NeoMed, Inc: Your ENFit™ Connection for Neonatal, Pediatric & Pharmacy Applications
ENFit™ transition is on the way. Has your NICU or Pharmacy identified a supplier that can deliver a solution that preserves your current feeding tube use protocols?
As implementation of the new NeoMed NeoConnect™ Enteral Delivery Feeding System with the ENFit Connector approaches, NeoMed is committed to providing strategic guidance to navigate through these changes. NeoMed’s solutions-based expertise in delivering pharmacy and NICU/PICU enteral devices will fill a critical gap as hospitals develop their compliance plans. We are the only enteral device manufacturer offering a full product line that allows pharmacy and clinical operations to standardize processes while using ENFit. Our unique understanding of the specialized needs of the neonatal/pediatric patient and pharmacy allows us to provide a comprehensive approach that meets both clinical and supply chain needs, while offering a cost competitive solution.
NeoMed's Low Dose Tip Design for ENFit™ Gains Acceptance from GEDSA
**Commercially available in the United States, if product is cleared for marketing by authorization of the FDA.**
NeoMed is proud to announce that our “low dose” ENFit™ syringe tip design has gained the acceptance of the industry group (GEDSA) for resolving low volume medication dosing accuracy concerns. GEDSA is currently working with FDA to ensure proper US regulatory pathways and NeoMed is expected to submit the first 510(k) for the low dose ENFit™ Syringe. NeoMed’s experience designing innovative delivery devices for Pharmacy, NICU and PICU led to this syringe tip design, which appears to address volume delivery variances raised with the original ENFit™ dimensional specifications, if the product is cleared for marketing authorization by FDA. NeoMed has offered syringe manufacturers royalty free access to the intellectual property rights for this design as it is expected to become the global standard.
Industry support for this ‘low dose” design is evidenced by the statement: “Recent concerns have been raised regarding accuracy of low doses of medication (< 2.0mL). A technical team of industry experts have worked collaboratively to identify a solution to address dose accuracy with a new ENFit low dose tip design. This design has been validated demonstrating the ability to deliver an accurate dose consistent with current practice with 95% confidence, fits appropriately into current practice and maintains compatibility with other ENFit devices”.
-GEDSA Position Statement Guidance on Adoption of ISO 80369-3 Standard ENFit™3 Connectors in California
NeoMed intends to submit one of the first Low Dose ENFit™ Syringe 510(k) submissions in March 2016.