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NATURAL RUBBER
LATEX ALLERGY:
CONSIDERATIONS FOR
ANESTHESIOLOGISTS
American Society of Anesthesiologists
Committee on Occupational Health of Operating Room Personnel
Jonathan D. Katz, M.D., Chair
Task Force on Latex Sensitivity
Robert S. Holzman, M.D., Chair
Robert H. Brown, M.D., M.P.H.
Rukaiya Hamid, M.D.
Carol A. Hirshman, M.D.
Sandra B. Kinsella, M.D.
Charise Petrovich, M.D.
Gail I. Randel, M.D.
Susan A. Vassallo, M.D.
Jonathan D. Katz, M.D.
5M603LC
NATURAL RUBBER LATEX ALLERGY:
CONSIDERATIONS FOR ANESTHESIOLOGISTS
This document has been developed by the Task Force on Latex Sensitivity of the ASA
Committee on Occupational Health of Operating Room Personnel but has not been
reviewed or approved as a practice parameter or policy statement by the ASA House of
Delegates. Variances from recommendations contained in this document may be
acceptable based on the judgment of the responsible anesthesiologist. The recommendations are designed to encourage quality care and safety for patients and health care
workers in the workplace but cannot guarantee a specific outcome. They are subject to
revision from time to time as warranted by the evolution of technology and practice.
Copyright © 2005 by the American Society of Anesthesiologists. All rights reserved.
Natural Rubber Latex Allergy: Considerations for Anesthesiologists
TABLE OF CONTENTS
Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Identification of High-Risk Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Routes of Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Signs and Symptoms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Operating Room Management of the Patient With Latex Allergy . . . . . . . . . . . . . 2
Treatment of Latex Allergy Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Chemistry of Latex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Glove Technology and Manufacturing Standards . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Clinical Manifestations of Latex Allergy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Routes of Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Populations at Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Diagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Prevention of Reactions in Previously Sensitized Individuals . . . . . . . . . . . . . . . . 12
Management of Latex-Sensitive Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Treatment of an Allergic Reaction to Latex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Management of the Health Care Worker With Latex Allergy . . . . . . . . . . . . . . . 18
Management of Health Care Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Future Directions and Implications for Anesthesiologists . . . . . . . . . . . . . . . . . . 19
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
TABLES
Table 1: Types of Reactions to Latex Gloves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Table 2: Diagnosis of Latex Allergy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Table 3: Screening Questionnaire for Latex Sensitivity . . . . . . . . . . . . . . . . . . . . 13
Table 4: Checklist for Management of Latex-Allergic Patients . . . . . . . . . . . . . . 15
Table 5: Treatment of Latex-Induced Hypersensitivity Reactions . . . . . . . . . . . . 17
APPENDIXES
Appendix A: Contents of a Latex-Safe Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Appendix B: Legislative, Regulatory, Legal and Informational . . . . . . . . . . . . . . 21
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Natural Rubber Latex Allergy: Considerations for Anesthesiologists
LATEX ALLERGY FOR THE ANESTHESIOLOGIST: A SUMMARY
BACKGROUND
A
llergy to natural rubber latex (NRL, or latex), which contains a complex blend of
water-soluble plant proteins, has become a major source of concern in clinical practice. The Food and Drug Administration (FDA) has received incident reports of thousands of allergic reactions involving latex-containing medical products, including
anaphylaxis, cardiac arrests and deaths. Latex is the inciting factor in at least 10 percent
of the anaphylactic reactions reported under anesthesia. Anesthesiologists, nurse anesthetists, operating room and critical care nurses and surgeons are at high risk of developing hypersensitivity to latex as a result of occupational exposure.
Identification of High-Risk Groups
1. Patients with a history of multiple surgical procedures, including those with
myelomeningocoele (spina bifida) and congenital genitourinary tract anomalies.
Patients with spina bifida have a 30-70 percent incidence of latex allergy.
2. Health care personnel with occupational exposure. Latex allergy is a major occupational health problem among health care personnel since the prevalence of latex sensitivity may be as high as 17 percent. Approximately 70 percent of adverse events
to latex reported by the FDA involve health care workers.
3. Other individuals with occupational exposure to natural rubber latex, including
hairdressers, greenhouse workers and those in latex product manufacturing.
4. Individuals with a history of atopy, hay fever, rhinitis, asthma or eczema.
5. Individuals with a history of food allergy to tropical fruits (such as avocado, kiwi,
banana), chestnuts, stone fruits and additional specific foods.
Routes of Exposure
Sensitization to latex can occur as a result of contact via skin or mucous membranes
or by inhalation, ingestion, and parenteral injection or wound inoculation. Latex gloves
are the source of exposure and sensitization among most medical personnel. Gloves vary
considerably in their latex content and ability to produce allergy. Powder in gloves,
which is used to facilitate donning, enhances the potential for sensitization by transcutaneous or inhalation exposure.
Signs and Symptoms
Three types of reactions can occur in individuals. The first two are generalized reactions and are not life-threatening:
1. Irritant contact dermatitis, usually due to drying and cracking of the skin.
2. Type IV (contact) hypersensitivity — also know as delayed type hypersensitivity.
Natural Rubber Latex Allergy: Considerations for Anesthesiologists
1
Usually occurs over a 24-hour period, is cell mediated and is limited to the site of contact (for example, skin reactions similar to poison ivy).
3. Type I (IgE-mediated) hypersensitivity — also known as immediate type hypersensitivity. This is a true allergic reaction and can have localized or systemic symptoms
that can include:
a. Hives, erythema, urticaria which may be localized or generalized.
b. Upper respiratory symptoms, including stuffy or runny nose, cough, asthma.
c. Red, itchy eyes, angioedema of eyelids.
d. GI symptoms, including diarrhea, nausea, vomiting, cramping.
e. Headache, anxiety, shortness of breath, itching.
g. Anaphylaxis, tachycardia, hypotension, cardiovascular collapse.
Operating Room Management of the Patient With Latex Allergy
1. Identify each patient who is at risk. A careful history frequently will elicit episodes
of previous allergic reactions or risk factors.
2. Patients who have a suggestive history and confirmatory laboratory findings must be
managed with complete latex avoidance.
3. When possible, the patient should be scheduled for elective surgery as the first case
of the day. Airborne latex-laden particles are presumed to be at their minimum levels at that time.
4. Signs displaying “Latex Allergy” should be posted on all O.R. doors. No one should
enter the O.R. with latex gloves, without scrubbing after taking off latex gloves or
while wearing latex-laden clothing from previous latex exposure.
5. Preview all equipment to be used, looking for possible latex-containing products.
6. A latex-free cart should accompany the patient throughout his/her hospital stay.
Treatment of a Latex Allergic Reaction
1. Contact dermatitis and Type IV reactions:
a. Avoid irritating skin cleansers.
b. Topical corticosteroids can be applied locally for rashes or hives.
2. Type I latex reactions:
a. Mild reactions respond well to antihistamines, and topical nasal steroids may be
useful.
b. Hives are treated with antihistamines and systemic steroids.
c. A reaction with airway involvement may require the use of systemic steroids,
bronchodilators, endotracheal intubation and epinephrine.
d. In the case of anaphylaxis, a formal anaphylaxis protocol is advisable.
