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

99.9999%
REMOVAL OF BACTERIA & SPORES

2X's
THE MATTRESS LIFE IF USING OUR BARRIER 

20
MINUTES SAVING ON ROOM TURN TIME

0
EPA REGISTERED DISINFECTANTS AVAILABLE FOR SOFT/POROUS PATIENT SURFACES

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 sleep apnea and 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.

How Soteria Works:

  • Soteria is the only FDA 510-K cleared, AMMI level 3 hospital bed barrier that covers a healthcare mattress and bed deck.

  • Soteria passed the AATCC 42 impact penetration test and AATCC 127 hydrostatic pressure test for AAMI level 3. AAMI level 3 means that the bed barrier samples withstood 50 cmH20 applied to them without leaking.

  • 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 the assignment of a unique FDA 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 the bed barrier's use life, which is up to 150 launderings as 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 greater than a six-log reduction in the tested microbes.

 

Soteria® Bed Barriers are available for most major brands, including the newest therapeutic beds and mattresses.

Advanta®

Affinity® Birthing

CareAssist®

 

Centrella®

GoBed®

Intouch®

Linet MultiCare

Stryker 22®

Stryker LD304®

S23®

TotalCare®

VersaCare®

“A bed/mattress itself is cleaner after patient discharge when the Soteria® Bed Barrier is removed, compared to beds/mattresses not using the barrier.”

(77% of environmental services staff agreed or strongly agreed after a 2018 clinical trial).

 

TRINITY GUARDION® LAUNCHES THE FIRST OF ITS KIND SOTERIA® ECOSYSTEM, COMBINING RFID TECHNOLOGY WITH AUTOMATION, TO MANAGE SOTERIA BED BARRIERS.

CLEANING VALIDATION

Soteria is designed to withstand the mechanical action of commercial washer/extractors as well as high heat and chlorine. The robust laundry process performed at the hospital laundry removes residual protein and hemoglobin 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. 

 

DEMONSTRATION OF THE BENEFITS OF THE SOTERIA BED BARRIER

INCREASING ROI

Healthcare mattresses are for most hospitals, the 5th largest investment they will make in medical equipment. Therefore, in this COVID-19 stressed time, it is mission critical for hospitals to get the full expected life from these assets that are often cut short using ineffective disinfection processes. Research demonstrates an alarming patient safety concern with healthcare mattresses, centered around re-processing; corroborating the FDA' Safety Advisory.

HOSPITAL MATTRESSES: SIGNIFICANT CONTRIBUTORS TO HOSPITAL ACQUIRED INFECTIONS. LEARN WHY BY CLICKING THE VIDEO: