1. What is ENFit™?
ENFit™ is the brand name under which the ISO 80369-3 compliant connectors will be branded worldwide by enteral device suppliers.
2. What is GEDSA?
GEDSA is the Global Enteral Devices Supplier Association. This is a group of suppliers worldwide that align on the timelines and way of transitioning to the new ISO compliant connector for enteral devices (ENFit™). Please be referred to stayconnected.org and gedsa.org for more information.
3. When will ENFit™ be an ISO standard?
The GEDSA consortium anticipates that the ISO 80369-3 (branded under the name ENFit™) will be published as ISO standard by mid 2015 (depending on ISO timelines).
4. Which companies join the ENFit™ launch/are part of GEDSA?
Major (enteral) tube feeding and medical devices companies such as Nutricia, Fresenius, Nestle, Abbott, Kimberly Clark, Covidien,Vygon as well as syringe manufacturers such as Becton Dickinson, and Bbraun are part of GEDSA. For a complete overview please be referred to the GEDSA website at gedsa.org.
5. Which part of the enteral feeding delivery system is affected by ENFit™?
ENFit™ compromises the following components:
- Feeding sets (only the connector from the feeding set to the feeding tube, not the one from the feeding set to the feeding pouch/bottle)
- Feeding tubes (connector to the feeding set)
- Medication port (connector to connect with syringes)
- Syringes (connector to connect with the connector of the feeding tubes and the medication port).
6. Why is ENFit™ needed?
The overall objective of the ISO 80369-3 (branded as ENFit™) is to reduce the likelihood of tubing misconnections between enteral feeding systems and IV (intravenous) or luer delivery systems.
7. What is the relation between ENFit™ and ENLock?
ENLock was a so called “Industry standard”, mainly adopted in the EU.
ENFit™ will be an ISO compliant connector, adopted worldwide by the industry.
ENLock was introduced in 2012 as a safer alternative and acted as a temporarily solution till ISO 80369-3 comes in (scheduled for publishing mid 2015).