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NeoMed’s Low Dose ENFit Syringe Design Gains GEDSA’s Acceptance in November Position Statement

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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