Comparison of Dosing Accuracy Between the ENFit LDT and a Neonatal-Specific ISO-Compliant Enteral Syringe

Author:

O'Mara Keliana1,Campbell Christopher2,O'Mara Ryan3

Affiliation:

1. Department of Pharmacy (KLO), WakeMed Health and Hospitals, Raleigh, NC

2. Department of Pharmacy (CTC), Augusta University Medical Center, Augusta, GA

3. Nuclear Engineering Department (RPO), North Carolina State University, Raleigh, NC

Abstract

OBJECTIVE To evaluate the dosing accuracy of 2 female enteral syringe types for use in neonates. METHODS This was an in vitro study evaluating dosing accuracy of ENFit with low dose tip (LDT) and Nutrisafe2 (NS2) syringes. Acceptable dosing variance (DV) was +/− 10%. Outcomes included tests exceeding 10% DV and DV by syringe size, dispensing source, and intended dosing volume. RESULTS A total of 300 tests were performed (LDT = 150, NS2 = 150) with 3 syringe sizes (0.5, 1, 3 or 2.5 mL). Compared with NS2, LDT had significantly more tests with unacceptable DV (48% vs 4.7%, p < 0.0001) and higher absolute DV (11.9% vs 3.5%, p < 0.001). Dosing variance was inversely proportional to syringe size, where the smallest syringes were least accurate (0.5 mL LDT 16.1% vs 4.6%, p < 0.001). The largest syringes had acceptable DV (3 mL LDT 8.8% vs 2.5 mL NS2 3.3%, p < 0.001). Bulk bottle with adapters demonstrated a higher DV with LDT compared with NS2 (13.3% vs 3.9%, p < 0.001). Medication cups without adapters were associated with acceptable DV for both LDT and NS2 (9.7% vs 2.9%, p < 0.001). CONCLUSIONS The Nutrisafe2 syringe has greater dosing accuracy as compared with ENFit LDT syringe. Smaller syringes are associated with greater dosing inaccuracy, but this effect was within acceptable DV for the NS2 syringe. Bulk bottle adapters did not improve the accuracy of the LDT. More clinical evaluations are needed to determine if the ENFit can be safely used in the neonatal population.

Publisher

Pediatric Pharmacy Advocacy Group

Subject

Pharmacology (medical),Pediatrics, Perinatology and Child Health

Reference23 articles.

1. ISO 80369-1: Small-bore connectors for liquids and gases in health-care applications. International Organization for Standardization. https://www.iso.org/obp/ui/#iso:std:45976:en. Published December 2010. Accessed January 31, 2022.

2. ISO 80369-3: Small-bore connectors for liquids and gases in health-care applications – Part 3: Connectors for enteral applications. International Organization for Standardization. https://www.iso.org/obp/ui/#iso:std:50731:en. Published July 2017. Accessed January 31, 2022.

3. Institute for Safe Medication Practices. ENFit enteral devices are on their way…Important safety considerations for hospitals. ISMP Medication Safety Alert. https://www.ismp.org/resources/enfit-enteral-devices-are-their-way-important-safety-considerations-hospitals. Published April 9, 2015. Accessed January 31, 2022.

4. ISO 20695: Enteral feeding systems—Design and testing. International Organization for Standardization. https://www.iso.org/standard/68853.html. Published March 2020. Accessed January 31, 2022.

5. Vygon and ANDHEO summary report. Study on the over-dosing risk of the <<ENFit Low Dose Tip>> syringe during its use. https://www.safe-enteral.com/wp-content/uploads/2018/11/summary-report_ldt-syringe-overdosing-risk_vf.pdf. Published March 2018. Accessed January 31, 2022.

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