3. Latex-free precautions must accompany the patient throughout the perioperative
period (PACU, ICU and discharge unit).
4. The details of any allergic reaction should be clearly documented on the patient’s
chart. Report any latex-induced reactions to the FDA MedWatch program (1-800FDA-1088).
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INTRODUCTION
N
atural rubber latex (NRL, natural rubber, or latex) is a processed plant product
that is manufactured using the milky cytosol harvested from the rubber tree,
Hevea braziliensis (Weeping Wood Tree). During latex processing, several chemicals are added to achieve the desired characteristics that have made it a ubiquitous
component of many medically related products. These characteristics include
excellent barrier qualities, deformability, elasticity, tactile sensitivity and high tensile strength.
The first description of allergic reactions resulting from rubber gloves appeared in
the American literature in 1933.1 Sporadic accounts of delayed contact dermatitis
appeared in subsequent years. A sharp increase in the number of reports of latexinduced allergic reactions began to appear in the late 1980s. This increase occurred
shortly after the promulgation of Universal Precautions by the Centers for Disease
Control,2 during which time the annual use of surgical gloves increased from 800 million to more than 20 billion.3
As the exposure to latex products continued to increase, so did the incidence and
severity of reported allergic reactions. Slater documented anaphylaxis and the first
deaths resulting from exposure to latex in 1989.4 Reports of intraoperative anaphylaxis from latex exposure quickly followed.5,6 Ownby et al. in 1991 described a
series of patient deaths resulting from exposure to latex cuffs on barium enema
catheters.7 In 1989, 0.5-percent of reported cases of intraoperative anaphylactic
shock were the result of latex allergy. Two years later, that number had increased to
12.5 percent,8 in 1999, 16.6 percent9 and remained consistent at 16.7 percent in
2003.10 Latex anaphylaxis may actually be decreasing currently because of the
attentiveness shown in the past decade to early identification and avoidance measures as well as prompt treatment.11 It is currently estimated that as many as 17 percent of health care workers (1 million individuals)12 and 73 percent of frequently
exposed patients, such as those with spina bifida, have been sensitized* to the latex
allergen.13 Recent data indicate a prevalence of latex sensitivity among anesthesiologists of 12.5 percent14 to 15.8 percent.15
Latex is ubiquitous in medical equipment and devices. Patients and health care
providers are at risk for developing sensitization to latex and possibly serious allergic
reactions following exposure to any of these products. The purpose of this booklet is
to identify the risk factors among anesthesiologists and their patients for such allergic reactions and to recommend strategies for avoidance as well as treatment should
allergic reactions develop.
*Sensitization is the process of developing an immunologic reaction to an antigen. In the case of latex sensitivity, this involves development of an IgE antibody to proteins found in latex. Patients are frequently
asymptomatic until a threshold of exposure triggers an allergic reaction.
Allergy is an acquired, abnormal immune response to a substance (an antigen) that does not normally cause
a reaction.
Natural Rubber Latex Allergy: Considerations for Anesthesiologists
3
Chemistry of Latex
Natural rubber** (cis-1,4-polyisoprene) is synthesized by specialized lactifer cells
of the tree Hevea braziliensis, indigenous to Brazil but commercially cultivated in
West Africa and Southeast Asia. Other rubber-producing species include the North
American desert shrub guayule (Parthenium argentatum) and the common ornamental rubber plant (Ficus elasticus).
Natural rubber latex consists of a complex mixture of polyisoprene, lipids, phospholipids and proteins. The total amount of protein present in natural rubber latex is
relatively constant at 1.6 percent-2.0 percent by weight. The amount of extractable
protein in the final manufactured latex product, however, can vary widely. The total
protein concentration of glove extracts has been found to range from 3 to 337 micrograms/gram.16 A number of chemicals, including preservatives (ammonia or sodium
sulfate), accelerators (thiurams, thiocarbamates, mercapto compounds, thioureas),
antioxidants (phenylenediamine) and vulcanizing compounds (sulfur) are added during the manufacturing process to yield the final product. These additional chemicals
account for as much as 5 percent of the final weight of a manufactured glove.
The protein content of latex is responsible for the majority of generalized allergic
reactions to latex. The proteins are found in three distinct formulations: water-soluble, starch-bound or latex-bound. There are at least 240 potentially allergenic proteins in the processed latex product. Eleven sensitizing proteins have been identified
or cloned so far and have been assigned allergen designations of Hev b1-b11 by the
International Union of Immunological Societies.
The protein content of latex gloves can vary up to 1,000-fold among different lots
marketed by the same manufacturer and 3,000-fold between gloves from different
manufacturers.17 In general, the protein content and allergen levels are highest in
powdered examination gloves and lowest in powderless gloves, which undergo additional washing and chlorination. These processes result in protein denaturation and
decrease the total protein content.
Three laboratory assays are currently available to determine the quantity of protein in a specimen. The Lowry test, a chemical method based on the binding of
chromogenic dye to protein residues, is the least sensitive of the three methods but
is currently the national standard (American Society for Testing and Materials,
ASTM D5712). There are also two immunochemical tests: the Latex Enzyme
Linked Immunosorbent Assay for Antigenic Protein (LEAP), which uses rabbit
IgG, and the Radioallergosorbent Test (RAST), which is a human IgE inhibition
assay. The ASTM is currently considering a new standard for glove protein levels
based on the Enzyme-Linked Immunosorbent Assay (ELISA), which can detect
protein levels <50 mcg/gm minimum under the existing standard.
Cornstarch is commonly used as a lubricant in order to facilitate the donning and
** “Natural rubber” is latex-based. “Synthetic rubber” is butyl- or petroleum-based. Synthetic rubber is
free of allergenic plant proteins and is generally considered to pose no hazards to individuals who are sensitized to latex proteins.
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American Society of Anesthesiologists
removal of surgical gloves. A typical pair of surgical gloves carries as much as 700 mg
of cornstarch powder.18 Cornstarch particles readily adsorb latex allergens and increase
allergenicity of the gloves.19 Additionally, cornstarch carrying the latex allergen is easily aerosolized and has been associated with respiratory allergic symptoms.20
Glove Technology and Manufacturing Standards
The Code of Federal Regulations currently categorizes medical gloves as Class I
medical devices, despite an ongoing effort to reconsider their classification as Class II
devices.* Absorbable dusting powder for lubricating gloves is a Class III medical device.
Since September 30, 1998, specific warning signage has been required on latex-containing products, such as “Caution: This product contains natural rubber latex which
may cause allergic reactions.”
A number of alternative glove materials are available, including synthetic rubber,
vinyl, nitrile, tactylon, neoprene, elastyren and polyurethane. Each of these materials
has specific qualities that permit (or prevent) their use in various clinical situations.
Historically, glove manufacturers have most frequently utilized latex because it is the
most economical alternative possessing the desired physical properties.
Several characteristics of medical gloves are of importance when considering utility
and safety, including barrier effectiveness, protein levels, powder content and endotoxin levels.
