Is the hospital bed barrier compliant with federal regulations & recommendations?
Yes, the Soteria Bed Barrier® is compliant with federal regulations. The barrier is a registered Class I medical device. It includes an RFID chip and barcode for traceability. Hospitals can also use piggyback labels on EVS log sheets to track compliance. The laundry process achieves a 6-log reduction or greater in pathogens including C. diff spores,22 exceeding recommendations, & the barrier is inspected over a light table after each laundering. On the contrary, not following the manufacturer’s cleaning & disinfection protocols (such as using a 1-step process) can result in a citation from CMS and creates significant risk according to the Joint Commission.65,66
References
22. Hooker EA, Ulrich D, Brooks D. Successful removal of Clostridioides difficile spores and pathogenic bacteria from a launderable barrier using a commercial laundry process. Infect Dis (Auckl). 2020;13:1-6. doi:10.1177/1178633720923657
65. Hospital Infection Control Worksheet. Centers for Medicare & Medicaid Services. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-15-12-Attachment-1.pdf. Published 2015. Accessed September 16, 2020. Section 2.d. environmental services:pg16,18.
66. Standards FAQs. The Joint Commission. https://www.jointcommission.org/standards/standard-faqs/critical-access-hospital/infection-prevention-and-control-ic/000002250/. Updated March 17, 2021. Accessed May 3, 2021.