Emerging Properties and Trends
By Kris Ellis
The proper use of effective medical gloves is a fundamental component of the effort to control the spread of pathogens. Given the range of choices that the market currently offers in terms of gloves, facilities must evaluate a number of factors in order to select the best possible gloving solution for their healthcare workers (HCWs). For their part, manufacturers must strive to provide good choices, which includes incorporating features and elements that address HCW needs and concerns.
According to Esah Yip, DSc, director of the Malaysian Rubber Export Promotion Council, excellent barrier properties are a primary consideration for the selection of gloves. Those with inferior barrier protection against bloodborne pathogens and other harmful infectious diseases should not be used in medical and healthcare environments, she says. Otherwise, both medical and healthcare professionals as well as their patients could be exposed to unnecessary infections.
Another prominent issue in regard to glove usage is the possibility of health risk to HCWs. This basically refers to the possible adverse reactions that can be elicited in sensitive users by the presence of excessive residual chemicals, which can give rise to irritant contact dermatitis or Type IV allergy, or the presence of certain proteins, which can cause Type I allergy, Yip continues. While most gloves, particularly those made of synthetic materials derived from petrol chemicals, do have residual chemicals, improvement in latex glove manufacturing technologies has led to the production of very low-protein latex gloves. The use of these gloves has been shown by many recent studies to markedly reduce the incidence of latex allergy.
Carolyn Twomey, director of clinical affairs for Regent Medical, notes that confusion oftentimes exists among HCWs in deciding whether or not they should promote a latex-free clinical environment in terms of surgical gloves, and in understanding the many types of latex-free (synthetic) gloves that are available, which include nitrile, neoprene, polyisoprene, and others.
I think the most important thing to do is start with the issue of latex-safe vs. latex-free, Twomey says. Do you really need to be latex-free? We find that a lot of people try to go that direction thinking that will be the simplest solution to their latex allergy issues when in fact its a very difficult leap to make to be latex-free.
Twomey explains that a latex-safe environment involves a number of things, including:
- The use of low-protein, powder-free gloves
- The presence of latex allergy policies and procedures to treat those patients and employees who are sensitive or allergic
- Having latex-free alternatives with which to treat patients
- Regular educational offerings for staff and patients on latex allergy and sensitivity.
Twomey also notes that switching to latex-free gloves eliminates only one of many possible sources of latex in the hospital. There are other latex products in the environment that you have to take a look at, and the other components are vast and very difficult to get rid of, she says.
Once you make that decision, and make that as a very proactive and not a knee-jerk reaction decision, but a proactive and well-informed decision, then its really important for the hospital to sit down and be educated, if they choose to go latex-free, as to what those latex-free alternatives are, what they play well with for example, some of them dont play well with alcohol, some do. This makes a big difference if youre using an alcohol-based hand prep or scrub. Twomey says manufacturers should be able to offer educational programs or consultants who can help facilities to understand complexities such as these so they can make an informed decision.
Malaysia, as the major glove supplier in the United States, has embarked on much research and development to address the latex protein allergy problem, Yip says. It has recently developed the Standard Malaysian Glove (SMG) Program, which ensures the manufacture of quality low-protein gloves that are not only high in barrier protection, but also low in allergy risk. The program was formulated in consultation with a number of relevant authorities such the U.S. Food and Drug Administration (FDA). SMG-certified gloves have to meet very stringent technical requirements, including strictly controlled low limits for residual extractable proteins and powder.
Yip notes that because they are natural rubber latex, SMG-certified gloves possess important glove qualities such as excellent barrier performance; high tensile strength; durability; excellent comfort, fit, and tactile sensitivity; and ease of donning. Latex gloves also have the ability to reseal when punctured by tiny needles, a property not observed in synthetic gloves such as nitrile and vinyl, she adds.
In fact, ECRI, the largest independent evaluator of medical devices, reported in the May 2004 issue of Health Devices that using lower-protein latex gloves is a better solution to the problem of latex sensitivity than switching entirely to synthetic alternatives, Yip continues. It recommends that hospitals purchase gloves with protein levels that are as low as possible, using the protein levels printed on their labeling or the SMG label as a guide.
