Please Note: This Technical Information Bulletin
(TIB) is currently under review by OSHA. OSHA is reviewing the medical
literature and studies. Among other issues, OSHA is assessing the accuracy of
the TIB's use of dissimilar terms interchangeably, and examining the TIB's
reliance on protein levels rather than allergen level as the relevant factor
for determining the allergenicity of natural rubber latex gloves. This TIB
will be revised as appropriate. The updated TIB will be available soon. April 12, 1999 MEMORANDUM FOR: REGIONAL ADMINISTRATORS THROUGH: R. DAVIS LAYNE Deputy Assistant Secretary FROM: STEVEN F. WITT Director Directorate of Technical Support SUBJECT: Technical Information Bulletin(1): Potential for Allergy to Natural Rubber Latex Gloves and other Natural Rubber Products
This
technical information bulletin is intended to alert field personnel to the
potential for allergic reactions in some individuals using natural rubber
latex (NRL) products, particularly gloves, in the workplace setting. Natural
rubber is utilized in a variety of products including gloves, airways, airway
masks, medication vial tops, anesthesia bags, various catheters, supplies for
intravenous use, dental dams, balloons, and other products.1,2, 3 NRL glove use in the health care
setting has risen dramatically since about 1987, due to the increased threat
of contracting HIV, hepatitis B, and other infectious agents in the course of
delivering health care to patients and the need for barrier protection.1,4 Thus, the frequency of exposure
to NRL among health care and other workers has increased. NRL
products are also used to provide barrier protection from some chemicals and
other agents in health care and other environments. (NOTE: While NRL gloves
are useful for certain purposes, they are not universally suitable. The
properties of a glove material for a specific use must be determined in
advance of use. Gloves appropriate for protection from the particular
chemical or agent must be used.) NRL gloves are also used to prevent
contamination of products in some workplaces (e.g., electronics and drug
manufacturing). Natural rubber articles are manufactured in some workplaces
(e.g., manufacturers of medical gloves, industrial gloves, balloons, rubber
bands, boots and shoes, and many other products). With
more widespread use of NRL gloves, there has been an increase in reported NRL
allergies, among patients as well as among workers, notably health care
workers. Rarely, these allergies can be fatal. In addition to reports from
the dermatology, allergy, and pulmonary literature of severe skin and
respiratory symptoms, life threatening reactions to NRL products have been
noted in pediatric patients with spina bifida who had undergone numerous
surgical procedures, resulting in repeated NRL exposure.5,6, 7 In addition, the US Food and Drug
Administration (FDA) received reports of numerous severe allergic reactions,
including several deaths, associated with exposure to NRL enema cuffs in
providing care to sensitized patients.8 NRL
is manufactured from a variety of plants, but mainly the rubber tree, Hevea
brasiliensis. The milky fluid from the tree contains variable amounts of
proteins which may be absorbed through the skin or inhaled and cause allergic
reaction in susceptible workers. NRL contains many proteins. A number of
these proteins, such as hevamine, hevein, and rubber elongation factor (REF),
may initiate allergic reaction to NRL. Studies have indicated that corn
starch powder, added to gloves to facilitate donning and removal, can serve
as a carrier for the allergenic proteins from the NRL. 2,3,9 In
addition, gloves, including those made from NRL as well as some other
materials, may contain chemical accelerators such as thiuram, carbamates, and
benzothiazoles to which a worker may also develop sensitization, resulting in
allergic contact dermatitis. Antioxidants, biocides, soaps, and other
chemicals used in the processing of NRL products may contribute to
sensitization as well. In
1987 the Centers for Disease Control and Prevention (CDC) recommended
universal precautions, the concept that blood and certain body fluids from
all individuals should be approached as if potentially infectious. The use of
barrier protection was subsequently required by OSHA's bloodborne pathogens
standard. The increased use of latex gloves in a variety of settings greatly
increased the exposure of health care workers to NRL.1,4 The
