Updated regulatory guidelines for enhanced safety features associated with enteral syringe are expected to propel growth of the market
Regulatory guidelines for design and manufacturing of enteral devices including enteral syringe were recently updated by various regulatory bodies. In 2015, new design standards were introduced in enteral feeding sets, enteral syringes, and enteral feeding tubes referred as ENFit. ENFit is a new connection standard that is developed by an international group of clinicians, manufacturers body Global Enteral Device Supplier Association (GEDSA), and regulators under aegis of Stay Connected initiative to prevent tubing misconnections and patient injury. Tubing misconnection occurs when enteral devices are connected to non-enteral devices such as IV lines, urinary catheters, and ventilator tubing. Global Enteral Device Supplier Association (GEDSA) promotes safe use of enteral devices including syringes. Market players that comply with ENFit standard design are receiving 510(k) clearance from the U.S Food and Drug Administration (U.S. FDA). For instance, in 2016, NeoMed and Medtronic received the U.S FDA 510(k) clearance for low dose tip ENFit syringes. NeoMed has offered royalty-free access of its design to all syringe manufacturers. Therefore, several manufacturers can implement this design standard to promote safe use of these devices, which in turn is expected to increase adoption of enteral syringes.
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