Comprised of manufacturers, distributors, and suppliers of enteral nutrition devices worldwide, the Global Enteral Device Supplier Association (GEDSA) facilitates information flow about the new ISO 80369-3 (ENFit) standard. GEDSA has recently published a position statement addressing concerns on low dose medications and the new ENFit connectors. NeoMed’s “low dose” ENFit syringe design solution has gained the acceptance of GEDSA and is expected to become the “global solution” that resolves those concerns regarding low volume medication dosing accuracy. NeoMed’s experience designing innovative delivery devices for Pharmacy, NICU and PICU led to syringe tip design modifications that address volume delivery variances raised with the original ENFit dimensional specifications.
Industry support for this “low dose” design is evidenced by the statement below:
“The clinical community has voiced its concerns regarding the potential impact the current design may have with respect to low dose administration of medication. In response to these issues, GEDSA has identified a solution that it believes will eliminate the risk of improper dosing. The specifications of, and access to the intellectual property rights to, this design have been provided to GEDSA’s members.”
Medtronic 11/5/2015
NeoMed’s product line with ENFit™ connectors (branded “NeoConnect™”) release is scheduled in accordance with GEDSA’s timelines for the first half of 2016. All NeoConnect products feature ENFit compliant or compatible connectors. NeoConnect product families will be available in the marketplace on schedule. This includes Pharmacy Syringes, Pharmacy Bottle Caps, the DoseMate™ Oral Administration Tip, and Syringe Coupler, Feeding Tubes, Extension Sets, Sterile Enteral Syringes, NeoSecure Self-Righting Tip Caps, and Hub Cleaning Tool. NeoMed’s “low dose solution” will be available in syringe sizes from 0.5 mL, 1 mL, 3 mL, and 6 mL.
NeoMed’s “low dose solution” features are shown below.
- Internal tip lumen mirrors traditional male syringe designs reducing dead space
- Minimal dead space increases delivery accuracy
- Significantly reduces dead space of typical ENFit™ syringes
- 0.5 mL, 1 mL, 3 mL, and 6 mL
**Commercially available in the United States, if product is cleared for marketing authorization by FDA.**
GEDSA’s “Position Statement in Support of ISO 80396-3” (May, 2015) outlines a protocol that supports using ENFit connections in all stages of filling, plunger operation, and dispensing when using ENFit syringes. NeoMed offers the only comprehensive product line from Pharmacy ENFit filling devices to bedside ENFit dispensing devices that meets these recommendations.
When preparing for an early 2016 ENFit adoption, NeoMed encourages planning and collaboration with your local NeoMed representative to help ensure a timely and seamless transition.
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