two major routes of exposure include dermal exposure and inhalational
exposure. NRL protein absorption has been reported to be enhanced when
perspiration collects under latex clothing articles.10 Exposure may also occur by the
respiratory route, particularly when glove powder acts as a carrier for NRL
protein which becomes airborne when the gloves are donned or removed. 2,3,9 Some investigations have
indicated that powder free gloves with reduced protein content reduce risk of
development of NRL allergy.11 Some questions regarding powder free glove
shelf life and ease of use have arisen and are being addressed. Importantly,
only non-NRL gloves must be used by those workers who are allergic to NRL. The
majority of health care workers are able to use NRL products to care for most
patients. Variations exist in the reported prevalence of NRL allergy. This
variation is probably due to different levels of exposure and methods of
estimating latex sensitization or allergy. Nevertheless, prevalence studies
indicate that from around 6% to 17% of the exposed health care workforce is
allergic to NRL.5,12, 13,14, 15 In a survey of active duty dental
officers in the U.S. Army, the prevalence of allergic symptoms correlated
with NRL use was reported to be 13.7%.16 An investigation of dental workers
using NRL skin prick testing at two consecutive American Dental Association
meetings revealed allergic responses in 9.1-9.7% of dental hygienists and
assistants, although dentists showed a lower rate of 5.1-6.7%.17 The general population exhibits a
lower rate of NRL sensitization (approximately 1 to 6%). 18,19 These prevalence statistics are
based on seroprevalence as well as skin test positivity and/or allergic
manifestations and do not refer to the more serious anaphylactic response,
which is rare but potentially life threatening in some individuals. In
addition to dentists, health care workers reported to have especially high
risks include operating room personnel consistently exposed to NRL (i.e.,
operating room nurses, physicians, and technicians).3,1818 NRL allergy has also been
reported in greenhouse workers, 20hairdressers,21 doll manufacturing workers,22 and workers in a glove
manufacturing plant,23 and may pose a risk to others as well.24 Use
of natural rubber products may result in several varieties of reactions (see
table). These reactions include irritant and several types of allergic
reactions. They can vary from localized redness and rash to nasal, sinus, and
eye symptoms to asthmatic manifestations including cough, wheeze, shortness
of breath, and chest tightness; and rarely, systemic reactions with swelling
of the face, lips, and airways that may progress rapidly to shock and,
potentially, death. When
gloves are associated with skin lesions, the most common reaction is irritant
contact dermatitis. Irritant contact dermatitis may be due to direct
irritation from gloves or glove powder, but may also be due to other causes,
such as irritation from soaps or detergents, other chemicals, or incomplete
hand drying. Irritant contact dermatitis presents as dried, cracked, split
skin. Although irritant contact dermatitis is not in itself an allergic
reaction, the breaking of the intact skin barrier due to these lesions may
afford a pathway for latex proteins to gain access, and thus promote
development of allergy.25 The
second type of reaction that may be associated with glove use is allergic
contact dermatitis (also known as type IV delayed hypersensitivity or
allergic contact sensitivity). When glove use has been associated with this
reaction, it appears to be due to the chemicals used in processing NRL or
other glove materials. The allergic contact dermatitis has an appearance
similar to the typical poison ivy reaction, with blistering, itching,
crusting, oozing lesions. Also, like poison ivy, this dermatitis may appear a
day or two after the use of gloves or exposure to other sources of chemical
sensitizers. The
third and potentially most serious type of reaction sometimes associated with
glove use is a true IgE/histamine-mediated allergy (also called immediate or
type I hypersensitivity) to glove protein [in the case of NRL allergy, to NRL
protein(s)]. This type of reaction can involve local or systemic symptoms. Localized
symptoms include contact urticaria (hives) which appear in the area where
contact occurred (in the case of gloves, the hands), but which can spread
