Research + Results
Data Generated by Third-Parties
AIONX® is producing disposable covers incorporating the AIONX® CleanSurface™ technology for hospital bed rails and other high touch surfaces in hospital rooms. Third party researchers have conducted a variety of studies involving the AIONX® CleanSurface™ technology generally and the AIONX® bed rail covers in particular. The AIONX® CleanSurface™ technology is registered with the EPA (EPA Reg. No. 91681-1) as an antimicrobial agent that effectively inhibits the growth of bacteria, fungi, algae, mold, and mildew that cause unpleasant odors, discoloration, staining, deterioration or corrosion on surfaces to which it is applied, including hospital surfaces. The EPA has not reviewed or approved, nor does AIONX® make, any claims that itsCleanSurface™ technology has efficacy against any particular pathogenic microbes.
Intensive Care Unit Clinical Study
A clinical trial in a tertiary care hospital demonstrated a consistent 90% decrease of opportunistic pathogenic bacteria by using an AIONX® bed rail cover (p-value < 0.008). Notable pathogens reduced included Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, and Pseudomonas spp. A 51% reduction of bacterial species was also recorded. The full study methodology and results can be discovered through the sited material below.
Esolen LM, Thakur L, Fuller T, Williams D, Jha K, Kariyawasam S, “The Efficacy of a Self-disinfecting Bedrail Cover in an Intensive Care Unit,” American Journal of Infection Control, in press – accepted for publication September 2017.
Acute Toxicity Study on Mammalian Cell Types
Researchers at North Carolina State University assessed acute toxicity of the AIONX® CleanSurface™ technology on three mammalian cell types: neonatal human epidermal keratinocytes (HEK), neonatal human dermal fibroblasts (HDF), and normal human osteoblasts (OST). They found that the AIONX® CleanSurface™ technology displayed good biocompatibility.
“Biocompatibility analysis of an electrically-activated silver-based antibacterial surface system for medical device applications.” Samberg M, Tan Z, Monteiro-Riviere N, Orndorff P, and Shirwaiker R (2012). Journal of Materials Science: Materials in Medicine.
Nursing Home Clinical Study
An efficacy study led by Penn State University researchers in nursing home cohort demonstrated 86.74% average reduction of bacterial contamination by AIONX®bed rail covers over a nearly 3 week period. The eradication of 8 bacterial species was also observed, among them strains of Staphylococcus aureus and Staphylococcus cohnii.
Kennett MJ, Kariyawasam S, unpublished data.
In Vitro Virus Study
Researchers at Utah State University assessed the antiviral capabilities of the AIONX® CleanSurface™ technology. Log 3 (99.9%) reduction of viability was observed of both murine norovirus CW1 and H1N1 influenza virus.
Day C, unpublished data.
In Vivo Animal Study
Penn State University researchers conducted preliminary rat studies to identify the effectiveness of using the AIONX®CleanSurface™ technology on indwelling residual hardware devices. The researchers observed a large, statistically significant reduction of infections when the AIONX® CleanSurface™ technology was present.
“Prophylactic Bactericidal Orthopedic Implants – Animal Testing Study.” Wysk R, Sebastianelli W, Shirwaiker R, Bailey G, Charumani C, Kennett MJ, Kaucher A, Abrahams R, Fuller T, Royer P, Voigt R, and Cohen P (2010). Journal of Biomedical Science and Engineering, 3.
In Vitro Bacteria Study
Researchers at Penn State University led a study to assess the ability of the AIONX® CleanSurface™ technology to effect gram positive and gram negative bacteria, as well as antibiotic-resistant bacterial strains, known to frequently contaminate hospital environments. Consistent log 7 reduction at 20 minutes and log 2 reduction at 5 minutes was observed of a known strain of Escherichia coli and Methicillin resistant Staphylococcus aureus (MRSA).
Denagamage T, Kariyawasam S, unpublished data.
Data Generated by Third Parties Submitted to the EPA
Animal-Based Toxicity Studies and Physical-Chemical Analyses
An independent, third-party lab performed the following EPA-mandated studies of the silver and copper ink used in the AIONX® CleanSurface™ technology: an assessment of accelerated storage stability and corrosion characteristics; a thorough chemical analysis of the materials; an atomic absorption spectrophotometer analysis of the active ingredients; an assessment of the material’s flammability, pH, viscosity, density/relative density, and explodability; a dermal sensitization test in guinea pigs; an acute oral toxicity test in rats; an acute dermal toxicity test in rats; a primary eye irritation test in rabbits; and a primary skin irritation test in rabbits. The EPA registered the AIONX® CleanSurface™ technology after reviewing the foregoing data.
Product Safety Labs, unpublished data.
* The AIONX® CleanSurface™ technology is registered with the EPA (EPA Reg. No. 91681-1) as an antimicrobial agent that effectively inhibits the growth of bacteria, fungi, algae, mold, and mildew that cause unpleasant odors, discoloration, staining, deterioration or corrosion on surfaces to which it is applied. The EPA has not reviewed or approved, nor does AIONX® make, any claims that its CleanSurface™ technology has efficacy against any particular pathogenic microbes.