ISO UK Timelines

Transcription

1 hat is ISO 80369? AN INTERNATIONAL STANDARD THAT AIMS TO STANDARDISE ALL KINDS OF SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS.

2 ISO UK Timelines End of 2015 Sept 2015 Mar yr TBC ISO Final Publication Introduction of Feed Sets with ENFit & temporary transition adaptors Introduction of Feeding Tubes and Syringes with ENFit Temporary transition adaptors removed from market

3 ISO standard is NOT a law! ISO Standard Law It is an international recommendation Not mandatory The decision is up to the hospitals

4 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

5 What does the standard tell us? 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

6 ENFit - Risk of Over-delivery

7 ENFit - Risk of Over-delivery

8 tion Dose Preparation Vol TBA for a 1kg baby Vol TBA for 3 kg baby e citrate 5mg/kg 10mg/ml 0.5mls 1.5 mls ine 1 3mg/kg 75mg/5mls ml ml 0.3 to 0.6 mls 0.3 mls 0.3 mls 1 ml 1 ml 1 ml barbitone 4 5mg/kg Varies Singleton uses 10mg/ml 0.5mls 1.5mls ine sulphate micrograms per Kg Varies Singleton uses 100 micrograms per ml 0.2 mls 2mls 0.6 mls 6 mls oxycholic acid 5mg/kg 50mg/ml 0.1 ml 0.3 ml n E 10 mg/kg 50mg/ml 0.2 ml 0.6ml n k 1 2mg 2mg/0.2 mls 0.1ml 0.2ml thiazide 10mg/kg 50mg/ml 0.2 mls 0.6 mls olactone 1 mg/kg 10mg/ml or 1 mg/ml 0.1mls or 1 ml 0.3mls or 3 mls ide 1mg/kg 8mg/ml mls 0.375ml acillin all volumes 50mg/kg 25mg/ml such as 0.05ml 2 mls will result 6mls e L (oral potassium) 1mmol/kg Kay Cee L1 mmol/ml 1 3 mls azole 3 6mg/kg 10mg/ml mls mls dine 4mg/kg 10mg/ml 0.4 mls 1.2 mls fil 250 microg/kg In an 2mg/ml overdose 0.125ml of 400% 0.375ml ethasone 16 micrograms per kg 2mg/5mls 0.04 ml 0.12 ml in 1 ml 100,000 U /ml 1 ml 1 ml 5 micrograms/kg maintenance dose 50 micrograms /ml 0.1ml 0.3ml mycin 12.5 mg/kg 25mg/ml 0.5 mls 1.5 mls oin 2.5mg/kg 6mg/ml 0.4 mls 1.25mls tamol 10 20mg/kg 120mg/5mls mls mls hoprim 2mg/kg 10mg/ml 0.2 mls 0.6 mls l hydrate 30mg/kg 100mg /ml 0.3mls 0.9mls nolol 250 micrograms per kg 1mg/ml 0.25 mls 0.75 mls le provided by Peter Mulholland Royal Hospital for sick children

9 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).

10 So what does GEDSA advise? ommendation from GEDSA (Global Enteral Devices Suppliers Association) 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

11 Neonatal concerns : ENFit volume displacement ISO/DIS 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.

12 Delivery with ENFit Tip Syringe As long as an ENFit compatible connector is used during filling, plunger operation, and delivery, the ENFit syringe tip is left almost empty once the 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 was displaced by the ENFit connector used to fill the syringe. 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 of dead space (approximately 0.07 ml), but there is no delivery error. This volume is accounted for when the plunger position is at zero.

13 Delivery with ENFit Tip Syringe As long as an ENFit compatible connector is used during filling, plunger operation, and delivery, the ENFit syringe tip is left almost empty once the plunger position is at zero. This is a theoretical assumption and does not work in reality. The syringe is filled using an ENFit Straw or an ENFit style pharmacy bottle adapter. The tip is not filled with fluid because volume was displaced by the ENFit connector used to fill the syringe. 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 of dead space (approximately 0.07 ml), but there is no delivery error. This volume is accounted for when the plunger position is at zero.

14 Reality!

15 Conclusion The risk remains up to 0.150ml over / under delivery with the use of a draw up device. Vygon will continue to provide the Nutrisafe2 system to meet the intent of the ISO and provide the best possible care and safety for neonatal patients. 15

16 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.

17 The solution NEONATOLOG K Enteral device Companies have invested heavily into ENFit and will change their whole range to ENFit as of March 20 Vygon will continue to provide the Nutrisafe 2 system to meet the intent of the ISO/ and provide Neonates with the best possible care and safety.

18 The Solution: Nutrisafe 2 NEONATOLOG Think SAFE, SMALL and ACCURATE! The compact design of Nutrisafe 2 connections minimises deadspace. Nutrisafe2 Reversed Luer ENFIt (ISO/DIS ) Maximum deadspace of the syringe connector* 0.056ml 0.099ml 0.191

19 The Solution: Nutrisafe 2 NEONATOLOG LUER Think SAFE, SMALL and ACCURATE! Nutrisafe 2 is incompatible with standard IV Luer devices. There is no risk of misconnection, increasing patient safety meeting the intent of ISO