Accommodating latex allergy concerns in surgical settings

Esah S. Yip

Since the nineteenth century, nurses and physicians have used natural rubber latex gloves to protect themselves and their patients from the transmission of viruses and harmful infectious diseases. These gloves provide effective barrier performance, as well as durability, comfort, fit, and tactility. In the late 1980s, the use of latex gloves in health care facilities increased significantly due to concerns about transmission of the AIDS virus. This sudden upsurge in glove demand led to the production of many inadequately manufactured latex gloves that were high in residual proteins and excessively powdered--the type of gloves now known to cause serious allergic reactions in individuals who are latex sensitive. This problem has raised concern among both health care professionals and latex glove manufacturers. This article examines latex allergy issues, discusses research findings pertaining to the use of unproved gloves that can help alleviate allergy problems, and highlights the need for proper glove selection for effective barrier protection in the OR.

TYPES OF REACTION

Three types of reactions have been associated with the use of disposable medical gloves--irritant contact dermatitis, type IV reaction of delayed hypersensitivity, and type I reaction of immediate hypersensitivity. Only one of the three reactions--type I--is a reaction to latex proteins in natural rubber latex gloves. Type 1 reaction affects about 1% of the general population, (1) although its prevalence is 3% to 16% among health care workers. (2) Irritant dermatitis, which is a reaction to non-proteinaceous irritants, and type IV allergy, which is a reaction to certain residual chemicals employed during manufacture of medical gloves, are more likely to occur and potentially less serious. These reactions can occur with use of either natural rubber latex or synthetic gloves and should not be mistaken for latex protein allergy.

IRRITANT CONTACT DERMATITIS. Irritant contact dermatitis is a nonallergic reaction resulting from sensitivity to soap, hand cream, powder, disinfectants, and temperature and pH extremes. Symptoms include itching, skin rashes or flakiness, burning sensations, inflammation, or blister formation.

TYPE IV REACTION. Type IV reaction causes symptoms that are very similar to those of irritant contact dermatitis. The allergic reactions are caused by the presence of residual chemicals, such as accelerators belonging to types of thiuram, thiazoles, and carbonates, which often are used in the manufacture of both latex and synthetic gloves. The allergic reaction is cell-mediated, and it occurs within hours after contact with the allergens.

TYPE I REACTION. Type I reaction results from exposure to certain allergenic proteins. In contrast with type IV, type I is immunoglobulin E (IgE) mediated (ie, involving the Ige anti-bodies of the immune system). Type I reaction commonly is caused by proteins found in foods, such as peanuts, watermelons, bananas, avocados, potatoes, tomatoes, and some seafood. Type 1 reactions also can be elicited by insect bites, penicillin, and certain other medications. Latex proteins are a recent addition to this list. Studies also have shown that there can be cross-reactivity among allergens from foods and latex proteins; that is, individuals can become sensitized by exposure to proteins from one source and react when later exposed to another source.

Type I reactions usually occur within minutes of contact with allergens. Symptoms can vary from mild reactions, such as urticaria, hay fever, and allergic conjunctivitis, to asthma and, in rare cases, anaphylaxis.

If another type of medical glove could provide the barrier protection, tactile properties, and reasonable cost of natural rubber latex gloves, it is possible that the health care community might deal with latex allergy by simply replacing natural rubber latex gloves with synthetic substitutes. The superior performance of natural rubber latex gloves over many synthetics, however, has prompted researchers and manufacturers to investigate and work toward alleviating allergic reactions to provide the best possible protection for health care workers and their patients.

LATEX PROTEINS

Natural rubber latex gloves are made from latex, a milky sap that comes from the Hevea brasiliensis tree. It comprises about 30% rubber particles dispersed in a liquid medium that also contains small amounts of nonrubber substances, such as carbohydrates and minerals. The bulk of latex is water, and total proteins comprise about 1% of latex. Fewer than 5% of the proteins in latex have been identified and characterized to show IgE-binding activity. (3)

When latex is processed into gloves, many of the soluble proteins are lost, leaving only a small fraction in the product. It is this residual fraction of extractable proteins that is implicated in allergic reactions. Not all residual extractable proteins demonstrate allergenic activity. Furthermore, this residual fraction is water soluble and can be removed from the gloves by proper processing, particularly adequate leaching.

