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What is known and objective As the global adoption of ENFit-compatible syringes becomes more widespread, it is important for syringe users to understand the risk of dosing inaccuracy for both the oral and enteral routes of use. Describing the risk of dosing inaccuracy specifically related to route of use is important to the end users' understanding of the clinical impact of device changes. The objective of this study was to compare the performance of female design ENFit low dose tip (LDT) syringes when used for enteral medication administration to the syringe performance during oral administration conditions. Methods This study was a secondary analysis of a prospective study conducted at the University of Florida Health Shands Hospital in conjunction with the University of Florida College of Pharmacy. Dosing variance (DV) up to 10% for low-risk medications and DV up to 5% is the target for high-risk medication administration is considered acceptable. The primary outcome was the frequency of administration volumes exceeding 10% of the expected amount when using the ENFit LDT syringe for both oral and enteral medication administration. Secondarily, the performance of standard ENFit syringes and the frequencies of DV exceeding 5 and 10% were also evaluated in the same conditions. Results and discussion A total of 264 tests were evaluated (ENFit LDT, n = 210; ENFit standard tip, n = 54). Using the LDT syringe for the enteral route resulted in statistically significant higher rates of unacceptable dosing variance >10% when compared to the oral application (26.9% vs 12.9%, P = .01). The frequency of LDT syringe DV >5% was significantly greater than >10% variance, regardless of oral or enteral use. Standard ENFit syringes had overall fewer tests with unacceptable dosing variance and showed no difference in performance between applications. What is new and conclusions This study raises additional clinical concerns specifically related to the enteral use of ENFit LDT syringes within commonly accepted dosing variance ranges. Enteral and oral application of LDT syringes yield unacceptably high rates of dosing variance for high risk medications with narrow therapeutic index.

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