beyond that area and become generalized. More generalized reactions include
allergic rhinoconjunctivitis and asthma. The presence of allergic
manifestations to NRL indicates an increased risk for anaphylaxis, a rare but
serious reaction experienced by some individuals who have developed an
allergy to certain proteins (e.g., insect stings, natural rubber,
penicillin). This type I reaction can occur within seconds to minutes of
exposure to the allergen (in the case of NRL, to natural rubber proteins)
either by touching a product with the allergen (e.g., gloves) or by inhaling
the allergen (e.g., powder to which natural rubber proteins from gloves have
adsorbed). When such a reaction occurs, it can progress rapidly from swelling
of the lips and airways to shortness of breath, and may progress to shock and
death, sometimes within minutes. While any of these signs and symptoms may be
the first indication of allergy, in many workers with continued exposure to
the allergen (in the case of NRL allergy, to natural rubber proteins), there
is progression from skin Types of Reactions
(contact
urticaria) to respiratory symptoms over a period of months to years. Some
studies indicate that individuals with latex allergy are more likely than
latex non-allergic persons to be atopic (have an increased immune response to
some common allergens, with symptoms such as asthma or eczema. 26 Once NRL allergy occurs, allergic
individuals continue to experience symptoms, which have included
life-threatening reactions, not only on exposure to NRL in the workplace but
also upon receiving or accompanying a family member receiving health care
services at inpatient as well as office-based settings. In addition, such
reactions have occurred on exposure to consumer goods such as balloons,
condoms, and other products. Moreover, some affected individuals continue to
experience asthmatic symptoms even without contact with NRL. Therefore,
development of allergy to NRL in an individual has lifestyle implications
beyond the workplace. Recommended Strategies
- Risk Reduction It
is of primary importance that barrier protection be used when hands would
otherwise contact infectious materials or hazardous chemicals. OSHA's
bloodborne pathogens standard requires that gloves be worn when it is
reasonably anticipated that hand contact may occur with blood, other
potentially infectious materials, mucous membranes, non-intact skin, or
contaminated items or surfaces, as well as when performing most vascular
access procedures [29 CFR 1910.1030, paragraph (d)(3)(ix)]. NRL is a glove
material that has been used in the health care environment for barrier
protection for a number of years. In response to reported NRL allergy in some
patients and health care workers, measures have been recommended to reduce
the risk of NRL allergy in workers. Primary
prevention involves reducing potential development of allergy by reducing
unnecessary exposure to NRL proteins for all workers. Food service workers or
gardeners, for example, do not need to use NRL gloves for food handling or
gardening purposes. Gloves made of NRL as well as synthetic materials have
been cleared for marketing as medical gloves by the FDA and can be used
effectively for barrier protection against bloodborne pathogens. General
administrative procedures(2A) that an institution can follow to reduce
worker exposure to NRL proteins include: (1) If selecting NRL gloves for worker use, designating NRL as a
choice only in those situations requiring protection from infectious agents; Providing
alternative suitable non-NRL gloves as choices for worker use (and as
required by OSHA's bloodborne pathogens standard [29 CFR 1910.1030, paragraph
(d)(3)(iii)] for workers who are allergic to NRL gloves). Use
of powder free gloves has been shown to reduce the dissemination of NRL
proteins into the environment and decrease the likelihood of reactions by
both the inhalation and dermal routes.2,27 Appropriate work practices when
wearing hand protective equipment, including NRL gloves, include avoidance of
contact with other body areas such as the eyes or face. Handwashing after
glove removal is required by OSHA's Bloodborne Pathogens Standard [paragraph
(d)(2)(v)] and helps to minimize powder and/or NRL remaining in contact with
the skin. Thorough clean-up of any residual powder in the workplace with
appropriate vacuum filters will decrease employees' exposure as well. Since
