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Dr. Babiec received his undergraduate
degree from Boston University and DMD from Tufts University School of
Dental Medicine. He served as a major in the United States Army Dental
Corps and remains a member of the Reserves. He opened his practice in
Shirlington, Virginia in 1980 and in Hayfield in 1986. A Master in the
Academy of General Dentistry, he is also a fellow of the International
College of Oral Implantology and of the Atlanta Craniomandibular Society.
Dr. Babiec has also received certificates from the US Dental Institute
(orthodontics), Misch Implant Institute, and TMJ Framework. He has had
several articles published and is currently in the process of co-authoring
a publication on latex allergies. A member of ALERT (Allergy To Latex
Education & Resource Team), he speaks throughout the country on the
subject of latex allergies. Dr. Babiec participated in creating one
of the first Minimal Latex Allergy facilities in the country.
Julie Seaton has been an active member
of the dental community since 1980, receiving her CDA from MATC in 1990.
She has worked in many different aspects of the dental field including
the dental supply industry, assisting in general dentistry, oral surgery
(specializing in IV sedation), periodontics, endodontics, and pedodontics.
Julie has been an active board member of ALERT since 1996. She has developed
protocols and guidelines for treating latex allergy patients in dental
offices that have been distributed throughout the US and Europe. A latex
allergy consultant, she works with organizations and dental offices
creating risk reduction programs to remove latex from the work environment
without increasing overhead. Along with Dr. Babiec, Julie is writing
a publication on the legal ramifications of latex allergy in the dental
office, and lectures throughout the country about latex allergies in
the workplace. For further information on latex allergies, call Julie
at 800-565-9705 or e-mail SeatonJM@aol.com.
Or contact ALERT (Allergy To Latex Education & Resource Team) 888-97-ALERT.
ALERT is a non-profit organization which provides information about
latex allergy and supports natural rubber latex (NRL) allergic individuals.
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Practitioners may remember the sudden changes that took
place and the turmoil that occurred when OSHA implemented its new Bloodborne
Pathogen guidelines. Be alert—changes are taking place in a new
area that you may be completely unaware of. These changes are being
driven by legal decisions and state legislation. OSHA recently issued
a Technical Information Bulletin (TIB) to all their field offices about
the pathogenicity and prevention of this problem: latex allergies. Though
latex allergies are not new and have always been an occupational hazard
in the healthcare industry, they are now being put under a new microscope.
Recent findings about their effects on healthcare workers and patients
have served as the catalyst for the changes that are taking place.
In the mid 1980s, due to AIDS and other infectious diseases, OSHA came
down with the Bloodborne Pathogen ruling which required that gloves
be worn by all healthcare workers. The demand for gloves then escalated
to the point of a shortage in most areas of the US. The demand created
by these “universal precautions” altered the manufacturing
and supply channels.
Allergy to natural rubber latex, commonly referred to as latex, appears
to have been an uncommon occurrence before 1980. However, the incidences
of allergic responses have increased dramatically since that time. In
the United States, attention to latex allergy was prompted by reports
of several fatalities due to anaphylaxis induced by latex retention
balloons used in barium enema procedures, and by frequent intraoperative
anaphylaxis among children with spina bifida. Between 1988 and 1992,
the Food & Drug Administration (FDA) received over 1000 reports
of adverse health effects from latex exposure; it was believed that
this figure represented only 10% or less of actual occurrences. Fifteen
deaths were attributed to this exposure. In a 1992 survey of US Army
Dental Corps officers (in which 1043 out of 1628 surveys were completed
- 64%), reactions consistent with latex allergy were as high as 13.7%.
Because of the ongoing nature of latex exposure, a Center for Disease
Control report estimates that 8-12% of all health care workers and 1-6%
of the general population are sensitized to latex. The highest incidences
in healthcare are in dental personnel, where reported incidences of
17-35% are mainly attributed to the large number of low quality powdered
latex gloves used by dentists, hygienists, and assistants.
Infants in daycare centers may have adverse reactions to gloves being
worn by daycare workers. Some have facial rashes that worsen after using
pacifiers or bottles containing latex. How many of us have had patients
who have commented that they “break out” after their visit
to the dentist?
