FDA to Review Infusion Pump Safety Issues

Recently, the U.S. Food and Drug Administration announced an initiative to review safety issues concerning external infusion pumps. External infusion pumps are used to deliver controlled amounts of fluids or medications to patients. Devices like insulin pumps deliver controlled amounts of insulin to people with diabetes.

However, some of these devices have experienced failures and safety problems. The FDA received more than 56,000 reports of adverse events from use of infusion pumps in the past five years. These adverse events included over 500 deaths as well as other serious injuries. Since 2005 FDA reports that 87 fusion pumps have been recalled due to safety concerns.

The most common types of safety defects with pumps include:

  • Software defects
  • User interface issues
  • Mechanical or electric failures

On November 21, 2008, Animas Corporation and the FDA issued a nationwide recall of the following pumps: IR1200 Insulin Pump, and the Animas IR1250 Insulin Pump. These pumps were recalled because of a battery defect that resulted in a device malfunction where the pump would stop administering insulin. If a patient does not get their advised dosage of insulin, it can result in health problems related to low blood sugar.

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