the reason for wearing gloves is to provide barrier protection from hazardous
substances, substitute materials must maintain an adequate barrier protection
and be appropriate for the hazard. At a minimum, gloves made from NRL or
other materials and used for a medical purpose should be labeled as medical
gloves. Such gloves must meet the FDA criteria for marketing, manufacturing,
and testing of medical gloves. The Health Industry Manufacturers Association
(HIMA), in conjunction with the FDA, has proposed general guidelines for use
of medical gloves with some recommendations for those individuals who are
allergic to natural rubber.28 One
institution has reported that a coordinated effort to identify NRL sensitive
individuals and reduce the use of "high allergenic" natural rubber
latex gloves substantially reduced aeroallergen levels and costs.4 Other investigators have reported
that some NRL allergic workers have been able to work wearing nonlatex gloves
when their coworkers wore powder free latex gloves. 29 Effective
September 30, 1998, the FDA requires labeling statements for medical devices
which contain natural rubber and prohibits the use of the word
"hypoallergenic" to describe such products.8 NRL gloves with a reduced level of
chemical accelerators must be labeled to eliminate confusion associated with
the "hypoallergenic" claim and to provide more specific information
to the user. Some NRL gloves and other devices produced before the effective
date of the FDA regulation may not carry the NRL labeling or may be labeled
"hypoallergenic". Such products may still be in use in some
facilities. It should be noted that such products should not be presumed to
be NRL free. The hypoallergenic claim referred to the chemical additives, and
such gloves may be powder free; however, they contain the NRL proteins to
which NRL allergic workers react.30 The FDA is currently exploring
options for reducing exposure to NRL proteins and powder. It is important to
note that these FDA regulations do not apply to non-medical devices,
including utility gloves. Recommended Worker
Evaluation and Management The
administrative procedures outlined above may not be sufficient to protect all
individuals who have already developed NRL allergy. The American College of
Allergy, Asthma, and Immunology has suggested that "safe zones" (areas
in which non-NRL products are used and NRL proteins have been thoroughly
removed from the environment) may be needed to protect those workers who are
already sensitized to NRL.5 Health care facilities should develop policies and procedures for
reducing the risk of NRL allergies in the workplace. Prudent risk reduction
strategy involves an initial survey and assessment, with a coordinated effort
to identify and catalogue all NRL products used in the workplace. An ongoing
program, involving close coordination with resource and materials management
staff, should be established to monitor the NRL content of incoming products
so that management staff can be prepared to choose appropriate products for
offering non-NRL alternatives to control NRL exposure as well as for creating
NRL safe zones.2 Mechanisms for reporting and managing cases should be in place. It
is not possible, at present, to determine which workers will become allergic
to NRL proteins, the extent of an individual worker's reaction, or the length
of time required for such allergic reactions to develop.3 It is also not possible, at present,
to predict who will progress from local contact urticaria to the more
dangerous allergic reactions, nor when this may occur. 2,3 Laboratory
and clinical evidence indicates that an association exists between allergy to
natural rubber proteins and allergy to certain foods and plants (e.g.,
avocado, banana, kiwi, chestnut) 31 and some aeroallergens (e.g.,
pollens, grasses).32 A history of multiple surgeries has also been reported to be a risk
factor for NRL allergy.2, 5 In
some institutions, periodic screening questionnaires for symptoms of NRL
allergy in workers with current or past history of significant NRL exposure
(e.g., surgical personnel) have been useful for ascertaining reaction rates
and managing those individuals experiencing reactions. 3,5,30 A medical evaluation of hand
dermatitis, by a physician experienced in dermatologic diagnoses, is
essential for taking preventive steps and assuring effective therapeutic
measures. Evaluation of signs/symptoms associated with latex allergy should
