Intravenous news: ICT.com report “In a letter to infection preventionists, Susan Gardner, director of the Office ofÂ Surveillance and Biometrics in the Center for Devices and Radiological Health at the Food and Drug Administration (FDA), is informing them about positive displacement needleless connectors and the possible link to several patient deaths associated with bloodstream infections (BSIs).
The FDA is requiring nine companies to conduct a post-market surveillance study on positive displacement needleless connectors to assess whether they may be associated with a higher rate of device-associated bloodstream infections than other types of needleless connectors, and to assess the factors that may contribute to a possible increased risk.
The FDA says it has become aware of information that raises concerns about the safety of positive displacement needleless connectors. These devices are intended for use as an accessory to an intravascular administration set to allow delivery of a wide range of fluids to a patient’s vascular system through a cannula inserted into a vein or artery. Needleless connectors may also be referred to as “valves” or “accesses.” “Positive displacement” refers to the positive pressure of fluid movement from a reservoir into the lumen of the catheter upon disconnection of an administration set or syringe.
The FDA has received three reports of death associated with BSIs and positive displacement needleless connectors. Infection control authorities are also concerned about positive displacement connectors and the devices association with BSI.”