SOTERIA® BED BARRIER
THE ONLY FDA 510(K) CLEARED BED BARRIER
Product Code (QTV) 

How Soteria Works:

• Soteria is the only FDA 510(k) cleared, AMMI Level 4 hospital bed barrier that covers a healthcare mattress and bed deck.
• Soteria is classified as a Level 4 barrier per ANSI/AAMI PB70. It resists penetration of bloodborne pathogens.
• 510(k) performance testing proves that the Soteria laundry process is highly effective through end-of-life, removing 99.9999% of vegetative and mycobacteria as well as C. diff. spores.
• Soteria is the only bed barrier cleared with its own unique FSA product code (QTV).
• Soteria protects the mattress surface with a sound barrier, which then protects the mattress core from patient fluids.
• Soteria’s unique design protects the bed deck from soiling.
• The Soteria Bed Barrier design, covers support surfaces and bed deck during patient/resident use.
• Our innovative and patented features, including a proprietary laundry process, allows for re-use
  after laundering.
• The product can be safely reused after laundering throughout its lifespan - 150 launderings - which was validated during testing of the Soteria Bed Barrier laundering process.
• After laundering the Soteria Bed Barrier once, there was more than a six-log reduction in viable microbes (e.g., Escherichia coli, Klebsiella pneumoniae, methicillin resistant Staphylococcus aureus (MRSA), Clostridioides difficile spores) on the bed barrier. After laundering the Soteria Bed Barrier 200 times, there was also a greater than six-log reduction in the tested microbes.
  

Re–engineering Clean for Patient Surfaces

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, long-term care, visitor beds and stretchers. It fits securely over the mattress and bed deck, attaching to the bed, without disrupting bed and mattress performance during patient care.

CLEANING VALIDATION

Soteria is designed to withstand the mechanical action of commercial washer/extractor, as well as high heat and chlorine. The robust laundry process performed at the hospital laundry, removes residual protein and hemoglobin to below the FDA Reprocessing Guidance, as well as 99.9999% of test organisms including C. diff. After the laundry wash cycle, Soteria is rinsed with a neutralizing additive before final extraction, bringing the barrier to a pH neutral condition and then dried at 160 degrees. After each laundering, the barrier is inspected on a light table then individually wrapped before returning to the facility. Soteria’s laundry process removes stains (including blood and betadine) and leaves the barrier smelling fresh and clean.