Occupationally-related airway diseases, including asthma and chronic
obstructive pulmonary disease (COPD, primarily chronic bronchitis and
emphysema), have emerged as having substantial public health importance.
According to a National Institute for Safety and Health (NIOSH) report,
2.5% of healthcare workers have developed latex-related asthma.
Why is this happening? A brief look at the manufacturing of latex gloves
may provide part of the answer. Natural rubber is a processed plant
product, over 99% of which is derived from the latex, or milky sap,
of a commercial rubber tree, “Hevea Brasiliensis.” Latex is
a complex intracellular product of a system of cells, the essential
function unit of which is rubber particle, a spherical droplet of polyisoprene
coated with a layer of protein, lipid and phospholipid.
Most natural rubber is produced in Africa and south Asia. Cultivated
rubber trees are tapped for latex, usually on alternate days. This is
generally done by cutting a spiral groove in the bark and placing a
spout and collection cup at the bottom of the groove. After being tapped
from trees, the latex is put in large vats for processing. Ammonia is
introduced to the milky sap where, over a period of time, it helps break
down the proteins in the latex.
The collected tree sap is very dilute. By centrifugation and a pouring
off of the unwanted fluids, a concentrated product of rubber particles
and proteins is obtained. The proteins come naturally from the tree.
You cannot remove proteins from polyisoprene, as it is part of the genetic
make-up of the product. Additional chemicals, such as accelerators and
antioxidants are added for strength, stretch and durability.
The manufacture of gloves involves the process of dipping “glove
formers,” which are ceramic hands that have been dipped in calcium
nitrate to promote adhesion, into the latex substrate. The “glove
formers,” now coated with the resultant latex concentrate of rubber
particles and naturally occurring proteins, are made heat-stable and
elastic by vulcanization (heating in the presence of sulphur). The slow
vulcanization oven process increases the temperature to get rid of any
remaining water, the sulfur makes the rubber molecules stick together,
and the accelerators makes it happen quicker.
As the gloves dry, the latex proteins rise to the surface of the glove.
The now dry gloves are put through a leaching process, which varies
depending on the production line. Essentially the gloves are washed
in water which removes a portion of the remaining proteins and chemicals.
When the glove is removed from the “former” or mold, it is
inverted. The proteins and remaining processing chemicals that had risen
to the surface and have not been “leached out” are now on
the inside, or skin side, of the glove.
Powder is added to the glove before it is boxed. Studies show that 90%
of natural rubber proteins absorb into the powder within 60 seconds
of the powder being introduced to the glove. These leftover contaminants
are responsible for the dermatologic, respiratory, and systemic components
of the allergic responses in those individuals sensitive to latex products.
The immune system can be simply viewed as having two components. The
innate immune system acts as a front line defense against infectious
agents and most potential pathogens. This collection of molecules and
cells check most of the invasives before they can establish an overt
infection. If the first line is breached, the adaptive immune system
is activated. It produces a specific reaction to each infectious agent
that normally neutralizes and eliminates that agent. The adaptive immune
system also remembers the infectious agent and can prevent it from causing
infection later (immunologic memory).
Hypersensitivity exists when the adaptive immune system responds in
an exaggerated or inappropriate form, possibly resulting in tissue damage.
This response is unique to the individual and can occur at time of second
contact with a particular antigen. Four types of hypersensitivity reactions
(Types I, II, III and IV) have been described, but reviews of researchers’
findings agree that these types of hypersensitivity do not necessarily
occur independent of each other. In dentistry, Type IV (delayed type
hypersensitivity) and Type I (immediate hypersensitivity) are most often
discussed in the literature and seen in clinical situations.
The irritant contact dermatitis reaction is the most common reaction
recognized. This reaction usually occurs 12-24 hours after contact with
latex gloves or latex dental dam, though the reaction may only occur
after repeated exposure to the antigen over days. This Type IV reaction
is generally characterized by redness in the tissues, cracking of the
epidermis, fissuring, itching, and scaling. Reactions to poison ivy,
poison oak, nickel, and some chemicals will also elicit this response.
