What is known and objective: The International Organization for Standardization (ISO) created enteral device specifications to reduce tubing misconnections. The Global Enteral Device Supplier Association (GEDSA) supports a female design: standard and low dose tip (LDT). Concerns include increased complexity of use with adapters, dosing accuracy and workflow. No peer-reviewed studies have evaluated dosing accuracy of the complete female system with adapters. The objective of this study was to compare dosing accuracy of the female design to legacy syringes.
Methods: An in vitro study was conducted at the University of Florida College of Pharmacy pharmaceutics laboratory. Assessments were completed for syringe size, dispense methods and volumes, and adapters when applicable. A gravimetric scale and specific gravity were used to calculate administration volumes. The primary outcome was frequency administration volume exceeded 10% expected amount.
Results and discussion: A total of 576 tests were performed. The LDT resulted in significantly higher rates of unacceptable dosing variance compared to legacy (21.2% vs 7.4%, P = 0.003). Variance exceeding 10% occurred more frequently with LDT 0.5 and 1 mL syringes, medication cup dispensing (liquid or tablet) and inappropriate LDT adapter use. Unapproved adapter processes compared to FDA-approved processes held a higher likelihood of unacceptable dosing variance (28% vs 7.4%, P < 0.001). FDA-approved use of adapters with prefilled syringes compared to bedside administration may result in higher rates of dosing inaccuracy (18.8% vs 5.6%, P = 0.06).
What is new and conclusions: This study raises clinical concerns of dosing inaccuracies with the LDT syringes, particularly with 0.5 and 1 mL sizes. The use of adapters significantly increases the opportunity for inaccurate dosing.
Keywords: adverse event; consumers; drug-related; infants; medicine use; paediatrics; pharmacists; premature neonates; skills training.
© 2019 John Wiley & Sons Ltd.