The problem with Luer connectors lies in their universality which sounds like an advantage, but is actually the source of misconnections with serious patient consequences. Health Care analytics company Novation is working with industry leaders on new design specifications to significantly reduce tubing misconnections which is expected to have an enormous impact on the health care supply chain and patient safety.
The Luer connector has become part of the furniture in hospitals the world over, this simple device allowing therapeutically dissimilar devices to be easily connected. The problem is that the very universality that provides this advantage can also permit inadvertent tubing misconnections, also referred to as small bore misconnections or wrong route errors. Such events present a serious patient safety issue, one that can be fatal, and one that is believed to be seriously underreported.
The group developing the small bore misconnection standards consists of clinicians, manufacturers and regulators, including the U.S. FDA, the International Organization for Standardization (ISO) with the Association for the Advancement of Medical Instrumentation (AAMI), and members of the medical device industry. Collectively, the group is developing what is known as the 80369 series, which will require small bore connector designs involving the Luer connector to be specific to the applications they were intended for and not a universal fit.
Efforts to educate the industry about the new standards have already begun, including an educational panel session at the recent Healthcare Supply Chain Association annual meeting in Washington, D.C.
“Novation is pleased to be working with several organizations to develop standards to help care providers reduce the chance for error and potential harm to patients,” said Stephanne Hale, Senior Clinical Manager, Novation. “While the vast majority of the hospital members we surveyed indicated they have taken steps to prevent tubing misconnections in their facilities, developing new standards to drive unique connectors for each delivery system will make it much more difficult, if not impossible, to connect unrelated delivery systems. We will be working with health care organizations to help them prepare for new products, which are expected to come to market in late 2014.”