FDA Issues Draft Guidance on Luer Connectors

The U.S. Food and Drug Administration (FDA) has issued a draft guidance document to help manufacturers of enteral (drug administration through the gastrointestinal tract) connection devices, such as Luer connectors.

Luer connectors certainly aren’t new technology. The luer connector was developed in 1896 by a surgical instrument manufacturer in Paris, France, the H. Wulfing Luer Company. Luer connectors were designed to securely attach hypodermic needles to glass syringes using a push fitting that also allowed for easy separation when administration was complete. Today, Luer connectors are used worldwide to connect a variety of vascular, enteral, respiratory, epidural, and intrathecal medical devices, components, and accessories.

The International Organization for Standardization describes the Luer connector as a “conical fitting with a 6 percent taper for syringes, needles, and certain other medical equipment.” Luer connectors have a male and a female component that are joined to form a secure yet detachable leak-proof connection. The connection is achieved by use of a push fitting (a Luer slip) or a screw-in threaded fitting (a Luer lock) that joins the male and the female tapered fittings.

The FDA, however, is concerned that the “use of common connector designs, such as luer connectors, has led to unintended connections between devices that have different intended uses and has resulted in serious and sometimes fatal consequences to patients.”

The draft guidance, titled “Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-Bore Connectors Intended for Enteral Applications” is intended to provide recommendations to 510(k) submitters regarding the agency expectations regarding design and testing to reduce the risk of unintended connections between enteral and non-enteral devices.

The draft guidance recommends that manufacturers design and test their enteral connectors using 80369-1 (published in 2010 and recognized by the FDA in 2011), an international standard that provides the general requirements for connectors for liquids and gases. The standard was developed with the help of the Arlington, Va.-based Association for the Advancement of Medical Instrumentation (AAMI). Tubing misconnections are a widely recognized problem in healthcare, but there are no firm numbers on how many such cases there are because not all incidents are reported, according to the AAMI. 

AAMI President Mary Logan said the “most commonly reported” misconnection involves enteral applications. Most connectors use the Luer lock, which “is like a universal serial bus port,” explained Logan. “The problem is it is universal.”

The guidance document also advised that color coding and labeling connectors are “no longer sufficient to satisfy safety concerns regarding misconnection hazards,” revising a recommendation from two years ago that advised manufacturers and hospitals to do just that.

In July 2010, the FDA issued a letter to healthcare professionals, hospital purchasing departments and manufacturers of enteral feeding tubes regarding luer lock misconnections. The
FDA advised manufacturers to assess the risks of misconnections for their devices and provide proposed solutions with validation for pre-market review.

“At that time, some manufacturers were using color coding and labeling to reduce the risk of misconnections; others were creating proprietary connectors designed to be incompatible with non-enteral devices. However, recent reports of adverse events have demonstrated that reliance on color-coding of enteral devices alone cannot adequately mitigate the risk of misconnections, especially with similarly color-coded PICC (percutaneously inserted central catheter) lines on the market,” according to the draft guidance.

Additionally, manufacturers should perform a risk assessment that analyzes “the risk of the proposed enteral connector misconnecting to non-enteral devices,” according to the FDA.
The remaining standards, expected to be published by 2014, focus on how to design a connector for a specific clinical application. One of the standards will focus on enteral connectors, and another on breathing systems. The goal, Logan said, is for the Luer lock connector to eventually only be used for intravascular applications. Once a standard is published, it can take a manufacturer up to 18 months to revamp their manufacturing process to meet its requirements, according to AAMI.

The agency will hold a comment period of 90 days from publication (July 27). To learn more, click here.