Trinity Guardion, Inc., has received FDA 510(k) clearance for its reusable Bed Barrier that it says re-engineers the way healthcare facilities protect patient mattresses from soiling.

“Advances in the cleaning of high-touch surfaces like mattresses have become a fundamental necessity,” said Infectious Disease physician Ardis Hoven, M.D., a Trinity Guardian board member, and former president of the American Medical Association. “The Soteria Bed Barrier helps protect the mattress and bed deck from patient soiling, and will become an essential contributor in a culture of safety.”

The Soteria Bed Barrier includes a proprietary laundry process that allows for re-use after laundering and was recently cleared for the assignment of a unique FDA product code (QTV).The reusable bed barrier is designed for acute- and long-term care beds and stretchers.The bed barrier is classified as a Level 3 barrier per AAMI Standard PB70 and the proprietary surface formulation allows for laundering that meets AMMI TIR 12 acceptance criteria for high-level disinfection plus spore removal (99.9999%) using a rigorous commercial healthcare laundry method.

Soteria meets CDC Guidelines for Environmental Infection Control in HealthcareFacilities, specifically Section G. The bed barrier is validated for 150 laundry cycles and is both RFID-chipped and bar-coded to enable tracking of laundry cycles and inventory management.

About Trinity Guardion – The company is headquartered in Batesville, Indiana. For more information, visit