New enteral nutrition connector of ISO 80369-3: a system presenting a real risk in premature infants and young children
The International Standards Organization (ISO) decided to create a new standard dedicated to the conception of medical devices connectors for enteral nutrition (feeding tubes, syringes, extension lines, etc). The publication is expected for 2016. This new connector, called ENFit™, is currently proposed to all patients, from premature infant to adults.
Concerns within the standard itself have been documented around the possible risks of delivering accurate doses of medicines in certain clinical practices across high risk sub-populations (e.g. neonatal patients).
The sampling and administration of a small dose of medication, in the range of tenth of milliliters, using a syringe equipped with the connector of the ISO 80369-3 is not precise enough, due to the important dead space generated by the large internal diameter of the connector.
Since 2012, the French Society of Neonatology warned the AFNOR (French association for standardization) and ISO committee around the real risk that the connector represented and asked that the project would not be accepted as it was.
Unfortunately, devices equipped with ENFIT™ connectors are already on the market, without taken into account the clinical risks for premature infants and young children.
What are the risks related to the ISO 80369-3 connector?
As indicated in the standard (annex A), “Laboratory testing also shows a mid tolerance E1 [ENFit] connector pair in a female to male orientation displaces a mean average of 0.150ml…”
As very low volumes of enteral drugs (0.05ml – 0.1ml) are administrated to patients in NICU, a high level of accuracy is required. This 0.150ml over-delivery could multiply by 4 the expected volume administrated and therefore be detrimental for neonatal patients’ health, especially for critical drugs.
The French Society of Neonatology recommends therefore an enteral nutrition system:
- Incompatible with Luer and other small-bore connectors used in different healthcare applications
- Allowing to connect components without leakage or cracking
- Having an internal dead space inferior to 0.1ml
- Generating a volume displacement inferior to 0.05ml
- With lowest possible weight and small connectors
Nutrisafe 2 is compliant with ISO 80369-1 > see the article