AORN Latex Guideline

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					                                                                       AORN Latex Guideline

                   I. Overview                                   Health care facilities and providers have an ethical
                                                             responsibility to prevent latex sensitization in patients
                  A. Introduction                            and employees by creating an environment in which
Preamble                                                     it is safe to be treated and to work. Many facilities in
Natural rubber latex allergy is a significant medical        the United States consciously have moved toward a
concern because it affects health care workers, as           latex-safe environment by switching from powdered
well as the general population. It crosses racial and        latex gloves (eg, examination, surgical) and other
ethnic boundaries, and it can affect males or                latex products to powder-free products with reduced
females anytime during their lives.                          latex protein content. High-protein, powdered latex
   There is no cure at this time, only prevention. Three     gloves and other products that create aerosolization
types of reactions are associated with latex products.       can contaminate a facility’s environment with latex
In order of frequency of occurrence they are an irri-        allergens.
tant reaction, a delayed hypersensitivity reaction (ie,          In 1998, Sussman et al reported a 1% annual
type IV), and an immediate hypersensitivity reaction         incidence of sensitization among powdered latex-
(ie, type I) (Table 1). Any individual who experiences       glove users, whereas users of powder-free, low-
any type of latex-associated reaction should be evalu-       protein, latex glove reported a 0% sensitization
ated by a qualified health care practitioner.                rate.4 In 1999, Levy et al studied a group of dental
                                                             students in both France and England, reporting that
Assumptions                                                  students who wore protein-rich (ie, high protein),
Natural rubber latex allergy can be a serious and            powdered latex gloves had a 15% and a 5% sensi-
potentially life-threatening condition. Health care          tization rate, respectively, while students who
workers and others who experience repeated expo-             wore powder-free, protein-poor (ie, low protein)
sure to latex allergens can develop a latex sensitiv-        gloves had a 0% sensitization rate.5
ity or allergy. Several hundred cases of severe                  It is unsafe to treat latex-allergic individuals in
allergic reactions and anaphylaxis and 17 deaths             an environment laden with latex allergens. Individ-
have been reported to the US Food and Drug                   uals who have been clinically diagnosed as either
Administration (FDA).1,2                                     sensitive or allergic to natural rubber latex should
   Sensitivity can be described as development of an         be treated or work in an environment that is latex-
immunologic memory to the specific latex proteins;           safe, with additional measures taken for the imme-
however, the affected individual may be asympto-             diate vicinity (ie, room) in which the individual
matic. Allergy is the demonstrated outward expres-           receives or provides care. If the entire care facility
sion of the sensitivity (eg, hives, rhinitis, conjunctivi-   is maintained as a latex-safe environment, few
tis, anaphylaxis). Sensitivity to natural rubber latex is    additional precautions will be needed for latex-
more common than the actual allergy; however, any            allergic individuals. If the facility is not maintained
individual sensitized to natural rubber latex is at risk     as latex-safe, comprehensive latex precautions will
of a life-threatening reaction and should be treated in      be required each time a latex-allergic individual
the same way as an allergic individual.                      presents for care or services.
   Powdered latex gloves are the most common item                This revised “AORN latex guideline” is based on
contributing to the latex load in health care facili-        research and expert opinion available at the time
ties. Recent estimates have shown a 20-fold increase         of its revision. Ongoing and future research likely
in medical glove use (in billions of pairs) since the        will enhance and expand current knowledge about
introduction of universal precautions in 1987.3 Dur-         this topic.
ing the manufacturing process, powder usually is                 Review of this document has been solicited from
applied to the glove as cornstarch slurry when the           content experts at the American Association of Nurse
glove still is on the mold or former. When the pow-          Anesthetists (AANA), the American College of Sur-
der slurry is applied to the glove, the extractable,         geons (ACS), the American Society of Anesthesi-
water-soluble proteins leach from the surface of the         ologists (ASA), the American Academy of Allergy,
glove onto the cornstarch particle. When dry, the            Asthma, and Immunology (AAAAI), the American
glove powder then acts as a vector that carries latex        College of Allergy, Asthma, and Immunology
proteins from the glove into the environment.                (ACAAI), the American Nurses Association (ANA),

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AORN Latex Guideline

Table 1

           Mechanism                     Terms Used                         Cause                   Signs and Symptoms

   Irritation                     Irritant contact dermatitis     Hand washing, insufficient      Dry, crusty hard bumps,
                                  (nonallergic irritation)        rinsing, scrubs, antiseptics,   sores, and horizontal cracks
                                                                  glove occlusion, glove          on skin may manifest as
                                                                  powder.                         itchy dermatitis on the back
                                                                                                  of the hands under the

   Type IV hypersensitivity;      Delayed type hypersensi-        Exposure to chemicals used      Red, raised, palpable area
   cell-mediated                  tivity; allergic contact der-   in latex manufacturing,         with bumps, sores, and hor-
                                  matitis; chemical allergy       mostly thiurams.                izontal cracks may extend
                                                                                                  up the forearm. Occurs
                                                                                                  after a sensitization period.
                                                                                                  Appears several hours after
                                                                                                  glove contact and may per-
                                                                                                  sist many days.

   Type I hypersensitivity; Immediate type hypersen-              Exposure to proteins in         Wheal and flare response
   immunoglobulin-mediated sitivity; latex allergy; pro-          latex on glove surface          or itchy redness on the skin
                            tein allergy                          and/or bound to powder          under the glove. Occurs
                                                                  and suspended in the air,       within minutes, fades away
                                                                  settled on objects, or trans-   rapidly after removing the
                                                                  ferred by touch.                glove. In chronic form, may
                                                                                                  mimic irritant and allergic
                                                                                                  contact dermatitis. Symp-
                                                                                                  toms can include facial
                                                                                                  swelling, rhinitis, eye symp-
                                                                                                  toms, generalized urticaria,
                                                                                                  respiratory distress, and
                                                                                                  asthma. In rare cases, ana-
                                                                                                  phylactic shock may occur.
Reprinted with permission from Latex Allergy: Protect Yourself, Protect Your Patients  1996 American Nurses Association. For the
complete text of this brochure, call (800) 274-4ANA and ask for WP-7, or visit the ANA Web site at

