What is the Stepped Needle® design and why is it important for infant IO access?
The Stepped Needle® tapers from 14 gauge at the outer shaft to 18 gauge at the insertion tip. This design serves two purposes: first, the 14G-to-18G transition provides tactile sensory feedback as the tip penetrates bone cortex and enters the medullary cavity, indicating correct placement. Second, the step acts as a physical depth limiter, preventing the needle from advancing beyond the intended depth into fragile infant bone marrow — critical for preventing far-cortex perforation in the small tibias of neonatal and infant patients.
What is the age and weight range for the NIO Infant?
The NIO Infant is indicated for patients from gestational age 36 weeks with a minimum weight of 5 lbs (2.3 kg) through 3 years of age. For patients aged 3–12 years, the NIO Pediatric is the appropriate device. For patients over 12 years and adults, use the NIO Adult (15G) or NIO+ Ruggerized adult device.
Is the NIO Infant manual or automatic?
The NIO Infant is a manual device — the provider applies controlled downward pressure to advance the Stepped Needle through the cortex. This differs from the NIO Pediatric and NIO Adult, which are semi-automatic and automatic spring-loaded devices respectively. The manual mechanism for the infant version reflects the reduced force required for infant bone penetration and provides finer tactile control appropriate for the smaller target anatomy.
What drugs and fluids can be administered via the NIO Infant IO route?
All medications, fluids, and blood products that can be administered intravenously can be administered via the IO route. This includes crystalloids (normal saline, lactated Ringer's), vasopressors (epinephrine, dopamine), analgesics (ketamine, fentanyl), anticonvulsants (lorazepam, midazolam), antibiotics, and blood products. IO pharmacokinetics are equivalent to IV administration. Maximum IO dwell time is 24 hours.
Does the NIO Infant come with the Go IO Start Kit?
The NIO Infant (NIO-I) is packaged in a blister pack with a fixation dressing for device securement post-insertion. The full IV extension set with 90° connector, stopcock, sharps safety block, and additional securing components are found in the Go IO Intraosseous Start Kit (sold separately). Safeguard Medical recommends pairing the Go IO kit with every NIO insertion to provide complete post-insertion IO access establishment capability.
When was the NIO Infant introduced?
The NIO Infant was introduced to the U.S. market in late 2019, filling a gap in automatic IO access for neonatal and infant patients not addressed by existing spring-loaded or drill-powered IO devices. It is the only IO device specifically designed with a depth-limiting Stepped Needle® for patients from gestational age 36 weeks through 3 years.
Why is the NIO Infant a manual device rather than automatic like the NIO Adult?
The NIO Infant is manual because infant tibias require significantly less insertion force than adult or older pediatric bone. A spring-loaded automatic mechanism calibrated for adult force would risk fracture or over-penetration in the thin, fragile cortex of a neonatal tibia. The manual mechanism combined with the Stepped Needle® depth-limiting geometry provides the force control and tactile feedback appropriate for infant bone anatomy.
Is the NIO Infant FDA-cleared?
Yes. The NIO Infant is FDA-cleared as a Class II medical device for intraosseous vascular access in patients from gestational age 36 weeks (minimum 5 lb / 2.3 kg) through 3 years via the proximal tibial route.
