NeoMed, a leading developer and manufacturer of enteral collection and delivery products for the specialized needs of low birth weight, neonatal and pediatric patients, has received FDA 510(k) clearance for our NeoConnect™ Low Dose Tip (LDT) Oral/Enteral ENFit* Syringes. NeoMed’s LDT ENFit Syringes, when used as intended, achieve accurate small volume doses while minimizing the risk of misconnections. The LDT technology will be available on NeoMed’s 0.5 mL, 1 mL, 3 mL and 6 mL ENFit syringes. The addition of the LDT technology completes NeoMed’s full portfolio of ENFit syringes in advance of the July 2016 California legislative mandate for all hospitals to provide a dedicated safety enteral system.
This FDA 510(k) clearance also included direct oral administration indications for use of all NeoConnect syringes with ENFit connectors. The ability to utilize a NeoConnect syringe (low dose or standard) for both oral and enteral delivery of fluids means that a facility will not have to maintain a separate inventory of legacy oral syringes once they transition to ENFit.
Aaron Ingram, President of NeoMed stated, “NeoMed has been a leader in the ENFit initiative representing the unique needs of the neonatal, pediatric and pharmacy customer. We pride ourselves as a company that strives to achieve the highest level of patient care and safety through product design, innovation, and quality. The LDT solution is a perfect example of this.”
Melinda Smith, VP of Quality and Regulatory Affairs stated, “A tremendous effort by a very talented cross-functional team spanning many enteral device manufacturers across the globe allowed us to reach this enormous milestone in such a short period of time and NeoMed thanks everyone involved.”
Ben Davis, VP of Engineering and Product Development added, “NeoMed’s Low Dose Tip design and the unique design features of our ENFit product family represent a paradigm shift in the direction of patient safety and clinical efficacy. This 510(k) marks the beginning of a new chapter in patient care and we are honored to lead the way.”
NeoMed developed the low dose tip design, which is now being adopted by industry, and has offered all syringe manufacturers royalty free access to the design. This 510(k) clearance is a critical milestone for the clinical community to support the launch of ENFit products. It also demonstrates NeoMed’s commitment to improve patient outcomes through product designs that meet safety, clinical, and regulatory guidelines. The NeoConnect family of ENFit products addresses recommendations from industry leaders such as GEDSA, ISMP, the Joint Commission, ASHP, and ASPEN.