be accomplished under the direction of a physician with expertise in NRL
allergy, with additional medical testing and treatment made available if
indicated. Provision
of latex-free procedure trays and crash carts for treatment of natural rubber
allergic individuals has been recommended.5 Although the fundamentals of
emergency response (i.e.,
assuring airway, breathing, and circulation) remain of primary importance
should a worker develop symptoms (including those caused by NRL allergy)
requiring resuscitation, these situations should be anticipated in the
workplace and provision of immediate access to non-natural rubber containing
equipment considered. Information
Availability Investigation
continues into various aspects of NRL allergy; our understanding of some
issues continues to evolve. Meanwhile, workers and workplaces need to be
aware of the present state of knowledge regarding NRL allergy and methods of
protection. Workers should be advised of symptoms of NRL allergy as well as
primary and secondary preventive measures for decreasing the risk of NRL
allergy development and NRL allergic reactions in workers who are allergic. The
National Institute for Occupational Safety and Health (NIOSH) published a
1997 Alert titled Preventing Allergic Reactions to Natural Rubber Latex in
the Workplace (NIOSH publication number 97-135). NIOSH can be reached by
calling 1-800-35-NIOSH (800-356-4674). OSHA
field staff and consultation personnel should be aware of the potential for
NRL allergy in workers exposed to NRL products. Please
distribute this bulletin to all Area Offices, State Plan States, and
Consultation Projects. Copies of this TIB may be used for outreach purposes. This
technical information bulletin (TIB) is not a new standard or regulation. This
TIB is advisory in nature and informational in content. The failure to
implement a specific recommendation in this TIB is not in itself a violation
of the General Duty Clause of the OSH Act. The General Duty Clause [Section
(5)(a)(1)] requires each employer to furnish to each employee employment and
a place of employment which are free from recognized hazards that are causing
or are likely to cause death or serious physical harm to his employees. LATEX
REFERENCES 1. Hunt
LW, Fransway AF, Reed CE, et al. An epidemic of occupational allergy to latex
involving health care workers. J Occup Environ Med. 1995 Oct; 37(10):1204-9 2. McCormack B, Cameron
M, Biel L. Latex sensitivity: an occupational health strategic plan. AAOHN J. 1995 Apr;
43(4): 190-6 3. Korniewicz DM, Kelly KJ. Barrier
protection and latex allergy associated with surgical gloves. AORN J. 1995
June; 61(6): 1037-44 4. Hunt LW, Boone-Orke
JL, Fransway AF, et al. A medical-center-wide,
multidisciplinary approach to the problem of natural rubber latex allergy. J
Occup Environ Med. 1996 Aug; 38(8): 765-70 5. American College of
Allergy, Asthma, and Immunology position statement. Latex
allergy - an emerging health care problem. Ann Allergy Asthma Immunol. 1995 Jul; 75(1):19-21 6. Kelly KJ, Setlock M,
Davis JP. Anaphylactic reactions during general anesthesia
among pediatric patients - United States. MMWR 1991; 40:437-43 7. Cawley M, Shah S,
Gleeson R, et al. Latex hypersensitivity in children with
myelodysplasia. J Allergy Clin Immunol. 1994; 93:181 8. US Food and Drug
Administration. Federal Register Notice. Final Rule:
Natural Rubber- Containing Medical Devices; User Labeling. 1997 Sept 30;
62(189): 51021-51030 9. Tomazic VJ, Shampaine
EL, Lamanna A, et al. Cornstarch powder on latex products
is an allergen carrier. J Allergy Clin Immunol. 1994; 93: 751-8 10. Turjanmaa K, Laurila
K, Makinen-Kiljunen S, Reunala T. Rubber contact urticaria. Allergenic
properties of 19 brands of latex gloves. Contact Dermatitis 1988; 19:362-7 11. Levy DA, Allouache S, Brion
M, et al. Effect of powdered vs. nonpowdered latex gloves on the prevalence of
latex allergy in dental students. J Allergy Clin Immunol. 1998; 101(1-p2):
S160 12. Yassin MS, Lierl MB,
Fischer TJ, et al. Latex allergy in hospital employees. Ann
Allergy 1994; 72: 245-9 13. Kaczmarek RG,
Silverman BG, Gross TP, et al. Prevalence of
latex-specific IgE antibodies in hospital personnel. Ann Allergy 1996;
76:51-6 14. Kibby T, Akl M.
Prevalence of latex sensitization in a hospital employee population. Ann Allergy 1997; 78:41-4 15. Lagier F, Vervloet D,
Lhermet I, et al. Prevalence of latex allergy in operating room nurses. J Allergy Clin Immunol. 1992; 90:319-22 16.
