AAMI News November 2016

Standards Target Tubing Misconnection Hazard

A nearly decade-long effort to prevent tubing misconnections is taking a giant step forward with the publication of a standard that updates the design of a specific type of connector that has been at the heart of this significant patient safety problem.

For about 100 years, manufacturers have used what is known as the Luer to  attach tubing, catheters, and syringes to their devices because of its universal design, low cost, and simplicity. But as the number of medical devices used to treat individual patients has grown, the benefits of this connector have become its liabilities.

Patients in intensive care units (ICUs), cardiac care, and the emergency department may be hooked up to a dozen devices at once—all with the same Luer connectors—increasing the risk that unrelated systems can be mistakenly attached to one another, resulting in patient injury or even death. The Food and Drug Administration (FDA) gives the example of a child admitted to the pediatric ICU who had both an IV line and a breathing tube. The IV tubing was mistakenly connected to the trach cuff port, causing continuous IV fluids to enter the child’s lungs. The child later died.

To physically prevent these misconnections from occurring, an international group of manufacturers, clinicians, and regulators, such as the FDA, have been working to standardize connector designs for specific medical applications. There are already four completed standards in this series, known as ISO 80369, and one more standard remains in development.

Last month, the group finalized ISO 80369-7, which focuses on connectors for IV or hypodermic applications.

Unlike the other standards in this series, 80369-7 doesn’t call for a wholesale redesign of the Luer connector. Instead, it defines critical dimensions essential for establishing non-interconnectability with the connectors characterized in other 80369 standards, said Scott Colburn, director of the standards program for the FDA’s Center for Devices and Radiological Health and convener of ISO/TC 210/JWG4.

“The Luer connector has had a standardized design since the mid-1980s under ISO 594-1 and -2. We updated the designs in those standards to fill in certain missing dimensions that were necessary to establish non-interconnectability with the other connectors defined in this series and relabeled them as 80369-7,” he explained. “But the Luer itself has not changed; it’s just been further defined.”

According to Colburn, developing the 80369 series of standards is just the tip of the iceberg. “The next big important step is not just having these standards published—not even having them be normatively referenced in other appropriate device standards—but working with all stakeholders, both here in the U.S. as well as internationally, to implement these new connectors into the market for the clinical applications they are intended.”