Allergy to natural rubber latex (NRL) has emerged as a significant occupational and public health issue. At this time it is estimated that from 1% to 6% of the general population and from 8% to 17% of the healthcare worker population are latex allergic. Certain populations are much more likely to develop latex allergy, such as persons born with congenital anomalies; those having experienced numerous operative or invasive procedures, especially as a child; or those with multiple allergies who have been exposed to NRL.
Latex allergy develops after repeated exposure to natural rubber latex products. As the extent and frequency of exposure to natural rubber latex increases, the potential for NRL sensitization and allergy increases. Continuing exposure of non-sensitized individuals to NRL promotes latex sensitization. Continuing exposure of sensitized individuals to NRL products promotes the further development of latex allergy. The amount of latex exposure needed to produce sensitization and allergy is unknown. Following implementation of the OSHA Bloodborne Pathogen Standard, utilization of latex gloves increased tenfold. Increased NRL glove use exposed and sensitized more health care workers and patients to NRL.
Experts believe natural rubber latex gloves are the most significant source of NRL exposure, sensitization, and allergy in the health care environment. Use of natural rubber latex gloves exposes patients and health care workers to NRL allergens via both direct and indirect routes. Direct routes of exposure include cutaneous, mucosal, percutaneous and parenteral routes. Indirect exposure occurs when natural rubber latex proteins become attached to or absorbed by the powder in gloves and other powdered NRL products. When powdered gloves are handled in any way, the box opened, the gloves donned or removed, the powder becomes airborne and inhaled or may settle on food and be ingested. Ingestion and inhalation are indirect routes of NRL exposure.
All medical exam and surgical (sterile) gloves are regulated by the FDA as medical devices and must meet certain standards. The current standards for medical gloves do not address protein content, allergenicity, residual powder limits, viral penetration, use of chemical accelerators, or other important areas. The FDA has proposed that medical gloves be reclassified as Class II medical devices with stricter regulatory controls and has recommended standards for protein and powder content of NRL gloves. The implementation of the standards is not assured at this time. Governmental agencies and professional organizations generally agree if NRL gloves are used, they should be of a low protein, low allergen variety and that powdered NRL gloves should be eliminated. Since September 1998, medical products containing NRL must be labeled. Currently, manufacturers of consumer products containing NRL are not required to inform consumers of this fact.
Allergy to NRL products is exhibited in a variety of ways, with both acute and chronic symptoms ranging from mild to severe. Allergy to the chemicals used in the processing of NRL gloves is manifested as allergic contact dermatitis, also known as Type IV allergy and delayed hypersensitivity. Type IV allergy is not a true natural rubber latex allergy. Acute symptoms of Type IV hypersensitivity include itching, redness, swelling, blisters that may break and ooze, and crusting. Acute symptoms resemble poison ivy, both immunologically and in appearance. Type IV acute symptoms may evolve into chronic symptoms of dry, cracked, thickened, peeling skin with crusting, scabbing and blisters. Reaction sites are usually limited to the area of contact, but may spread. There is no systemic involvement.
Persons with Type I latex protein allergy exhibit symptoms that may occur at the area of contact and/or may be systemic. Type I reactions include, but are not limited to: rhinitis, conjunctivitis, hives, angioedema, asthma, intestinal disorders, and anaphylaxis. Approximately half of the people who develop Type I latex protein allergy develop latex-related occupational asthma. Symptoms of Type IV hypersensitivity and Type I allergy may both be exhibited by the same person.
Diagnosis of NRL allergy is not always straightforward. Several types of tests are currently used. Blood tests for NRL allergy have varying levels of reliability. Skin testing for NRL allergy is problematic. There is no FDA approved NRL latex allergen extract available in the US to standardize NRL skin testing. Challenge testing may help to clarify latex allergy in ambiguous cases. Both skin and challenge testing run the risk of provoking severe allergic reactions in allergic individuals. Experts agree that the best indicator for the diagnosis of natural rubber latex allergy is patient history.
There is no cure for NRL allergy. There is no desensitizing therapy available for NRL allergy. Prevention, early diagnosis, and subsequent avoidance of all contact with NRL are essential to prevent patients and health care workers from becoming sensitized to NRL and developing NRL allergy. NRL allergy should be prevented from disrupting people's lives, negatively affecting their health status, and depriving them of safe health care or preferred employment.
The New York State Nurses Association believes that latex sensitization and allergy are preventable through avoidance of Natural Rubber Latex (NRL). To accomplish this:
Employers have a responsibility to provide a workplace in which all efforts have been made to eliminate recognized occupational health hazards, including exposure to NRL. This includes development, adoption and implementation of appropriate policies and procedures, use of personal protective equipment, and staff education.
Employees have the right to participate in the identification of existing occupational hazards and in the development and implementation of efforts to eliminate recognized occupational hazards, including NRL.
All persons have the right to safe health care and to expect that all efforts have been made to eliminate the hazards associated with receiving health care, including but not limited to:
Employers have the responsibility to make reasonable accommodations for workers affected or disabled by NRL allergy, including but not limited to: utilization of latex alternative products; removal or abatement of latex contamination throughout the health care environment; provision of health, compensation, and disability benefits as appropriate; reassignment as needed to meet the health care workers' needs and within the confines of collective bargaining agreements that exist; and rehabilitation and vocational training as appropriate and necessary.
Consumers have the right to information regarding the contents, ingredients and materials used in the manufacture or preparation of goods and services through highly visible, easily understood labeling.
Efforts should be made by governmental agencies and professional and trade organizations to eliminate the inappropriate use of natural rubber latex products, including gloves and other products, and to educate the public about the potential for sensitization and allergy development related to exposure to NRL products.
The FDA proposal limiting protein content in NRL medical gloves should be accepted as currently proposed. However, any future revisions to the proposal should include eliminating powder from NRL medical gloves and recommendations from reputable sources regarding viral penetration, chemical barrier protection and other appropriate criteria, as this information becomes available.
Further research is needed regarding the development of sensitivity and allergy to NRL; prevention, diagnosis and treatment of latex allergy; medical glove requirements and alternatives to natural rubber latex.
Facilities that fail to keep patients safe by not taking all necessary actions to prevent patient harm from NRL allergy should be reported to the NYS Department of Health and Joint Commission on Accreditation of Healthcare Organizations.
Facilities that fail to keep employees safe by not taking all necessary actions to prevent employee harm from NRL allergy should be reported to OSHA or the NYS Department of Labor's Public Employee Safety and Health program.
All healthcare facilities and agencies establish multidisciplinary latex allergy workgroups. The workgroups should include representatives from administration, nursing, medicine, pharmacy, respiratory therapy, dietary, central supply, housekeeping and all high risk clinical specialty areas and, also, when appropriate, labor unions.
A "latex resource person," preferably a registered nurse, should be identified to facilitate the work of the latex allergy workgroup and act as the institutional contact for latex related questions and issues.
The latex allergy workgroup should:
NYSNA is committed to creating safe health care environments in which registered nurses and others work and patients can receive care. Eliminating the hazard of Natural Rubber Latex (NRL) product use in health care will eliminate NRL exposure, sensitization and allergy.
Approved by the NYSNA Board of Directors, 1/18/00. This statement was developed under the direction of the Council on Nursing Practice.
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For more information on nursing practice, contact NYSNA's Education, Practice and Research Program at 518.782.9400, ext. 282 or by e-mail.