Barrier effectiveness is the ability of a material to withstand vigorous physical, bacterial or viral testing. The Food and Drug Administration (FDA) and the American
Society for Testing and Materials (ASTM) have established standards for surgical
gloves. These standards address such performance issues as barrier protection confidence (number of tears, holes or other defects), resistance to penetration from bloodborne pathogens and various strength requirements. The current acceptable quality
level (AQL) using ASTM Standard D 3577-88 (“Standard Specification for Rubber
Surgical Gloves”) is 2.5 — meaning that 2.5 gloves per 100 are allowed to have barrier
defects. The allowable failure rate for non-sterile examination gloves is 4 percent.
Although the FDA now requires identification of the latex content of medical
equipment, and some glove manufacturers label the protein levels of their gloves, there
is no requirement to quantify the allergen level. While a correlation exists between total
protein and allergen content, the concepts are not identical. The amount and type of
protein as well as the manufacturing process determine the allergenicity or antigenicity
of the latex product. Ammonia, which is usually added to the fresh latex as an anticoagulant during the harvesting process, decreases extractable protein levels. However,
gloves are typically produced by a process of dipping, which is associated with the great*Class I means the devices are subject to only general controls sufficient to provide reasonable assurance of
the safety and effectiveness of the device, but the device is not life-supporting or life-sustaining and does
not present a potential unreasonable risk of illness or injury. Class II means general controls alone are
insufficient to provide reasonable assurance of safety and effectiveness and there is sufficient information to
establish special controls, including the promulgation of performance standards, postmarket surveillance,
patient registries, development and dissemination of guidance documents. Class III means the class of
devices for which premarket approval is or will be required.
Natural Rubber Latex Allergy: Considerations for Anesthesiologists
5
est antigenicity among latex products. Conversely, chlorination, which is used during
the processing of powder-free gloves, renders surface proteins insoluble and less susceptible to migration onto the wearer’s skin. As a result of these and other inconsistencies in the manufacturing process, allergen levels vary significantly in gloves from
different manufacturers and even from lot to lot produced by the same manufacturer. A
misleading claim of “hypoallergenic” has been a source of confusion for many health
care workers. The label “hypoallergenic” specifically refers to potential sensitization to
various processing chemicals that can cause contact dermatitis, and not to latex protein
content. Gloves labeled as “hypoallergenic” carry as much as 192 micrograms allergen/g
rubber.21 As of Sept. 30, 1998, the FDA required removal of the “hypoallergenic” claim
from any product that contains latex.
The term “glove powder content” encompasses several particulate components,
including dusting or donning powder, mold-release compounds and manufacturing debris.
Dusting or donning powder must meet specifications of the United States Pharmacopoeia
(USP) to be acceptable for use as a lubricant for medical gloves. Cornstarch is currently the lubricant most commonly used for medical gloves, but calcium carbonate, oat
powder, talc and lycopodium have all been used. The amount of particulate matter on
a medium-size powdered glove is 120-400 mg. In order for a manufacturer to make the
claim that their gloves are “powder free” or “powderless,” they must either meet the
FDA limit of <2 mg/ glove or the Office of Device Evaluation’s negative iodine test. At
this time, there are no federal requirements that define acceptable maximum powder
levels, although the FDA has recommended a limit of 120 mg of powder per glove,
regardless of size, in order to reduce exposure to particles and airborne allergens.
Glove powder is a biologically active substance and has been implicated in a number
of adverse health outcomes.22 Glove powder, specifically cornstarch, promotes latex sensitization as a result of bonding with protein from the latex.23 This protein-bearing
powder is readily aerosolized and can remain suspended in the air for as long as five
hours. Potentially allergenic powder is also easily transferred from the hands of the
wearer to items of clothing, other areas such as skin and hair, and inanimate objects such
as food and telephones.24 There is one report in which family members were sensitized
from allergens brought home from the workplace by an asymptomatic worker.25
Endotoxins are lipopolysaccharides found in the outermost wall of gram-negative
bacteria. The manufacturing process commonly employed to produce medical gloves is
vulnerable to endotoxin contamination. Endotoxin is found in highest concentrations
on the internal surface of powdered, non-sterile examination gloves. Three quarters of
the endotoxin can be released as respirable airborne particles by gently snapping inverted gloves.26 The endotoxin is responsible for some of the tissue irritation resulting from
latex glove use and can also serve to enhance hypersensitivity reactions.
Clinical Manifestations of Latex Allergy
Three distinct types of reactions can occur in persons exposed to latex-containing
products: irritant contact dermatitis, Type IV hypersensitivity or Type I hypersensitivity. (Table 1)
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Table 1: Types of Reactions to Latex Gloves
REACTION
SIGNS/SYMPTOMS
Irritant
Dermatitis
Scaling, drying,
cracking of skin
Direct skin
irritation by gloves,
powder, soaps
Identify reaction,
avoid irritant,
possible use of
glove liner, use of
alternative product
Itching, blistering,
crusting (delayed 672 hours)
Chemical additives
used in manufacturing (such as
accelerators)
Identify offending
chemical, possible
use of alternative
product without
chemical additive,
possible use of
glove liner
Proteins found
in latex
Identify reaction.
Type IV Delayed
Hypersensitivity
Type I —
Immediate
Hypersensitivity
CAUSE
MANAGEMENT
Avoid latex-containing products.
Use of nonlatex
or powder-free, lowprotein gloves by
co-workers
A. Localized
contact
urticaria
Itching, hives in area
of contact with latex
(immediate)
B.Generalized
reaction
Runny nose, swollen
eyes, generalized rash
or hives, bronchospasm,
anaphylaxis
Anaphylaxis protocol
(Based on Hazard Information Bulletin, OSHA. 1998.)
Natural Rubber Latex Allergy: Considerations for Anesthesiologists
7
1. Irritant dermatitis. Irritant dermatitis is the most frequently observed reaction
to latex products, accounting for 80 percent of work-related reactions to latex gloves.27
This type of reaction results from the drying action of the corn starch and/or other irritant chemicals found in gloves and can be exacerbated by the soaps and mechanical irritation required for surgical scrubbing. Irritant dermatitis is not mediated by the
immune system and is not a true allergy. However, the resulting deterioration in skin
integrity possibly enhances absorption of latex protein allergens and is believed to accelerate the onset of allergic reactions.
2. Type IV delayed hypersensitivity. Type IV delayed hypersensitivity, also called
T-cell mediated contact dermatitis, allergic contact dermatitis, and delayed hypersensitivity, directly involves the immune system, in contrast to irritant dermatitis. Among
the immunologic responses to latex, 84 percent are Type IV.28 This type of reaction is
usually a response to the chemical additives used during the manufacturing process,
specifically the accelerators, rather than to the latex proteins themselves. The resulting
skin reactions are similar to those caused by poison ivy. Like poison ivy, the skin rash
usually appears six to 72 hours after initial contact and may progress from a mild dermatitis to oozing skin blisters. It is important to recognize that not all patients with
Type IV reactions progress to Type I reactions. However, 79 percent of Type I patients
previously had Type IV symptoms.29
3. Type I immediate hypersensitivity. Type I immediate hypersensitivity, also
called IgE mediated anaphylactic reaction or anaphylactic reaction, results when an
antigen induces the production of an antibody of the immunoglobulin E class. Reexposure to the inciting antigen triggers a cascade of events, including the release of histamine, arachidonic acid, leukotrienes and prostaglandins.