Berky ZT, Luciano WJ, James WD. Latex glove allergy: a survey of the US Army
Dental Corps. JAMA 1992; 268: 2695-7 17. Hamman CP, Turjanmaa
K, Rietschel R, et al. Natural rubber latex
hypersensitivity: incidence and prevalence of type I allergy in the dental
professional. JADA 1998 Oct; 129:43-54 18. NIOSH Alert:
Preventing Allergic Reactions to Natural Rubber Latex in the Workplace. US Department of Health and Human Services (NIOSH)
Publication No. 97-135, 1997; 7 19. Nightingale SL. From
the Food and Drug Administration Office of Health Affairs.
JAMA 1995 May 24-31;
273(20): 1564 20. Carillo T, Blance C,
Quiralte J, et al. Prevalence of latex allergy among greenhouse
workers. J Allergy Clin
Immunol. 1995 Nov; 96(5-p1): 677-86 21. Van der Walle HB, Brunsveld VM. Latex
allergy among hairdressers. Contact Dermatitis. 1995 Mar; 32(3):177-8 22. Orfan NA, Reed R, Dykewicz
MS, et al. Occupational asthma in a latex doll manufacturing plant. J Allergy
Clin Immunol. 1994 Nov; 94(5): 826-30 23. Tarlo SM, Wong L,
Roos J, Booth N. Occupational asthma caused by latex in a
surgical glove manufacturing plant. J Allergy Clin Immunol. 1990; 85(3):
626-31 24. Williams PB, Akasawa
A, Dreskin S, Selner JC. Respirable tire fragments contain
specific IgE-binding and bridging latex antigens. Chest 1996 Mar; 109(3
suppl): 13s 25. Forrester BG. Rubber
contact urticaria. Occupational Medicine: State of the Art Reviews. 1994 Jan-Mar 9(1): 75-80 26. Mace SR, Sussman GL,
Liss G, et al. Latex allergy in operating room nurses. Ann Allergy Asthma Immunol. 1998 Mar;
80:252-6. 27. Allmers H, Brehler R, Chen
Z, 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. J Allergy Clin Immunol. 1998 Nov; 102(5): 841-6. 28. Health Industry
Manufacturers Association/FDA. Gloves: Information about
Medical Gloves. 1994: 12 pages. (Available from HIMA, 1200 G Street NW, Suite
400, Washington, DC 20005-3814) 29. Tarlo SM, Sussman G, Contala A, Swanson MC. Control of airborne latex by use
of powder-free latex gloves. J Allergy Clin Immunol. 1994; 93: 985-9 30. Seymour, J. Gloves,
alternatives to latex. Nursing Times 1995 Aug 9-16;
91(32): 46-8 31. Blanco C, Carrillo T, Castillo R, et al. Latex allergy: clinical features
and cross-reactivity with fruits. Ann Allergy. 1994 Oct; 73:309-14 32. Frankland AW. Food reactions in pollen and latex allergic patients [editorial]. Clin Exp Allergy. 1995; 25: 580-1 1A. The Directorate of Technical Support issues
technical information bulletins (TIBs) to provide OSHA field staff with
information regarding safety and health issues. TIBs are initiated based on
information provided by the field staff, scientific investigations, technical
publications, and concerns expressed by safety and health professionals,
employers, and the public. This information has been compiled based on a
thorough evaluation of available facts, and in coordination with appropriate
parties. 2A. The American Academy of Allergy, Asthma, and
Immunology and American College of Allergy, Asthma, and Immunology issued a
joint statement July 21, 1997 which advises that latex glove purchase and use
should consist of only low-allergen, powder-free latex gloves. The National
Institute for Occupational Safety and Health (NIOSH) also recommends that if
latex gloves are chosen, provide and use reduced protein, powder-free gloves.18 A 1998 Guideline for infection control in health
care personnel, consisting of consensus recommendations of the Hospital
Infection Control Practices Advisory Committee (HICPAC) to the CDC, included
several recommendations regarding latex hypersensitivity, but did not include
advice about use of powder-free gloves throughout an institution and made no
recommendation for institution-wide substitution of non-latex products in
health care facilities to prevent sensitization to latex (Am J Infection
Control 1998;26:339).
|
||||||||||||||||
|