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Qi D Van Eikema Hommes. Song, Qingyang S.M. Massachusetts Institute of Technology System Design and Management Program. System Design and Management Program. Massachusetts Institute of Technology. Engineering Systems Division 2013-01-23T19:46:45Z 2013-01-23T19:46:45Z 2012 2012 http://hdl.handle.net/1721.1/76510 823635427 Thesis (S.M. in Engineering and Management)--Massachusetts Institute of Technology, Engineering Systems Division, System Design and Management Program, 2012. Cataloged from PDF version of thesis. Includes bibliographical references (p. 65-66). The goal of this thesis is to investigate and demonstrate the application of a systems approach to medical device safety in China. Professor Leveson has developed an accident modeling framework called STAMP (Systems Theoretic Accident Modeling and Processes.) Traditional accident models typically focus on component failure; in contrast, STAMP includes interactions between components as well as social, economic, and legal factors. In this thesis, the accident of the artificial heart at a level II hospital in China was used as a test case to study whether Causal Analysis based on STAMP (CAST) is used to outline the interactions between the different medical device system components, identify the safety control structure in place, and understand how this control structure failed to prevent artificial heart accident in a Chinese hospital. The analysis suggested that further changes might be necessary to protect the Chinese public and so, based on the results of the CAST, a new set of systemic recommendations was proposed. by Qingyang Song. S.M. in Engineering and Management 66 p. eng Massachusetts Institute of Technology M.I.T. theses are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. See provided URL for inquiries about permission. http://dspace.mit.edu/handle/1721.1/7582 Engineering Systems Division. System Design and Management Program. A system theoretic approach to design safety into medical device Thesis application/pdf false Publication unknown unknown <Publication xmlns="https://www.openaire.eu/cerif-profile/1.1/" id="dde66ba5-575d-48f7-babb-4f36b5413114"> <Type xmlns="https://www.openaire.eu/cerif-profile/vocab/COAR_Publication_Types">http://purl.org/coar/resource_type/c_1843</Type> <Language>eng</Language> <Title>A system theoretic approach to design safety into medical device</Title> <PublishedIn> <Publication> </Publication> </PublishedIn> <PublicationDate>2012</PublicationDate> <Authors> <Author> <DisplayName>Song, Qingyang S.M. Massachusetts Institute of Technology</DisplayName> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> </Authors> <Editors> </Editors> <Publishers> <Publisher> <DisplayName>Massachusetts Institute of Technology</DisplayName> <OrgUnit /> </Publisher> </Publishers> <License>http://dspace.mit.edu/handle/1721.1/7582</License> <Keyword>Engineering Systems Division.</Keyword> <Keyword>System Design and Management Program.</Keyword> <Abstract>The goal of this thesis is to investigate and demonstrate the application of a systems approach to medical device safety in China. Professor Leveson has developed an accident modeling framework called STAMP (Systems Theoretic Accident Modeling and Processes.) Traditional accident models typically focus on component failure; in contrast, STAMP includes interactions between components as well as social, economic, and legal factors. In this thesis, the accident of the artificial heart at a level II hospital in China was used as a test case to study whether Causal Analysis based on STAMP (CAST) is used to outline the interactions between the different medical device system components, identify the safety control structure in place, and understand how this control structure failed to prevent artificial heart accident in a Chinese hospital. The analysis suggested that further changes might be necessary to protect the Chinese public and so, based on the results of the CAST, a new set of systemic recommendations was proposed.</Abstract> <Access xmlns="http://purl.org/coar/access_right" > </Access> </Publication>