Reactions usually begin within minutes of exposure. Symptoms can run the entire
spectrum from mild (skin redness, hives, itching), to more severe (cough, hoarse voice,
chest tightness, runny nose, itchy or swollen eyes), to life-threatening (bronchospasm
and shock). Type I reactions from latex exposure have been reported in patients and
health care workers and in a variety of clinical settings, including: vaginal deliveries,30
gynecological examinations,31 dental procedures,32 intra-abdominal33 and genitourinary5
surgery and during the act of donning gloves.34
Routes of Exposure
Latex exposure can occur as a result of contact with the skin or mucous membranes
or by inhalation, ingestion and parenteral injection or wound inoculation. Among
health care workers, the most frequent route of exposure to latex allergens is by cutaneous contact and/or inhalation, and the most common source is medical gloves. In the
case of cutaneous exposure, the sensitizing antigens of latex penetrate the skin after
being solubilized by sweat. A history of eczema or contact dermatitis is associated with
a higher incidence of allergy as a result of the disruption of skin integrity. The potential for harmful exposure is further enhanced by the use of powdered gloves, which promote access of the allergen to the circulation.
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American Society of Anesthesiologists
The cornstarch powder frequently found on the inner surface of the gloves actively
binds allergen. This complex is readily aerosolized with frequent glove changes.
Within hospitals, the concentration of latex aeroallergens is often highest in operating
rooms, where powdered latex gloves are frequently donned and removed.34 The
aerosolized powder/allergen complex can become as dense as 1000 ng/m3 air and
remain suspended in the air for up to five hours.24
The aerosolized latex allergen is readily inhaled and has been associated with conjunctivitis, rhinitis, cough, hoarse voice, chest tightness and bronchospasm. Baur et al.
have demonstrated a direct relationship between the development of allergy-related
symptoms in hospital workers and latex allergen concentrations in their work area.35
Airborne allergens have also been shown to affect individuals who are in the immediate vicinity but not themselves using latex products.36 Replacing high-allergen gloves
with powderless low-allergen gloves can reduce ambient allergen levels 10-fold.34
Patients with Type I latex allergy can also develop anaphylactic reactions as a result
of exposure to certain foods, including some tropical fruits (see below). In one report,
17 percent of latex allergic patients also had anaphylactic reactions to some of these
foods.37
Populations at Risk
The reported prevalence of latex allergy varies greatly depending upon the population studied and the methods used to detect sensitization. As is the case with all allergy-causing substances, the greater the exposure in a population, the greater the number
of sensitized individuals. This was well demonstrated by Tarlo et al. in a study of dental students.38 The incidence of positive skin tests to latex increased as a function of the
duration of training: 0 percent of year one and two students, 6 percent of year three,
and 10 percent of year four students.
There are several populations at increased risk.
1. Patients with a history of multiple surgical procedures. This group includes
patients with congenital genitourinary tract anomalies and those with spina bifida. In
one study of spina bifida patients, 60 percent were reported to have Type I latex allergy
as determined by history, RAST and/or skin prick test, although not all had demonstrated allergic symptoms.39 The two main risk factors for the clinical expression of latex
hypersensitivity in this population are frequency of exposure and a prior history of
atopy.40 There is accumulating evidence for a genetic predilection to latex sensitivity in
children with spina bifida.41,42
2. Health care personnel. Depending upon the methodology of diagnosis, the
prevalence of latex sensitivity among health care personnel has been reported from 2.9
percent43 to 17 percent.12 More recent studies of health care personnel usually have
reported a higher prevalence of latex sensitivity than older ones. Approximately 70 percent of adverse events to latex reported in the FDA’s MedWatch database involve health
care workers, and in most cases the medical personnel were patients themselves.44 The
American College of Allergy, Asthma and Immunology (ACAAI) has identified latex
allergy as “a major occupational health problem.”45 Among health care workers, a hisNatural Rubber Latex Allergy: Considerations for Anesthesiologists
9
tory of atopy, eczema or hand dermatitis and frequent use of disposable gloves are associated with a greater risk for developing latex allergy.46,47
Current data indicate a prevalence of latex sensitization of 12.5 percent to 15.8 percent among anesthesiologists and nurse anesthetists.14,15 Brown et al. identified predisposing risk factors such as skin symptoms with latex glove use (hives, rash, itching), a
history of atopy and a history of allergy to certain fruits (bananas, avocados, kiwis). In
contrast to most other studies, duration of exposure to latex gloves, either by age or by
years of work as an anesthesiologist, did not increase the risk of sensitization. While
2.4 percent of their study population was sensitized and exhibited symptoms of latex
allergy, 10.1 percent was sensitized but manifested no clinical symptoms of Type I
hypersensitivity at the time of the study. This latter group was considered to be
presymptomatic and have occult disease. The authors concluded that with further
avoidance of latex exposure, these presymptomatic but already sensitized individuals can
reduce skin reactivity and serum levels of latex-specific IgE and prevent progression to
symptomatic disease. Their report also noted that 24 percent of the anesthesiologists
and nurse anesthetists studied had irritant or contact dermatitis.
3. Other individuals with occupational exposure such as rubber industry workers
and hairdressers. The prevalence of latex allergy is thought to be similar to that of
health care workers, although this population has not been studied as extensively.
4. Individuals with a history of atopy, hay fever, rhinitis, asthma or eczema. In a
number of reports examining latex allergy in various populations, atopy was one of the significant predisposing risk factors. In a study of latex sensitization in a low-risk pediatric
population, Bernardini et al. reported that all the children with latex sensitization were
atopic whereas only 29 percent of non-sensitized subjects had positive skin prick responses to environmental or food allergens.48 Liss et al. demonstrated a five-fold increase in
positive skin tests among atopic health care workers compared to non-atopic workers.43
5. Individuals with a history of food allergy to tropical fruits (such as avocado,
kiwi, banana), chestnuts or stone fruits.49 These plants contain several proteins similar, or in some cases identical, to those found in latex.
6. Individuals with severe hand dermatitis who wear latex gloves. It has been proposed that the dermatitis (contact or allergic) disturbs the integrity of the skin and facilitates absorption of latex allergen.
7. General population. The prevalence of latex allergy in the general population
has been reported to range from <1 percent to 6.7 percent.50,51 The latter figure is of particular interest because it was observed in a random sample from an ambulatory surgical practice. Increased risk factors include non-Caucasian race, younger age, a history
of food allergies, asthma and/or atopy, spinal cord abnormalities, stated latex allergy and
symptoms when exposed to latex. Unfortunately, the specificity and positive predictive
value of history alone in a general population is low.
Diagnosis
Warshaw outlined a sequential evaluation for patients with suspected latex sensitivity.52 (Table 2). His recommendations include a careful medical history and focused
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American Society of Anesthesiologists
Table 2: Diagnosis of Latex Allergy
Complete History
+ risk factors
+ clinical symptoms and signs suggesting
contact dermatitis or urticaria
Evaluate delayed hypersensitivity by
patch testing to rubber additives
Avoid specific
additives
– or + with immediate symptoms
Radioallergosorbent Test (RAST) [due to low sensitivity
of RAST, may go directly to Skin Prick Test (SPT)]
Avoid Natural
Rubber Latex
(NRL)
SPT, Scratch Chamber and/or Use Test
Avoid NRL
Consider other urticarial-inducing
agents or irritant dermatitus
If conjunctival/respiratory symptoms
are prominent, consider inhalation
challenge test, nasal provocation test
or hooded exposure chamber test
(Modified with permission from the publisher and author. Warshaw EM. Latex allergy. J Am Acad Dermatol. 1998;
39:1-24.)
