Abstract
Purpose: To review current and potential future regulatory status of intravascular brachytherapy (IVB) systems. Methods: There are three approved IVB systems; two commercial IVBs are hand-operated manual devices; the third is remotely operated. In three Guidances, the Nuclear Regulatory Commission (NRC) applied certain regulatory concepts applicable to remotely operated high dose rate (HDR) afterloaders to manually operated IVBs. This article reviews these Guidances, newly released NRC regulations on the medical use of by-product material, and potential regulatory issues related to IVB systems. Results: The Guidances are specific. However, newly released NRC regulations on the medical use of byproduct material, including HDR afterloaders, omit IVB systems as a category. NRC licensure of IVB systems is considered case-by-case. Conclusions: The current limited application of regulations applicable to HDR remote afterloaders to hand-held IVB systems could lead to other HDR-like regulations for hand-held IVB systems in future regulations.
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