Published: August 12th, 2010Federal regulators are warning that positive displacement needleless connectors used for intravenous access may increase the risk of hospital-acquired infections and death, leading to a request that manufacturers gather additional information on the potential problem. The FDA issued an initial communication on August 11, warning that several peer-reviewed clinical studies reported an increase in bloodstream infections once hospitals began using needle-free IV connectors that use positive displacement. The studies found that switching to other needleless connectors resulted in the infection rates dropping again. At least three deaths may be associated with positive displacement needleless connector bloodstream infections.Positive displacement needleless connectors allow multiple IV sets and catheter hubs to deliver fluids and drugs into a patient without the risk of needle stick injuries to hospital staff or patients. They are also frequently referred to as luer activated valves or positive pressure systems.In a letter to infection control practitioners, the FDA also announced it will require nine companies to conduct postmarket surveillance studies on positive displacement connectors to see whether they are indeed associated with higher hospital infection rates.The postmarket surveillance studies seek to answer two questions: What is the rate of bloodstream infections when that company’s specific positive displacement needleless connectors are used, and how does that rate compare to the rates of other needleless coneectors? And are there certain patient demographics, illnesses or uses that appear to have a stronger correlation with positive displacement needleless connector bloodstream infections than others?The FDA hopes the information will allow the agency to make a more sound and fact-based recommendation on the use of the needleless systems.Concern over the systems is nothing new. In October 2008, the Society for Healthcare Epidemiologists of America and the Infectious Disease Society of America recommended against the use of positive displacement needleless connectors unless there was first a thorough assessment of the risk and benefits. The recommendations were included in a report on useful strategies in preventing bloodstream hospital infections.