Natural Rubber Latex Allergy: Considerations for Anesthesiologists
11
physical examination, followed by patch, serologic, challenge and skin-prick tests. A
positive history (Table 3) and/or physical examination and one confirmatory in vivo or
in vitro test establish the diagnosis of latex sensitivity.
Elements of a patient’s medical history may be especially suggestive of sensitivity to
latex. Five specific areas of history are mentioned in the “Guidelines for the
Management of Latex Allergies in Health Care Facilities” published by ACAAI.53
These include screening patients for risk factors, contact dermatitis, contact urticaria,
aerosol reactions and a history of reactions that suggest an allergy to latex. A history of
various food allergies, especially to tropical fruits, is also common.
The definitive test for diagnosis of Type IV delayed hypersensitivity to chemicals in
latex-containing products is a positive patch test using a standardized patch test screen
or a fragment of the offending latex product.54 The timing of the reaction to this challenge is of diagnostic importance and may appear anytime from eight hours to five days
after exposure. A latex glove provocation test has also been described to identify Type
IV allergy.55 In this test, the response to a latex glove on one hand is compared to that
of a vinyl glove on the other. The rapid onset of itching, redness, swelling or blistering
represents a positive reaction.
A Type I latex allergy can be diagnosed by history plus in vitro, and/or in vivo tests.
There is no universally accepted standardized serum test to assess Type I latex allergy.
The FDA has approved four different serum tests for latex-specific immunoglobulin E,
which utilize technologies classified as either RAST (Radioallergosorbent Test) or
EAST (Enzymeallergosorbent Test). The commercially available assays are: AlaSTAT®, Immunolite®, Pharmacia Coated Allergen Particle test (CAP®) and HY-TEC®.
Unfortunately, these test for specific proteins that may not include the offending antigen in a particular patient. False negative results can be found in as many as 30 percent
of those patients tested.54 Konrad et al. indicated some advantages of the CAP® test for
use in anesthesia personnel.56 Nevertheless, several in vitro methods may be necessary
to detect all latex-sensitized individuals.57
A skin-prick test using antigens extracted from various glove products is the current
“gold standard” to determine Type I latex allergy, since it has a sensitivity and specificity close to 100 percent. Although no standardized commercial test antigen has been
approved by the FDA for skin-prick testing, one preparation is currently undergoing a
multicenter trial for licensing.14 The skin-prick test must be performed with appropriate safeguards because severe reactions can result from concentrated allergen administered to a sensitized patient.58
Prevention of Reactions in Previously Sensitized Individuals
Preventive measures vary depending upon the latex product being used and the type
of reaction. For example, moisture, heat and friction tend to exacerbate the nonimmunologic contact dermatitis that is frequently observed in response to the use of
latex-containing gloves. Wearing a soft glove liner, reducing exposure to other irritants
(e.g., soaps) and treatment with topical corticosteroids can usually control these symptoms. The use of most protective hand creams, however, is contraindicated because the
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American Society of Anesthesiologists
Table 3: Screening Questionnaire for Latex Sensitivity
1. Sex: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ■ Male . . . . . . . ■ Female
2. Race: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ■ Caucasian . . ■ Black
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ■ Hispanic . . . . ■ Other
3. Have you ever been told by a doctor
that you are allergic to latex? . . . . . . . . . . . . . . . . . . . . . . . . . . ■ yes . . . . . . . . ■ no
4. How many surgeries have you had in the past? . . . . . . . . . . . . _______________________
5. Do you suffer from:
Seasonal hay fever? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ■ yes
Asthma? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ■ yes
Eczema? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ■ yes
Autoimmune disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ■ yes
. . . . . . . . ■ no
. . . . . . . . ■ no
. . . . . . . . ■ no
. . . . . . . . ■ no
6. Do you have on-the-job exposure to latex? . . . . . . . . . . . . . . . ■ yes . . . . . . . . ■ no
7. Were you born with problems involving your spinal cord? . . . . ■ yes . . . . . . . . ■ no
8. Do you catheterize yourself to urinate? . . . . . . . . . . . . . . . . . . ■ yes . . . . . . . . ■ no
9. Do you have any food allergies? . . . . . . . . . . . . . . . . . . . . . . . . ■ yes . . . . . . . . ■ no
10. Are you allergic to bananas? . . . . . . . . . . . . . . . . . . . . . . . . . . ■ yes
Kiwi fruit? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ■ yes
Avocados? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ■ yes
Guacamole? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ■ yes
Chestnuts? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ■ yes
. . . . . . . . ■ no
. . . . . . . . ■ no
. . . . . . . . ■ no
. . . . . . . . ■ no
. . . . . . . . ■ no
11. Are you allergic to latex or products containing rubber? . . . . . ■ yes
If yes, are the symptoms a rash? . . . . . . . . . . . . . . . . . . . . . ■ yes
Hives? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ■ yes
Itching? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ■ yes
Wheezing? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ■ yes
Difficulty breathing? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ■ yes
Watery eyes? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ■ yes
Anaphylaxis? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ■ yes
. . . . . . . . ■ no
. . . . . . . . ■ no
. . . . . . . . ■ no
. . . . . . . . ■ no
. . . . . . . . ■ no
. . . . . . . . ■ no
. . . . . . . . ■ no
. . . . . . . . ■ no
12. Do you have allergic symptoms while:
Blowing up balloons? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ■ yes
During dental examinations? . . . . . . . . . . . . . . . . . . . . . . . . ■ yes
On contact with diaphragms/condoms? . . . . . . . . . . . . . . . . ■ yes
During vaginal or rectal exams? . . . . . . . . . . . . . . . . . . . . . . ■ yes
While wearing rubber gloves? . . . . . . . . . . . . . . . . . . . . . . . ■ yes
. . . . . . . . ■ no
. . . . . . . . ■ no
. . . . . . . . ■ no
. . . . . . . . ■ no
. . . . . . . . ■ no
(Prepared by the ASA Task Force on Latex Sensitivity, 1999.)
Natural Rubber Latex Allergy: Considerations for Anesthesiologists
13
oil-based ingredients found in these products degrade the molecular structure of latex
and facilitate the transfer of latex proteins from the gloves to the hands of the wearer.59
In the case of Type IV hypersensitivity, prevention relies upon accurate identification of the offending rubber additive or component by patch testing. If the individual
needs to continue to wear latex gloves, gloves manufactured using different chemical
additives should be worn. For example, an individual allergic to thiurams will often
tolerate gloves made with mercapto compounds. Details of the chemical processing of
different brands of latex gloves are available from the manufacturer.
The most effective strategy is complete avoidance of latex-containing products.
This can best be accomplished by establishing a latex-safe work environment that prevents exposure of individuals who are not previously sensitized and avoids potential
reactions in individuals who have already been sensitized.