the Association of Practitioners of Infection Control,                 ♦ Allergenic: A substance that can elicit a hyper-
Inc (APIC), the Spina Bifida Association, and the                        sensitivity reaction in certain individuals.7
National Institute of Occupational Safety and Health                   ♦ Allergy: An immune reaction to an environmen-
(NIOSH) division of the Centers for Disease Control                      tal agent that results in a symptomatic reaction.6,7
and Prevention, as well as the AORN Board of                           ♦ Antigen: Any molecule or substance, more
Directors and other recognized experts. This guide-                      often a protein, that has the ability to bind to
line may not apply to every individual and may                           an antibody.6,7 “The name arises from their
require modification based on specific needs of a                        ability to generate antibodies.”6
given patient, health care provider, or situation.                     ♦ Irritant contact dermatitis: A nonallergic,
                                                                         cutaneous response to an irritant. Normally
Definitions                                                              this reaction is primarily localized to the site
For purposes of this document the following defini-                      of exposure. This is not a latex allergy.
tions apply.                                                           ♦ Allergic contact dermatitis (type IV: T-cell
   ♦ Allergen: A substance that in some individuals                      mediated/delayed hypersensitivity): A
      can cause an allergic or hypersensitivity reac-                    delayed, T-cell mediated hypersensitivity
      tion but is not normally considered harmful.6                      response attributed to chemicals (ie, antigens)

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                                                                              AORN Latex Guideline

    used in the latex and some synthetic manu-            workers with significant exposure to latex is reported
    facturing processes and absorbed through the          to be 10% to 17%.18 Although latex-sensitive individ-
    skin.6 This reaction generally is localized to        uals do not always present with clinical symptoms,
    the contact area.                                     these individuals should be assessed for latex allergy.
  ♦ Latex: Also known as natural rubber latex, this       For those who are latex-sensitive but have yet to
    milky cytosol is acquired by tapping the com-         manifest frank symptoms, there is no predictor of
    mercial rubber tree, Hevea brasiliensis.              whether or when they will react; therefore, all indi-
  ♦ Latex allergy (type immunoglobulin E [IgE]-           viduals presenting with natural rubber latex sensitiv-
    mediated/immediate hypersensitivity response):        ity should be treated as if they are allergic.
    A localized or systemic allergic response to             In 1992, Lagier et al reported a 10.7% latex allergy
    one or more specific proteins (ie, antigens)6         rate in French perioperative nurses.19 A study of Cana-
    found in latex to which the individual has been       dian perioperative nurses by Mace et al, in 1997,
    sensitized and has developed antibodies.              reported a 6.9% latex allergy prevalence.20 Studies of
  ♦ Latex-free environment: An environment in             perioperative personnel demonstrate sensitivity rates
    which all latex-containing products, not sim-         between 2.5% and 15.8%. In 1992, Arellano et al
    ply gloves, have been removed. This state is          reported a 9.9% latex sensitization rate in a study of
    considered unattainable due to the ubiquitous         101 anesthesiologists, radiologists, and surgeons.21 In
    nature of latex products.                             1996, Grzybowski reported an 8.9% rate for hospital
  ♦ Latex-safe environment: An environment in             RNs in general, but showed perioperative nurses to be
    which every reasonable effort has been made to        less affected than nurses in other areas. One possible
    remove high-allergen and airborne latex sources       explanation for this disparity was that nurses in the
    from coming into direct contact with affected         OR who were latex sensitive or allergic may have
    individuals. The airborne latex protein load          transferred to other nursing units.22 In 1997, Konrad et
    should be less than 0.6 ng per cubic meter.8          al reported a 15.8% positive skin prick test rate for
  ♦ Latex precautions: Interventions to prevent           anesthesiologists.23 In 1998, Brown et al identified
    reactions in people (eg, patients, health care        12.5% of anesthesiologists at a tertiary care hospital as
    workers) allergic to latex proteins.                  sensitized (ie, IgE antibody positive by skin test or
  ♦ Reactions associated with latex: Irritant con-        serology) with only 2.5% expressing symptoms.24
    tact dermatitis, allergic type IV cell-mediated
    contact dermatitis, and type I IgE-mediated                          B. Pathophysiology
    latex allergy. Only the type I IgE-mediated           The major component of natural rubber latex is the
    response constitutes a true latex allergy.            hydrocarbon, cis-1, 4 polyisoprene. Chemicals
  ♦ Sensitization: The development of immunological       such as sulfur, ammonia, mercaptobenzothiazole,
    memory in response to exposure to an antigen.         thiuram, and antioxidants may be added during the
  ♦ Sensitivity: A clinical manifestation of symptoms     manufacturing process. Latex protein content and
    or response that develops after sensitization.        residual chemical levels differ among producers
                                                          due to variations in manufacturing processes.
Prevalence                                                   Several natural rubber latex proteins responsible
Numerous studies indicate prevalence rates for IgE-       for allergenic reactions have been identified (Table
mediated latex allergy from 0.8% to 6.5% of the gen-      2), and sensitivity appears to differ among risk
eral population.1,9-13 Latex allergy is believed to be    groups.25-28 Proteins in natural rubber latex may
responsible for 70% of anaphylactic reactions occur-      cause a range of mild to severe or even life-threaten-
ring in anesthetized children with myelodysplasia         ing type I allergic reactions. Dipped products made
(eg, spina bifida).12 Further, there is a large popula-   from liquid natural rubber latex (eg, gloves, balloons,
tion of latex-sensitive individuals. Varying sensitiza-   condoms) contain a greater amount of soluble pro-
tion rates have been reported for both patients with      teins than dry gum rubber or heat molded latex prod-
myelodysplasia and health care workers.14-17 Accord-      ucts and, therefore, can release more allergen.2,9,29
ing to Sussman, the prevalence rate of latex sensitiza-      Several types of synthetic materials also may be
tion among patients with spina bifida is between          referred to as latex (eg, butyl, petroleum-based
35% and 70%. The sensitization rate for health care       materials) but these do not contain the proteins

