More safety in enteral nutrition with ENFit™

A new international design standard for small-lumen connectors in healthcare is meant to increase patient safety worldwide. It reduces the risk of incorrect connections during the medical administration of liquids or gases. 

The new standard is laid down in ISO standard 80369-1:2010 and will successively replace the Luer system and other connectors. The norm will establish a new standard for six different indications

  • for enteral and gastric applications,
  • for ventilation systems and for motorised gas applications,
  • for urethral and urological applications,
  • for applications in systems with an inflatable cuff for limbs,
  • for neuraxial applications
  • as well as for intravascular and subcutaneous applications.

Connectors for enteral nutrition

In the first step, the standard will be implemented for enteral and gastric applications (ISO 80369-3). The standard is been implemented globally step-by-step since the end of 2015. The reverse Luer lock connector as the universal connector in enteral nutrition is thus being replaced – all manufacturers will gradually switch to the new standard connector for enteral nutrition ENFit™. 

Switch to ENFit™

The switch to ENFit™ will take place step-by-step, and started at the end of 2015. All manufacturers will follow a common transition plan to ensure that the transition runs as smoothly as possible for all users – in other words, a plan that ensures that no treatment interruptions are required and that existing stocks of material can still be used up. 

During the transition phase, until all products are available in the new design, there will be adaptors between the existing systems and the new connector. 

Background

The implementation of the new standards is supported by the global initiative "Stay connected", which was launched by the GEDSA (Global Enteral Device Supplier Association) to support the global introduction of the new standards.

Under the auspices of the GEDSA, experts in the field of medicine, economics and authorities came together to support and promote the development of new international standards for small-lumen connectors in healthcare. These are designed to reduce the risk of incorrect connections, to increase the integration possibilities of medical devices of different manufacturers and to decrease the probability of treatment interruptions owing to system incompatibilities. 

 

 

Contact

Do you have questions regarding the transition to ENFit™ in your organisation or in general? Our colleagues are happy to answer.

> Contact form