Consumer demand pushes quality of latex gloves
FDA labeling rule will add to choice
Growing concerns about latex allergy are having an impact on the quality of latex gloves and nonlatex alternatives. Hospitals now can demand gloves with lower protein and powder levels and less leakage, latex experts say. The voluntary standards recently set by the American Society for Testing & Materials (ASTM) in W. Conshohocker, PA, also give hospitals an expectation of minimal performance, says Kok-Kee Hon, chairman of the ASTM consumer rubber products subcommittee.
Meanwhile, the Food and Drug Administration (FDA) is moving forward with its proposed rule requiring manufacturers to label the protein and powder content of latex gloves, which will enable hospitals to choose those with the lowest levels. The final rule is expected sometime next year.
The bottom line: Even hospitals that continue to use latex gloves will be able to reduce levels of employee sensitization, Hon says. "When the manufacturer reduces the level because of the [ASTM] standard requirements, there will be very low protein and there will be a decrease in sensitization. The people who are sensitized now have to avoid using latex gloves, period. For the people who are not sensitized now, the new standards can help to decrease the opportunity to be sensitized. The impact is an overall improvement in the quality of the glove, not only in the strength they must maintain, but in the hazards they may remove." A new test for antigenic proteins will allow even narrower limits on the potential allergens, Hon says.
In its proposed rule, the FDA predicted that labeling would heighten customer demand for lower protein and powder levels. "The main thing we were trying to do with the rule is to give [consumers] the ability to make that choice," explains Mel Stratmeyer, PhD, chief of the health sciences branch in the office of science and technology, center for devices and radiological health. "At the present time, they don’t have that ability."
When it comes to strength and durability, however, choosing the best glove can still be problematic. The primary test of glove integrity is the water-leak test, in which water is placed in the glove and the glove is inspected for any leakage through tiny holes. Tests of durability, or the likelihood of the glove to develop tears or cracks during use, have not yet been standardized. Neither have tests of viral penetration. "We recognize that we need to look at something other than some of the properties we’re looking at now," Stratmeyer says.
The FDA also may consider the issue of expiration dating, Stratmeyer says. "How do these products hold up over time? A lot of it depends on storage conditions. If expiration dating were there, a manufacturer would have to be held responsible for that product meeting all the requirements at the time it was on the expiration date."
The water-leak test, though crude, actually is adequate for basic glove integrity, says Donald Beezhold, PhD, senior scientist at the Guthrie Research Institute in Sayre, PA, who specializes in latex allergens. "Even if you have a glove that has a small pinhole and it leaks virally contaminated blood, and it’s on an area of intact skin, the likelihood of being contaminated is extremely remote." However, durability is an important issue. Vinyl gloves have performed poorly in some durability tests, although nitrile and neoprene have durability that rivals latex, Beezhold adds.
The spotlight on glove manufacturing — including lawsuits, proposed legislation, and consumer awareness — may have led to improvements in glove quality. In 1998, when University of Virginia (UVA) researchers in Charlottesville tested 18 glove brands for leakage, they found some low-protein, low-powder brands that performed poorly. When researchers repeated tests with 2,144 gloves from nine brands last year, they found better results. Leakage rates were below FDA thresholds when gloves were tested out of the package, and gloves also showed minimal leakage after manipulation.
"These newer brands seem to be working better than what we saw before," says Barry M. Farr, MD, MSc, hospital epidemiologist in the UVA Health System and UVA professor of medicine and epidemiology. "It looks like the gloves may be getting better, [based on] the testing we’ve done."
That mirrors the experience at Kaiser Permanente, which gives its hospitals the choice of using powder-free latex gloves or nitrile. (Latex-sensitive employees would use nitrile.) "Nitrile approaches latex in terms of strength and durability," says Wendy Huber, MD, a dermatologist at South Sacramento Kaiser Medical Center and chair of Kaiser’s latex alternative products sourcing and standard team. "The nitrile glove of today is comparable to the latex glove of a couple of years ago. That’s says a lot."
With the focus on latex allergy, vendors now are promoting the properties of gloves that will reduce the potential for sensitization. This gives hospitals new choices and more information as they seek to protect health care workers. At Marshfield (WI) Clinic, Bruce Cunha, RN, MS, COHN-S, manager of employee health and safety, has seen new synthetic and latex products. The clinic uses synthetic exam gloves and gives employees a choice of synthetic or powder-free latex surgical gloves. The latex gloves are coated with silicon to provide a barrier between the skin and the latex. Since the clinic implemented this program in 1996, there hasn’t been a single new case of latex allergy among workers, Cunha says.
"It’s one of the first times, without having a regulatory mandate, that companies have had to go out and basically reevaluate how they do their product," he says. "There’s a whole new field out there now that’s opened with the issue of latex that companies can go after. They’re now putting the time and effort into finding out how to make new and better and safer products."
Cunha controlled the costs of switching to synthetics by providing vinyl gloves for employees who were doing a quick, simple function. For procedures that require greater dexterity and durability, employees use nitrile gloves. "We almost doubled our glove costs to go synthetic, but we’re finding that’s drastically dropping," he says. "Nitrile gloves have gone down significantly [in price]. As more product is available and more companies get into the market, they’re going to drop even further."
However, not all hospitals have responded to the concerns about latex sensitization related to powdered gloves. In a Washington, DC-based American Nurses Association survey, 61% of respondents said their facilities still use powdered latex gloves. (See Hospital Employee Health, January 2002, "Hospitals don’t have enough safety devices.")
Cost is simply not an excuse to continue using powdered latex gloves, asserts Lise C. Borel, DMD, director of the National Latex Allergy Network in West Chester, PA. "In this day and age, and with availability and cost issues, there’s absolutely no reason to continue the use of powdered latex gloves," she says. "Time and practice have shown that the reduction of overall exposure reduces the amount of reported reactions by both patients and employees."
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