FDA Grants Clearance for Groundbreaking Bed Barrier

BATESVILLE, Ind., October 5, 2022 (Newswire.com) - Trinity Guardion, Inc. has received FDA 510(k) clearance for its innovative Soteria® Bed Barrier that re-engineers the way healthcare facilities protect patient mattresses from soiling.  

The Soteria Bed Barrier is the first-of-its-kind launderable and reusable healthcare bed barrier that provides a protective physical barrier to protect the bed and mattress from patient soiling, helping to reduce contamination during use. Designed for acute and long-term care beds and stretchers, it fits securely over the mattress and bed deck and attaches to the bed frame without disrupting bed and mattress performance during patient care. 

More than a mattress cover, the Soteria Bed Barrier defines a new category for surface protection between mattress and patient. Its innovative and patented features, including a proprietary laundry process that allows for reuse after laundering, was cleared with the assignment of a unique FDA product code (QTV). 

The Soteria Bed Barrier is classified as a Level 3 barrier per AAMI Standard PB70; this is similar to other protective equipment such as protective apparel and drapes intended for use in healthcare facilities. The Soteria 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 Health-Care Facilities, specifically Section G. The Soteria Bed Barrier is validated for 150 laundry cycles and is both RFID-chipped and barcoded to enable tracking of laundry cycles and inventory management.

"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 Guardion 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."

"Because mattresses are soft, porous surfaces to reduce skin injuries, they are very difficult and time-consuming to clean and disinfect," added Edmond Hooker, M.D., epidemiology DrPH and Trinity Guardion advisor. "The Soteria Bed Barrier and its laundry process are important innovations offering bed protection that is both clinically and economically beneficial." 

Bruce Rippe, Trinity Guardion CEO, commented on the FDA clearance and Soteria commercialization. "We are so pleased the FDA has recognized that the Soteria innovation defines a new product category, setting a new performance standard. We are honored to become a solution that helps facilities by reducing mattress exposure to patient soiling."

The YouTube video link demonstrates the Soteria protection barrier.

Addressing Mattress Safety

Over the last decade, there has been increasing discussion and evaluation of mattress soiling during patient use. The following links provide some of the official perspective. Soteria is designed to help address these concerns.

• The CDC addressed hospital surface-area safety, including bedrails in 2020: https://www.cdc.gov/hai/prevent/environment/surfaces.html.
•  CDC provides guidance on routine mattress maintenance and between-patient decontamination procedures to minimize potential risks to patient: https://www.cdc.gov/infectioncontrol/guidelines/environmental/background/laundry.html.
• The ECRI Institute's 2019 Top 10 Health Technology Hazards report lists mattresses as the #2 hazard: https://www.ecri.org/Resources/Whitepapers_and_reports/Haz_19.pdf.
• Following its 2013 safety advisory, the FDA issued a poster "Keeping Patients Safe from Contaminated Mattresses" in 2017: https://www.fda.gov/media/109132/download.

About Trinity Guardion

Trinity Guardion Soteria Bed Barrier is re-engineering clean for patient surfaces. Trinity Guardion is headquartered in Batesville, Indiana. For more information, visit https://trinityguardion.com/.

Source: Trinity Guardion, Inc.