BELLEFONTE, PA, February 17, 2023 – The FDA has issued a 510(k) Clearance for the Shippert Tech Intraosseous Safety Sheath. As a Critical Care physician, Dr. Brian Shippert has seen colleagues accidentally stick themselves while removing interosseous (IO) needles from patients. While using a winged cork screw, he realized a design solution to this serious needle stick problem. Shippert patented the Intraosseous Safety Sheath (IOSS). In 2019, he contracted with Actuated Medical to develop the IOSS medical device. The Actuated Medical Team refined the device, performed FDA required testing, wrote and submitted the FDA 510(k) premarket application. The IOSS received clearance (K220890) in October 2022.
Intraosseous needles are inserted into bone to infuse fluids quickly when vascular access is difficult. These needles carry high risk of accidental needle sticks as they are often troublesome to remove from the bone matrix. The IOSS device encloses around the IO needle prior to removal then acts as a protective cover as the IO needle is pulled out of the bone. The IOSS is indicated for use with 25mm or 45mm EZ-IO vascular access needles. Shippert Tech is contracting with Actuated Medical on the next phase of making the IOSS available to hospital systems.
“We teamed with Dr. Shippert to realize his dream of making the IO needle easier to remove and safer than currently available methods for clinicians. We are excited to see this medical device available to clinicians,” said Maureen L. Mulvihill, President and CEO of Actuated Medical.
“I took my patent to Actuated Medical and they have been very thorough. They completed the development, wrote and submitted the FDA 510(k). Because of the Actuated Medical team and their expertise, my patent is an FDA cleared medical device,” Brian Shippert, DO, Critical Care Physician, Shippert Tech, LLC.