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AORN Latex Guideline

Table 2
  Name                 Description                           MW (kD)      Plant family        Cross-food
  Hev b 1              Rubber elongation factor                14.6                           Papain
  Hev b 2              Beta one=third gluconase               34-36           PR2
  Hev b 3              Prenyltransferase                      24-27
  Hev b 4              Microhelix                            110/50
  Hev b 5              Acidic protein                         16-24                            Kiwi
  Hev b 6.02           Hevein protein                           4.7           PR3              Kiwi, avocado, banana
  Hev b 7              Patatin homologue                      43-46                            Potato
  Hev b 8              Hevea profilin                        14-14.2        Profilin           Pollens, celery
  Hev b 9              Hevea enolase                            51                             Molds
  Hev b 10             Mn superoxide dismutase                22-26                            Molds
  Hev b 11             Class I chitinase                        33           PR3               Banana, avocado
  Hev b 12             Lipid transfer protein                  9.4          PR-14              Peach, stone fruit
  Hev b 13             Esterase                                 42
 Suggested by Robert Hamilton, PhD, Latex Committee, Chairman, American Academy of Asthma, Allergy, and Immunology.

that cause allergic reactions. There have been case             lead to dry, thickened, and cracked skin. Health
reports, however, of individuals having a type I                care workers experiencing irritant contact dermatitis
natural rubber latex-allergic reaction because syn-             or skin breakdown should be referred to an occupa-
thetic materials may have been mixed with or con-               tional health practitioner, allergist, dermatologist, or
taminated with natural rubber latex. 29 Water                   immunologist for further diagnostic testing. This type
extractable, residual chemicals found in both latex             of dermatitis is reduced by removing the irritant
and synthetic gloves usually are implicated in the              source after it is identified. Thoroughly washing and
development of allergic contact dermatitis in indi-             drying hands, using only powder-free gloves, chang-
viduals who are presensitized.30-33                             ing gloves more frequently, or changing glove types
                                                                can reduce skin irritation.11,36,37
         C. Reactions Associated                                   Other palliative measures include using only
     With Latex and Synthetic Products                          water- or silicone-based moisturizing creams,
Reactions associated with latex and synthetic products          lotions, or topical barrier agents. Avoid using oil- or
include irritant contact dermatitis, allergic contact der-      petroleum-based skin agents with latex products.
matitis (type IV), and immediate IgE hypersensitivity           These agents may cause breakdown of the latex
reactions (type I).34,35 Only the type I hypersensitivity       product. Some skin care agents may help reduce
reaction constitutes a latex allergy. Some individuals          glove-related problems and have been clinically for-
may present with a single complaint or a combination            mulated not to interfere with the glove’s barrier
of all three reactions listed above. Irritant and allergic      integrity. Always check with the manufacturer of the
contact dermatitis are the most common clinical reac-           skin care agent to verify that the chosen agent is latex
tions associated with latex and other additives.34,35           compatible before putting the product into use.38
   Irritant contact dermatitis is the result of damage             Allergic contact dermatitis (ie, delayed hypersen-
to the skin, but it is not an allergic reaction. Soaps          sitivity) is a type IV immune reaction. It is a T-cell
and cleansers, multiple hand washings, inadequate               mediated allergic reaction and usually is localized
hand drying, or mechanical irritation (ie, sweating,            to the area of contact. Chemical additives used in
rubbing inside powdered gloves) may cause skin                  the manufacturing processes (eg, accelerators) and
irritation. It also can be caused by chemicals added            not the latex itself causes previously sensitized T-
during glove manufacture. An acute localized                    cell lymphocytes to stimulate proliferation of other
response is evidenced by redness, swelling, burning,            lymphocytes and mononuclear cells, resulting in
and itching. Chronic exposure to the irritant can               tissue inflammation and dermatitis.

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                                                                                    AORN Latex Guideline

Table 3
  Decreased cardiac output                                       Altered renal perfusion
  Assess physical status and document changes. Report:           ♦ Monitor serum and urine electrolytes and osmolar-
  ♦ Vital signs, including, temperature, pulse rate, blood          ity and document.
     pressure, cardiac rhythm, respiratory rate.                 ♦ Monitor urine output every hour; document
  ♦ Lung sounds (eg, rales, wheezing, stridor).                     changes.
  ♦ Jugular vein distention, pulmonary pressures.                ♦ Monitor laboratory data for elevation in BUN
  ♦ Skin color, rashes, temperature, moisture.                      (blood urea nitrogen) and creatinine levels, acid-
  ♦ Changes in level of consciousness or mentation.                 base imbalances, particularly sodium (Na+) and
  ♦ Changes in patient’s level of anxiety.                          potassium (K+).
  Defining characteristics: Hypotension, tachycardia,            Defining characteristics: Decreased urine output,
  decreased central venous pressure, decreased pul-              decreased venous filing, hemoconcentration.
  monary pressures, decreased cardiac output, oliguria.
                                                                 Altered level of consciousness
  Ineffective breathing pattern
                                                                 ♦ Obtain neurological checks; report and record any
  ♦ Monitor respiratory status and observe for changes.
  ♦ Monitor arterial blood gases and note changes.
                                                                 ♦ Observe for seizure activity; report and record
  ♦ Check breath sounds and report changes.
  ♦ Monitor chest x-ray reports.
                                                                 ♦ Monitor vital signs.
  Defining characteristics: Dyspnea, wheezing, tachyp-
                                                                 Defining characteristics: Fainting, changes in alert-
  nea, cyanosis, stridor, tightness of chest.
                                                                 ness, changes in orientation.
  Impaired skin integrity
  ♦ Observe for signs of local or generalized flushing.          Gastrointestinal
  ♦ Watch for development of rashes; note character.             Defining characteristics: Abdominal cramping, diar-
  ♦ Assess for swelling/edema.                                   rhea, nausea, and vomiting.
  Defining characteristics: Urticaria, pruritus, edema, angio-
  edema, eczema hypersensitivity, dermatitis erythema,
                                                                 Potential anxiety/fear
  swelling, inflammation, vesiculation, blister formation.
                                                                 ♦ Recognize patient’s level of anxiety and note signs
  Fluid volume deficit                                              and symptoms.
  ♦ Assess fluid balance (I & O) every hour.                     ♦ Assess patient’s coping mechanisms.
  ♦ Assess for edema.
  Defining characteristics: Decreased urine output, con-         Knowledge deficit
  centrated urine, decreased venous filling, hypotension,        ♦ Assess patient’s knowledge of his or her condition
  thirst, tachycardia.                                             and allergens.

