Author Affiliation: Department of Anesthesia and Critical Care, University of Chicago, Chicago, Ill.
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.
Small SD. Medical Device–Associated Safety and RiskSurveillance and Stratagems. JAMA. 2004;291(3):367-370. doi:10.1001/jama.291.3.367