Conformis (NSDQ:CFMS) has secured an FDA 510(k) clearance for its new vaporized hydrogen peroxide (VHP) sterilizers, the company said in an SEC filing filed this week.
In December 2019, Conformis announced that it received a warning from the FDA regarding issues related to the VHP sterilizers that it uses as an alternative sterilization method for a small amount of products. The warning did not question product sterility, but prompted the Billerica, Mass.–based company to respond with its plan to replace the VHP sterilizers with the new Steris VHP LTS-V unit.
Last week, the company received notification from the FDA that its Steris VHP LTS-V onsite sterilizer is now cleared. Conformis said in the March 16 SEC filing that it plans to bring the new unit into service on or about March 31, as it processes different product groups over time while existing VHP sterilizers are decommissioned as appropriate.
VHP is used in low-temperature sterilization for a variety of medical instruments and materials, including polypropylene, brass and polyethylene. Unlike ethylene oxide, a carcinogen also used in low-temperature medtech sterilization, VHP emits no toxic by-products.