Enteral Connections: Safety Initiatives

Evi Dewhurst

It’s been on the radar for years now: safer small-bore connectors. Enteral safety concerns generated rapid change, for the good of the patient and the health care provider. Yet, even after all these years, confusion reigns as to which initiatives will pass, what exactly they mean and when they will become the standard.

For relevant and top-of-mind information to share on this topic of safe enteral connectors, I took a good look at the recently updated AAMI (Advancing Safety in Medical Technology) Collaboration, titled “Stay Connected: FAQs About Small-Bore Connectors And Tubing Misconnections”, dated October 2013. Several highlights became apparent immediately.


A fantastic list of resources. To revisit what has been researched to reduce the risk of small-bore misconnections, this AAMI Collaboration update provides a concise list of reference points:

Sentinel Event Alert, Issue 36: Tubing misconnections—a persistent and
potentially deadly occurrence from The Joint Commission (TJC)

Case studies, a safety calendar, videos, webinars, and other resources from the
U.S. Food and Drug Administration (FDA)

Clinical recommendations from the American Society for Parenteral and
Enteral Nutrition (A.S.P.E.N.)

A letter to surveyors about the need to review hospitals’ prevention policies
from the Centers for Medicare & Medicaid Services (CMS)

Making Healthcare Safer II: An Updated Critical Analysis of the Evidence for
Patient Safety Practices from the Agency for Healthcare Research & Quality (AHRQ)


Anticipated changes. Many changes have taken place, but the question on everyone’s mind is, “What’s coming next?” Non-luer compatible delivery system-specific connections are moving toward international standards, and are currently under development. It’s possible that early 4th quarter 2014 will see new connectors available to the market.


Products affected by changes. These products need to provide the non-interconnectibility standards and will be affected by safety changes:

·      Respiratory systems and driving gases

·      Enteral feedings

·      Limb cuff inflation applications

·      Neuraxial applications

·      Urethral and urinary applications (planned)


Anticipated product change timeline. Be prepared for a transition period occurring in stages. Manufacturers will roll out applicable products in time for health care facilities to adopt them in a timely manner. It’s understood that these changes take time to incorporate and all parties anticipate working together to improve safety.


Are these standards mandatory? No federal mandates existed as of August 2013 for manufacturers or health care organizations. However, a California law is expected to go into effect in 2016, which affects manufacturers and the health care industry across the board:

“Effective Jan. 11, 2016, a California law (HB 1867) will prohibit general acute care, acute psychiatric, and special hospitals from using an epidural, intravenous or enteral feeding connector that fits into a connection port other than the type for which it was intended. It is expected that all medical device manufacturers/suppliers will comply with the new California law. In doing so, they will develop modified products that incorporate the new connectors and phase out products with old connectors.”

It seems likely that once California law has been established in this matter, other states will also follow suit.


Incidents can occur, no matter how diligent your team is. Although many tubing misconnections are caught and corrected before an incident can occur, these are often not reported, which can make it appear that potential incidents are exceedingly rare. As the FAQ states, “All organizations are one human error away from a harmful tubing misconnection.” Health care facilities are familiar with putting patients first, and implementing a safety system should be a natural goal in line with this view.


Will a universal color code be assigned for these safe tubing connections? Color-coding is not included in the 80369 standards. Instead, the standards are more concerned with shape and size of the connector.


Safer connections are a way to advance patient safety and minimize human error. Now is the time to begin planning your health care facility’s transition to small-bore safety connections. While 2016 may seem distant, the process could take upwards of a year, depending on your team and facility process in adopting new products and standards. Begin your research now to find the right product fit for your unit.


View the “Stay Connected” website for updates and resources.