A system theoretic approach to design safety into medical device
Name
823635427-MIT.pdf
Description
Full printable version
Size
3.56 MB
Format
Adobe PDF
Checksum (MD5)
870cede30e1f02e6ebdbbd80be83823f
Author(s)
Song, Qingyang S.M. Massachusetts Institute of Technology
Advisor(s)
Qi D Van Eikema Hommes.
Date Issued
2012
Publisher
Massachusetts Institute of Technology
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.
Description
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).
Subjects
Engineering Systems Division.
System Design and Management Program.
MIT Department
System Design and Management Program.
Massachusetts Institute of Technology. Engineering Systems Division
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