nutrisafe2 was the first safety enteral feeding system totally incompatible with Luer and specially designed for premature babies, infants. With more than 10 years of experience in the neonatal safety enteral feeding field, Vygon capitalizes customer feedbacks and optimizes its Nutrisafe2 range for neonatal use. compliant with ISO 80369
Nutrisafe2 maximized the dose accuracy and minimizes the risk of volume displacement thanks to its compact design, which is essential for the delivery of small low dose volumes of drugs, such as morphine, digoxin, caffeine, methadone… Compared to ENFit connector or Low Dose Tip (LDT) syringe , Nutrisafe2 divides by 4 the over-delivery risk.
Specially designed for preterm infants, neonatal patients, the small compact design of nutrisafe2 minimises the size, weight and deadspace of the connection. Thanks to its small size, the Nutrisafe2 enteral feeding connector reduces by 70% the deadspace compared to ENFit ISO 80369-3 connector.
nutrisafe2 is a unique safe enteral feeding system incompatible with Luer and the other small-bore connectors described within ISO 80369. Compliant with the ISO 80369-1, nutrisafe2 mitigates the risk of tubing misconnection with unrelated systems (IV, respiratory, neuraxial…), the patient safety is therefore increased.
As a survey conducted in NICUs from 11 countries shows, very low volumes of enteral drugs (0.05ml – 0.1ml) are daily administrated to neonatal patients. Mis-dosing of many enteral medicines can be detrimental for patient health, so a high level of accuracy in drug administration is requested. The design of ENFitTM connector, with a possible 0.148ml over-dosing, is judged by the 126 interviewed neonatal specialists to provide inadequate dose accuracy for ENFitTM universal use in neonatology.
Concerns have been raised about the possible risks of delivering inaccurate doses of medicines with ENFit in certain clinical practices across high risk subpopulations (e.g. neonatal patients). As laboratory testing shows a mid-tolerance ENFit connector pair in a female to male orientation displaces a mean average of 0,148 ml of fluid, neonatal specialists rose important concerns about the possibility of ENFitTM syringes to be accurate for low dose administrations.
The Part 3 of the ISO 80369 series is dedicated to the enteral application. It specifies the shape and dimensions for the enteral connector, named by industry ENFitTM, and the functional performances of this enteral connector.
The Part 1 of the ISO 80369 series provides: General requirements for small-bore connectors for liquids and gases in healthcare applications, and a framework for testing connectors of different medical applications against each other to ensure non-interconnectability.
Creation of a European working group (CEN CHeF FTG, CR 13825:2000), the purpose is to discuss the medical tubing misconnection risks and see if Standards can help to address this issue. Creation of an official Working Group in the European Standard Committee (CEN BTTF 123 “Small Bore Connectors”). creation of the ISO/IEC JWG 4 “Small Bore Connectors”. Publication of the first standard connector design dedicated to enteral application (ISO 80369-3)
The International Organization for Standard (ISO) published the ISO 80369-3 in order to create a standardized safety enteral feeding connector called ENFit.