The production of high-protein, high-powdered gloves in the late 1980s is believed to be a result of improper leaching during some manufacturing processes. This resulted in a residual extractable protein content as high as 1,000 [micro]g per g to 2,000 [micro]g per g of gloves, as determined by the modified Lowry method, a test that is widely used for protein estimation of gloves. Positive clinical skin test reactions elicited by such high protein levels have been demonstrated in individuals who are latex sensitive. (4,5)

With advancements in manufacturing technologies, it is possible to reduce the residual extractable protein content in natural rubber latex gloves to less than 50 [micro]g per g of gloves. (6) Technologies now available include

* the use of low protein latex,

* the application of proper leaching protocols during processing,

* chlorination and/or polymer coating, and

* enzymatic or chemical treatment.

Powder-free natural rubber latex gloves, especially those treated by chlorination, have markedly reduced residual extractable protein fraction, due in part to the extensive washing adopted during the process of chlorination. Powdered or powder-free latex gloves with very low protein content often are associated with low allergen content. (7,8)

LOW-PROTEIN NATURAL RUBBER LATEX GLOVES

A number of recent independent hospital studies have shown that changing from high-protein, high-powder gloves to low-powder or powder-free natural rubber latex gloves that are low in protein and allergens resulted in dramatic decreases in the incidence of latex allergy. More importantly, the use of these improved gloves enabled workers who are latex sensitive to work alongside colleagues wearing natural rubber latex gloves. Other observations and conclusions from studies include the following.

* A reduction of aeroallergen levels in a work place to an undetectable level within 24 hours was reported by one study. Six of seven allergic individuals tested showed significant decreases in their latex-specific IgE antibodies. (9)

* Two of three nurses from an Ontario hospital who had stopped working because of latex allergy were able to return to work, and no extra costs were incurred from the change to low-protein natural rubber latex gloves during a three-year period. (10)

* Concentration of the latex allergen also was greatly reduced in a work site at the Mayo Clinic, Rochester, Minn. The number of latex allergy cases was reduced, and the change has allowed individuals with latex allergies to continue to work at their usual jobs. The change resulted in a cost savings of $200,000 per year at the clinic. (11)

* One study reported that providing a completely latex-free environment in most surgical suites may be unrealistic; however, a significant reduction in aeroallergen can be achieved by switching to low-allergen gloves. (12)

* The replacement of high-allergen latex gloves with very low-allergen latex gloves enabled all latex-allergic health care workers in one study to continue in their work assignments in a hospital. The prevalence of hand eczema also diminished significantly. Only a few clinicians who were latex allergic needed to use latex-free gloves during procedures, but none of them had symptoms from the low allergen latex gloves used by their coworkers, even though the gloves were powdered. (13)

* One study concluded that primary prevention of occupational natural rubber latex allergies can be achieved if a change to powder-free latex gloves with reduced protein levels is properly carried out and maintained. (14) Another study similarly concluded that latex sensitization can be controlled by exclusive use of powder-free latex or synthetic gloves. (15)

These research studies indicate that the development of low-protein, low-allergen natural rubber latex gloves has provided a solution for alleviating the latex allergy problem.

BARRIER PROTECTION

Although it is necessary to accommodate the specific needs of individuals who are latex sensitive, it is vital that the most important criteria for wearing gloves--to protect all health care personnel and their patients against viral transmission and infectious diseases--is not overlooked. In addition to one's skin, gloves function as a defense barrier for patients and health care providers. This is particularly critical during surgical procedures, when contamination by microorganisms must be minimized to avoid infection. The effectiveness of the barrier is directly related to the appropriate selection and use of gloves.

The majority of examination and surgical gloves used in health care facilities are made of natural rubber latex, because they offer a less expensive means of providing the needed barrier protection and other qualities essential for safe and effective performance (eg, comfort, fit, good grip, tactility, durability, ease of donning). Concerns about latex protein allergy, however, have caused a number of health care facilities to seek alternatives. Polyvinyl chloride (PVC) and nitrile synthetic examination gloves are available today; however, because of the inferior properties of PVC gloves in strength, fit, tactility and in-use barrier performance, (16-27) no surgical gloves are made of this material.

Synthetic surgical gloves made of neoprene, nitrile, polyurethane, thermoplastic co-polymer, and the newly developed polyisoprene also have been introduced into the marketplace. As properties of gloves vary depending on the materials from which they are made, it is important to make an informed choice when selecting gloves for safe use, especially with reference to their in-use barrier performance.

