Accuracy for oral medications is critically important especially for neonate, pediatric, and geriatric patients. In addition, dose accuracy is imperative for any medication with a narrow margin of safety. Visante has long held the position that the new ENFit syringes may compromise dose accuracy due to the female syringe tip and the “low-dose tip” feature. On October 12, 2021, the FDA issued a Safety Communication regarding the potential for overdose with the ENFit Low Dose Tip (LDT) Syringe. The FDA recommends taking the following steps to mitigate the risk of overdose:

• Ensure the syringe is free of air bubbles and the moat of the syringe is free from fluids by tapping or flicking the tip of the syringe before medication administration.
• Use a filling adapter, such as an ENFit compatible cap or medication straw, to prevent fluid and medications from entering the moat area of the syringe tip.
• Be aware that using a medicine cup to fill may cause fluid or medications to enter the moat of the syringe and lead to possible overdose.
• Use a new syringe to flush the medication or fluid after administering any medication to prevent overdose due to the dead space (remaining fluid in the tip of the syringe after administration) in the syringe.

We applaud the FDA for formally acknowledging the safety concerns with the ENFit Low Dose Tip Syringe. Medication safety experts will quickly recognize that the aforementioned steps are meant to address the unintended consequences arising from the design of the new enteral connection and the ENFit Low Dose Tip Syringe. Overdose prevention will depend on education, training, accessories and compliance by healthcare staff as well as lay people who care for persons receiving enteral medications. Additional complexity is created when an ENFit accessory is added to a prefilled enteral or oral syringe. Studies have found that the use of adapters may result in higher rates of inaccurate doses.1 ENFit Low Dose Tip Syringe dose variance is greater when used for enteral administration than when used with oral administration.2

The ENFit Low Dose Tip Syringe dose accuracy concerns are likely to persist until the ENFit enteral connection is re-engineered to eliminate the risk. Until that time we strongly urge healthcare organizations to monitor for unexpected and / or adverse patient outcomes that may be related to overdosing with ENFit Low Dose Tip Syringes.

1. O’Mara K, Gattoline SJ, Campbell CT. Female low dose tip syringes‐increased complexity of use may compromise dosing accuracy in paediatric patients. J Clin
Pharm Ther. 2019;00:1–8. https://doi.org/10.1111/jcpt.12810
2. O’Mara K, Campbell C. Dosing inaccuracy with enteral use of ENFit ® low-dose tip syringes: The risk beyond oral adapters. J Clin Pharm Ther. 2019;00:1–5.
https://doi.org/10.1111/jcpt.13079

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