Why is the luer standard changing?
“Actions must be taken at the patient bedside, within all levels of health care organizations and throughout the channels of regulation, manufacturing, and distribution of these devices in order to eradicate the serious problem of tubing misconnections.”
Peter B. Angood, M.D., Vice President & Chief Patient Safety Officer for The Joint Commission of the FDA.
FDA has participated in an international effort to develop and implement standards for non interchangeable connectors for small bore medical connections. The International Organization for Standardization (ISO) has developed a series of standards for incompatible connectors used in intravascular (IV), breathing systems, enteral, urethral/urinary, cuff inflation and neuraxial applications. Once implemented, ISO 80369 removes the ability to make inappropriate connections or misconnections in a clinical setting through non-compatible luer connection groups called out in ISO 80369.