ISO Standards on enteral feeding systems

Patients within healthcare settings receive medication and other therapies through a variety of tubes and catheters. The connectors of these different delivery systems are often compatible and can be connected to each other. Patient injuries, and even deaths, have occurred when medicines, liquid feeding formulas or air have been accidentally delivered through the wrong tube. These errors are called tubing misconnections.

“The reporting of inadvertent intravenous administration of breast milk in 1972 is one of the earliest publications of an enteral misconnection.»

 

Tubing misconnection between intravenous and enteral feeding

The International Organisation for Standardisation (ISO) decided to mitigate the likelihood of tubing misconnections. The creation of the ISO 80369 series promotes the patient safety by specifying designs of non-interconnectable connectors for liquids and gases in several healthcare applications (respiratory, enteral, urology, limb cuff inflation, neuraxial, and I.V).

In order to get the technical and market expertise, the International Organisation for Standardisation encouraged industry to be part of the ISO working groups.

As the inventor of Nutrisafe, one of the first safe enteral feeding systems, Vygon knows how safety in enteral therapy is important and what processes should be implemented to reach the ISO’s objective. That’s why Vygon decided to join the Standard Committee from the start to work on the creation of the ISO 80369 series, particularly for the enteral application.

The challenge of the working group was to eliminate the problem of misconnection, without introducing any other safety concerns.

ISO International Organization for Standard

1991-1995

  • Discovery of the first patient injuries and deaths linked to tubing misconnections.
  • Clinical concerns are raised and health authorities are informed.

1995

  • Vygon creates one of the first reverse-Luer safety enteral feeding system, called Nutrisafe1.

1997-1999

  • Creation of a European working group (CEN CHeF FTG => CR 13825:2000).
  • The purpose is to discuss misconnection risks and see if standards can help to address these issues
  • Vygon takes part in this discussion group.

2001

  • Creation of an official Working Group in the European Standard Committee (CEN BTTF 123 “Small Bore Connectors”).
  • Vygon joins this European Working Group.

2005

  • Vygon understands that a reversed-Luer can be reversed and misconnection is still possible. Vygon decides to modify Nutrisafe1 in order to be totally incompatible with Luer and compliant with neonatal requirements.
  • Vygon invents the first safe non-Luer enteral feeding system designed for neonates, called Nutrisafe2.

2007

  • Transfer from European Committee to International Committee (creation of the ISO/IEC JWG 4 “Small Bore Connectors”).
  • Vygon is a member of the ISO committee.

2008

  • Publication of the Part 1 “General requirements” as EN 15546-1 (named in 2010 : ISO 80639-1).

2015

  • Publication of the Part 20 “Common test methods” (ISO 80369-20).

2016 

  • Publication of the first standard connector design dedicated to enteral application (ISO 80369-3).
History ISO 80369-3