January 21, 2004

Medical Device–Associated Safety and RiskSurveillance and Stratagems

Author Affiliations

Author Affiliation: Department of Anesthesia and Critical Care, University of Chicago, Chicago, Ill.

JAMA. 2004;291(3):367-370. doi:10.1001/jama.291.3.367

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.

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