Frequently Asked Questions
Will the dye be depleted if the SafeTouch MicroDefense gloves are continually exposed to light?
No. As long as there is light and oxygen, the gloves are active. Heat aged SafeTouch MicroDefense gloves (accelerated aging equivalent to 3 years shelf life) did not show significant difference in bactericidal efficacy compared to fresh SafeTouch MicroDefense gloves. SafeTouch MicroDefense gloves were also exposed to “light” (equivalent to 30 days in an open box environment). Again, there was no significant difference in bactericidal efficacy compared to fresh SafeTouch MicroDefense gloves.
What are the different classifications of bacteria?
Bacteria are classified as Gram-positive or Gram-negative. This classification came from a staining property observed by Hans Gram in 1884. It was observed that some bacteria could be stained with a dye, whereas others could not. It was later found that bacteria have different cell wall structures. Gram-positive bacteria allow substances to cross the cell wall more easily. The cell wall of Gram-negative bacteria is multi-layered and therefore, it is harder for substances to cross their cell wall.
What are some examples of Gram-negative bacteria?
Gram-negative bacteria include Esherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, Acinetobacter baumannii among others.
What are some examples of Gram-positive bacteria?
Gram-positive bacteria include MRSA, Staphylococcus aureus, Enterococcus faecium, Streptococcus pyogenes, Enterococcus faecalis (VRE) among many others.
What type of bacteria survive longer on surfaces, allowing the possibility of infection transfer?
Based on a study conducted by Hirai that measured the survival of different types of bacteria on cotton lint, the results showed that Gram-positive bacteria live longer on surfaces, which may mean that these bacteria are available for transfer and cause HAIs. Gram-negative bacteria are known to die more quickly on surfaces, especially if the surface is dry.
What about in a clinical environment? Is there a survival difference between Gram-positive and Gram-negative bacteria?
The pattern of lower survival of Gram-negative bacteria is also seen in the clinical environment. In the Wilson et al. study, Gram- positive bacteria such as Staph a. were found in numerous locations in the hospital environment, but Gram-negative bacteria such as E. Coli were not found on any surfaces sampled, despite there being a number of patients in the ward with E. Coli infections.
Do biocides kill Gram-positive or Gram-negative bacteria easily?
All bacteria respond to biocides differently, requiring different contact times and concentrations for inactivation. In general, Gram-negative bacteria are harder to kill with biocides.
How is the bactericidal efficacy of SafeTouch MicroDefense gloves measured?
SafeTouch MicroDefense gloves start generating singlet oxygen and killing bacteria immediately upon exposure to light and oxygen. In compliance with ASTM D7907-14 requirements, the contact time during which the bacteria have been exposed the external surface of the glove containing antimicrobial agent needs to be measured at intervals of 5 mins, 10 mins, 20 mins and 30 mins. At the end of each contact time, the glove is transferred into a validated neutralizer to stop the bactericidal activity. This will stop the singlet oxygen-killing activity on the microbes, which will in turn allow the calculation of bacteria kill. Additional testing has been conducted at shorter contact times of 1 min and 2 mins on Staphylococcus aureus with bacteria kill rates of 99.898% and 99.998% respectively.
Are SafeTouch MicroDefense gloves effective against viruses?
We believe SafeTouch MicroDefense gloves can kill viruses apart from bacteria. That is why we call them “antimicrobial”, rather than the more limited “antibacterial”. However, all our tests are based on ASTM D7907 Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves. This test method specified the glove to be tested against 4 specific bacteria. As MicroDefense is a new technology, there is no other standard that we can use to test for viral efficacy. Nevertheless, we are working on adapting D7907 to test for viruses. This work will take a longer time to complete. One of the challenges we face is that viruses only replicate inside the living cells. Once exposed to the environment, they are destroyed quickly, making it difficult to test.
Meanwhile, we believe that SafeTouch MicroDefense gloves’ test data, as we believe that most HAIs attributable to hand-surface contamination are bacteria. Viruses like Hepatitis and HIV are spread through fecal-oral route or transmission through contaminated syringes, needles or sharps, infected blood transfusions. The more common flu virus is mainly spread to others by droplets made when people with flu, cough, sneeze or talk. These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs. Less often, a person might get flu by touching a surface or object that has flu virus on it and then touching their own mouth, nose, or possibly their eyes.
What is the intended use and indication of SafeTouch MicroDefense gloves in the technical file?
SafeTouch MicroDefense gloves are intended to be used in the context of medical examinations and diagnostic and therapeutic procedures conducted under non-sterile conditions. Furthermore, the use of the device is intended to help prevent cross contamination.
Their indication is stated as “Any medical condition requiring an examination, a diagnostic or therapeutic procedure on the intact skin or mucosa under non-sterile conditions.”
Can all glove materials cause skin reactions?
All gloves, whether latex or synthetic, can cause reactions in some individuals. Specific reactions vary depending on the material and the manufacturing process.
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