Considerations regarding real time off-site monitoring.
This article presents a discussion of some issues that require special design consideration involving real time off-site monitoring. "Off-site" refers to a patient monitored away from the location of a health care professional (HCP) responsible for the patient's care. "Real time" refers to a minuscule delay between sensing, recording and transmitting a signal to a distant site. With the current health care climate it is foreseen that more patients are and will be monitored in real time and off-site (e.g. home, long term care). Special considerations are given to issues of signal robustness, false alarms, procedures to respond to an alarm, and appropriate response time. Each of these issues is discussed, as is the proposed approach, based on common sense and knowledge available in the public domain. To maximize patient safety, this approach includes carefully selected indications and target population, back-up communication equipment, and identification of an emergency response process.
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Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, USA.
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D015716:Electrocardiography, Ambulatory; D004867:Equipment Design; D006801:Humans; D013686:Telemetry