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ENFit™ Products

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.

Syringes
Feeding Tubes
Amber Pharmacy
Pharmacy Caps
Extension Sets
Pump Solution
DoseMate
Syringe-to-Syringe Coupler
Cleaning Tool
Transfer Lids

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 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 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

NeoConnect LDT and Oral Enteral Syringes 510k Clearance

August 2016 GEDSA Position Statement Supporting ENFit Low Dose Tip SyringeJuly 2016 GEDSA Guidance Document Supporting ISO 80369-3 ENFitAugust 2016 ISMP Medication Safety AlertApril 2016 ISMP Medication Safety Alert