AT RISK FOR LATEX ALLERGY

AT RISK FOR LATEX ALLERGY

Many hospitals have adopted a policy restricting products made with natural rubber latex (NRL) in order to minimize the risk of latex-sensitive allergic reactions among patients and staff. NRL is manufactured mainly from the milky fluid of a rubber tree (Hevea brasiliensis) and contains variable amounts of proteins, which can be absorbed through the skin or inhaled. People who work frequently with medical supplies, such as nurses and lab technicians, are particularly at risk for extreme latex sensitivity because of their high exposure to rubber.

For some people, any contact with NRL can be life threatening. Sensitized workers can also develop occupational allergies—including respiratory, cardiovascular, and skin disorders—through contact with the proteins. Studies have also shown that cornstarch—which is added to latex gloves to facilitate donning and removal—as well as antioxidants, biocides, soaps, and other chemicals used in the processing of latex products can also contribute to sensitization.¹

Reported cases of latex allergy among healthcare workers and patients began rising significantly in the late 1980s with the sharp increase in the use of latex medical products, especially gloves, as a precaution against the spread of HIV, hepatitis B, and other infectious agents. The U.S. Centers for Disease Control and Prevention recommended in 1987 that blood and certain body fluids be treated as potentially infectious. The use of barrier protection was subsequently required by the U.S. Occupational Safety & Health Administration (OSHA) bloodborne-pathogens standard.

Attention was drawn to latex allergy in the United States after latex retention balloons used in barium enema procedures were blamed for several fatalities due to anaphylaxis.² A high incidence of intraoperative anaphylaxis among children with spina bifida has also been attributed to the high prevalence of latex allergy among these children, probably induced by early and repeated exposures to NRL.³

Multiple centers in different countries, using a variety of assessment instruments and criteria, have found that between 8 and 17% of exposed healthcare workers are at risk for latex reactions. Among the general population, prevalence rates of up to 7% for antibodies to NRL allergy have been recorded.⁴ Latex-allergy cases with severe skin and respiratory symptoms have been reported in dermatology, allergy, and pulmonary literature.

Allergic reactions to latex vary in severity from mild contact dermatitis (also known as Type-IV delayed hypersentitivity) to severe systemic (or Type-I) reactions—the most serious and potentially lethal. Symptoms range from mild irritation and delayed hypersensitivity in allergic contact dermatitis to immediate hypersensitivity in anaphylactic symptoms. Anaphylaxis is characterized by severe hypotension, rash, and bronchial spasm. Systemic allergic symptoms can include redness, itching, swelling of the lips and tongue, breathlessness, dizziness, nausea, abdominal pain, and shock.

In 1997, FDA issued a final rule that required labeling of medical devices containing NRL. Products and medical device packaging containing NRL are now required to carry a label declaring the presence of natural rubber latex and noting its potential for causing allergic reactions. FDA also prohibits the use of the word hypoallergenic on labeling of medical devices containing natural rubber.⁵ In 1999, OSHA issued a technical information bulletin to alert field personnel to the potential for allergic reactions in some individuals using natural rubber latex gloves and other products made from the material.⁶

Last year, Congress established National Latex Allergy Week to raise public awareness about latex allergy and the importance of early detection, proper management, and proper prevention tactics. The resolution also establishes funding for research into the causes of latex allergy and for improved diagnostic, management, and prevention strategies.⁷

The Consumer Product Safety Commission (CPSC) is currently considering a petition to request a rule declaring NRL a "strong sensitizer" under the Federal Hazardous Substances Act. That designation indicates that a substance has significant potential for causing hypersensitivity. The petition claims that individuals have developed latex allergies or suffered allergic responses through exposure to NRL in consumer products. In toys and other products intended for children, the petition asks the CPSC to declare NRL a "banned hazardous substance."⁸

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REFERENCES

1.Position statement, American College of Allergy, Asthma & Immunology, "Latex Allergy: An Emerging Healthcare Problem," Annals of ACAAI 75 (April 1995): 19–21.
2.D Gelfand, "Barium Enemas, Latex Balloons, and Anaphylactic Reactions," Am J Roentgenol 158 (1991): 1–2.
3.M Cawley et al., "Latex Hypersensitivity in Children with Myelodysplasia," [abstract] J Allergy Clin Immunol 93 (1994), 181.
4.National Institute for Occupational Safety and Health, Proposed Data Collections Submitted for Public Comment and Recommendations: Applying Schema Matching to Latex Allergy Prevention, Federal Register, 65 FR 247, 80879–80880, December 22, 2000.
5.US Food and Drug Administration, Federal Register Notice. Final Rule: Natural Rubber–Containing Medical Devices, User Labeling, 62 FR 189, 51021-51030, September 30, 1997.
6.OSHA Technical Information Bulletin, Potential for Allergy to Natural Rubber Latex Gloves and Other Natural Rubber Products, April 12, 1991.
7.U.S. House of Representatives, Concurrent Resolution 387, July 27, 2000.
8.Unified Agenda of the Consumer Product Safety Commission, Federal Register, 65 FR: 231 74830–74839, November 30, 2000.

Tilak M. Shah is president of Polyzen Inc. (Cary, NC), an independent developer of specialty polymer formulations and manufacturer of specialty disposable components and devices for medical industry OEMs. He has more than 30 years' experience working with polyurethane and other elastomers.

Photo courtesy of Polyzen Inc.