What is ISO 80369 ?

AN INTERNATIONAL STANDARD THAT AIMS TO STANDARDISE ALL KINDS OF

SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE

APPLICATIONS.

ISO 80369-03 UK Timelines

ISO 80369-3 Final

Publication

ISO 80369-3 Final

Publication

Introduction of Feed Sets with

ENFit & temporary transition adaptors

Introduction of Feed Sets with

ENFit & temporary transition adaptors

Introduction of Feeding Tubes and Syringes

with ENFit

Introduction of Feeding Tubes and Syringes

with ENFit

Temporary transition adaptors

removed from market

Temporary transition adaptors

removed from market

End of 2015 Sept 2015 Mar 2016 +1yr TBC

ISO standard is NOT a law !ISO Standard  ≠ Law

It is an international recommendation

Not mandatory

The decision is up to the hospitals

What does the standard tell us?

The Intent

• “The patient connector needs to be one that is non-inter connectable with any other connectors in the patient care area..”

The User Needs

• “The very fragile preterm infants require supplementary characteristics for the medical devices compared to larger and more robust patients.[…]

• Very small volumes (less than 0,1ml) are sometimes administered and require precise dosage possibilities.” 1

The Concern

“Concerns have been raised about the possible risks of delivering accurate doses of medicines in certain clinical practices across high risk subpopulations (e.g. neonatal

patients) when using a reversed connection system (female to male). This orientation may introduce inadvertent displacement of fluid…”

“Laboratory testing also shows a mid tolerance E1 [ENFit] connector pair in a female to male orientation displaces a mean average of 0.150ml…”

Timescales

Feed administration sets with transition adaptors from September 2015

Enteral syringes and tubes from March 2016

What does the standard tell us?

ENFit - Risk of Over-delivery

ENFit - Risk of Over-delivery

ation Dose Preparation Vol TBA for a 1kg baby Vol TBA for 3 kg babyne citrate 5mg/kg 10mg/ml 0.5mls 1.5 mlsdine 1‐3mg/kg 75mg/5mls 0.06 – 0.2ml 0.2‐0.6mlc 0.3 to 0.6 mls 0.3 mls 0.3 mlsn  1 ml 1 ml 1 mlbarbitone 4‐5mg/kg Varies – Singleton uses 10mg/ml 0.5mls 1.5mlshine sulphate 20‐200 micrograms per Kg Varies – Singleton uses 100 micrograms per 

ml0.2 mls‐ 2mls 0.6 mls ‐6 mls

eoxycholic acid 5mg/kg 50mg/ml  0.1 ml 0.3 mlin E 10 mg/kg 50mg/ml 0.2 ml 0.6mlin k 1‐2mg  2mg/0.2 mls 0.1ml 0.2mlothiazide 10mg/kg 50mg/ml 0.2 mls 0.6 mlsolactone 1 mg/kg 10mg/ml or 1 mg/ml 0.1mls or 1 ml 0.3mls or 3 mlsmide 1mg/kg 8mg/ml 0.125 mls 0.375mlxacillin 50mg/kg 25mg/ml 2 mls 6mlsee L (oral potassium) 1mmol/kg Kay Cee L1 mmol/ml 1 ml 3 mlsnazole 3‐6mg/kg 10mg/ml 0.3‐0.6 mls 0.9‐1.8mlsudine 4mg/kg 10mg/ml 0.4 mls 1.2 mlsafil 250 microg/kg 2mg/ml 0.125ml 0.375mlmethasone 16 micrograms per kg  2mg/5mls 0.04 ml 0.12 mltin 1 ml 100,000 U /ml 1 ml 1 mln 5 micrograms/kg 

maintenance dose50 micrograms /ml 0.1ml 0.3ml

omycin 12.5 mg/kg 25mg/ml 0.5 mls 1.5 mlstoin 2.5mg/kg 6mg/ml 0.4 mls 1.25mlsetamol 10‐20mg/kg 120mg/5mls 0.41‐0.83 mls 1.25‐2.5 mlsthoprim 2mg/kg 10mg/ml 0.2 mls 0.6 mlsl hydrate 30mg/kg 100mg /ml 0.3mls 0.9mlsanolol 250 micrograms per kg 1mg/ml 0.25 mls 0.75 mls

mall volumes such as 0.05ml will result In an overdose of 400% 

ble provided by Peter Mulholland – Royal Hospital for sick children

ENFit Survey – Neonatal Suitability

By Vygon• 119 users: 100% involved in Neonatology• 11 countries : BE, DK, FR, DE, IT, NL, NO, SP, CH, SW, UK• In the hospitals : Questionnaire (drugs’ administration protocol, needs)

• Discussion on accuracy and associated risk.• ENFit samples with 0.12ml potential variation.• Would the ENFit design be acceptable for use in a neonatal environment?