   The onset of type IV reactions is slow, usually               ucts when there are breaks in the wearer’s skin is
occurring during 18 to 24 hours and peaking at 48                believed to contribute to latex protein sensitization.
hours after exposure. Reactions may present as                   This is due to absorption of solubilized latex pro-
pruritis, erythema, swelling, crusty thickened skin,             teins associated with the product.43,44
pimples, blisters, and other skin lesions. Symptoms                 Latex allergy (ie, immediate hypersensitivity) is a
usually resolve within three to four days after expo-            systemic type I IgE-mediated response to plant pro-
sure.39,40 Each exposure may lead to increased sensi-            teins in natural rubber latex. In sensitized individu-
tization and a more severe reaction. Diagnosis is                als, an anti-latex IgE antibody stimulates mast cell
made by a health care provider experienced in                    proliferation and basophil histamine release, leading
chemical allergy testing—patch tests commonly are                to local swelling, redness, edema, itching, and sys-
used. Treatment involves education; thoroughly dry-              temic reactions, including anaphylaxis.39,44 Type I
ing hands; using water- or silicone-based moisturiz-             reactions are immediate, with the onset of symp-
ing creams, lotions, or topical barrier agents; avoid-           toms usually occurring in minutes. 39 Symptoms
ing oil- or petroleum-based products unless they are             include rhinitis, conjunctivitis, urticaria, laryngeal
latex compatible; and avoiding the identified                    edema, bronchospasm, asthma, angioedema, ana-
causative agent.38,41,42 Continued use of latex prod-            phylaxis, and death. 39,45-48 These responses can

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AORN Latex Guideline

Table 4
                                                                                                  Yes     No
    1. Have you ever had allergies, asthma, hay fever, eczema, or problems with rashes?           ❑       ❑
    2. Have you ever had respiratory distress, rapid heart rate, or swelling?                     ❑        ❑
    3. Have you ever had swelling, itching, hives, or other symptoms after contact                ❑        ❑
       with a balloon?
    4. Have you ever had swelling, itching, hives, or other symptoms after a dental               ❑        ❑
       examination or procedure?
    5. Have you ever had swelling, itching, hives, or other symptoms following a vaginal          ❑        ❑
       or rectal examination or after contact with a diaphragm or condom?
    6. Have you ever had swelling, itching, or hives during or within one hour after              ❑        ❑
       wearing rubber gloves?
    7. Have you ever had a rash on your hands that lasted longer than one week?                   ❑        ❑
    8. Have you ever had swelling, itching, hives, runny nose, eye irritation, wheezing,          ❑        ❑
       or asthma after contact with any latex or rubber product?
    9. Have you ever had swelling, itching, or hives after being examined by someone              ❑        ❑
       wearing rubber or latex gloves?
   10. Has a physician ever told you that you had rubber or latex allergy?                        ❑        ❑
   11. Are you allergic to bananas, papaya, avocados, kiwifruits, other stone fruits,             ❑        ❑
       tomatoes, raw potatoes, or chestnuts?
   12. Have you ever had an unexplained anaphylactic episode? If so, please describe.             ❑        ❑

occur when materials containing latex come into             health care provider experienced in latex allergy
contact with the skin, mucous membranes, or inter-          diagnosis and management. Table 3 provides ana-
nal tissues. Aerosolization of very small amounts of        phylactic reaction assessment criteria with which
natural rubber latex proteins may cause some indi-          health care workers should be familiar.
viduals to react after inhaling traces of powder from
latex gloves or balloons.49,50 The severity of repeat           D. Population Affected/Risk Factors
reactions is unpredictable; therefore, individuals          Children with myelodysplasia or a history of multi-
who have suffered any type I reaction are consid-           ple surgeries beginning in infancy and any individ-
ered to be at high risk for anaphylaxis.                    ual with a past history of type I reaction or positive
   Latex allergy is diagnosed by a history of type I        test results to natural rubber latex are at high risk
reactions to latex products, such as gloves, balloons,      for developing anaphylaxis. People at risk for
or condoms, and a skin prick test—no FDA-approved           developing latex sensitization include individuals
reagent is yet approved in the United States—or             occupationally exposed to latex (eg, health care
serum test to identify IgE antibodies to latex. Individu-   workers, food service workers); atopic individuals
als may experience irritant, type IV, and type I reac-      with a history of asthma, eczema, and rhinitis; peo-
tions simultaneously. If a patient or health care           ple who react to medications; and individuals with
worker experiences any form of reaction to a medical        multiple environmental allergies. People with a
device that may contain latex (eg, medical gloves),         history of type I allergic reactions to certain foods
the individual should be carefully evaluated by a           (eg, banana, avocado, chestnut, kiwi) also are at

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                                                                                     AORN Latex Guideline

Table 5

  Persons at high risk for systemic reactions
  ♦ Children with a history of frequent surgeries or use of instrumentation, particularly if begun in early infancy, as
     with congenital malformations like myelodysplasia (eg, spina bifida) or genitourinary problems.
  ♦ Verifiable history of latex allergic reactions, particularly if intraoperative or asthmatic.
  ♦ Positive test results to serum latex antibody test (eg, radioallergosorbent/enzyme-linked immunosorbent assay) or
     skin prick test.
  ♦ History of any immunoglobulin E-mediated symptoms, (eg, urticaria, rhino-conjunctivitis, asthma, bronchospasm)
     when in contact with natural rubber latex products.

  Persons at risk for developing latex allergy
  ♦ Occupational exposure to latex products, particularly to powdered products such as gloves, or to aerosolized latex
  ♦ History of latex-fruit syndrome or progressive reactions to foods known to cross-react with NRL—including
     bananas, kiwifruits, avocados, stone fruits, raw potato, tomato, papaya, or chestnuts—or a history of a latex
     glove-associated contact dermatitis.

