt.edu.

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