FDA Warns Medical Manufacturers About Using "Latex Free" Labels

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FDA Warns Medical Manufacturers About Using "Latex Free" Labels

Main Category: Allergy
Also Included In: Public Health | Medical Devices / Diagnostics
Article Date: 10 Mar 2013

The U.S. Food and Drug Administration has just issued a warning to medical device manufacturers stating that they should provide accurate information about their products that don't contain natural rubber latex (NRL) and stop labeling them as "latex free".

NRL is natural milk-like substance found in plant sources, after repeated exposure to NRL some people can have severe allergies, and develop hives or rashes. In some cases the reactions can be so bad that the patient experiences wheezing and serious breathing difficulties.

Latex allergy is caused by people's immune system responding to the substance as if it were a pathogen - a substance that harms health.

The new draft recommendations want to put a stop to medical products using labels such as "does not contain latex" which are not always scientifically accurate. The FDA would rather have manufacturers use the labeling statement "not made with natural rubber latex" to indicate when NRL isn't directly used as a material in the product.

William Maisel, M.D., M.P.H., deputy director for science in the FDA's Center for Devices and Radiological Health, said:

"Consumers rely on and expect accurate labeling and product information, especially when they are concerned about allergic reactions. Our recommendations regarding natural rubber latex provide consistent, scientifically accurate language for health care providers, patients and consumers who want to avoid this material due to possible sensitivity or allergy."

When manufacturers use labels such as "latex free", it makes people think there is absolute no trace of NRL in the product. However, there is always a chance that medical products can become contaminated with NRL allergens in the production process.

There is currently no test to reveal whether a product is free of NRL either. Therefore, replacing the labels will be more truthful - because there is a chance there might be trace elements of NRL in the product.

A growing number of health care professionals are becoming allergic to latex products

There are two types of latex; natural and synthetic. Only natural latex contains the proteins that trigger NRL allergy, not synthetic latex - "latex free" fails to specify what particular type of latex is being used.

Who is at risk of developing latex allergy?

NRL sensitization is more common among people who use NRL gloves, such as doctors, nurses, dentists, and hairdressers.

The following people have a higher-than-normal risk of developing latex allergy.

Doctors, nurses, and other health care workers
Patients who underwent multiple surgical procedures, especially when they were (are) children
Patients requiring regular/continuous urinary catheters with a rubber tip
People who underwent spinal surgery
Individuals with eczema
People affected by asthma
Patients who have other allergies
Workers in the rubber industry
Workers in car-tire factories
Condom users

Powder-free latex gloves reduce allergy rates among health care workers - the most effect public health strategy to prevent allergic sensitization to latex is to stop using powdered latex gloves, scientists at the Medical College of Wisconsin reported in the Journal of Occupational and Environmental Medicine (August 2011 issue).

Written by Joseph Nordqvist
Copyright: MediLexicon International Ltd

Original article posted on Medical News Today.
Articles not to be reproduced without permission of Medical News Today

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