  Persons who should be evaluated for latex allergy
  ♦ History of any unexplained anaphylaxis—particularly if occurring in a medical or dental setting.
  ♦ History of hives or itching after incidental latex exposure, such as dental or gynecological examinations, or on
     contact with balloons, condoms, or natural rubber latex gloves.
  ♦ History of multiple surgical procedures.
                                               Risks suggested by Dr. B. Lauren Charous, Milwaukee Medical Clinic

increased risk for latex sensitization. This is                with mucous membranes of the mouth, vagina,
because of a cross reactivity that exists between              urethra, or rectum.45,46 Triggering items include
natural rubber latex proteins and certain food aller-          latex gloves, latex glove powder, orthodontic elas-
gens.10,22,24,51 Table 4 provides a sample question-           tic, dental dams, nasogastric tubes, balloons, paci-
naire suitable for assessing patients and others for           fiers, urinary catheters, enema kits, barium enema
their risk of latex allergy or sensitization.                  catheters, condoms, and balloon catheters. Case
   The ACAAI recommends that individuals with                  reports describe intraoperative anaphylaxis after
known latex allergy and those at high risk for                 the peritoneum or other internal tissues are con-
allergy be treated in a latex-safe environment.                tacted by surgical gloves.39,45-48
Individuals designated as at risk for developing                  Inhalation of latex proteins can lead to bron-
latex sensitization should be assessed carefully,              chospasm or laryngeal edema. Aerosolized glove
and health care facility protocol should be fol-               powder is the most common source of latex protein
lowed in determining the need for testing for                  inhalation. 49,50 Latex proteins bind to the glove
immediate hypersensitivity to natural rubber latex             starch powder during the manufacturing process
(Table 5).10,12,52,53                                          and are expelled into the air when gloves are
                                                               opened, donned, or removed.50 Latex proteins, par-
                        E. Exposure                            ticularly when bound to starch glove powder and
Systemic exposure to latex can occur through the               then aerosolized, can and have caused serious
following routes: mucous membrane, ingestion,                  health problems for both patients and employees.3
inhalation, or intravascular or cutaneous contact.             Use of powdered latex gloves in the same room as a
The majority of severe latex reactions result from             sensitized individual can produce an allergic reac-
latex proteins coming in contact with internal tis-            tion. Use of powder-free gloves results in only small
sues during invasive procedures or after contact               or negligible amounts of latex in the air.8,50,54-56

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AORN Latex Guideline

   Cutaneous exposure to latex products can trigger         FDA has required that all FDA-cleared medical
serious systemic reactions in highly sensitized individu-   devices containing natural rubber latex carry a warn-
als. Examples of products that have triggered reactions     ing statement.69-71 This statement reads “Caution: This
include gloves, condoms, anesthesia masks, tourni-          product contains natural rubber latex which may
quets, electrocardiogram electrodes, adhesive tape,         cause allergic reactions.” This label warning will facil-
elastic bandages, condom catheters, rubber shoes,           itate alternative product selection for latex-allergic
elastic in clothing, balloons, and racquet handles.         individuals. This ruling does not include pharmaceu-
                                                            ticals or products that are not regulated by the FDA.
                   F. Prevention                               A latex-free cart may be helpful for consolidating
The goals of prevention are twofold: to prevent             latex-free items in a single place for ease of location
reactions in individuals who are latex-sensitized           and use. Specialty patient care areas, such as the OR,
and to prevent initial sensitization of nonsensitized       emergency, and labor and delivery departments,
persons. The only effective preventive strategy at          should develop a list of items to meet their special
this time is latex avoidance. Working in an environ-        care needs. Emergency carts (ie, code carts) also
ment that is free of powdered, high-allergen latex          should contain latex-free items (eg, syringes, latex-
gloves and products will help minimize sensitiza-           free gloves, resuscitation equipment). Manufacturer
tion of health care workers.4,5 The NIOSH, AAAAI,           documentation should be obtained to ensure the
ACAAI, and others recommend and encourage the               latex-free status of contents for all carts (eg, code,
use of low-allergen, powder-free latex gloves as an         latex, other specialty carts). It is important that each
important factor in developing a latex-safe environ-        cart be latex-free as emergency situations can occur
ment.8,37,38,41,50,53,55-65 For patients or staff members   without respect for any individual patient considera-
with a known allergy to natural rubber latex pro-           tions. A sample of items to be included in a latex-free
teins, additional precautions are necessary. The            cart can be found in Table 6.
presence of even small amounts of residual                     Pretreating latex-allergic individuals with certain
aerosolized latex in the air or on surfaces can trig-       medication regimens (eg diphenhydramine, raniti-
ger a life-threatening reaction. Latex-allergic indi-       dine, corticosteroids) may prevent initial allergy
viduals should be treated or work in an environ-            symptoms, but it also may give care providers with a
ment using strict latex avoidance. Although it is           false sense of security.9,34,39,53 This practice remains
impossible to remove all latex from the environ-            controversial. Pretreated latex-allergic individuals
ment (eg, wheels on carts), all latex that may poten-       may present with anaphylaxis as the first sign
tially contact the individual should be removed.            observed by the health care team.72
   When establishing a latex-safe environment, perti-          The use of medication vials with rubber stoppers
nent clinical data should be obtained on every latex        also is controversial when caring for latex-sensitive or
or latex-containing product used in the facility, with      allergic patients. Protein can be leached from the vial
an emphasis placed on the protein and powder con-           stopper. Even when the single-puncture or the pop-
tent of each product, if powdered gloves or other           the-top-off method is used, individuals already sensi-
powdered items are used. Latex products selected for        tized to natural rubber latex can react.73 One study
use should be low-allergen and powder-free. The             reported that the amount of latex found in a medica-
protein content should be less than 50 µg/dm2 using         tion vial after 40 punctures was below the level of
the American Society for Testing and Materials              detection using standardized methods.74 Another
(ASTM) D5712 total protein test66 and less than 10 µg       study suggested that medication vials should be
per dm2 by the ASTM D6499 antigen test.67                   changed to synthetic vial tops or be clearly labeled as
   AORN’s “Recommended practices for product                is required for other medical devices.75 Coring of the
selection in perioperative practice settings” provides      stopper also is a concern. Coring may occur from
guidance to assist practitioners with product evalua-       repetitive puncturing of a multi-use vial stopper. This
tion and selection.68 A master list or directory of prod-   raises a concern about latex-containing particulate
ucts containing latex and appropriate latex-free sub-       matter potentially contaminating the medication. In
stitutes for those products should be maintained by         two studies, the use of sharp needles reportedly
the health care facility and be readily accessible to all   caused coring fragments in 73% of solutions in test
health care providers. Since September 30, 1998, the        vials using multi-dose insulin stoppers.75,76 Whenever

