News and Publications

ASTRO-supported NRC Final Rule for definition of medical event published

July 17, 2018

The long-anticipated, ASTRO-supported final rule making essential changes to the NRC’s definition of medical events was published in the Federal Register on Monday, July 16. The modifications to 10 CFR 35, Medical Use of Byproduct Material, change the definition to one based on activity, rather than dose, and are consistent with ASTRO positions. The policy win follows more than a decade of ASTRO-led advocacy.

The specific language follows:
§ 35.3045 Report and notification of a medical event.

  1. For permanent implant brachytherapy, the administration of byproduct material or radiation from byproduct material (excluding sources that were implanted in the correct site but migrated outside the treatment site) that results in:
    1. The total source strength administered differing by 20 percent or more from the total source strength documented in the post-implantation portion of the written directive;
    2. The total source strength administered outside of the treatment site exceeding 20 percent of the total source strength documented in the post-implantation portion of the written directive; or
    3. An administration that includes any of the following:
      1. The wrong radionuclide;
      2. The wrong individual or human research subject;
      3. Sealed source(s) implanted directly into a location discontiguous from the treatment site, as documented in the post-implantation portion of the written directive; or
      4. A leaking sealed source resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue.

 

In addition, the Final Rule keeps the Compatibility Category for the definition of medical events at Category C. This means that Agreement States must adopt the essential objectives of the requirement to avoid conflicts, duplications or gaps. In our comment letter on the proposed rule, we expressed concerns that the “essential objectives” were not explicitly defined. The Commission has now defined the essential objective as maintaining a consistent national program for reporting medical events. The Commission states: “Agreement States’ use of dose-based criteria for implementing these reporting requirements would not be compatible with this provision because it conflicts with the essential objective of this provision to maintain a consistent national program for reporting MEs.”

The Final Rule is effective on January 14, 2019

View the Final Rule and the guidance document.

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