What are Medicom SafeTouch MicroDefense antimicrobial gloves?
SafeTouch MicroDefense gloves are Canada’s only gloves with antimicrobial technology. Designed to kill up to 99.999% of selected microbes upon contact with the outside of the glove, they provide healthcare professionals and patients with a higher level of protection than ordinary gloves.
What is the purpose of SafeTouch MicroDefense antimicrobial gloves?
Though conventional gloves provide a barrier between healthcare worker and patient, they do not address the issue of transient transmission, where microbes are transmitted from one surface to another. SafeTouch MicroDefense gloves are designed to help reduce the spread of (Healthcare Associated Infections (HAIs), as they are proven to kill up to 99.999% of selected microbes.
Why are SafeTouch MicroDefense gloves necessary to provide active protection against HAIs?
Medical gloves are intended to prevent cross-contamination between the patient, the healthcare provider and its environment. However, conventional gloves only provide passive protection because gloves that become contaminated due to inappropriate storage, inappropriate use and improper donning and removal techniques may themselves become vehicles for the transmission of microbes. Conversely, MicroDefense gloves take an active approach to preventing HAIs, as they continuously and effectively reduce or inhibit microbial colonization on the glove surface within a short amount of time, thus further reducing the risk of cross-contamination.
Do MicroDefense gloves replace the need for hand hygiene?
Although MicroDefense gloves are proven to be effective against a wide range of microbes, they do not eliminate the need for proper hand hygiene. SafeTouch MicroDefense gloves serve as an additional precaution or tool to help reduce the spread of HAIs. Hand rubbing or washing protocols should still be performed before donning and after removing the gloves.
What does non-leaching mean?
SafeTouch MicroDefense gloves are designed to be non-leaching to ensure that their active ingredient does not transfer to patients. To further ensure the safety of the active ingredient, the gloves have also been tested for biocompatibility.
What materials are in contact with my skin when using SafeTouch MicroDefense gloves?
MicroDefense gloves’ technology is only on the outside of the glove. The inside of the glove that touches a wearer’s skin is similar to that of a standard examination glove, so the wearer’s skin is not exposed to the antimicrobial technology.
How does SafeTouch MicroDefense glove singlet oxygen work?
MicroDefense technology uses a special dye that absorbs visible light. The dye is raised from a ground state to an excited quantum state, where its energy level is raised. The energy is then transferred to a proximal oxygen molecule found in the air. This raises the oxygen molecule to an excited quantum state, as well. The ground state of oxygen present in air is a triplet electronic configuration, written as 3O2.
Upon sensitization by the dye molecule, the electronic configuration changes and enters the singlet state, 1O2. This singlet oxygen state is reactive and more oxidative compared to ground state oxygen and therefore, is able to kill microbes such as bacteria by oxidizing the cells’ protein and lipid. Using the dye as a catalyst, singlet oxygen can be generated continuously as it absorbs light and air.
What are the advantages of using singlet oxygen antimicrobial system?
Singlet oxygen is a non-selective system that can react rapidly against many microbial components. There is not one single protection mechanism that bacteria can protect itself from singlet oxygen. This is in contrast to antibiotics, which require a very specific mechanism to treat a patient. As singlet oxygen is transient, it does not lead to the release of persistent biocides into the environment. SafeTouch MicroDefense technology transforms standard examination gloves from passive medical devices to medical devices with active protection that actively reduce or inhibit microbial colonization.
Has singlet oxygen technology been used before commercially?
While it has not received as much attention as traditional biocides, singlet oxygen has been researched for a wide variety of uses for many years and a number of important commercial applications are known. In humans, singlet oxygen-generating dyes are used in a cancer treatment known as photodynamic therapy (PDT). It is also used I dental disinfection prior to procedures like root canal treatments, in which the dye is sprayed into the patient’s mouth, a light is applied, and disinfection is achieved quickly and safely. The most common use, however, is in laundry powders, where a singlet-oxygenating dye is washed into clothing, where it then acts as a photo bleach.
Is there literature regarding potential of resistance using singlet oxygen antimicrobial system?
Experimental studies have been done and reported in the literature about singlet oxygen efficacy and resistance. In these studies, typically 99.9% or 99.99% of bacteria were killed with singlet oxygen, leaving only the most robust microbes. These were then re-cultivated and re-exposed to singlet oxygen. This cycle was repeated 10 or 20 times and the bacteria-killing efficacy was measured. In all cases, no decrease in efficacy or resistance development was detected.
Many of the mechanisms bacteria use to confer resistance involve processes internal to the cell. In the MicroDefense system however, the singlet oxygen is generated purely exogenously to the cell – the dye is separated from the bacteria, it does not leach and it cannot enter the cells.
Other literature has noted that this makes development of resistance especially difficult, because singlet oxygen is short lived and with a short length of diffusion, so nothing the bacterial cell does internally will affect the process of oxidation by singlet oxygen.
How much light is needed to activate SafeTouch MicroDefense gloves?
SafeTouch MicroDefense gloves have been tested under common lighting conditions at hospitals of 1000 lux and 500 lux. Results show that there was no significant difference in bactericidal efficacy. Further testing at lower light levels are underway.
Would differences in lighting type affect the efficacy of SafeTouch MicroDefense gloves (e.g., LED, fluorescent, incandescent light bulb)?
No. SafeTouch MicroDefense gloves are activated by any white light source. They are specifically activated by light in the 600-700 nm range, but any white light sources meet this criteria; otherwise, they would be coloured.
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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