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Medical Forum / Diseases and Disorders / AIDS / October 2004

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Federal Government Debates Latex Regulations

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PaulKing - 07 Oct 2004 19:47 GMT
Federal Government Debates Latex Regulations

Federal agencies have not yet been able to reach a consensus regulation of
latex gloves, exposure to which has resulted in a growing epidemic of
allergic reactions.
FDA
In September of 1997, the Food and Drug Administration (FDA) issued a
final rule (Federal Register, Volume 62, page 5102) requiring cautionary
statements in the labeling of all medical devices that contain natural
rubber likely to come in contact with humans. The rule provides that such
products must contain the following cautionary statement in bold print:
"Caution: This product contains natural rubber latex which may cause
allergic reactions." Additionally, the FDA issued a final ruling that the
labeling of medical devices that contain natural rubber, likely to come in
contact with humans, shall not contain the term "hypoallergenic".
Lawsuits Increase
Over the last few years, there has been a significant increase in the
amount of workers' compensation claims filed against employers on behalf
of individuals who have suffered latex allergic reactions. Additionally, a
significant number of claims have been filed against the manufacturers,
suppliers and distributors of latex gloves and products. The claims filed
in the Federal District court throughout the United States have been
joined in one action for pretrial management and discovery in accordance
with a Multi-District Litigation Order issued by the court.
OSHA
The Occupational Safety & Health Administration of the United States
Department of Labor has issued a technical information bulletin in draft
form to alert field personnel to the potential allergic reactions in some
individuals using natural rubber latex (NRL) products, particularly
gloves, in the workplace setting. OSHA has indicated that a "safe zone"
may need to be established to protect workers who are already sensitized
to NRL. It has indicated that health care facilities may be required to
develop policies and procedures for reducing the risk of NRL allergies in
the workplace. It has also recommended that there be mechanisms for
reporting and managing cases of allergic reactions. Since the allergic
reactions may be systemic and immediate, OSHA has recommended that the
fundamentals of an emergency response (i.e., assuring airway, breathing
and circulation) remain of primary importance if a worker develops
symptoms requiring resuscitation, that these situations should be
anticipated in the workplace, and that provision of immediate access to
non-natural rubber containing equipment be considered.
It should be noted that, once NRL allergy occurs, allergic individuals
continue to experience symptoms, which have included life-threatening
reactions, not only on exposure to NRL in the workplace but also upon
receiving or accompanying a family member receiving healthcare services at
inpatient as well as office-based settings.
Congressional Hearings
The regulation of NLR products has been a concern both for the federal
government and for individual states. The Federal government has initiated
agency evaluations and Congress is conducting oversight investigatory
hearings on latex allergies in the healthcare industry. Some state
governments are now considering enacting legislation in order to protect
the health of those exposed to NLR products.
GMCarter - 07 Oct 2004 23:53 GMT
>Federal Government Debates Latex Regulations
>
>Federal agencies have not yet been able to reach a consensus regulation of
>latex gloves, exposure to which has resulted in a growing epidemic of
>allergic reactions.

Gloves are not condoms.
PaulKing - 08 Oct 2004 09:21 GMT
"Gloves are not condoms"

SO TRUE.

Gloves are not used internally on a very delicate part of the body.

Gloves are not subject to moist internal surfaces.

Gloves are not rubbed for hour on end into the skin.

Gloves don't have toxic lubricants.

Condoms present a far, far greater risk then gloves.

FAR GREATER

_______

"According to the A m e r i c a n Academy of A l l e rg y, Asthma &
Immunology (AAAAI), the greatest danger of severe reactions occurs when
latex comes in contact with moist areas of the body or internal
surfaces."

________

"...... new concerns are arising regarding allergic or other toxic
reactions to various components of latex condoms such as vulcanization
accelerators, latex proteins, spermicides and finishing powders."

"* Studies are needed to evaluate the best lubricants to use in the
manufacture of condoms. Evidence suggests that the right quantity, type
and placement of lubricant is important for condom functionality,
acceptability and safety.
In addition, the added value and risk presented by spermicidal lubricants
and by dry finishing powders (e.g. talc or cornstarch) should be
critically examined."

"Since the late 1980s the reported incidence
of allergy to natural rubber latex has increased dramatically, as much as
12 -fold."

