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Title: Risk evaluation of medical and industrial radiation devices

Abstract

In 1991, the NRC, Division of Industrial and Medical Nuclear Safety, began a program to evaluate the use of probabilistic risk assessment (PRA) in regulating medical devices. This program represents an initial step in an overall plant to evaluate the use of PRA in regulating the use of nuclear by-product materials. The NRC envisioned that the use of risk analysis techniques could assist staff in ensuring that the regulatory approach was standardized, understandable, and effective. Traditional methods of assessing risk in nuclear power plants may be inappropriate to use in assessing the use of by-product devices. The approaches used in assessing nuclear reactor risks are equipment-oriented. Secondary attention is paid to the human component, for the most part after critical system failure events have been identified. This paper describes the risk methodology developed by Lawrence Livermore National Laboratory (LLNL), initially intended to assess risks associated with the use of the Gamma Knife, a gamma stereotactic radiosurgical device. For relatively new medical devices such as the Gamma Knife, the challenge is to perform a risk analysis with very little quantitative data but with an important human factor component. The method described below provides a basic approach for identifying the most likelymore » risk contributors and evaluating their relative importance. The risk analysis approach developed for the Gamma Knife and described in this paper should be applicable to a broader class of devices in which the human interaction with the device is a prominent factor. In this sense, the method could be a prototypical model of nuclear medical or industrial device risk analysis.« less

Authors:
 [1]; ;  [2]
  1. Lawrence Livermore National Lab., CA (United States)
  2. Nuclear Regulatory Commission, Washington, DC (United States). Office of Nuclear Material Safety and Safeguards
Publication Date:
Research Org.:
Lawrence Livermore National Lab., CA (United States)
Sponsoring Org.:
Nuclear Regulatory Commission, Washington, DC (United States)
OSTI Identifier:
10124176
Report Number(s):
UCRL-JC-115429; CONF-940312-54
ON: DE94006608; TRN: 94:003623
DOE Contract Number:  
W-7405-ENG-48
Resource Type:
Conference
Resource Relation:
Conference: 2. Probabilistic safety assessment and management conference (PSAM),San Diego, CA (United States),20-24 Mar 1994; Other Information: PBD: Mar 1994
Country of Publication:
United States
Language:
English
Subject:
99 GENERAL AND MISCELLANEOUS//MATHEMATICS, COMPUTING, AND INFORMATION SCIENCE; 62 RADIOLOGY AND NUCLEAR MEDICINE; RADIATION SOURCES; RISK ASSESSMENT; MEDICINE; INDUSTRY; MONTE CARLO METHOD; 570000; 550600; HEALTH AND SAFETY

Citation Formats

Jones, E.D., Cunningham, R.E., and Rathbun, P.A. Risk evaluation of medical and industrial radiation devices. United States: N. p., 1994. Web.
Jones, E.D., Cunningham, R.E., & Rathbun, P.A. Risk evaluation of medical and industrial radiation devices. United States.
Jones, E.D., Cunningham, R.E., and Rathbun, P.A. Tue . "Risk evaluation of medical and industrial radiation devices". United States. https://www.osti.gov/servlets/purl/10124176.
@article{osti_10124176,
title = {Risk evaluation of medical and industrial radiation devices},
author = {Jones, E.D. and Cunningham, R.E. and Rathbun, P.A.},
abstractNote = {In 1991, the NRC, Division of Industrial and Medical Nuclear Safety, began a program to evaluate the use of probabilistic risk assessment (PRA) in regulating medical devices. This program represents an initial step in an overall plant to evaluate the use of PRA in regulating the use of nuclear by-product materials. The NRC envisioned that the use of risk analysis techniques could assist staff in ensuring that the regulatory approach was standardized, understandable, and effective. Traditional methods of assessing risk in nuclear power plants may be inappropriate to use in assessing the use of by-product devices. The approaches used in assessing nuclear reactor risks are equipment-oriented. Secondary attention is paid to the human component, for the most part after critical system failure events have been identified. This paper describes the risk methodology developed by Lawrence Livermore National Laboratory (LLNL), initially intended to assess risks associated with the use of the Gamma Knife, a gamma stereotactic radiosurgical device. For relatively new medical devices such as the Gamma Knife, the challenge is to perform a risk analysis with very little quantitative data but with an important human factor component. The method described below provides a basic approach for identifying the most likely risk contributors and evaluating their relative importance. The risk analysis approach developed for the Gamma Knife and described in this paper should be applicable to a broader class of devices in which the human interaction with the device is a prominent factor. In this sense, the method could be a prototypical model of nuclear medical or industrial device risk analysis.},
doi = {},
journal = {},
number = ,
volume = ,
place = {United States},
year = {1994},
month = {3}
}

Conference:
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