 110                                                        2004 Standards, Recommended Practices, and Guidelines
                                                                                AORN Latex Guideline

possible, medications should be used from a latex-          Table 6
free vial. When this is not possible, arrangements
with the pharmacy should be made in advance so               SUGGESTED CONTENTS
medications can be drawn into a latex-free delivery          FOR A LATEX-SAFE CART
device under aseptic conditions (eg, inside the phar-                Note: All items must be latex-free.
macy’s hood). If neither of these solutions is possible,
the stopper should be removed and the medication               Safety needles (25 g through 15 g)
withdrawn using a latex-free syringe. AORN does not            Syringes (multiple sizes)
recommend this practice unless all other options               3-way stopcocks
have been exhausted.                                           IV tubing
   Reprocessing instruments previously processed in            Blood tubing
steam and potentially exposed to latex contamina-              Tourniquets
tion via sterilization tape, container gaskets, or             Assorted tape (.5”, 1”, 1.5”)
gloves worn in processing is considered unneces-               Underpads and small chux
sary by most experts because proteins are denatured            100% silicone or polyvinyl chloride (PVC) uri-
by heat and steam.53,77,78 Health care facilities are              nary catheters
cautioned not to heat sterilize a known latex prod-            Silicone or PVC external catheters—pediatric
uct in an attempt to render it safe for use on a latex-            and adult
allergic individual.                                           Urinary drainage system
   Sterilization of medical products by means other            Feeding tubes (5 Fr to 10 Fr)
than heat has not been well studied in relation to             Feeding pump bag and tubing
latex allergy. Each facility should contact the manu-          Bulb syringe (60 cc)
facturer of the sterilizing agent or technology to ver-        Blood pressure cuffs and connecting tubing
ify its safe use for individuals with a latex allergy.         Stethoscope
                                                               Examination gloves
  G. Managing Latex-Allergic Individuals                       Sterile gloves
                                                               Oxygen delivery supplies (eg, cannula, masks)
Patients                                                       Anesthesia breathing bag
Preparing a health care facility to care for latex-aller-
gic patients is a complex process that can be costly           The role of the task force is to develop a protocol
and labor intensive. A multidisciplinary task force to      for creating a latex-safe environment for patients who
address latex issues should be formed and may               are latex-allergic. Removing devices and supplies
include representatives from the following areas:           with high latex protein content and discontinuing use
   ♦ administration,                                        of powdered latex products should be an integral
   ♦ risk management,                                       part of the protocol. The possible increase in pur-
   ♦ quality management,                                    chase costs for nonlatex items must be weighed
   ♦ safety management,                                     against the costs of potential anaphylactic episodes
   ♦ surgical services,                                     or patient death. The protocol also should include a
   ♦ sterile processing,                                    mechanism for patient education about latex allergy
   ♦ distribution,                                          and its management.
   ♦ anesthesia services,                                      Patient safety cannot be compromised. If a facility
   ♦ materiel management,                                   is maintained as latex-safe, additional preparation for
   ♦ pharmacy,                                              latex-allergic patients may not be necessary. If a facil-
   ♦ laboratory,                                            ity makes the conscious decision not to continuously
   ♦ infection control,                                     maintain a latex-safe environment, special prepara-
   ♦ family medicine,                                       tion and precautions will be required every time a
   ♦ department of surgery,                                 latex-allergic individual presents for care.64,79-82
   ♦ department of allergy and immunology, and
   ♦ various nursing departments (eg, intensive             Employees
     care unit, emergency, medical-surgical, home           Latex-allergic individuals should be counseled
     care, education, occupational health).                 about the risk of working in environments with

2004 Standards, Recommended Practices, and Guidelines                                                         111
AORN Latex Guideline

high latex use. They should use only nonlatex             information infrastructure as a data set useful in the
gloves and avoid all products containing latex. The       practice of nursing. The perioperative patient-
ACAAI suggests that these individuals wear an             focused model provides the conceptual framework
allergic identification bracelet or tag, always carry     for the PNDS and the model for perioperative nurs-
an epinephrine auto-injector device, and avoid            ing practice.84 The patient and his or her family
environments where powdered latex gloves are              members are at the core of the model. The model
used or balloons are allowed.52                           depicts perioperative nursing in four domains and
   For both facility and employee protection,             illustrates the relationship between the patient, fam-
employees new to a facility should be assessed to         ily members, and care provided by the periopera-
determine the risk or presence of latex-related           tive professional nurse. The patient-centered
problems. This can be done through the employee           domains are
health service or a similar mechanism during the              ♦ D1—safety,
pre-employment history and physical examination.              ♦ D2—physiological responses to surgery,
A simple questionnaire can be used as part of the             ♦ D3—patient’s and family members’ behav-
initial assessment. People at high risk for latex sen-           ioral responses to surgery, and
sitivity should have further evaluation for latex             ♦ D4—health system in which perioperative
allergy. Individuals considered at high risk                     care is provided.
    ♦ have existing allergies, particularly to fruits        Each data element in the PNDS is represented by
      (eg, latex-fruit syndrome)83;                       a unique identifier. The domains are represented
    ♦ have hand dermatitis or eczema; and                 by the letter “D” followed by numbers one to four
    ♦ use gloves regularly.                               to indicate the particular domain being addressed.
   Low-risk employees with a negative clinical his-       Nursing diagnoses are represented by the letter “X”
tory of latex reactions do not need allergy testing,      and a number unique to the diagnosis; interven-
but they should be evaluated if symptoms sugges-          tions are represented by the letter “I” and a unique
tive of latex sensitivity develop during their            number; and outcomes are represented by the let-
employment. For people with contact dermatitis,           ter “O” and a unique number. These designations
the causative agent should be identified and              are used in this document as appropriate.
avoided if possible. If the dermatitis appears on the
hands, the use of glove liners under latex or nonla-                        B. Assessment
tex gloves that do not contain the triggering agent       Perioperative nurses assess, document, and com-
has been found to be helpful.41,52                        municate patient status to all members of the
   All employees should be educated about latex           health care team. Data collection involves the
sensitivity and allergy and be able to recognize the      patient and his or her significant others. Assess for
symptoms of a latex reaction. Employees should be         the following risk factors:
encouraged to report development of any symp-                ♦ history of multiple surgeries beginning at an early
toms to the facility’s employee health service or               age (eg, spina bifida, urinary malformations);
other designated mechanism.                                  ♦ food allergies (eg, latex-fruit syndrome);83
                                                             ♦ exposure to latex; and
   II. Nursing Process Application                           ♦ history of allergic reaction to latex.
                                                             Assess for inadvertent latex exposure and impend-
   A. Perioperative Nursing Vocabulary                    ing anaphylaxis. Table 7 provides a summary of
The perioperative nursing vocabulary is a clinically      symptoms of latex exposure and possible anaphy-
relevant and empirically validated standardized           laxis for both conscious and anesthetized patients.
nursing language. It relates to the delivery of care in
the perioperative setting. This standardized lan-                       C. Nursing Diagnosis
guage consists of a collection of data elements (ie,      The perioperative nurse analyzes the assessment
the Perioperative Nursing Data Set [PNDS]) and            data when determining nursing diagnoses. Follow-
includes perioperative nursing diagnoses, interven-       ing is a partial list of nursing diagnoses that may be
tions, and outcomes. In 1999, the PNDS was recog-         associated with latex-allergic individuals (“X” =
nized by the ANA committee on nursing practice            nursing diagnosis, “D” = domain).

