Cleanroom workers at risk for latex allergy

Cleanroom workers at risk for latex allergy

By Sheila Galatowitsch

Arlington Heights, IL — Cleanroom personnel who use or work around latex products are at risk of allergic reactions that can range from mild to life-threatening, and one medical specialist in latex sensitivity recommends not using latex gloves at all until more is known about the allergic properties of natural rubber latex.

Although cleanroom personnel have not formally been included in the risk groups affected, which primarily includes healthcare workers and patients, experts emphasize that any group using latex gloves regularly is at risk.

Latex allergic reaction is a growing, but unexplained, healthcare phenomenon, according to health industry groups. Until 10 years ago, natural rubber latex had been used commercially for more than 50 years with only a few isolated reports of allergic sensitivity to its proteins. In the late 1980s, reports increased significantly worldwide. Some believe the rise in reactions can be attributed to the more widespread use of gloves after the onset of the AIDS epidemic in the same timeframe.

Since 1988, the U.S. Food and Drug Administration has received more than 1,000 reports of allergic reactions, including 16 deaths, from latex sensitivity. An FDA spokeswoman said that 400 of the reports were directly related to medical gloves. The deaths were associated with one particular product, a latex-cuffed enema tip, that the manufacturer has since modified. In 1991, the FDA issued a medical alert on latex allergy.

In the past five years, latex allergy has become a major occupational health problem, even “epidemic among highly exposed healthcare workers and in others with significant occupational exposure,” according to the American College of Allergy, Asthma and Immunology (ACAAI; Arlington Heights, IL). Between 8 and 17 percent of exposed healthcare workers are at risk, reports the ACAAI.

Based on a 1994 study of volunteer blood donors from the general population, more than six percent of the U.S. population, or 18 million Americans, may have evidence of latex sensitivity, according to ACAAI. Over 600,000 people are currently employed in cleanrooms worldwide. Among the top three glove materials for cleanroom use, latex is most widely used.

Risk factors for developing latex allergy include occupational exposure; a history of allergies or hay fever; dermatitis; and certain food allergies, particularly to tropical fruits and vegetables. Some studies suggest that glove-associated dermatitis, a common condition that results from sweating or rubbing under the glove, may increase risk substantially.

Allergic reactions range from eczema, dermatitis, hives, itching, breathing difficulties, swollen red skin, tears, itching eyes or blurring vision, and nausea, to rare instances of anaphylactic shock and death. Latex-allergic workers are urged to use only non-latex gloves and other products, and avoid all latex-containing products. Personnel working with allergy sufferers should also use low-protein, powder-free gloves or a non-latex substitute.

Risk for cleanroom workers

Cleanroom workers have an “enormous potential” for developing latex sensitivity, says Dr. B. Lauren Charous, chairman of the ACAAI Latex Hypersensitivity Committee and an allergist with the Milwaukee Medical Clinic (Milwaukee, WI). “If you wear low-allergen, non-powdered gloves, you can have a lower rate of sensitization, but if a competitively priced non-latex product is available it should be used,” Charous says, citing vinyl or nitrile alternatives.

Overall, Charous discourages the use of latex gloves until more is known about the problem. “Until we have a better handle on what the cause is and how to prevent it, if you can do without latex gloves, do without them.” If that is impossible, substitute low-allergen latex gloves, and pay attention to the warning symptoms of a possible reaction. “If you start seeing a reaction, you don`t belong in latex gloves,” he says.

Dr. Milton Gold, an allergist with The Hospital for Sick Children (Toronto) has co-authored guidelines for dealing with latex sensitivity in healthcare workers and patients. Gold says that cleanroom workers are “subjected to the same problems as healthcare workers in hospitals. If there are signs of a potential reaction, workers must report it so that it can be investigated and determined what alternative gloves they should be wearing.” In some cases, the problem has been so severe that a worker has to switch to a job or profession that does not involve latex. Gold recommends that sensitive individuals wear medical bracelets and inform doctors and dentists that they are allergic to latex.

In 1993, after urging by ACAAI and other health groups, the FDA proposed medical device content labeling for natural rubber latex, and a ban on the term “hypoallergenic” that is sometimes applied to latex and non-latex gloves.