A facility-wide strategy is necessary to establish a latex-safe health care environment.60 ACAAI guidelines recommend a thorough review of glove usage to prevent
unnecessary exposure to latex.53 An important first step is to limit latex use to situations
where it is thought that they are superior to non-latex-containing products.60 The June
1997 National Institute for Occupational Safety and Health (NIOSH) alert titled
“Preventing allergic reactions to natural rubber latex in the workplace” recommends the
use of non-latex gloves for all activities that do not involve contact with potentially
infectious materials.61 When latex-containing products are considered optimal, emphasis should be placed on purchasing and using only low-antigen, powderless items.
Review articles may provide information on the latex content of various medical supplies.62
Management of Latex-Sensitive Patients
The first step in managing latex-sensitive patients is to promptly identify each
patient who is at risk (Table 4). An accurate clinical history usually provides most of
the important diagnostic information. When time permits, a more thorough evaluation
may be helpful to delineate the specific offending agent and the risk of serious reaction.
Patients who have a suggestive history and/or confirmatory laboratory findings must
be managed with complete latex avoidance. Avoidance is most easily accomplished if a
latex allergy task force and comprehensive institutional policies are already in existence
(see “Recommendations” below). Unfortunately, latex is ubiquitous in the health care
environment, but exposure can be limited.
1. The patient’s care must be carefully coordinated among the responsible anesthesiology, surgical, nursing and other hospital support teams.
2. When possible, the patient should be scheduled for elective surgery as the first
case of the day. Aerosolized latex antigen is believed to be at its lowest level throughout the operating room suite at this time.
3. Signs signifying “Latex Allergy” (for those with established allergy) or “Latex
Alert” (for those with suspected allergy or with an at-risk history for whom latex precautions appear to be justified) should be posted inside and outside of the operating
room as well as in perioperative care areas.
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American Society of Anesthesiologists
Table 4: Checklist for Management of Latex-Allergic Patients
PREOPERATIVE
•
Solicit specific history of latex allergy or risk for latex allergy
History of chronic care with latex-based products
History of spina bifida, urological reconstructive surgery
History of repeated surgical procedures (e.g., >9)
History of intolerance to latex-based products: balloons, rubber gloves, condoms,
dental dams, rubber urethral catheters
History of allergy to tropical fruits
History of intraoperative anaphylaxis of uncertain etiology
Health care workers, especially with a history of atopy or hand eczema
•
Consider Allergy Consultation
In vitro testing
In vivo testing
•
Minimize latex exposure for at-risk patients
Latex alert: patients with significant risk factors for latex allergy but no overt signs or symptoms
Latex allergy: patients with or without significant risk factors for latex allergy and positive history,
signs, symptoms or allergy evaluation
•
Carefully coordinate care between surgical anesthesia and nursing teams
Have lists available of nonlatex product alternatives
First case of the day is preferable to decrease aeroallergen concentration
Display “Latex Allergy” or “Latex Alert” signs inside and outside O.R.
INTRAOPERATIVE
•
Anesthesia equipment
Latex-free gloves, airways, endotracheal tubes
Masks — polyvinylchloride if available or old, well-washed black rubber masks
Rebreathing bags — neoprene if available or old, well-washed black rubber bags
Ventilator bellows — neoprene or silicone if available or old, well-washed black rubber bellows
Breathing circuit — disposable, polyvinylchloride, packaged separately from a latex rebreathing bag
Remove rubber stoppers from multidose vials
Beware of latex intravenous injection ports, Penrose-type tourniquets and rubber bands;
use nonlatex glove as tourniquet; tape latex injection ports or use silicone injection ports or stopcock
Blood pressure cuffs — if new latex, cover with soft cotton
Ambu-type bag — assure that bag and valve do not have latex components — alternative is silicone
self-inflating bag
Check syringe plungers; reconstitute medications every six hours
Dilute concentration of epinephrine (0.01 mg/ml, or 1:100,000) available
•
Surgical equipment
Avoid latex surgical gloves
Avoid latex drains (e.g., Penrose drain)
Avoid latex urinary catheters
Avoid latex instrument mats
Avoid rubber-shod clamps
Avoid latex vascular tags
Avoid latex bulb syringes for irrigation
Avoid rubber bands
POSTOPERATIVE
•
•
•
Medical Alert tag
Warning sign posted on chart
Warning sign posted on bed
(Modified with permission from the publisher and author. From Holzman RS. Clinical management of latex-allergic children. Anesth Analg. 1997; 85:529-533.)
Natural Rubber Latex Allergy: Considerations for Anesthesiologists
15
4. A latex-free cart containing items likely to be used should accompany the
patient throughout his/her hospital stay (Appendix A). Additionally a list of the
available non-latex product alternatives should be prominently displayed in patient
care locations and readily available through the purchasing and central supply areas
of the facility.
5. The patient should be instructed to obtain a medical alert bracelet or necklace.
6. Pharmacological prophylaxis. The use of allergy-attenuating premedication
is controversial. Recommendations by Sockin and Young in 1991 included preoperative prophylaxis with diphenhydramine, cimetidine and methylprednisolone.63
Others have argued that pretreatment might serve only to attenuate the early
immune responses, leaving anaphylaxis as the first evidence of an allergic reaction.64
More recently, Setlock et al. have demonstrated that premedication is not universally successful in preventing latex anaphylaxis.65 Current opinion as expressed by
Holzman has moved away from administering allergy-attenuating premedication.66
With the ubiquitous presence of latex, it is extremely difficult to make an operating room and perioperative care area completely latex free. Furthermore, the degree
of latex avoidance measures necessary to avert allergic reactions is not known. For
example, systemic allergic reactions were reported as a result of administration of
medication whose only exposure to latex was contact with the rubber stopper in the
medication vial.67 Others have been skeptical that the contact between medication
and the latex plungers of disposable syringes, ports of intravenous tubing or stoppers
of medication vials provides sufficient exposure to produce a reaction among latex
allergic patients.68 Consistent with this opinion is a report by Yunginger et al. in
which the investigators were unable to detect latex-allergenic proteins in a multidose vial until there had been 40 punctures.69 However, more recent data documents
the transfer of latex proteins from medication stoppers in sufficient quantities to
elicit a dermal reaction in latex allergic subjects.70
Treatment of an Allergic Reaction to Latex
Contact dermatitis and Type IV latex reactions can usually be successfully treated with interventions such as the avoidance of irritating skin cleansers and treatment
with topical corticosteroids.
The treatment of a systemic reaction to latex generally follows the sequence outlined for other systemic allergic reactions (Table 5). The offending agent should be
identified and removed to limit patient exposure. This can be a difficult process
when the reaction is occurring in the operating room and the source of latex exposure is unclear.
Type 1 latex reactions may present with a spectrum of symptoms and signs.
These are generally systemic histamine-like reactions. The treatment depends upon
the severity of the symptoms.
1. Mild reactions frequently resemble an attack of hay fever and respond to antihistamines. Topical nasal steroids may be used when rhinitis is a prominent symptom.
