In the News
|The FDA has published final guidance on small-bore connectors used in enteral applications. 2.11.15|
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 firstname.lastname@example.org.
ISO-IEC International Standards Development for Small-bore Connectors
This section is for official communications from the international committee developing the small-bore connectors standards (ISO/TC210-IEC/SC 62D/JWG4) and information on international efforts related to the implementation of the standards.
- Timeline for international standards development process
- Please e-mail email@example.com with any questions.
AAMI Resources (US)
- Tubing Challenges Focus of FDA Guidance 02.11.15
- 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
- Standards Developer and Committees Honored for Pioneering Work AAMI News, June 2013
- Ambitious Standards Initiative on Small-Bore Connectors Moves Forward 04.24.13
- CMS Warns of Luer Misconnection Dangers 03.18.13
- New FDA Standards Head Outlines Priorities AAMI News, September 2012
- FDA Issues Feeding Tube Misconnection Guidance Document 07.30.12
- From the President: Finding Inspiration in Real People 06.29.12
- 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
- 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
- Tubing and Luer Misconnections: Preventing Dangerous Medical Errors 2.10.15
- How Luer and Other Small-Bore Connectors Are Used in Clinical Settings 2.10.15
- Tips for Healthcare Providers: Preventing Tubing and Luer Misconnections 2.10.15
- Information for Manufacturers of Small-Bore Connectors and Medical Devices with Connectors 2.10.15
- Draft Guidance for Industry and Food and Drug Administration Staff—Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnection with Small-Bore Connectors Intended for Enteral Application 7.27.12
- Preventing Tubing and Luer Misconnections: Tips for Health Care Providers 7.24.12
- Look. Check. Connect. Safe Medical Device Connections Save Lives: Case Studies 12.17.08
- Luer Connector Misconnections: Under-Recognized but Potentially Dangerous Events, A Patient Safety Webcast Sponsored by FDA’s MedSun KidNet Subnetwork 11.19.08
Institute for Safe Medication Practices (ISMP)
- ISMP: Plan Now for Upcoming Changes in Enteral Feeding Device Connectors 10.13.14
- ISMP Medical Safety Alert 7.15.10
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 StayConnected2014.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
- Stay Connected: New Standards for Patient Safety Panel DiscussionConvened 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.