A workshop on developing risk assessment methods for medical use of radioactive material. Volume 1: Summary

A workshop was held at the Idaho National Engineering Laboratory, August 16--18, 1994 on the topic of risk assessment on medical devices that use radioactive isotopes. Its purpose was to review past efforts to develop a risk assessment methodology to evaluate these devices, and to develop a program plan and a scoping document for future methodology development. This report contains a summary of that workshop. Participants included experts in the fields of radiation oncology, medical physics, risk assessment, human-error analysis, and human factors. Staff from the US Nuclear Regulatory Commission (NRC) associated with the regulation of medical uses of radioactive materials and with research into risk-assessment methods participated in the workshop. The workshop participants concurred in NRC`s intended use of risk assessment as an important technology in the development of regulations for the medical use of radioactive material and encouraged the NRC to proceed rapidly with a pilot study. Specific recommendations are included in the executive summary and the body of this report. An appendix contains the 8 papers presented at the conference: NRC proposed policy statement on the use of probabilistic risk assessment methods in nuclear regulatory activities; NRC proposed agency-wide implementation plan for probabilistic risk assessment; Risk evaluation of high dose rate remote afterloading brachytherapy at a large research/teaching institution; The pros and cons of using human reliability analysis techniques to analyze misadministration events; Review of medical misadministration event summaries and comparison of human error modeling; Preliminary examples of the development of error influences and effects diagrams to analyze medical misadministration events; Brachytherapy risk assessment program plan; and Principles of brachytherapy quality assurance