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Quality & Innovation in Healthcare
 

Update on the new ENFitâ„¢ Enteral connection (ISO80369-3) and its adoption by Vygon (UK) Ltd 

Posted by   on 13-October-2016 
Update on the new ENFitâ„¢ Enteral connection (ISO80369-3) and its adoption by Vygon (UK) Ltd

Dear Customer

Changes affecting nasogastric products

As the inventor of Nutrisafe2®, the first safe enteral feeding systems with a lockable non-luer system to reduce the risk of misconnection errors, we are pioneers in developing safe enteral therapy for patients and clinicians.

In July 2016, the International Standards Organisation published the ISO 80369-3 to create a standardised enteral feeding connection that prioritises patient safety. Known as ENFit™, the design of the new connection prevents the likelihood of tubing misconnections (e.g. injecting milk into the intravenous line).

We have been committed to, and involved in, the delivery of ISO 80369-3 for several years and to maximise patient safety we recommend two separate approaches. One focuses on the specific needs of neonates and another for adults and children.

Nutrisafe2® for premature babies

Whilst ENFit™ meets the needs for adults and children, there is a risk that ENFit™ syringes may produce dosing errors because they cannot deliver the accuracy required by premature babies.

Therefore, for these patients, we recommend the continued use of Nutrisafe2® as the system provides the dosing accuracy needed. Nutrisafe2® is ISO 80369-1 compliant and benefits from the clinical success we have achieved over 10 years in more than 30 countries.

Our recommendation is based on the following key facts:

1. As indicated in the ISO 80369-3 – Annex A – Subpopulation:

“Concerns have been raised about the possible risks of delivering inaccurate doses of medicines in certain clinical practices across high risk subpopulations (e.g. neonatal patients) if using a reversed connection system (female to male). […] Laboratory testing also shows a mid-tolerance E1 connector pair in a female to male orientation displaces a mean average of 0,148 ml […] of fluid.”

2. Currently, it is proposed that a new syringe design, called Low Dose Tip (LDT) syringe, can address the concerns of over dosing. But laboratory testing (1,2) shows the results are inconclusive:

  • by following the current practices, the accuracy of the LDT syringe is equivalent to ENFit™ (1), so unacceptable for neonatology.
  • by following a new strict syringe protocol, the accuracy seems to be acceptable (2).


 

But this protocol may lead to involuntary dosing errors due to human factors and chemical/microbial contamination risks of the dispenser and syringe preparation area.

Nutrifit™ for adults and children

To meet the nasogastric feeding needs of adult and paediatric patients, Vygon is developing a new product range called Nutrifit™ that will be ENFit™ compatible. We are planning to launch Nutrifit™ next year and we will keep you informed of developments over the coming months.

In summary, our aim is to offer a safe and secure nasogastric enteral feeding system for every patient. Therefore, based on the current evidence available, our recommendation is:

  • Nutrisafe2® for premature babies.
  • Nutrifit™ for adults and children.


 

Changes affecting Gastrostomy and Gastrojejunostomy feeding tubes.

We are already supplying ENFit™ compatible MIC-KEY products including MIC-KEY low profile feeding tubes, MIC-KEY jejunostomy tubes and MIC-KEY extension sets. Further MIC products (those characterised currently by funnel connectors) will be available from February 2017. The full list and relevant dates are available via our updated product code matrix - please go to www.bit.ly/VygonENFit. Further updates about the changes will be sent in the coming months as the transition of Vygon products to ENFit compatible versions is finalised.

For further information on nasogastric and gastrostomy feeding systems, or if you have any questions, please contact our Vygon Customer Services on 01793 748800, or email customerservice@vygon.co.uk.

Yours faithfully

 

Max Richards

Business Development Manager

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