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American Society of Anesthesiologists
Table 5: Treatment of Latex-Induced Hypersensitivity Reactions
ACUTE MANAGEMENT
Initial therapy
1. Stop administration/reduce absorption of offending agent
(Consider a variety of potential routes of exposure-administration, including mucosal
contact and inhalation)
2. Remove all latex from the surgical field
3. Change gloves
4. Discontinue all antibiotic and blood administration
5. Maintain the airway and administer 100 percent O2
6. Intubate the trachea (as indicated)
7. Administer 25-50 ml/kg of crystalloid or colloid (as indicated)
8. Administer epinephrine
Intravenous: 0.1 mcg/kg or approximately 10 mcg in an adult
Subcutaneous (in the absence of an I.V.): 300 mcg (0.3 mg)
Endotracheal: five to 10 times the intravenous dose, or 50-100 mcg in an adult
From a metered dose inhaler: 3 inhalations of 0.16 to 0.20 mg epinephrine/inhalation
From a nebulizer: eight to 15 drops of 2.25 percent epinephrine in 2 ml normal saline
9. Discontinue all anesthetic agents
10. Consider use of Military Anti-Shock Trousers (MAST)
11. Display prominent signs such as “latex allergy” or “latex alert” on the inside of the
operating room as well as on the entry doors for those entering
Secondary therapy
1. Administer antihistamine
Diphenhydramine 1 mg/kg I.V. or IM (maximal dose 50 mg)
Ranitidine 1 mg/kg I.V. (maximal dose 50 mg)
2. Administer glucocorticoids
Hydrocortisone 5 mg/kg initially and then 2.5 mg/kg q 4-6 hours
Methylprednisolone 1 mg/kg initially and 0.8 mg/kg q 4-6 hours
3. Administer aminophylline for bronchospasm (may be ineffective during anesthesia)
Loading dose 5 to 6 mg/kg
Continuous infusion 0.4-0.9 mg/kg/hr (check blood level)
4. Administer inhaled Beta-2 agonists for bronchospasm
5. Administer a continuous catecholamine infusion for blood pressure support
Epinephrine 0.02-0.05 mcg/kg/min (2-4 mcg/min)
Norepinephrine 0.05 mcg/kg/min (2-4 mcg/min)
Dopamine 5-20 mcg/kg/min
Isoproterenol (same dosing as epinephrine)
6. Administer sodium bicarbonate
0.5 to 1 mg/kg initially, with titrations using arterial blood gas analysis
Natural Rubber Latex Allergy: Considerations for Anesthesiologists
17
2. Hives may develop locally or systemically. Antihistamines and systemic
steroids are used to treat these symptoms.
3. A more severe reaction, involving the airway, will require more aggressive
treatment with antihistamines, systemic steroids, H2 blockers, oxygen and possibly
bronchodilators, endotracheal intubation and epinepherine.
4. In the case of anaphylaxis, a formal anaphylaxis protocol is required.
Anaphylaxis may require artificial airway support, intravascular volume expansion,
administration of vasoactive medication and other life-support techniques. It is of
critical importance to have previously created a latex-free crash cart.
5. The details of any allergic reaction should be clearly recorded, including a
description of the anesthetic agents and techniques, surgical products used, resuscitative measures required, laboratory evaluation as well as the perioperative course. It is
important to immediately initiate a laboratory workup because many of the pathognomonic findings of anaphylaxis, such as serum mast cell tryptase levels, complement
C3 and C4, and histamine will be transiently altered but return to baseline within four
hours. With a severe reaction, elevated tryptase levels may persist for longer, even
several days.71 The patient should be referred to an allergist, and the patient’s chart
should be flagged in order to alert subsequent caregivers.
Management of the Health Care Worker With Latex Allergy
Health care workers who are regularly exposed to latex are at risk for sensitization.
Personnel sensitized to latex must avoid all direct contact with latex-containing products. For anesthesiologists, the most frequent offending products are latex examination and surgical gloves. High-quality, powderless, non-latex gloves should be
available at every anesthetizing location for individuals who prefer not to use latex
products. Those affected should have proper allergy identification and should
always carry an epinephrine autoinjector device. Latex allergic anesthesiologists
with positive histories and/or confirmatory laboratory tests should be counseled on
the risks of continued work in environments with high latex use and on strategies to
limit exposure.
The wearing of powderless, low-latex-allergen gloves by co-workers is also critical
because this simple step can reduce levels of latex aeroallergen by more than ten-fold
in the operating room.34 Exposure to aerosolized latex occurs when gloves are
changed as well as when powder in the room and on clothing is mobilized. The use
of powderless gloves with low (or preferably no) allergen content will limit sensitization of health care workers and allow those who already manifest inhalant allergic
reactions to return to work. Moreover, the wearing of nonlatex gloves by co-workers
would eliminate this significant source of allergen.
Ultimately, the prevention of allergic reactions will occur only when institutions
adopt strict policies to protect workers from unnecessary latex exposure. NIOSH has
recommended that employers take specific steps to protect workers from latex exposure and allergy in the workplace.61
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American Society of Anesthesiologists
Management of Health Care Facilities
A successful strategy to manage latex allergies in health care settings requires facility-wide commitment.72 A multidisciplinary latex allergy task force should include
broad representation from the hospital staff: medical, nursing, administration, pharmacy, occupational health, central supply, dietary services and housekeeping.
Members from this committee can provide a useful latex allergy consultation service.
In addition, this committee should have the responsibility to develop60:
1. a process to evaluate all glove selection and utilization;
2. a mechanism for reporting and evaluating all suspected latex reactions;
3. policies and protocols for management of the latex-sensitive patient and the
latex-sensitive health care worker; and
4. educational programs for all hospital employees.
Even so, the task is difficult. Specific steps to be taken by employers and workers
are found in the NIOSH Alert61 (Appendix C).
Future Directions and Implications for Anesthesiologists
Attention is now being turned to immunotherapy for latex-allergic patients, using
the same principles of desensitization that have proven effective for patients with
insect allergy. Strategies that have been applied include subcutaneous, percutaneous
and sublingual desensitization. While the latter strategies may generally be safer and
more effective,73 subcutaneous desensitization has been the more standard approach.
Nevertheless, at this time, the benefits of immunotherapy include an improvement in
cutaneous symptoms with a possible improvement in rhinitis and asthma.74,75
Conclusion
Latex allergy continues to be an important medical problem for health care workers and their patients. We have re-examined the definition of latex allergy, updated
our understanding of the offending allergens, the factors that enhance sensitization,
the threshold levels that sensitize and elicit reactions in sensitized individuals, current
diagnostic techniques, avoidance measures, the barrier properties of non-latex alternatives and the roles of premedication and immunotherapy. Fifteen years after its
emergence as an international concern in specific patient populations and ultimately
in health care workers, latex allergy is a well-defined condition with established diagnostic criteria and rational treatment and prevention strategies. However, notwithstanding an expanding fund of knowledge and a suggestion of immunotherapy’s
efficacy, avoidance remains the only effective treatment.76
Natural Rubber Latex Allergy: Considerations for Anesthesiologists
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Appendix A
Contents of a Latex-Safe Cart
Latex-free or glass syringes
Hypodermic needles
I.V. catheters
I.V. extension tubing-polyvinyl chloride
Latex-free I.V. tubing
Stopcocks — three-way, single, in-line manifold
Latex-free heparin lock caps
Latex-free heparin lock, T-piece with side port
Alcohol wipes — new box
Latex-safe tape — from new box
Latex-free I.V. tourniquets
Sterile gauze pads
Thermometer-esophageal
Disposable blood pressure cuffs — all sizes
Isolation stethoscope
Sterile cast padding
Latex-free electrocardiogram electrodes
Latex-free oximetry finger sensors — disposable
Policy binder with all policies on latex protocols
Neon signs for all doors
Latex-free Ambu bag
Oxygen nasal cannula
Oxygen extension tubing
Endotracheal tubes — polyvinyl chloride
Oral airways — polyvinyl chloride
Code and emergency medications in ampoules
Vinyl gloves — small, medium, and large sizes
Sterile synthetic gloves — sizes 6 to 9
100-percent silicone Foley catheter — assorted sizes
Urimeter
Quick reference guide on latex-safe materials
Epidural and spinal trays
Suction catheters — polyvinyl chloride, 8-Fr to 14 Fr
Anesthesia circuits — latex-free bag and tubing
Anesthesia machine set up for minimal latex content
Anesthesia medications in ampules from pharmacy
In-line high efficiency particulate air filter
20
American Society of Anesthesiologists
Appendix B
Legislative, Regulatory, Legal and Informational Resources
Several federal agencies, state legislatures and various medical organizations have
developed policies regarding latex exposure.
