Organizations Release FAQs about Small-Bore Connectors and Tubing Misconnections

The Association for the Advancement of Medical Instrumentation (AAMI), patient safety groups, and other stakeholders today released a new resource intended to help the healthcare community prepare for upcoming changes to medical device small-bore connectors that are designed to prevent tubing misconnections and enhance patient safety.

Stay Connected is a comprehensive list of 23 frequently asked questions (FAQs) related to small-bore connectors, which have long posed a threat to patient safety because of a design issue. A commonly used type of small-bore connector, called the Luer connector, has a universal design that allows the tubing of one medical delivery system to be connected to an unrelated systema potentially fatal flaw. New design standards are in the works for small-bore connectors and the new FAQ document explains the changes and their impact.

"Having a unique connector for each type of medical delivery system instead of one universal Luer connector will reduce the risk of accidentally connecting unrelated system, like connecting a feeding tube to an intravenous line, says Gina Pugliese, vice president at the Premier Safety Institute.

The FAQ document is being unveiled today by AAMI, the Joint Commission, the American Society of Parenteral and Enteral Nutrition, the Premier Safety Institute, and the newly formed Global Enteral Device Supplier Association (GEDSA) at the 2013 Healthcare Supply Chain Expo in Washington, D.C. Representatives from each group will discuss the plan during an afternoon panel session titled New Standards for Patient Safety.  The FAQ document is available for free on AAMIs website.

AAMI and its stakeholder partners are excited to move this project forward, says AAMI president Mary Logan, who is speaking on the panel. Too many tragedies have resulted from misconnections, and we all hope the new connectors will significantly reduce the number of adverse events.

While misconnections in the tubing delivering medication, oxygen, and fluids are rare, their occurrence can have dire consequences. In 2006, the Joint Commission called misconnections a persistent and potentially deadly occurrence. To help prevent these events, an international group of clinicians, manufacturers, and regulators, are collaborating with the International Organization for Standardization (ISO) and AAMI to develop the ISO 80369 series of Small-Bore Connector Standards.

Standards for newly designed connectors will provide for easier integration of different manufacturers devices, promote better patient safety, and help ensure that connectors for unrelated delivery systems are incompatible. A phased approach will start with enteral devices as early as the fourth quarter of 2014.  The better facilities understand this initiative, the easier it will be for them to prepare for the adoption of these new connectors.

The FAQ document answers questions such as:
- What changes are coming?
- What products will be impacted by the new standards?
- How should organizations prepare for the changes?

Tom Hancock, executive director of GEDSA, notes, Its really important that the healthcare community keep up with these changes. They are coming, and they will have a huge impact on clinical practice.  The "Stay Connected document can be downloaded for free at That page also contains others AAMI resources related to the small-bore connectors challenge. The organizations that collaborated on the Stay Connected document plan to release other resources in the future.
Source: Association for the Advancement of Medical Instrumentation (AAMI)