Emerging Properties and Trends
By Kris Ellis
The proper use of effective medicalgloves is a fundamental component of the effort to control the spread ofpathogens. Given the range of choices that the market currently offers in termsof gloves, facilities must evaluate a number of factors in order to select thebest possible gloving solution for their healthcare workers (HCWs). For theirpart, manufacturers must strive to provide good choices, which includesincorporating features and elements that address HCW needs and concerns.
According to Esah Yip, DSc, director of the Malaysian RubberExport Promotion Council, excellent barrier properties are a primaryconsideration for the selection of gloves. Those with inferior barrier protection against bloodbornepathogens and other harmful infectious diseases should not be used in medicaland healthcare environments, she says. Otherwise, both medical andhealthcare professionals as well as their patients could be exposed tounnecessary infections.
Another prominent issue in regard to glove usage is thepossibility of health risk to HCWs. This basically refers to the possibleadverse reactions that can be elicited in sensitive users by the presence ofexcessive residual chemicals, which can give rise to irritant contact dermatitisor Type IV allergy, or the presence of certain proteins, which can cause Type Iallergy, Yip continues. While most gloves, particularly those made ofsynthetic materials derived from petrol chemicals, do have residual chemicals,improvement in latex glove manufacturing technologies has led to the productionof very low-protein latex gloves. The use of these gloves has been shown by manyrecent studies to markedly reduce the incidence of latex allergy.
Carolyn Twomey, director of clinical affairs for RegentMedical, notes that confusion oftentimes exists among HCWs in deciding whetheror not they should promote a latex-free clinical environment in terms ofsurgical gloves, and in understanding the many types of latex-free (synthetic)gloves that are available, which include nitrile, neoprene, polyisoprene, andothers.
I think the most important thing to do is start with theissue of latex-safe vs. latex-free, Twomey says. Do you really need to belatex-free? We find that a lot of people try to go that direction thinkingthat will be the simplest solution to their latex allergy issues when in fact itsa very difficult leap to make to be latex-free.
Twomey explains that a latex-safe environment involves anumber of things, including:
Twomey also notes that switching to latex-free gloveseliminates only one of many possible sources of latex in the hospital. Thereare other latex products in the environment that you have to take a look at, andthe other components are vast and very difficult to get rid of, she says.
Once you make that decision, and make that as a veryproactive and not a knee-jerk reaction decision, but a proactive andwell-informed decision, then its really important for the hospital to sitdown and be educated, if they choose to go latex-free, as to what thoselatex-free alternatives are, what they play well with for example, some ofthem dont play well with alcohol, some do. This makes a big difference if youreusing an alcohol-based hand prep or scrub. Twomey says manufacturers shouldbe able to offer educational programs or consultants who can help facilities tounderstand 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 proteinallergy problem, Yip says. It has recently developed the StandardMalaysian Glove (SMG) Program, which ensures the manufacture of qualitylow-protein gloves that are not only high in barrier protection, but also low inallergy risk. The program was formulated in consultation with a number ofrelevant 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 andpowder.
Yip notes that because they are natural rubber latex,SMG-certified gloves possess important glove qualities such as excellent barrierperformance; high tensile strength; durability; excellent comfort, fit, andtactile sensitivity; and ease of donning. Latex gloves also have the abilityto reseal when punctured by tiny needles, a property not observed in syntheticgloves such as nitrile and vinyl, she adds.
In fact, ECRI, the largest independent evaluator of medicaldevices, reported in the May 2004 issue of HealthDevices that using lower-protein latex gloves is abetter solution to the problem of latex sensitivity than switching entirely tosynthetic alternatives, Yip continues. It recommends that hospitalspurchase gloves with protein levels that are as low as possible, using theprotein levels printed on their labeling or the SMG label as a guide.
However, Yip says, synthetic gloves with good barrierperformance should be used by those who are know to be allergic to latex.
The Biogel Eclipse, a powder-free surgical glove made fromdeproteinised natural rubber latex, was recently introduced by Regent Medical.The Eclipse was developed to provide a cost-effective safety option forfacilities wanting to reduce HCW exposure to antigenic proteins found instandard latex surgical gloves.
Milt Hinsch, technical services director for Regent Medical,says Regent began development on this type of glove many years ago. We werespeculating that there might be a way in which we could manufacture our latexgloves 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 thelowest we can claim by FDA regulations is 50Âµg or less, so were even belowthose levels. On the ELISA test, we are below detectable levels in almost everyinstance. So were already as low as we can measure, but we decided we mightbe able to get even lower if we were to do some things on the front end with thelatex before we even brought it in to the factory.
Hinsch explains that Regent, using new technologies, foundthat it could reduce the allergen levels of the latex by 90 percent coming into the factory before the production process even began. So weknew that coming out of the other end they would be extremely low, and we gotsome test results that looked very encouraging.
The raw material, when we get it, is actuallyenzyme-treated, notes Virginia James, medical glove product manager forRegent Medical. The enzyme treatment breaks down the proteins to smallermolecules, which enables us, as we manufacture and wash the gloves, to removemore of it. One of the other great things that is happening is, in the finishedproduct, the glove is actually softer and more form-fitting.
James says this also gives users a glove that has excellentfit, feel, and comfort, and still provides the protection of natural rubberlatex with the properties, such as good tensile strength and elongation, thatmake latex gloves so effective.
Nonetheless, James again emphasizes the fact thatde-proteinised rubber latex gloves still contain potential allergens. Evenwith the raw material having 90 percent less antigenic proteins, the fact is itsstill a natural rubber latex product and we know it still has proteins in it. Soby no shape or form are we promoting this product for anyone who is eithersensitized or allergic to natural rubber latex.
Pyrogens and Endotoxins
Another issue that HCWs may begin to hear more about in thenear future in relation to gloves is that of pyrogens and endotoxins. Pyrogens and endotoxins are created when bacteria arekilled and left on a device; gram-negative bacteria, specifically, Hinschsays. Pyrogens means fire-producing bodies; in this case,fever-producing bodies that, if theyre left on a device, can be injected orintroduced into the body, and a fever can be spiked. Of course thats notgood, because then you have inflammation, fever, and patients are less able tofight off infection.
Hinsch explains that pyrogens are not allowed on any medicaldevices, 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 andendotoxins on surgical gloves, it became apparent that this could be cause forconcern. Since the process of inserting medical devices into the bodyrequires that they be handled with gloves that could theoretically be carryinglarge numbers of pyrogens and endotoxins, this issue needed to be addressed. TheFDA agreed that gloves with pyrogens and endotoxins could contaminateimplantable devices, injection devices, and tubing, and they asked us to go tothe ASTM, which we did, and develop a standard for pyrogens and endotoxins,which weve done; it is a guidance document, not a testing standard, whichoutlines different testing methods for pyrogens and endotoxins [ASTM D7102-04],Hinsch says.
Despite not having a claim for the last 10 years, Regent neverstopped 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 showsthat 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 isthe maximum limit that the FDA is looking at right now. Hinsch also identifies powdered gloves as a major concern inthis 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 sittingaround for some period of time with this powder on them, growing bacteria beforetheyre ever sterilized or packaged, and by the time they are, they can end upwith huge amounts of pyrogens and endotoxins on them. This is just another nailin the coffin of powdered gloves as far as were concerned.