FEDERAL AGENCIES
The U.S. Food and Drug Administration (FDA): <www.fda.gov>
Center for Devices and Radiological Health (CDRH): <www.fda.gov/cdrh/
index.html>
In September 1997, the FDA issued its “Medical Glove Powder Report.” Nine
recommendations were made, including: 1) Establish a maximum allowable powder
level for powdered gloves; 2) Standardize the maximum allowable amount of powder
on powder-free gloves; 3) Establish a maximum allowable glove protein level; and 4)
Require labeling on all medical gloves of glove powder content and water-soluble
protein.
Effective September 30, 1998, the FDA requires that all medical devices containing latex carry a warning for those allergic. The rule also prohibits the use of the
claim “hypoallergenic” on labels of products that contain latex.
The National Institute for Occupational Safety and Health (NIOSH):
<www.cdc.gov/niosh/homepage.html>
NIOSH issued an alert, “Preventing Allergic Reactions to Natural Rubber Latex
in the Workplace,” in June 1997. (DHHS Publication No. 97-135).61 In this, they
listed a series of recommendations for employers and workers to minimize exposure to
latex. Prominent among these are: 1) Use of non-latex products whenever possible;
and 2) When latex gloves are used, they should be powder-free.
The Centers for Disease Control and Prevention (CDC): <www.cdc.gov>
The CDC is updating its guidelines for infection control in health care personnel.
They describe several strategies for health care workers with “Latex Hypersensitivity,”
including: 1) Develop an institutional protocol for managing personnel with latex
allergy; 2) Provide workers with a non-latex or low-allergen powderless latex gloves;
and 3) Consider targeted substitution of non-latex gloves and/or powder-free latex
gloves.
The Occupational Safety and Health Administration (OSHA):
<www.osha-slc.gov/SLTC/LatexAllergy/index.html>
OSHA Standard 29 CFR 1910.1030 contains a requirement that an employer
must provide “hypoallergenic gloves, glove liners, powderless gloves or other similar
alternatives” to employees who are allergic to latex gloves.
Natural Rubber Latex Allergy: Considerations for Anesthesiologists
21
STATE LEGISLATION
Bills aimed at limiting the use of latex gloves have been introduced in more than a
dozen state legislatures. Currently, many states prohibit the use of latex gloves in the
food service industry, although none have gone as far as prohibiting the use of latex
gloves in health care. Specific state regulations should be consulted.
MEDICAL ORGANIZATIONS
The American Academy of Allergy, Asthma and Immunology (AAAI):
<http://allergy.mcg.edu>
The American College of Allergy, Asthma and Immunology (ACAAI):
<www.allergy.mcg.edu/physicians/latex.html>
ACAAI has issued guidelines urging hospital employee health services to take a
leadership position in identifying, managing and preventing latex-related problems
among workers. Among their recommendations is that the FDA should establish
maximum levels of extractable latex allergens in gloves and that the use of powdered,
high-protein latex gloves should be discouraged. In 1997, the ACAAI and the AAAI
published a joint statement advocating the use of powder-free, low-allergen gloves to
reduce aeroallergen exposure.77
The American Academy of Dermatology: <www.aad.org>
The American Academy of Dermatology released its Position Paper on Latex
Allergy in July 1998. Among its recommendations are: 1) Encourage all food preparation services to use only non-latex gloves. 2) Routinely use latex-safe operating
rooms for all trauma surgery. 3) Encourage all medical facilities to exclusively use
powder-free gloves with low latex allergen levels. 4) Encourage all medical facilities to
provide non-latex gloves for general physical examinations. This document also provides a detailed description of a “latex-safe” environment.
The American Medical Association (AMA): <www.ama-assn.org>
The House of Delegates of the AMA has passed resolutions in 1996 (503, A-96)
and 1997 (504, I-97), which “supports the appropriate labeling of latex containing
medical devices with warnings about possible allergic reactions. The AMA strongly
encourages health care facilities to provide non-latex alternatives of at least comparable efficacy alongside their latex counterparts in all areas of patient care.”
LITIGATION
Worker’s Compensation: Disability related claims by employees who have developed latex allergy are growing exponentially.
Product liability: The first product liability lawsuit against a glove manufacturer
was filed in 1991. Latex-related litigation has been called the “next big tort.”
Americans with Disabilities Act (ADA): Under the provisions of the ADA,
employers are required to provide reasonable accommodations to employees with
medical-related disabilities such as latex allergy. Exactly what this involves will vary
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with each situation. In the case of anesthesiologists, provision of suitable alternatives
to latex-containing products is considered the minimal accommodation.
OTHER ORGANIZATIONS WITH INTEREST IN ISSUES RELATED TO
LATEX SENSITIVITY
Latex Allergy Links: <latexallergylinks.tripod.com>
Provides a comprehensive, up-to-date listing of latex allergy-related sites
MedicAlert: <www.medicalert.org>
2323 Colorado Avenue
Turlock, CA 95382
Telephone: (800) 432-5378
The Spina Bifida Association of America: <ww.sbaa.org>
4590 MacArthur Blvd NW, Suite 250
Washington, D.C. 20007-4226
Telephone: (202) 944-3285; (800) 621-3141
Fax: (202) 944-3295
American Latex Allergy Association: <www.latexallergyresources.org>
3791 Sherman Road
Slinger, WI 53086
Telephone: (888) 97-ALERT
Fax: (262) 677-2808
e-mail: <[email protected]>
Canadian Latex Allergy Association
96 Cavan Street
Port Hope, Ontario, Canada LIA 3B7
Telephone: (905) 885-5270
Fax: (905) 885-2839
e-mail: <[email protected]>
LATEX-FREE PRODUCTS CAN BE ORDERED THROUGH THESE
CATALOGS:
Decent Exposures:
Telephone: (800) 524-4949
CETRA Products for Latex-free Living: <www.latexfree.com>;
<www.schoolhealth.com>
Telephone: (888) LATEX-NO
Natural Rubber Latex Allergy: Considerations for Anesthesiologists
23
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Notes
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Notes
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