Information on the barrier integrity of medical gloves now is available, especially for the three common types of examination gloves--latex, PVC, and nitrile. Numerous studies have compared in-use barrier performance of medical gloves made from synthetic materials, particularly PVC, and natural rubber latex. Ten studies by various clinical researchers show that PVC examination gloves consistently leaked significantly more than natural rubber latex gloves. (16-25) In one report, 63% of PVC gloves leaked compared to 7% of natural rubber latex gloves. (17) Inferior barrier property also has been reported for polyethylene gloves. (18) On the other hand, nitrile gloves, made of a synthetic that more closely approximates the properties of latex, display better barrier performance than PVC. (23,24)

Effectiveness of gloves in providing protection against virus leakage when they are punctured with small-diameter needles also was studied. Both PVC and nitrile gloves were found to have high leakage rates (ie, 78% and 53%, respectively) compared to negligible or undetectable leakage by natural rubber latex gloves. (26) The resealing property of natural rubber latex has been confirmed by another study, which reported that the amount of viral penetration in PVC and nitrile gloves was significantly greater than in natural rubber latex gloves. (27)

The capability of synthetic surgical gloves, including neoprene, nitrile, copolymer, and polyisoprene gloves, to provide effective barrier protection also has been studied, (28-31) although not as frequently. Unlike PVC gloves, neoprene and nitrile gloves showed leakage rates comparable to latex gloves. Co-polymer had a viral leakage rate 1.5 to 2.7 times that of neoprene, (28) and polyisoprene had a viral leakage rate about five times higher than natural rubber latex and neoprene. (30)

Findings of these studies were summed up by Denise Korniewicz, RN, DNSc, FAAN, in her presentation at a recent international glove conference.

   Although non-latex surgical gloves
   provide basic barrier protection, the
   rate at which they break or tear while
   performing routine surgery makes
   them inferior to latex surgical gloves....
   the data clearly supports high
   quality surgical latex gloves as the
   glove material of choice and the use
   of nonlatex gloves for patients and
   health care workers who are allergic
   to latex. (32)

There are many good reasons why health care workers who are not sensitive to latex proteins should use latex gloves that are low-protein, low-allergen, and low-powder or powder-free. The recommendation to use low-protein, low-allergen, powder-free gloves whenever latex gloves are needed is supported by many organizations, such as the National Institute for Occupational Safety and Health; (33) AORN; (34) the American Nurses Association; (35) and the American College of Allergy, Asthma & Immunology. (36) Synthetic gloves also should be stocked, however, and used by health care workers when they care for patients who have been diagnosed with or are at risk for developing a type I allergy and by health care workers who themselves have been diagnosed with a type I allergy to latex proteins.

NOTES

(1.) G M Liss, G L Sussman, "Latex sensitization: Occupational versus general population prevalence rates," American Journal of Industrial Medicine 35 (February 1999) 196-200.

(2.) K Turjanmaa et al, "Natural rubber latex allergy" (Review) Allergy 51 (September 1996) 593-602.

(3.) H Alenius, K Turjanmaa, T Palosuo, "Natural rubber latex allergy," Occupational and Environmental Medicine 59 (June 2002) 419-424.

(4.) E Yip et al, "Allergic responses and levels of extractable proteins in NR latex gloves and dry rubber products," Journal of Natural Rubber Research 9 no 2 (1994) 79-86.

(5.) E Yip, G L Sussman, Allergenicity of latex gloves with reference to latex protein sensitive individuals in a Canadian population," Journal of Natural Rubber Research 3 no 3 (2000) 129-141.

(6.) E Yip, P Cacioli, "The manufacture of gloves from natural rubber latex," Journal of Allergy and Clinical Immunology 110 no 2 suppl (August 2002) S3-14.

(7.) E Yip et al, Correlation between total extractable proteins and allergen levels of natural rubber latex gloves, Journal of Natural Rubber Research 12 no 2 (1997) 120-130.

(8.) T Palosuo et al, "Measurement of natural rubber latex allergen levels in medical gloves by allergen-specific IgE-ELISA inhibition, RAST inhibition, and skin prick test," Allergy 53 (January 1998) 59-67.

(9.) H Allmers et al, "Reduction of latex aeroallergens and latex-specific IgE antibodies in sensitized workers after removal of powdered natural rubber latex gloves in a hospital," Journal of Allergy and Clinical Immunology 102 (November 1998) 841-846.

(10.) S M Tarlo et al, "Outcomes of a natural rubber latex program in an Ontario teaching hospital," paper presented at the 56th annual meeting of the American Academy of Asthma, Allergy, and Immunology, 5 March 2000.

(11.) L W Hunt et al, "Management of occupational allergy to natural rubber latex in a medical center: The importance of quantitative latex allergen measurement and objective follow-up," Journal of Allergy and Clinical Immunology 110 no 2 suppl (August 2002) S96-106.

