Nasogastric tubes (NGT, Class II medical device) are used for administration of food/medication and gastric decompression. Nationally, approximately 120,000 preterm infants (born prior to 34 weeks of gestation) in the US require the use of an NGT due to partial development of essential reflexes and lack of coordination/strength to support feeding. Verification methods in practice address the clinical problem of the significant risk of misplacement or displacement (may increase risk of injury/harm to patient) of NGT in insertion and use. Current gold standard practice to verify the placement of NGT in the selected population of neonates requires the use of radiography; subsequently increasing (1) time endured per intervention, (2) cost of care, and (3) risk to patient safety. Implications to replace the existing standard may cater to support accessibility of care while protecting the integrity of patient safety in delivery of intervention.
VeriFeed is characterized as an improved neonatal NGT consistent with two major design modifications to address the clinical problem: (1) an invertible cone for securement of the tube at the esophagogastric junction (EGJ) and (2) an accessory wire coated with 100% hypromellose (HPMC) for gastric acid indication. The average force required to retract the secured device from the EGJ is 2.51 N (assessed with force gauge) noted as 10 times less force than that required to crack an egg. Impartial dissolution of coating in gastric acid (pH 2.5, 37°C) was visually observed in 8 seconds, disbarring the time to administer an X-ray by a significant factor. The design modifications operate to eliminate radiation, minimize cost and time of procedure, reduce probability of associated risks from inefficient verification (increased probability of patient harm/injury), and create a solution that is accessible in home, emergency, and hospital settings.