Safety Issues
Infusion pumps have been a source of multiple patient safety concerns, and problems with such pumps have been linked to more than 56,000 adverse event reports from 2005 to 2009, including at least 500 deaths. As a result, the U.S. Food and Drug Administration (FDA) has launched a comprehensive initiative to improve their safety, called the Infusion Pump Improvement Initiative. The initiative proposed stricter regulation of infusion pumps. It cited software defects, user interface issues, and mechanical or electrical failures as the main causes of adverse events.
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