However, Yip says, synthetic gloves with good barrier performance should be used by those who are know to be allergic to latex.
The Biogel Eclipse, a powder-free surgical glove made from deproteinised natural rubber latex, was recently introduced by Regent Medical. The Eclipse was developed to provide a cost-effective safety option for facilities wanting to reduce HCW exposure to antigenic proteins found in standard latex surgical gloves.
Milt Hinsch, technical services director for Regent Medical, says Regent began development on this type of glove many years ago. We were speculating that there might be a way in which we could manufacture our latex gloves to reduce the latex proteins and allergens further than where they were, he says. Right now they are below detectable level of latex proteins, and the lowest we can claim by FDA regulations is 50µg or less, so were even below those levels. On the ELISA test, we are below detectable levels in almost every instance. So were already as low as we can measure, but we decided we might be able to get even lower if we were to do some things on the front end with the latex before we even brought it in to the factory.
Hinsch explains that Regent, using new technologies, found that it could reduce the allergen levels of the latex by 90 percent coming into the factory before the production process even began. So we knew that coming out of the other end they would be extremely low, and we got some test results that looked very encouraging.
The raw material, when we get it, is actually enzyme-treated, notes Virginia James, medical glove product manager for Regent Medical. The enzyme treatment breaks down the proteins to smaller molecules, which enables us, as we manufacture and wash the gloves, to remove more of it. One of the other great things that is happening is, in the finished product, the glove is actually softer and more form-fitting.
James says this also gives users a glove that has excellent fit, feel, and comfort, and still provides the protection of natural rubber latex with the properties, such as good tensile strength and elongation, that make latex gloves so effective.
Nonetheless, James again emphasizes the fact that de-proteinised rubber latex gloves still contain potential allergens. Even with the raw material having 90 percent less antigenic proteins, the fact is its still a natural rubber latex product and we know it still has proteins in it. So by no shape or form are we promoting this product for anyone who is either sensitized or allergic to natural rubber latex.
Pyrogens and Endotoxins
Another issue that HCWs may begin to hear more about in the near future in relation to gloves is that of pyrogens and endotoxins. Pyrogens and endotoxins are created when bacteria are killed and left on a device; gram-negative bacteria, specifically, Hinsch says. Pyrogens means fire-producing bodies; in this case, fever-producing bodies that, if theyre left on a device, can be injected or introduced into the body, and a fever can be spiked. Of course thats not good, because then you have inflammation, fever, and patients are less able to fight off infection.
Hinsch explains that pyrogens are not allowed on any medical devices, in IV tubing, or on anything else that will be injected into the body. While the FDA had originally not regulated the presence of pyrogens and endotoxins on surgical gloves, it became apparent that this could be cause for concern. Since the process of inserting medical devices into the body requires that they be handled with gloves that could theoretically be carrying large numbers of pyrogens and endotoxins, this issue needed to be addressed. The FDA agreed that gloves with pyrogens and endotoxins could contaminate implantable devices, injection devices, and tubing, and they asked us to go to the ASTM, which we did, and develop a standard for pyrogens and endotoxins, which weve done; it is a guidance document, not a testing standard, which outlines different testing methods for pyrogens and endotoxins [ASTM D7102-04], Hinsch says.
Despite not having a claim for the last 10 years, Regent never stopped removing pyrogens and endotoxins, nor did they stop testing for them, according to Hinsch. We have now 15 to 20 years of data behind us that shows that we consistently had non-pyrogenic levels of pyrogens and endotoxins.
There is an acceptance level that is spelled out in the U.S. Pharmacopeia, so its very clear as to what this level should be, and this is the maximum limit that the FDA is looking at right now. Hinsch also identifies powdered gloves as a major concern in this respect; specifically, the corn starch that may be contained in the powder, since corn starch is a basic food for bacteria. The gloves can be sitting around for some period of time with this powder on them, growing bacteria before theyre ever sterilized or packaged, and by the time they are, they can end up with huge amounts of pyrogens and endotoxins on them. This is just another nail in the coffin of powdered gloves as far as were concerned.