New Infusion Pump Regulations

The US Food and Drug Administration (FDA) received 56,000 reports of problems associated with infusion pumps from 2005-2009. Over 19,000 serious patient injuries and 710 deaths were attributed to infusion pump problems. Most of the deaths were from accidental drug overdoses caused by operator error or device malfunction. The most common problems, according to the FDA, involved the infusion pump software, human factors (operator error), breakage and malfunction, and alarm and battery failure. Jeffrey Shuren, MD, the Director of the FDA's Center for Devices and Radiological Health, noted that many infusion pump problems are caused by design defects and therefore are foreseeable and preventable. The FDA's regulations will require infusion pump manufacturers to provide detailed design and engineering information in their premarket submissions, and they also must test their infusion pumps in clinical settings instead of using simulation testing. The FDA could also begin inspecting manufacturing plants prior to device approval.

The FDA's new regulations are a huge step forward in reducing patient harm caused by infusion pump problems and errors. I was particularly pleased to see that infusion pumps will need to be tested by clinicians in the "real world." Real-world use of infusion pumps is the best way to determine if the pumps are easy to use and function properly (e.g. alarm appropriately, etc.).