1. Ailsa Kennedy HETF Lead PENG
ENFit Update
Ailsa Kennedy
HETF Lead PENG

2. Lucky Me!!!

3. ENFit Background Where are we now…. Open to the floor….
Presume you are all in the midst of transition and will be aware of the background.

4. Background ISO 80369-3: UK timelines
A new International Standard (ISO ) is being published this year, covering all connectors on enteral devices.
In order to comply with this International Standard, a new global enteral feeding device connector design (named ENFit)
will be introduced nationwide from September 2015.
This change will impact all enteral feeding devices** within the UK.
The ENFit introduction will be a 2-stage process, with transition giving sets and gravity sets made available from September 2015.
ENFit feeding tubes and syringes will be introduced from 14th March 2016.

5. EPSG Members

6. Background
PENG representation to industry led Enteral Plastic Safety Group from 2013.
Clinical Representation BPNG, NNNG, Scotland, Procurement Scotland England, Wales and Northern Ireland.

7. The Challenge…Connecting a System Designed Not to Connect
CURRENT
NEW
Female Luer Connector from Administration Set or Female Luer Syringe
Female ENFit Connector from Administration Set
Male ENFit Connector for Feeding Tube
Male Luer Feeding Tube Port

8. NHS England Small Bore Connector Group 2014
Chaired by Paul Sharpe intensive care consultant from Leicester. The group was established in 2014 to advise NHS England on the safe introduction of medical devices with new connector designs into the NHS
Unfortunately disbanded in Summer 2016 , safety aspect transferred to NHS improvement and as part of the restructure committees were rationalised. Implementation concerns to be rasied via MHRA.

9. Dose Accuracy of ENFit® Low Dose Tip vs
Dose Accuracy of ENFit® Low Dose Tip vs. Common Enteral/Oral Tip Syringes
Note: Target is ±10% of a 0.2mL dose delivered in a 1mL syringe.

10. All boxes pf ENFit syringes will be labelled as above
All boxes pf ENFit syringes will be labelled as above. Best practice to use medicine straw to ensure dose accuracy.

11. Where we are now….
Delayed implementation initiated by syringe low dose concerns.
Delay in availability of enteral devices.
Impact on adaptor usage, volumes requested are much higher than forecast.
Suitability of ENFit products coming onto the market.
Supply and demand issues.
Services at the mercy of industry and enteral feed contact suppliers…
Risk to patient care.
Medication administration concerns.

12. Open To The Floor
We are experiencing problems with obtaining supplies of enteral feeding products from Supply Chain. Is this something that you are aware of? And is it country wide?
Has there been stock piling going on?
Also, a couple of our suppliers have reported that they are low on stocks, and we cannot get the transition adapters anywhere.
Is there any information regarding these issues that you can point me towards?