On April 13, 2016, GEDSA made available a summary of the performance testing for the low dose syringe tip design. The GEDSA Update explains that “the low dose tip ENFit syringe design was found to perform substantially equivalent to standard orientation (male) syringes that are commonly used today, and the design was found to outperform reverse system (female) syringes that are in use today.” Usability testing results demonstrated “Overall, users found the low design feature acceptable for filling and administering enteral doses.”
Officially, GEDSA reports that “The low dose syringe is compliant with the ISO 80369-3 standard and will be introduced in the market after required regulatory approvals/clearances. The low dose syringe design is available for all manufacturers to use through a fee free license agreement offered by its designer.”
Release of NeoMed’s product line with ENFit™ connectors (branded “NeoConnect™”) is scheduled in advance of the California legislation’s effective date of July 1, 2016 upon FDA 510(k) clearance of NeoMed’s low dose syringes. NeoConnect product families will be available in the marketplace on schedule and include ENFit-compliant or ENFit-compatible connectors. NeoConnect includes a complete line of pharmacy syringes, pharmacy bottle caps, the DoseMate™ oral administration tip, syringe coupler, feeding tubes, extension sets, sterile enteral syringes, NeoSecure self-righting tip caps, and a feeding tube hub cleaning tool. In addition, NeoMed’s “low dose solution” will be available in syringe sizes 0.5 mL, 1 mL, 3 mL, and 6 mL.
You can find GEDSA's update here.
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