Answer: No• But: not accepted by the ISO working (due to absence of pharmacists).

So what does GEDSA advise?

“When highly accurate dose delivery is required using the ENFit connection in the female to male orientation, the use of draw up adaptors (e.g. a draw up straw ) is recommended”.

For precise dosing (+/‐ 0.15ml) as requested in NICUs, correctly use a

draw up device to minimize the ENFit syringe inaccuracy

commendation from GEDSA (Global Enteral Devices Suppliers Association)

Neonatal concerns :ENFit volume displacementISO/DIS 80369‐3.2 – Annex A :

“Concerns have been raised about the possible RISKS of delivering accurate doses of medicines in certain clinical practices across high RISK subpopulations (e.g. neonatal PATIENTS) when using a reversed connection system (female to male)…”

“Laboratory testing also shows a mid tolerance ENFit connector pair in a female to male orientation displaces a mean average of 0.150ml […] of fluid.”

As long as an ENFit compatible connector is used during filling, plunger operation, anddelivery, the ENFit syringe tip is left almost empty once the plunger position is at zero.

The syringe is filled using an ENFitStraw or an ENFit style pharmacybottle adapter.

The tip is not filled with fluidbecause volume was displacedby the ENFit connector used to fill the syringe.

An ENFit Feeding Tube/Extension Set is used fordelivery and it re-occupies the space within the tip.

There may be a small amount of deadspace (approximately0.07 mL), but there is no delivery error.This volume is accounted for when the plunger position is at zero.

Delivery with ENFit Tip Syringe

Delivery with ENFit Tip SyringeAs long as an ENFit compatible connector is used during filling, plunger operation, and delivery, the ENFit syringe tip is left almost empty oncethe plunger position is at zero.

The syringe is filled using an ENFit Straw or an ENFit style pharmacy bottle adapter.

The tip is not filled with fluid because volume wasdisplaced by the ENFitconnector used to fill thesyringe.

An ENFit Feeding Tube/Extension Set is used for delivery and it re-occupies the space within the tip.

There may be a small amount ofdead space (approximately0.07 mL), but there is no delivery error. This volume is accounted for when the plungerposition is at zero.

This is a theoretical assumption and does not work in reality.

Reality!

Conclusion

15

Vygon will continue to provide the Nutrisafe2 system to meet the intent of the ISO 80369 and

provide the best possible care and safety for neonatal patients.

The risk remains up to 0.150ml over / under delivery

with the use of a draw up device.

So what does this mean to Neonates?

Whilst the intent to prevent misconnections is met by the ENFit enteral connector, it

introduces the problem of inaccurate and uncertain administration of low volume medications, such as those delivered to

Neonatal patients.

NEONATOLOGThe solution

Vygon will continue to provide the Nutrisafe 2 system to meet the intent of the ISO/80369-3 and

provide Neonates with the best possible care and safety.

UK Enteral device Companies have invested heavily into ENFit and will change their whole range to ENFit as of March 20

NEONATOLOG

The compact design of Nutrisafe 2 connections minimises deadspace.

Think SAFE, SMALL and ACCURATE!

The Solution: Nutrisafe 2

Nutrisafe2 Reversed Luer

ENFIt(ISO/DIS80369-

3)

Maximum deadspace of the syringe connector* 0.056ml 0.099ml 0.191

NEONATOLOG

Nutrisafe 2 is incompatible with standard IV Luerdevices.

There is no risk of misconnection, increasingpatient safety meeting the intent of ISO 80369-3.

Think SAFE, SMALL and ACCURATE!

The Solution: Nutrisafe 2

LUER