 112                                                      2004 Standards, Recommended Practices, and Guidelines
                                                                                 AORN Latex Guideline

  ♦ X 32 (D2)—latex allergy response (risk for);             Table 7
  ♦ X 30 (D3)—knowledge deficient related to                  SYMPTOMS OF LATEX EXPOSURE
    latex hypersensitivity (risk for/actual);                 AND POSSIBLE ANAPHYLAXIS
  ♦ X 50 (D1)—skin integrity, impaired, related to
    manifestations of allergic reaction (risk for/actual);
                                                                Conscious Patient     Anesthetized Patient
  ♦ X 7 (D2)—breathing pattern, ineffective,
                                                                Itchy eyes                   Facial edema
    related to facial angioedema, bronchospasm,
                                                                Generalized pruritis             Urticaria
    and laryngeal edema (risk for/actual);
                                                                Shortness of breath                   Rash
  ♦ X 8 (D2)—cardiac output, decreased, related to
                                                                Sneezing                     Skin flushing
    severe latex-allergic reaction (risk for/actual);
                                                                Wheezing                   Bronchospasm
  ♦ X 61 (D2)—tissue perfusion, ineffective,
                                                                Nausea                   Laryngeal edema
    renal, related to hypotension and decreased
                                                                Edema                               Edema
    cardiac output (risk for/actual);
                                                                Vomiting                     Hypotension
  ♦ X 18 (D2)—fluid volume, risk for deficient
                                                                Abdominal cramping            Tachycardia
  ♦ X 11 (D2)—acute confusion related to physio-
                                                                Diarrhea                    Cardiac arrest
    logic condition and decreased circulation;
  ♦ X 64 (D3)—verbal communication, impaired,
                                                                Feeling of impending doom
    related to hypotension and decreased cardiac
    output (risk for/actual);
  ♦ X 47 (D1)—sensory perception, disturbed,
    related to hypotension and decreased cardiac                                 E. Planning
    output (risk for/actual); and                            The perioperative nurse develops a plan of care for
  ♦ X 4 (D1)—anxiety, related to change in physi-            the latex-allergic patient that prescribes interven-
    ological status in response to latex.                    tions to attain expected outcomes. Interventions
                                                             and activities are selected according to the proce-
          D. Outcome Identification                          dure to be performed as well as to address the
The following is a partial list of nursing outcomes          latex allergy. The following is a partial list of inter-
that may be associated with the latex-allergic indi-         ventions that may be associated with the latex-
vidual (“O” = outcome, “D” = domain).                        allergic individual (“I” = interventions).
   ♦ O 2 (D1)—The patient is free from signs and                ♦ I 30—Develops individualized plan of care.
     symptoms of injury caused by extraneous                    ♦ I 139—Implements latex-allergy precautions
     objects.                                                      as needed.
   ♦ O 3 (D2)—The patient is free from signs and                ♦ I 27—Ensures continuity of care.
     symptoms of chemical injury.                               The natural rubber latex-allergic individual should
   ♦ O 11 (D2)—The patient has wound/tissue per-             be identified by the admitting practitioner, and this
     fusion consistent with or improved from base-           information should be made available to the entire
     line levels established preoperatively.                 health care team, thus providing a continuous safe
   ♦ O 13 (D2)—The patient’s fluid, electrolyte,             level of care. The latex-allergic individual should be
     and acid-base balances are consistent with or           treated in a latex-safe environment with emphasis
     improved from baseline levels established               placed on the removal of all latex-containing devices
     preoperatively.                                         and products within the immediate care environ-
   ♦ O 14 (D2)—The patient’s respiratory status is           ment. Figure 1 provides a simple flow chart to assist
     consistent with or improved from baseline               with planning for a latex-safe procedure.
     levels established preoperatively.
   ♦ O 15 (D2)—The patient’s cardiac status is                               F. Implementation
     consistent with or improved from baseline               Implementation refers to actually performing the
     levels established preoperatively.                      activities comprising the interventions identified in
   ♦ O 23 (D3)—The patient participates in deci-             the individualized plan of care. This includes tak-
     sion making affecting the perioperative plan            ing latex-allergy precautions as appropriate. If the
     of care.                                                patient is to be cared for in a facility-wide, latex-

2004 Standards, Recommended Practices, and Guidelines                                                         113
AORN Latex Guideline

