Professional Documents
Culture Documents
LATEX ALLERGY:
CONSIDERATIONS FOR
ANESTHESIOLOGISTS
American Society of Anesthesiologists
Committee on Occupational Health of Operating Room Personnel
Jonathan D. Katz, M.D., Chair
5M603LC
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
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
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 patients
chart. Report any latex-induced reactions to the FDA MedWatch program (1-800FDA-1088).
2
INTRODUCTION
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.
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.
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.
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 wearers 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 Evaluations 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)
6
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
B.Generalized
reaction
Anaphylaxis protocol
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 FDAs 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
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
10
Avoid specific
additives
Avoid Natural
Rubber Latex
(NRL)
SPT, Scratch Chamber and/or Use Test
Avoid NRL
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.)
11
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
. . . . . . . . no
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 patients 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.
14
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
(Modified with permission from the publisher and author. From Holzman RS. Clinical management of latex-allergic children. Anesth Analg. 1997; 85:529-533.)
15
17
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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
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.
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
Workers 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
22
23
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Notes
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Notes
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