"Latex allergy is incurable, although the symptoms, such as itching,
soreness, painful blistering, runny noses, swollen eyes, asthma symptoms
and anaphylaxis can be ameliorated.
Everyone who has contact wi th natural rubber latex is potentially at risk
from sensitisation.
Both patients and health care workers can be at risk from allergic
reactions to natural rubber latex. Over the past decade, allergic
reactions to natural
rubber latex have become a major public health concern."

" Once a person has developed latex allergy, however mild, they are
“sensitised” to latex and are at risk from severe allergic reactions."

"Delayed cell-mediated reactions are the most common form of
hypersensitivity reaction to natural rubber latex. These reactions are to
individual chemical residues from the production process such as
accelerants used in the vulcanisation process which is required to
strengthen the product.
The residual chemicals may bloo on the surface of the products and can be
absorbed through the skin upon contact."

Condoms contain compounds known to cause cancer and serious birth defects
in substantial quantities
SOURCE. Condom Industry web site and Beacon Pharmaceuticals, July 2001

___________

COMMON LUBRICANTS AND THEIR SIDE EFFECTS
Nonoxynol 9: Poison by intraperitoneal route. Mutation data reported. When
to decomposition, it emits acrid smoke and fumes (HC, . 958).
Parrafin: Possible carcinogen with experimental tumorigenic data by
implant route. (HC, p. 982; HOP, p. 212).
Chlorhexidine: Mildly toxic by ingestion. Skin irritant. Mutation data
reported (HC, p. 167).
Lidocaine: Poison by ingestion and subcutaneous routes. Excitement,
hallucinations, distorted perceptions, changes in heart rate, and dyspnea.
Anaesthetic rapidly absorbed by mucous membranes. Excessive doses may
cause methemoglobinemia (HC, p. 439;
HOP, p.341.)
Mineral oil/petrolatum: A human teratogen that causes testicular tumors in
the fetus.
of vapor or particles can cause pneumonia.
Possibly
produces gastrointestinal tumors. Deposits accumulate in the lymphnodes
and dissolves and prevents the absorption of vitamin A from the intestines
(HC, p. 885; HOP. p. 206, 410.)
Polyethylene glycol: Moderately toxic. Eye irritant. Possible carcinogen
and flammable. Many glycols produce severe acidosis, central nervous
system damage, and congestion (HC, p. 1053; HOP, pp. 193-195.)
Sodium borate: A.K.A. borax. Toxic to all cells. Prolonged absorption
casues anorexia, vomiting, diarrhea, and anemia (HOP, p. 396).
Propylene glycol: Slightly toxic. Causes convulsions, mutations, and
surface EEG changes (HC, p. 1086).
Carboxymethylcellulose,
hydroxymethylcellulose,
polyscorbate 60:
The first of these compounds has been shown to cause cancer in animals.
Used in cosmetics, inhalation of these products could cause chemical
pneumonitis. Bodily implantation of these substances will cause foreign
body [antibody] reaction (HOP, p. 308).
Triethanolamine: Moderately toxic by ingestion. Liver and kidney damage
has been demonstrated in animals from chronic exposure. Possible
carcinogen (HC, p. 1273).
Methylparaben, propylparaben: Close chemical cousins of benzoic acid.
Poisonous and moderately toxic. An allergen. Causes dyspnea and allergic
dermatitis (HC. pp. 132, 695, 702).
Source: The Hazardous Chemicals Desk reference (HC) and The Handbook of
Poisoning (HOP).
GMCarter - 08 Oct 2004 10:32 GMT
>"Gloves are not condoms"

snip

>"Delayed cell-mediated reactions are the most common form of
>hypersensitivity reaction to natural rubber latex."

LOL. So for those few people who develop (has there EVER been a
case??) an allergic reaction from using latex condoms, they could
CONTINUE to use it and, like DNCB, be cured of HIV. Gosh. Where's Frod
Show??

Lubricant with nonoxynol-9 is a bad idea--actually, a lot of us were
arguing that 10 years ago! So we do agree there. Many companies are
making lube with out N9 but not enough yet.

And there are plastic condoms.

The risk of allergy or the allergic response from condom use is MUCH
MUCH less than the risks associated with becoming HIV infected.

        George M. Carter
PaulKing - 09 Oct 2004 22:47 GMT
All latex exposure accumulates together in the blood stream. How could you
possibly determine the point of entry/

What a silly comment.

Latex is latex is latex.

Latex exposure is latex exposure. Internal 'moist' contact is by far the
worst.
GMCarter - 10 Oct 2004 00:52 GMT
>All latex exposure accumulates together in the blood stream.

Remarkable statement! Any support for it?
George M. Carter
 
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