Over a dozen government and professional organizations in the United States and Europe have issued regulations and guidance concerning quality management in the practice of remote afterloading brachytherapy. Information from the publications of these organizations was collected and collated for this report. This report provides the brachytherapy licensee access to a broad field of quality management information in a single, topically organized document.
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ABSTRACTA workshop was held at the Idaho National Engineering Laboratory, August 1618,1994 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 scoping document for future methodology development. This report contains a summary of that workshop, related technical papers, presentation material, and a transcript of the workshop.Participants included experts in the fields of radiation oncology, medical physics, risk assessment, human-error analysis, and human factors. Staff from the U.S. 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.
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