Small-Bore Connectors

AAMI is leading the small-bore connectors initiative, an international effort to decrease tubing misconnections and increase patient safety. This page is primarily intended for a US audience, to provide an understanding not only of the standards development process, but also of the market and regulatory implications in the US. In addition, there is a section below which provides a timeline for the international standards development process and any other information that pertains globally.

AAMI is the Secretariat for the international joint working group developing the small-bore connectors standards within ISO and IEC and welcomes collaboration from international organizations interested in partnering with us on the global implementation of the standards. Interested parties should contact celliott@aami.org.

AAMI Resources (US)

• Comments from AAMI/CN, Small-bore connectors committee meeting 3.14.16
• Report of the AAMI and GEDSA information session on 80369-3 connectors 10.14.15
• Video from the AAMI and GEDSA information session on 80369-3 connectors 10.14.15
• TJC Issues Alert In Preparation for New Tubing Connector Standards 08.20.14
• AAMI 2014 Conference session presentation: Small-bore Connectors—New Standards and Designs 05.31.14
• Small-Bore Connectors Testing Program information and contribution form
• Stay Connected: FAQs about Small-bore Connectors and Tubing Misconnections
• Ambitious Standards Initiative on Small-Bore Connectors Moves Forward 04.24.13
• CMS Warns of Luer Misconnection Dangers 03.18.13
• FDA Issues Feeding Tube Misconnection Guidance Document 07.30.12
• Patient Safety Congress Focuses on Technology Hazards 05.30.12
• Connectors Bill Advances in California Legislature 04.18.12
• Dangerous Connections: Healthcare Community Tackles Tubing Risks, BI&T, Vol. 45, No. 6, Nov./Dec. 2011
• ANSI/AAMI/ISO 80369-1:2010: Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements

American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.)

• ASPEN to Provide Continuing Education on New Enteral Connectors April 2014
• Tubing Misconnections: Normalization of Deviance, Nutrition in Clinical Practice, June 2011
• Enteral Feeding Misconnections: An Update, Nutrition in Clinical Practice, June 2009

Centers for Medicaid & Medicare Services (CMS)

• Luer Misconnection Adverse Events, March 8, 2013

FDA (Food and Drug Administration)

• Reducing Risks Associated with Medical Device Misconnections 10.07.16
• Final Guidance for Industry and Food and Drug Administration Staff: Safety Considerations to Mitigate the Risks of Misconnections with Small-Bore Connectors Intended for Enteral Applications 2.11.15

Institute for Safe Medication Practices (ISMP)

• ISMP: Plan Now for Upcoming Changes in Enteral Feeding Device Connectors 10.13.14
• ISMP Medical Safety Alert, July 15, 2010

Premier

• Presentation and recording from webinar "Transitioning to ENFit Connectors—A Safer Enteral Feeding System" 7.14.16
• Presentation and recording from August 20, 2014 webinar 8.20.14

Stay Connected

Stay Connected is a program designed to facilitate the transition from medical device applications that allow connection between unrelated delivery systems to new, safer connectors that ensure compatibility and consistency while reducing the likelihood of tubing misconnections. Stay Connected is organized by the Global Enteral Device Supplier Association (GEDSA) in partnership with leading industry organizations. GEDSA invites everyone to stay connected as the tubing connectors are introduced through a three-phase communications program—Aware, Prepare, and Adopt—to ensure a successful transition to safer connectors.

For more information, visit StayConnected.org.

The Joint Commission (TJC)

• Sentinel Event Alert 53: Managing risk during transition to new ISO tubing connector standards 8.20.14
• Enteral Feeding Misconnections: A Consortium Position Statement, The Joint Commission Journal on Quality and Patient Safety, May 2008
• Error-Avoidance Recommendations for Tubing Misconnections When Using Luer-Tip Connectors: A Statement by the USP Safe Medication Use Expert Committee, The Joint Commission Journal on Quality and Patient Safety, May 2008

World Health Organization (WHO)

• Avoiding Catheter and Tubing Misconnections. Patient Safety Solutions, Volume 1, Solution 7, May 2007

Other

• Stay Connected: New Standards for Patient Safety Panel Discussion Convened at Healthcare Supply Chain Expo 2013. Washington D.C. 10.22.13
• California Bill AB 1867: Health facilities: equipment standards 06.06.12
• Safe Systems, Safe Patients: Common Connectors Pose a Threat to Safe Practice, Texas Board of Nursing Bulletin, Volume 37, No. 2, April 2006
• Tubing Misconnections American Nurses Training Association
• Tubing Misconnections Premier Inc.