Relief For Latex Allergy Sufferers As FDA Clears New Medical Glove

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Article Title:

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Relief For Latex Allergy Sufferers As FDA Clears New Medical Glove

Article Description:

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Most allergies are easy to cope with by simply avoiding the

trigger. Sometimes that's easier said than done, such as in the

case of a latex allergy. Estimates vary, but anywhere from 3

percent to 22 percent of all health care workers are sensitized

to traditional latex. FDA recently cleared for marketing the

first device made from a new form of natural rubber latex called

guayule latex.

Additional Article Information:

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460 Words; formatted to 65 Characters per Line

Distribution Date and Time: 2008-07-29 11:00:00

Written By: Norm Howe

Copyright: 2008

Contact Email: mailto:info@...

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Relief For Latex Allergy Sufferers As FDA Clears New Medical Glove

Copyright © 2008 Norm Howe

Validation and Compliance Institute

http://www.vcillc.com

Most allergies are easy to cope with by simply avoiding the

trigger. Sometimes that?s easier said than done, such as in the

case of a latex allergy. Estimates vary, but anywhere from 3

percent to 22 percent of all health care workers are sensitized

to traditional latex.

For those in the healthcare profession, as well as patients who

suffer from a latex allergy, every day there are materials that

must be handled or avoided with caution, or suffer the

consequences, ranging from a mild rash, to, worst-case scenario,

anaphylactic shock.

Traditional latex gloves are made from the milky sap of a rubber

tree, Hevea braziliensis. That sap contains a protein that can

trigger allergic reactions, particularly after prolonged and

repeated contact. Allergic reactions run the gamut from skin

redness, rash, hives, or itching, to respiratory symptoms such as

difficulty breathing, coughing spells and wheezing, and, rarely,

shock.

Health care workers first began using traditional latex gloves in

the 1890s. The HIV epidemic of the 80s ushered in modifications

in glove materials, which made them more sensitizing to those

with latex allergies.

Some health care institutions responded by shifting to

alternative glove materials for their workers. The U.S. Food and

Drug Administration (FDA) also implemented numerous steps to

address the glove allergy problem, including working with the

industry to develop a consensus standard that identifies maximum

protein and powder levels for medical gloves. In addition, a 1998

rule requires that all medical devices containing latex carry a

statement on the label warning about the risk of allergic

reactions.

Most recently, FDA cleared for marketing the first device made

from a new form of natural rubber latex called guayule latex. The

product, the Yulex Patient Examination Glove, is derived from the

guayule bush, a desert plant native to the Southwestern United

States. The new material provides flexibility and strength

comparable to latex.

Available data on the new guayule latex show that even people who

are highly allergic to traditional latex do not react on first

exposure to guayule latex proteins. Because there is no data on

people?s long-term experience with the Yulex glove, which is made

by the Yulex Corporation of Maricopa, Ariz., the product will

carry a warning (for now) about the potential for allergic

reactions.

Products such as the Yulex glove, which utilize new materials in

inventive ways, are a benefit to both healthcare workers and

patients. To get the FDA stamp of approval, companies such as VCI

LLC can help. VCI specializes in compliance services that meet

FDA standards, as well as expertise in validation, production,

quality, and R & D. VCI also offers manufacturers a proactive

approach to getting it right the first time--before a product

even hits the shelf--thus negating the need for a reactive

response down the road.

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Norm Howe, Senior Partner at Validation and Compliance Institute,

consultants for the pharmaceutical and medical device industries.

He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA.

He has held many management positions in FDA regulated industries,

most at BASF. http://www.vcillc.com