1. When and how will Nutricia launch ENFit™?
For the EU, MEA, and ANZ region the launch of ENFit™ compliant connectors looks as follows:
- From late Q3 2015: feeding sets (incl. medication port) with new ENFit™ connectors & ENFit™ transition connectors as well as enteral-specific syringes with ENFit™ connector will be introduced.
- From Q1 2016: The introduction of enteral feeding tubes with ENFit™ connector.
For the UK/Ireland region the launch looks slightly different:
- From September 2015: feeding sets (incl.ENFit™ medication port) with new ENFit™ connectors & ENFit™ transition connectors will reach the market.
- From March 2016 enteral-specific syringes with ENFit™ connector & enteral feeding tubes with ENFit™ connector will be introduced.
2. Will there be a transition period?
Yes above launch timelines (end Q3 2015 for EU, MEA and ANZ) and September 2015 for UK/Ireland) resemble the start of a so called transition period, which will approximately last 12 months.
3. How long will this transition period last?
The transition period is scheduled to last approximately 12 months.
4. How does this transition period differ from the current situation?
Main difference is that the transition feeding sets get 2 adapters; one on the medication port and one on the end of the feeding set. This will make the feeding set compatible with current/old feeding tubes and syringes as well as with new ENFit™ feeding tubes and syringes.
5. What happens after the transition period?
CBU’s are asked to switch forecast from transition sets to final sets (without adapters). ENFit™ syringes and ENFit™ tubes are by this moment already introduced.
Loose adapters will remain available as spare parts for a longer period to avoid any compatibility issues.
6. Do all feeding sets get ENFit™?
Yes*, Nutricia and other GEDSA partners will switch all enteral feeding sets to ENFit™ compliant ones as of late Q3 2015.
7. Do all feeding tubes get ENFit™?
Yes*, Nutricia and other GEDSA partners will switch all enteral feeding tubes to ENFit™ compliant ones as of Q1 2016.
Nutricia focusses on an earlier launch of enterostomy tubes (as of mid Q1 2016) and nasal tubes (as of end Q1 2016).
8. Will containers and Nutrison/feeding pouches/bottles get ENFit™?
No, containers and pouches are outside the ENFit™ scope
9. Do Top Fill (TF) reservoirs and accessories get ENFit™?
Top Fill reservoir connectors not, when there is a feeding set connected to it, the bottom part (connecting to the tube) will.
Some accessories (such as PEG connectors), which do contain a connector fitting the ENFit™ scope, (such as a connector to the tube), will change.
10. When and how will Nutricia launch ENFit™?
A gradual phase in will start as of end Q3 2015 (or September 2015 for UK & Ireland). Global Supply Chain is extensively discussing with CBU’s the Supply Chain phase-in phase-out schedule. Please ask your local Supply Chain and or contact global supply chain for more specific details or questions.
11. When are the competitor launches of ENFit™ into the market?
All companies belonging to the GEDSA consortium have similar launch timelines per region (see timelines explained on slide 6).
12. Will Vygon launch ENFit™?
This is unknown yet, they will probably try to postpone as long as possible and keep the Nutrisafe connector since they have monopoly on this neonatal standard. However since neonatal is included in the ENFit™ (ISO 80369-3) standard and Nutrisafe is not ISO compliant, we expect that local authorities will raise the issue that Vygon is selling enteral devices that are not ISO compliant. Our expectation is therefore they will gradually be lowering focus/sales of Nutrisafe. This whole process however can take a few years till the device standard EN1615 including the ENFit connector standard is published.