For much of the past decade, the Global Enteral Device Supplier Association (GEDSA) has been developing new design standards for small bore connectors to reduce the likelihood of misconnections. As of July 2016, the FDA’s 510(k) clearance of NeoMed’s ENFit Low Dose Tip design has effectively removed all regulatory obstacles remaining for distribution and implementation of ENFit (ISO 80369-3 compliant devices) into the acute and alternate care marketplace.
NeoMed, Inc. is pleased to announce that over 40 hospitals in the United States and Europe have successfully transitioned to NeoMed’s NeoConnect™ family of ENFit products, caring for a wide patient population from adults to neonates in a variety of clinical settings from Children’s to Community Hospitals. NeoMed’s NeoConnect products are designed to comply with the rigid requirements of the new safety standard while minimizing change to current processes, protocols, and policies.
Now that a significant number of hospitals have successfully transitioned to ENFit, NeoMed and other industry experts believe that the transition of over 7,000 U.S. hospitals will gain momentum in 2017. For this reason, NeoMed has developed several programs designed to help navigate through this global conversion including the “NeoMed Transition Program.” This program helps to identify hospital staff training needs, establish and review process protocols, and ensure supply chain integrity before conversion.
NeoMed develops innovative enteral collection and delivery products supporting the specialized feeding and medication dosing needs of the low birth weight, neonatal and pediatric patient. We are committed to improve patient outcomes through product designs that meet safety, clinical, and regulatory guidelines while supporting cost containment objectives.
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