Our unique ENFit designs are exclusive to NeoMed and protected by a portfolio of intellectual property such as patents, provisional patents, trademarks and copyrights as well as regulatory market authorizations all over the world.
Now that the July 1, 2016 deadline has passed for California legislation that prohibits the use of intravenous, epidural, or enteral feeding connections that would fit into a connection port other than the type for which it was intended, hospitals and suppliers nationwide are preparing for the imminent transition to ENFit. NeoMed has released our ENFit solution for the Pharmacy and NICU into commercial distribution to meet the demands of the clinical community.
What is ENFit?
ISO 80369 is an international series of standards created to establish requirements for small-bore connectors for liquids and gases, making it difficult, if not impossible, for unrelated delivery systems to be connected. ISO 80369-3, or ENFit, specifies the dimensions and requirements for the design and functional performance of enteral medical devices and accessories.
Why do we need a new ISO connection standard?
GEDSA was formed to help introduce international standards in small bore medical device tubing connectors. Recently, the International Standards Organization approved ISO 80369-3 defining a safe design for enteral feeding connectors. ISO 80369-3 specifies the dimensions and requirements for the design and functional performance of enteral medical devices and accessories. These global standards are being implemented to minimize the risk of accidental misconnections of enteral systems to other small bore connectors, such as IV lines, resulting in patient harm.
When can we get new devices using the ENFit connector?
Now that NeoMed’s ENFit Low Dose Tip has received FDA 510(k) clearance, NeoMed has launched our NeoConnect® ENFit solutions for the Pharmacy and NICU into commercial distribution and is leading the enteral device industry to meet the demands of the clinical community. Two hospital networks in the United States have successfully transitioned to ENFit. Each facility is “live” using NeoMed’s comprehensive ENFit solution (NeoConnect®) including the Low Dose Tip Syringe dosing oral medications and Enteral Feedings in the NICU/PICU. Each Hospital is using NeoMed’s Pharmacy and NICU/PICU solution exclusively! Only NeoMed has both the product availability and experience to support a successful transition to ENFit.
How do we transition?
Over 7,000 US hospitals as well as 700 in Canada and 7,000 in Europe expect a reliable and committed supply of ENFit products during their transitions. NeoMed has designed a Loyalty Program (see details attached) for our current Pharmacy and NICU/PICU customers that provides assurances that the ENFit solution will be available with a predetermined GO LIVE date. Our unique understanding of the specialized needs of the neonatal/pediatric patient and pharmacies allows us to develop a comprehensive approach that meets clinical and supply chain needs in a cost-effective way. NeoMed solutions are designed to minimize process disruptions by recognizing the need to preserve efficacy, safety, and continuity of protocols.
"ISMP expresses our gratitude to NeoMed for providing us with samples of the new ENFit devices for simulation in preparing this article. We would also like to express our appreciation to Jamie Sklar, RN, MS, CCRN, and Sean O’Neill, PharmD, both from The Children’s Hospital of Philadelphia, for their assistance during preparation of this article."
ISMP Medication Safety Alert April 2016
|August 2016 GEDSA Position Statement Supporting ENFit Low Dose Tip Syringe||July 2016 GEDSA Guidance Document Supporting ISO 80369-3 ENFit||August 2016 ISMP Medication Safety Alert||April 2016 ISMP Medication Safety Alert|