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Medical DeviceAssociated Safety and Risk
Surveillance and Stratagems
Stephen D. Small, MD
JAMA. 2004;291:367-370.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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Devices are ubiquitous in the delivery of modern health care. Diagnostics and therapeutics rely on a bewildering, constantly changing array of devices used to monitor and treat patients. Trends in device evolution include increasing complexity and autonomy of operation, device-device interactions, miniaturization, and integration with information technology. Managing risk associated with devices has thus long been a central concern of policy makers, manufacturers, and those providing health care.
The emerging international patient safety movement has called attention to the unacceptably high prevalence of preventable patient injuries as a consequence of medical management.1-6 The accompanying translation of safety science from other risky industries has brought new perspectives to how all stakeholders think about health care.1, 7-8 The view of a clinical service supported by an administrative structure has broadened to include other elements that shape health outcomes. Newer ecological models incorporate the skills, knowledge, experience, attitudes, and values . . . [Full Text of this Article]
Author Affiliation: Department of Anesthesia and Critical Care, University of Chicago, Chicago, Ill.
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Matthew H. Samore, R. Scott Evans, April Lassen, Patricia Gould, James Lloyd, Reed M. Gardner, Rouett Abouzelof, Carrie Taylor, Don A. Woodbury, Mary Willy, and Roselie A. Bright
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