Ambitious Standards Initiative on Small-Bore Connectors Moves Forward


Posted April 24, 2013

A year from now, hospitals and other healthcare facilities will likely start to see newly designed small-bore connectors on the market, the end result of an ambitious and sweeping effort to eliminate a significant patient safety hazard—misconnections.

To prepare for what’s expected to be a huge change for both the medical device industry and healthcare facilities, AAMI is working with other organizations to spread the word about what’s coming down the pike.

An international joint working group is developing a series of standards that will, when implemented, make tubing misconnections involving small-bore connectors virtually impossible because the design of the connector will no longer be universal. Instead, the design of each connector will be specific to its application.

The working group, ISO/TC 210 & IEC/SC 62D JWG4—for which AAMI serves as secretariat—is working on what’s called the 80369 series. Specifically, they are:

  • 80369-2, Small-bore connectors for liquids and gases in healthcare applications – Part 2: Connectors for breathing systems and driving gases *
  • 80369-3, Small-bore connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications
  • 80369-5, Small-bore connectors for liquids and gases in healthcare applications – Part 5: Connectors for limb cuff inflation applications
  • 80369-6, Small-bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications *
  • 80369-7, Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
  • 80369-20, Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods

The new designs have undergone or will undergo testing, based on the application.  As soon as the testing and standards approval processes are complete, members of industry are expected to redesign their connectors and submit them to the U.S. Food and Drug Administration for clearance. Once approved, manufacturing of the new connectors is expected to begin in earnest.

AAMI has already adopted 80369-1, which provides guidance to manufacturers on how to create a small-bore connector for their own devices.

The timeline shows the anticipated dates for the different steps in the standards development process. [Please contact Colleen Elliott at celliott@aami.org for current timeline information.]

The new connectors will start to reach the market as early as mid-2014 and extending into 2015.  The impact on healthcare delivery organizations is expected to be monumental because all of the old connectors will have to be replaced with the new ones.

AAMI is participating in efforts led by The Joint Commission and including the FDA, the American Hospital Association, industry, and other partners to help prepare the marketplace for this change. The purpose of this campaign is to:

  • Generate broad based awareness of the need for this change
  • Facilitate rapid adoption of new global standard tubing connectors
  • Minimize disruption to the supply chain and clinical practice while maximizing increases in patient safety

The AAMI Small-bore Connectors Committee is considering partnering with the Coalition of Organizations for Reporting Adverse Events (CORE) to gather data on adverse events involving small-bore connectors and to measure the impact of the new standards by comparing before and after data.

A committee representative will be at the AAMI booth in the Expo Hall during the Annual Conference in Long Beach, CA, June 1-3. It will be a chance for those interested in learning to ask questions and provide input.

The impetus for this standards initiative stems from what many experts see as an underreported problem in healthcare: tubing and catheter misconnection errors, which have injured, and in some cases even killed, patients.  Misconnection occurs when tubing to or from a medical device is unintentionally attached to another device that performs a completely different function. For example, there have been documented cases of feeding tubes being mistakenly connected to ventilators or trach tubes. Such misconnections can happen because of the universal design of what’s called the Luer connector, which allows physiologically incompatible systems to become connected.

The Centers for Medicare & Medicaid Services released a memo  in early April to all of its state surveyors, asking them to pay close attention to what hospitals are doing to prevent tubing misconnections while work is completed on the new standards and connectors (https://www.premierinc.com/quality-safety/tools-services/safety/safety-share/bulletin_Tubing_Misconnections_04042013.jsp)

In California, a law will go into effect Jan. 1, 2016 prohibiting the use of an epidural, intravenous, or enteral feeding connector that fits into a connection port other than the type for which it was intended.

If you have any questions about the small-bore connectors committees or standards, please contact Colleen Elliott, director of Standards, at celliott@aami.org or 703-253-8261.