(12.) B A Elliott, "Latex allergy: The perspective from the surgical suite," Journal of Allergy and Clinical Immunology 110 no 2 suppl (August 2002) S117-120.

(13.) K Turjanmaa et al, "Long-term outcome of 160 adult patients with natural rubber latex allergy," Journal of Allergy and Clinical Immunology 110 no 2 suppl (August 2002) S70-74.

(14.) H Allmers, J Schmengler, C Skudlik, "Primary prevention of natural rubber latex allergy in the German health care system through education and intervention," Journal of Allergy and Clinical Immunology 110 (August 2002) 318-323.

(15.) K J Kelly et al, "A four-year prospective study to evaluate the efficacy of glove interventions in preventing natural rubber latex sensitization in healthcare workers at two hospitals," (Abstract) Journal of Allergy and Clinical Immunology 111 part 2 no 2 (2003) 426.

(16.) D M Korniewicz et al, "Integrity of vinyl and latex procedure gloves," Nursing Research 38 (May/June 1989) 144-146.

(17.) D M Korniewicz et al, "Leakage of virus through used vinyl and latex examination gloves," Journal of Clinical Microbiology 28 (April 1990) 787-788.

(18.) R C Klein, E Party, E L Gershey, "Virus penetration of examination gloves," Biotechniques 9 (August 1990) 196-199.

(19.) R J Olsen et al, "Examination gloves as barriers to hand contamination in clinical practice," JAMA 270 (July 21, 1993) 350-353.

(20.) D M Korniewicz, "Leakage of latex and vinyl exam gloves in high and low risk clinical settings," America Industrial Hygiene Association Journal 54 (January 1993) 22-26.

(21.) D M Korniewicz et al, "Barrier protection with examination gloves: Double versus single," American Journal of Infection Control 22 (February 1994) 12-15.

(22.) A Douglas, T R Simon, M Goddard, "Barrier durability of latex and vinyl medical gloves in clinical settings," American Industrial Hygiene Association Journal 58 (September 1997) 672-676.

(23.) A Rego, L Roley, "In-use barrier integrity of gloves: Latex and nitrile superior to vinyl," American Journal of Infection Control 27 (October 1999) 405-410.

(24.) D M Korniewicz et al, "Performance of latex and non-latex examination gloves during simulated use," American Journal of Infection Control 30 (April 2002) 133-138.

(25.) M A Baumann et al, "The permeability of dental procedure and examination gloves by an alcohol based disinfectant," Dental Materials: Official Publication of the Academy of Dental Materials 16 (March 2000) 139-144.

(26.) H Hasma, A B Othman, "Barrier performance of NR, vinyl and nitrile gloves on puncture," paper presented at the Inter national Liquid Elastomers Conference; Latex 2001, Munich, 4-5 Dec 2001.

(27.) J M Broyles, K P O'Connell, D M Korniewicz, "PCR-based method for detecting viral penetration of medical exam gloves," Journal of Clinical Microbiology 40 (August 2002) 2725-2728.

(28.) S W Newsom, M O Smith, P Shaw, "A randomised trial of the durability of non-allergenic latex-free surgical gloves versus latex gloves," Annals of the Royal College of Surgeons of England 80 (July 1998) 288-292.

(29.) K O'Connell et al, "Testing for viral penetration of non-latex surgical and exam gloves: A comparison of three methods," in press.

(30.) D M Korniewicz, L Garzon, M Feinleib, "Failure rates in latex and non-latex surgical gloves," in press.

(31.) D M Korniewicz et al, "A laboratory based study to assess the performance of surgical gloves," AORN Journal 77 (April 2003) 772-779.

(32.) D M Korniewicz, "Barrier integrity of gloves: Use of laboratory and clinical methods to determine barrier effectiveness," paper presented at the International Rubber Glove Conference 2002, Kuala Lumpur, Malaysia, 10-12 Sept 2002.

(33.) NIOSH Alert: Preventing Allergic Reactions to Natural Rubber Latex in the Workplace, no 97-135 (Washington, DC: US Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, 1997).

(34.) "AORN latex guideline," in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2003) 103-116.

(35.) "Position statements: Latex allergy," American Nurses Association, http://nursingworld.org/readroom/position/workplac/wklatex.htm (accessed 27 Aug 2003).

(36.) "Latex Allergy--An emerging healthcare problem. Latex Hypersensitivity Committee, Annals of Allergy, Asthma & Immunology 75 (July 1995) 19-21.

Esah S. Yip, DSc, is the director, Washington office, Malaysian Rubber Export Promotional Council, Washington, DC.

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