Responding to concerns that feeding solutions and epidural local anesthetic solutions were potentially fatal when inadvertently administered intravenously, California passed a law establishing deadlines for the adoption of different connectors for these different applications. Starting July 1, 2016, California Health and Safety Code 1279.7(d) prohibits health facilities, including general acute care hospitals, acute psychiatric hospitals, skilled nursing facilities and special hospitals, from using enteral feeding connectors that would fit into a connector other than the type it was intended for, unless an emergency or urgent situation exists and the prohibition would impair the ability to provide health care.
In parallel with the California requirements, there is an ongoing effort led by the International Organization for Standardization (ISO) to specify designs of small-bore connectors for various clinical applications that reduce the likelihood of clinically significant tubing misconnections. As there are many devices not regulated by these standards using connectors in this size range, it is impossible to prevent all misconnections. For example, endotracheal tubes come in many sizes, with inner diameters ranging from at least 2 mm to 11 mm in 0.5 mm increments. Designing a small connector that cannot be pushed inside the lumen of an endotracheal tube is impossible, and prohibiting those endotracheal tube sizes that could cross-connect with small-bore connectors would cause more harm than good.
The ISO work group carried out an extensive risk analysis of possible misconnections that might result when the same connector is used in different applications. Significantly reducing the identified unacceptable risk is the basis of this series of standards. The second Draft International Standard for enteral connectors (80369-3, also known as ENFit) was approved by 96% of voting countries. Consequent to that vote, a US provisional standard (AAMI/CN3) was developed and recognized by the FDA. Until the final ISO standard is published, the provisional standard helps manufacturers and providers meet the intent of the California law.
Concerns have been raised regarding dose accuracy for small ISO 80369-3 ENFit-tip syringes (≤ 2 ml). A device design solution that is ENFit compliant is has just passed final validation. One large syringe supplier (B-D) has indicated they will not support this low-dose design and will delay marketing their syringes until they have a design they support. However, other syringe manufacturers believe they will meet the California deadline with this new design.
CHPSO recommends that California providers work with their supplier representatives and distributor networks to understand their specific supply projections. In particular, to avoid patient care disruptions, you should confirm that your syringe supplier has adequate supply of syringes before you convert to ENFit feeding tubes. All providers should endeavor to stock some of the new syringes and administration sets as soon as practicable in the event a patient should be transferred in who has a feeding tube with the new ENFit connector. Also, the patient transfer checklist should include verification of the type of connector used by a patient with an enteral feeding tube so that appropriate preparations can be made for those with the new connector during this transition period.