FDA Issues Feeding Tube Misconnection Guidance Document
Posted July 30, 2012
To help combat the deadly problem of tubing misconnections, the U.S. Food and Drug Administration (FDA) has issued a draft guidance document to help manufacturers weigh the risk of small-bore connectors for enteral feeding tubes.
The guidance document, Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-Bore Connectors Intended for Enteral Applications, recommends manufacturers design and test their enteral connectors using 80369-1, an international standard AAMI helped develop that provides the general requirements for connectors for liquids and gases.
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.
AAMI President Mary Logan says the “most commonly reported” misconnection involves enteral applications.
Most connectors use the Luer lock, which “is like a universal serial bus port,” says Logan. “The problem is it is universal.”
The Luer lock could enable a clinician to incorrectly connect say an enteral feeding tube to an intravenous (IV) tube very easily, the FDA says.
The document is written for FDA staff and for enteral connector manufacturers who submit their products under the 510(k) program, a regulatory pathway for thousands of devices. It recommends that manufacturers includes with their submissions evidence that “each proposed enteral connector is physically incompatible with non-enteral devices.”
The guidance document also says 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.
“Recent reports of adverse events have demonstrated that reliance on color-coding of enteral devices alone cannot adequately mitigate the risk of misconnections,” the guidance document reads.
Additionally, manufacturers should perform a risk assessment that analyzes “the risk of the proposed enteral connector misconnecting to nonenteral devices,” the FDA says.
Logan characterizes the guidance document as an interim measure to prevent misconnections until more standards are published.
80369-1, published in 2010 and recognized by the FDA, is the first in a series of seven standards being developed by a joint International Organization for Standardization and International Electrotechnical Commission working group, for which AAMI serves as secretariat.
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 says, 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, Logan says.
The FDA says it will pay attention to the standards’ development, and “update this guidance as appropriate.”
The agency will hold a 90-day comment period on the document. To read it, click here.