A system theoretic approach to design safety into medical device

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.

Department dc:contributor.department

Massachusetts Institute of Technology. Engineering Systems Division.

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2012

Author dc:creator

• Song, Qingyang S.M. Massachusetts Institute of Technology

Advisor dc:contributor.advisor

• Qi D Van Eikema Hommes.

• Engineering Systems Division.
• System Design and Management Program.

Statement dc:rights

• 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.

Licence dc:rights.uri

• http://dspace.mit.edu/handle/1721.1/7582

Language dc:language.iso

eng

Handle dc:identifier.uri

http://hdl.handle.net/1721.1/76510

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/76510