At this level, the response is contained mostly in the tissues, and
will soon clear up after the allergen is removed. Barriers may be effective
at this level. Various authors state that the contact dermatitis is
caused by remainders of the chemicals involved in the manufacturing
process of gloves. However, it is believed that the breaking of the
skin offers a route for latex antigens to be introduced to the blood
system of the individual.
Allergic contact dermatitis occurs 6-48 hours after contact. Similar
cutaneous responses can be seen as well as vesicles, papules, blisters
and crusting. Early cellular responses are also noted. T-type lymphocytes
will stimulate macrophages to release various components that contribute
to the heightened cutaneous response.
Though most people will be familiar with skin responses of Type IV reactions,
airborne molecules and proteins in the powder from gloves and other
latex products can be inhaled and result in an allergy-type response,
usually not recognized as such by the individual. Most authors agree
that exhibiting Type IV responses does not preclude one from developing
a Type I (immediate hypersensitivity) or anaphylactic reaction. This
reaction is characterized by an allergic reaction immediately following
contact with an antigen. Prominent symptoms are bronchospasm, rash,
hypotension, nausea, vomiting, cramping, and rhino conjunctivitis. The
latter is a serious, life-threatening condition that needs to be treated
immediately.
Who is at risk?
1. Patients who have had multiple surgeries. Patients with spina bifida
have been shown to have sensitization rates of over 60%.
2. Healthcare workers. Since the advent of mandatory bloodborne pathogens
regulation, incidences of latex allergy have escalated. As dental care
workers, we have high levels of proteins against our hands and we breath
it everyday as we put on and remove our gloves. It settles in our hair,
our clothing, even the carpet, and stays in our ventilation systems
indefinitely.
3. Workers in the latex industry.
4. Atopic individuals. People who have multiple allergies are at increased
risk to developing latex allergies.
Certain fruits such as avocado, kiwi fruit, bananas and chestnuts show
some cross-reactivity. People allergic to these may be more susceptible
to developing allergy to latex products. Likewise, those who are sensitive
to latex should avoid contact with these foods.
By current government statistics, it can be estimated that approximately
one million health care workers may have latex allergy in one form or
another. Regardless of how high the current statistics are, the fact
is that adults, children and infants are being affected, as new cases
are being reported everyday. Current information is inconsistent concerning
the influence of age, sex, race, and length of exposure on the risk
of latex allergy.
The prevention of adverse latex reactions depends on identification
of patients who are allergic. A careful and complete health history
will help identify some persons at risk for latex allergy. Once identified
and diagnosed, avoidance of latex products is the only measure that
can avert a serious allergic reaction. Both the American College of
Allergy, Asthma and Immunology and the American Academy of Allergy,
Asthma and Immunology have issued recommendations for latex testing
and latex avoidance.
If your current health history form does not include questions regarding
latex allergy, have it modified. Questions can be worded as follows:
Are you sensitive or allergic to latex?
Have you experienced itching, rash or wheezing after using latex gloves
or handling a balloon?
Have you had any unusual or unexplained reactions during a surgical
procedure?
Put these questions in bold print so they are very noticeable to patients.
Never attempt to diagnosis patients with a positive health history.
Rather, consult with an allergist and get a positive diagnosis from
him/her.
OSHA’s bloodborne pathogens standard (29 CFR 1910.1030, paragraph
d 3 ix) requires that gloves be worn when it is reasonably anticipated
that hand contact may occur with blood and other bodily fluids and tissues.
Likewise, the employer is required to provide alternative suitable non-latex
gloves for workers.
All medical grade gloves sold in the US are required to meet multiple
standards, as defined by the American Society for Testing (ASTM) and
adopted by the FDA, before permission to market the gloves is given.
Latex is the benchmark by which all medical gloves, including vinyl,
are compared. As you search for alternative choices, you should be aware
that there is great variability in gloves. We will discuss this in depth
in a future article.