Figure 1                                                        ♦ Notify all other care providers of patient’s
 FLOW CHART FOR PLANNING                                          allergy status.
 A LATEX-SAFE PROCEDURE                                         ♦ Educate patient about latex-safe plan and
                                                                  ensure involvement of all providers.
                                                                ♦ Involve patient, family members, and signifi-
    Review the procedure.
                                                  No              cant others in planning patient’s care.
    Any latex components?
                                                                ♦ Plan for a latex-safe environment of care.
                                                                ♦ Secure latex-free products for all latex-con-
                                              Proceed.            taining items on surgeon’s preference card
               Yes                                                and those used by anesthesia care provider.
                                                                ♦ Notify surgeon if no alternative product is
  Are there alternative prod-                                   ♦ Notify anesthesia care provider if latex-con-
 ucts or equipment available?                                     taining product is to be used, and develop
                                                                  plan for emergency care if needed.
                                                                ♦ Remove all latex items from OR unless no
     Yes                     Can an alternative tech-             nonlatex alternative exists.
                            nique be used to protect               – Remove boxes of latex gloves and replace
                           the patient from exposure?                with nonlatex gloves (eg, sterile, nonsterile).
  Proceed.                                                         – Double-check all supplies and equipment for
                                                                     latex and remove any latex-containing items.
     Yes                                                      Intraoperative activities
                            Consult with physicians/          The following activities should be performed dur-
                          other members of the health         ing the surgical procedure.
  Proceed.                   care team/supervisor.               ♦ Continue implementing the perioperative
                                                                    latex-safe plan of care.
 Developed by Raphael Landreneau, clinical educator, Our         ♦ Mark the OR room doors with “Latex precau-
 Lady of the Lake Regional Medical Center, Baton Rouge, La.
                                                                    tions” signs.
                                                                 ♦ Mark the patient’s admitting bed and transport
safe environment, no additional latex precautions                   vehicles.
should be needed. If latex or latex-containing                   ♦ Provide latex-sensitive patients with a “latex
products remain in the patient’s immediate care                     allergy” identification band and ensure that
environment, those products should be removed.                      the bed and chart also are clearly labeled.
  Nursing interventions are composed of many                     ♦ Remind all health care team members of the
and varied activities. To care for the latex-allergic               necessity for following latex avoidance
individual, some or all the following activities will               procedures.
be appropriate, particularly if the patient is not in a          ♦ Restrict traffic flow in the room before and
facility-wide latex-safe environment.                               during the procedure.
                                                                 ♦ Use latex-free IV tubing or replace injection
Preoperative activities                                             ports with three-way stopcocks. Tape over any
The following activities should take place before                   remaining ports to prevent inadvertent use.
the surgical procedure.                                          ♦ Use medication in ampules or latex-free vials
   ♦ Notify OR of potential or known latex-allergic                 when available.
     patient 24 to 48 hours (or as soon as possible)             ♦ Use latex-free syringes.
     before scheduled procedure.                                 ♦ Use latex-free blood pressure cuffs and con-
   ♦ Identify the patient’s risk factors for latex allergy          necting tubing. If they are not available, wrap
     and communicate same to health care team.                      the patient’s arm to prevent blood pressure
   ♦ Schedule procedure as first case of the day if                 cuff tubing or tourniquet cuff tubing from
     the facility is not latex-safe.                                coming into contact with the patient’s skin.

 114                                                          2004 Standards, Recommended Practices, and Guidelines
                                                                             AORN Latex Guideline

  ♦ Do not use latex tourniquets (eg, Penrose            and ongoing. The patient’s progress toward attain-
    drains) to start IV lines or as drains in a wound.   ment of outcomes should be documented using the
  ♦ Use a 100% silicone (ie, not silicone coated)        recognized, standardized perioperative nursing
    or polyvinyl chloride catheter if a urinary          vocabulary.84 Outcome indicators will vary accord-
    catheter is ordered for a procedure.                 ing to the specific desired outcome and may include
  ♦ Verify that additional items requested after the        ♦ physiological indicators (eg, neurological sta-
    case is in progress are latex-free before deliv-           tus, cardiovascular status);
    ering them to the sterile field.                        ♦ cognitive indicators (eg, repeats instructions
  ♦ Be prepared for the possibility that the proce-            correctly, asks appropriate questions);
    dure may require more than the scheduled                ♦ affective indicators (eg, verbalizes and
    equipment (eg, laparoscopy to open).                       demonstrates willingness to comply with
  ♦ Monitor for anaphylactic reactions to latex                treatment regimen); and
    throughout the procedure as reactions may               ♦ supportive resources (eg family members par-
    occur immediately after induction (eg, IV                  ticipate in care planning and delivery).
    exposure) or up to 40 minutes later.
  ♦ Have IV fluids and medications for treatment         Patient satisfaction
    of allergic reaction available immediately.          Evaluation of patient progress is based on observa-
  ♦ Inform postanesthesia care unit (PACU) staff         tions of the patient’s responses to nursing interven-
    members in advance of the patient’s arrival time.    tions and the effectiveness of interventions in mov-
                                                         ing the patient toward the desired outcome. Desired
Postoperative activities                                 patient outcomes, nursing interventions, and poten-
The following activities should be performed after       tially applicable nursing diagnoses are articulated in
the surgical procedure.                                  the standardized perioperative nursing vocabulary
    ♦ Continue the perioperative latex-safe plan of      which provides the basis for documentation of peri-
       care.                                             operative nursing practice. Ongoing assessment
    ♦ Ensure that latex-free supplies are available to   should be used to revise diagnoses, outcomes, and
       follow the patient to all future locations        the plan of care as needed. Revisions in diagnoses,
       within the health care facility.                  outcomes, and the plan of care should be docu-
    ♦ Provide a latex-free resuscitation bag, oxygen     mented. The patient, his or her significant others,
       mask, and supplies.                               and other health care providers should be involved
    ♦ Transport the patient to a latex-safe area.        in the evaluation process when appropriate.
    ♦ Provide education for patient and his or her
       family members or significant others.                             III. Conclusion
   If the latex-allergic patient is not cared for in a
facility-wide, latex-safe environment, he or she is at   This guideline has been designed to promote a safe
risk for reaction upon arrival in the PACU. When         health care environment for latex-sensitive and
the patient re-enters the mainstream care environ-       latex-allergic patients and health care workers. The
ment, he or she is at risk because of the aerosolized    document addresses prevalence, history, patho-
powder-containing latex proteins being transferred       physiology, risk factors, prevention, and nursing
through the air or shed from scrub attire of individu-   process applications. This guideline can be used as
als working with or near powdered latex products.        a resource by facilities developing latex-safe poli-
In a nonlatex-safe facility, it may be necessary to      cies, procedures, and protocols. The guideline may
use a positive pressure isolation room if a latex-safe   not apply to every individual and may require
environment of care has not been previously estab-       alteration based on specific needs.
lished in preparation for the patient.
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