Under the labeling proposal, any medical device that contains latex would be labeled as such with a cautionary message indicating that some people may be allergic to latex. The term “hypoallergenic” is objectionable because it does not have a uniform and well-defined meaning, according to proponents of the ban. The proposals were published last summer in the Federal Register. The agency is reviewing public comments before issuing a final rule sometime this year.

Industry does not object to the proposals in general, but does have concerns about the scope and some of the details surrounding implementation, according to Ann Baldwin, director of technology and regulatory affairs for the Health Industry Manufacturers Association (HIMA; Washington, DC). For example, HIMA is urging the FDA to provide an alternative to the term “hypoallergenic” if it is banned in the final rule. The group is also urging the FDA to give industry more flexibility in content labeling.

Meanwhile, the FDA and health groups are pushing manufacturers to voluntarily reduce protein levels in latex gloves, and most manufacturers have responded. HIMA reports that industry and government scientists have developed a standardized test method that can be used to assess latex products for protein levels. The FDA is now permitting manufacturers to use the test, called the ASTM Standard Test Method for Analysis of Protein in Natural Rubber and Its Products, as a basis for labeling.

Problem spurs litigation

Another result of increased latex sensitivity is a wave of litigation. Approximately 200 plaintiffs have filed suit in state and federal courts claiming that latex glove manufacturers were negligent in selling products that caused disabling latex sensitivities. All of the current plaintiffs are healthcare workers, according to attorney Robert Jenner (Rockville, MD).

Jenner heads a forum for the Association of Trial Lawyers of America, where attorneys representing latex-allergy plaintiffs meet and exchange information. (Jenner himself does not represent latex-allergy plaintiffs.) Jenner says he is not aware of any suits filed on behalf of cleanroom workers. None of the liability cases has gone to trial yet, although at least one is scheduled to go to trial later this year. Virtually every major U.S. latex glove maker is a target of these product liability lawsuits, Jenner says.

Suppliers to the cleanroom market agree that cleanroom workers are being affected by the health problem. “More people today are wearing latex than ever before, so there are more instances of latex sensitivity. That is why latex alternatives or latex-free gloves are becoming an increasingly important issue,” says Steve Martin, national sales manager for CT International (San Luis Obispo, CA), a manufacturer of latex gloves for both the medical and cleanroom industries. Alternatives include use of glove liners, or replacement of latex with vinyl or nitrile gloves.

Manufacturers reduce protein content in latex by chlorinating the gloves during manufacture. Chlorination draws out the majority of the proteins that cause sensitivity in humans, but it can also create problems in some cleanroom applications. “Those users may opt for a washed product, rather than just a chlorinated, powder-free product. The washing leaches out the majority of the chlorides, as well as other extractables,” Martin says.

For the past six years, glove manufacturer Ansell Edmont Protective Products Division (Eatontown, NJ) has spent several million dollars funding latex allergy research. The company has also established an educational program for healthcare workers called AnsellCares, which is directed by an independent scientific advisory board.

The program recently started to target cleanroom workers, according to Russell Thompson of Thompson Nightingale International (TNI; Milwaukee, WI), a consultant hired by Ansell to organize the outreach efforts. Because cleanroom gloves undergo more processing than medical gloves, they are less likely to cause protein allergies, Thompson says, but the potential for reactions still exists.

People at risk should learn to recognize the symptoms of a possible reaction. “If you catch it early and avoid latex, it doesn`t get to the point where it is a life-threatening problem,” Thompson says. He also cautions users to be aware that the allergenicity of gloves can vary widely. A low-protein count does not necessarily guarantee a low-allergen glove.

Indeed, the issues surrounding latex allergy are complicated and not easily condensed. Mark Francois, director of investor relations for Safeskin Corp. (San Diego), points out that there are two types of allergies associated with latex gloves. The first is contact dermatitis, which results from contact with residue manufacturing chemicals. It is typically confined to the hands and will likely disappear when a worker switches to a low-residue latex or non-latex glove.

The second, more pernicious, allergic response is to the latex proteins themselves. It develops over time until the sufferer has a generalized sensitivity to latex. This condition can be controlled by substituting low-allergen latex or non-latex gloves, or by avoiding all contact with latex.

To minimize risk of either allergic response, cleanroom workers should use low-chemical, low-protein, powder-free latex gloves, Francois says. “If the worker is using a cleaner glove, there is less likelihood of having any allergic response.”


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