Medical Event Criteria for Prostate Brachytherapy Implants Survey

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Purpose: The Organization of Agreement States (OAS) has been requested to participate in two Part 35 workshops that the NRC is hosting in June and August. The workshops are about medical issues that are either very early in the rule language development stage or issues that are being considered for rulemaking. Your input will be valuable to frame the issues, especially medical event criteria for prostate brachytherapy implants. In 2008, the NRC proposed an activity based criteria for these seed implants (i.e. a certain percentage of seeds were not placed in the prostate). This rulemaking was suspended when the NRC learned that many of the Veterans Affairs Hospital medical events would not have been captured.

The regulatory agencies that have conducted investigations in response to allegations or reported medical events found that their licensees did not necessarily have medical event criteria for prostate brachytherapy implants. Most licensees felt that since their implants were clinically acceptable, the implants did not need to be reviewed against medical event criteria. In order to better represent the Agreement States, the OAS Board is requesting that each Agreement State respond to a brief survey. The survey focuses on activities in your state regarding the status of medical event criteria for prostate brachytherapy implants.

Deadline: June 6, 2011

Note: If you need additional information or clarification please contact WI staff:

Cheryl Rogers: 608-266-8135
Chris Timmerman: 608-267-3657
Megan Shober: 920-448-5346