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   Source To Surgery - January 1993, Vol. 1 Issue

FDA Call Worldwide Conference
Seeks Input on Latex Allergy Disorder

When 400 plus scientists, manufacturers, nurses, clinicians, regulators, and other allied health personnel entered the ballroom of the Hyatt Regency Baltimore in early November, there was more than a reasonable doubt in many minds about the reality of the newly reported medical condition called latex allergy. Two and one-half days and 60 scientific presentations later, there remained little doubt that the condition of latex allergy was very real and the increase in reported incidence was growing rapidly.

Billed as the "International Latex Conference: Sensitivity to Latex in Medical Devices" and sponsored by the Food and Drug Administration, Center for Disease Control, and National Institute of Allergy and Infectious Diseases, speakers and interested viewers from around the world converged to learn the current state- of-the-art knowledge or lack of knowledge regarding this allergy.

Latex hypersensitivity has been reported to cause anaphylactic reactions, asthma, eczema, urticaria and death. Anaphylaxis and deaths in the radiological suite have been attributed to improperly manufactured barium enema balloon catheters. Anaphylaxis in the operating rooms was first reported in a spina bifida patient series and is now being documented in the general population as well. Its cause is unknown.

Possibly the most disturbing reports came from Finland, Central Europe and the U.S. that the greatest at-risk population for latex allergy are health care workers. Continual exposure to latex in exam gloves and surgical gloves (estimates now range from 5.5 to 6 million health care workers must glove daily due to now enforced OSHA-Universal Precautions regulations) may be a part of the cause. However, recent reports released by hospitals inquiring of manufacturers about latex, reveal hundreds of medical devices, especially operating room products, contain natural rubber latex.

Switching to vinyl gloves from latex does not appear to be a viable alternative as recent studies indicate that latex affords nine times the barrier protection of vinyl and for most health care workers in this HIV, HBV age, that's not good enough. There are emerging alternatives for health care workers as newer synthetic materials begin to appear on the market. The bad news is they are expensive - very expensive - which will do little for health care cost containment. While synthetics will isolate the hypersensitive from direct hand contact with latex, they afford no protection from other latex bearing products whose route of sensitization may be through inhalation of latex particles.

Only a few glove manufacturers have been successful in lowering protein allergen levels to negligible amounts by extensive leaching and washing of the latex during the manufacturing process. Numerous hot water leaching baths and post-process washings are required to reduce or remove the water soluble proteins from gloves.

What to do next? As an FDA publication reports, there's the rub. Until reliable tests for the allergy are developed, the best protection for patients and health care workers is a careful history and avoidance should the history indicate past problems. FDA may soon require all device manufacturers to label all products which contain natural rubber latex. Latex precaution protocols are being developed at many hospitals and alternative product lists are being developed to those products known to contain latex.

When scientists and clinicians were questioned by the conference participants as to whether or not this latex allergy was the "tip of an occupational health iceberg," the answer seemed to be a universal "yes."


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