Infusion Pump Problems Lead to FDA Initiative to Reduce Risk

Federal regulators have issued new draft guidance aimed at increasing the quality and safety of drug infusion pumps, which have been plagued by defects and recalls in recent years that have resulted in more than 500 deaths. 

The new infusion pump safety initiative, announced by the FDA on April 23, will require manufacturers to undergo more risk assessments before gaining approval for new or modified devices, and they will be expected to submit additional design and engineering information for premarket approval.

Infusion pumps are small medical devices that deliver drugs into the body. They are increasingly worn by Type 1 diabetics as an alternative to daily injections of insulin by syringe or an insulin pen. However, hospitals also use infusion pumps to deliver a wide variety of drugs, such as antibiotics, chemotherapy and anesthesia drugs.

The new guidance comes following an FDA advisory panel meeting in March which was called by regulatory agency due to a disturbing trend in the quality of infusion pumps. According to FDA, there have been 56,000 adverse event reports from people reporting problems with infusion sets in the last five years. In addition, there were 87 infusion pump recalls announced between 2005 and 2009.

Last summer, a recall was issued for Medtronic Paradigm insulin pump Quick Sets after the company determined that about 60,000 infusion sets used with the pumps were defective and could give too much insulin to users due to an air pressure problem.

A number of Medtronic insulin pump lawsuits have been filed over diabetic-related injuries resulting from the defective infusion sets. The FDA issued a warning letter to the company over its manufacturing processes, noting that it had quality assurance problems and that the on-site medical professional hired to determine if there was a medical problem with the devices had only a high school diploma.

FDA reviewers found that the most common cause of death and injury from the use of either defective insulin pumps or from using them incorrectly was hypoglycemia; lower than normal blood glucose. However, the FDA also has identified a growing number of insulin pump-related automobile accidents.

Between 2006 and 2009, there were at least 29 adverse event reports of motor vehicle accidents associated with insulin pumps. In some cases, drivers wearing insulin pumps and suffering from low glucose levels lost consciousness or died while driving and crashed into other vehicles, drove off the road, into lakes, and even slammed into buildings at high speed.