Be assured that there are non-latex gloves, such as vinyl, neoprene,
nitrile, etc., which are high quality, comfortable, and of comparable
cost. When choosing gloves, select the appropriate glove for the task
at hand.
All medical grade gloves sold in the US, regardless of glove material,
must meet or better the maximum allowable failure rate, or AQL (Acceptable
Quality Level). This grading refers to the major, minor and pinhole
defects of gloves. However, no barrier is 100% effective, no matter
what the product. Wearing gloves should not be a substitute for thorough
and conscientious hand washing. It cannot be assumed that gloves will
always provide an intact barrier against exposure to pathogenic microorganisms.
A hand care regimen should be established and maintained, utilizing
appropriate skin care products that enhance healing and help maintain
moisture. Petroleum-based products should not be worn where glove use
is mandatory, as they may enhance the contact of any antigens with the
skin.
FDA requirements state that all manufacturers must label devices that
contain natural rubber latex with a statement that reads “Caution:
This Product Contains Natural Rubber Latex Which May Cause Allergic
Reactions.” The FDA is also requiring that all “hypoallergenic”
claims on medical devices be removed because they incorrectly imply
that the devices may be safely used by people who are sensitive to latex.
Manufacturers had until September 30, 1998 to comply with the new law.
The regulation does not apply, however, to latex-containing devices
that do not come in contact with people.
What else can be done in the office? Aside from gloves (usually the
main contributor of latex in the office), other latex-containing products
abound, such as rubber dams, gutta percha, stoppers in anesthetic carpules,
ambu bags and stethoscopes. These need to be identified and substitutions
found. The ventilation system must be cleaned of all the latex protein-containing
powder which circulates throughout the office. Carpets, drawers, records—the
entire office—will need a “spring cleaning.” Certain
tapes, pencil erasers, rubber bands and other office supplies have non-latex
substitutes.
Can latex be completely removed from our environment? The answer is
no. Latex is in almost everything we use, from gloves to undergarments.
Tennis shoes have latex in them, as do tires, adhesives, even some carpets
and diapers. In 1941, when America went to war, the Japanese took control
of 95% of the world’s supply of rubber and plunged the US into
a crisis. Rubber was and is so widely used, and there was no synthetic
alternative at that time. Four days after the attack on Pearl Harbor,
the use of rubber in any product not essential to the war effort was
outlawed. Synthetic rubber was finally successfully produced by 1945,
and serviceable synthetic rubber accounted for 85% of US consumption.
In 1973, the OPEC oil embargo quadrupled the price of the raw materials
used to make synthetic rubber. Until 1968 over 90% of vehicles in America
ran on synthetic tires. Radial tires, which are made from latex, changed
the scene. By 1993, radial tires accounted for 95% of the market.
Transportation is just part of the rubber boom. In the last 20 years,
with the increased demand for gloves and condoms due to AIDS and other
infectious diseases, latex use has more then doubled. Latex’s ability
to withstand heat and steam in sterilization, and its ability to adhere
to steel and glass, makes it vital in the production of many products,
including tubing, stoppers, syringes and other pharmaceutical, medical,
and dental products. Some say that there is not a viable substitute
for latex, but in 1945 we got along just fine with synthetic rubber.
With more than one million healthcare workers now having latex allergy,
with over 10,000 people documented as wearing medic-alert latex allergic
bracelets, with more than 15 deaths documented from latex allergy, how
can we not do anything? To do nothing is to possibly endanger your life,
your patients, even in some cases, your family.
Other alternatives are available. The cost of changing an office to
“minimal latex” is as it says, “minimal.” Cost comparison
studies done by John Hopkins University and the Mayo Clinic show that
there is no significant increase in overhead when switching to non-latex
supplies, especially gloves. In dental offices that have been converted
through onsite consultation, there has been a decrease in overhead in
most cases.
Create a risk reduction program that works for you and the size of your
office. Risk assessment surveys are available to help you determine
if your employees may have latex allergies. Medi-Watch, which is run
by the FDA, is where to report your allergy. This information is vital
in determining the extent and severity of these allergies. If you have
been diagnosed with latex allergy, call them to report it! Their number
is 800-FDA-1088.
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