Cadaver testing to validate design criteria of an adult intraosseous infusion system

The FAST 1 intraosseous (IO) infusion system was designed to deliver fluids and medications into the adult sternum in the prehospital and battlefield environments. To test the prototype in 106 cadavers and excised sterna and compare it with other IO devices. The insertion force was similar to that of other IO devices (mean, 8.5 kg; range, 2.3-19.6 kg). In 39 of 39 trials, the depth-control mechanism inserted the portal within 1.0 mm of a predetermined distance below the anterior surface of the cortical bone. If misplaced, underpenetration was more likely than overpenetration (mean displacement, -0.3 mm; SD, 0.5 mm). After release, the portal could not be advanced further into the manubrium. Marrow was accessed in 75 of 77 trials. Mean flow rates were 109 mL/min for normal saline solution and 102 mL/min for hypertonic saline/dextran, similar to the Cook Sur-Fast device. The cadaver and bench tests demonstrated the reliability and safety of the FAST 1 system at the design/prototype stage.