New Standard Targets Potentially Fatal Tube Misconnections

MPMN does not generally cover medical device standards, but a newly adopted standard from the Association for the Advancement of Medical Instrumentation (AAMI; Arlington, VA) is bound to have a direct and vital impact on manufacturers of connectors--not to mention patients and hospitals.

Designated as ANSI/AAMI/ISO 80369-1, the new international standard--the first in a series of seven to deal with connectors--seeks to reduce tubing misconnections among different types of medical devices. Directed at manufacturers, it provides guidance on how to create small-bore connectors for their devices. Designed to convey liquids or gases in patient-care environments, small-bore connectors are used in enteral feeding tubes, breathing systems, and many other medical applications.

Patients often have multiple lines connected to them to deliver medicine and nutrients. The danger is that many devices use the universal luer lock connector, a type of small-bore connector that is easy to misconnect. All too frequently, healthcare workers mistakenly connect such devices as feeding tubes to devices used for other applications, such as drug delivery.

The new standard offers manufacturers information on how to create proprietary connectors for their devices. "The standard provides the framework for risk mitigation and how to validate the new design," remarks Scott Colburn, deputy director of the standards program for the FDA's Center for Devices and Radiological Health and cochair of the ISO Technical Committee 210/Joint Working Group 4, which developed the standard.

Each of the remaining standards in the series will focus on a specific clinical application and how to make a connector for it, including breathing systems and systems for driving gases, enteral applications, urethral and urinary tubing, limb cuff inflation or noninvasive blood pressure devices, neuraxial applications used to deliver medications to spinal fluid, and intravascular or hypodermic applications.

For more information on misconnections and efforts to eradicate them, see the MPMN articles "Making the Right Connection," "Tubing Connection Mishaps Draw Fire from Mainstream Media," and "Partnership Seeks to Eradicate Neonatal IV/Enteral Misconnections."

Concerned about misconnections? Let us know your thoughts on this crucial topic in the comments section.