viernes, 8 de marzo de 2013

Press Announcements > FDA issues draft guidance for manufacturers to accurately label medical products that are not made with natural rubber latex

FDA NEWS RELEASE

For Immediate Release: March 8, 2013
Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA issues draft guidance for manufacturers to accurately label medical products that are not made with natural rubber latex
The U.S. Food and Drug Administration today issued draft recommendations to medical product manufacturers for providing consumers with accurate information about products that are not made with natural rubber latex (NRL).
NRL is a milky fluid found in rubber trees and other plant sources. Prolonged or repeated exposure to NRL can result in sensitivity or allergy. Mild reactions may include skin redness, rash, hives, or itching. More severe reactions may include respiratory symptoms such as difficulty breathing, coughing spells and wheezing. Rarely, anaphylactic shock may occur.
The FDA is encouraging manufacturers of FDA-regulated medical products to stop using statements on labels such as “latex free” or “does not contain natural rubber latex” because these statements are not scientifically accurate. Instead, the FDA recommends manufacturers use the labeling statement – “not made with natural rubber latex” – to indicate when NRL was not used as a material in the medical product or product container.
“Consumers rely on and expect accurate labeling and product information, especially when they are concerned about allergic reactions,” said William Maisel, M.D., M.P.H., deputy director for science in the FDA’s Center for Devices and Radiological Health. “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.”
The terms “latex free” and “does not contain natural rubber latex” suggest that the medical product is completely without NRL. However, even when medical products are not made with NRL, there is a chance that products can become contaminated with NRL allergens during manufacturing or packaging processes. There is no test to show that a medical product is completely free of NRL allergens. Additionally, it is not necessary for a medical product to be completely without NRL allergen proteins to be considered safe for use by some individuals with NRL allergies.
Also, phrases such as “latex free” that are not specific about the kind of latex being referred to can cause confusion. Latexes may be natural or synthetic. Synthetic latex, such as nitrile and polyvinyl chloride, does not contain the proteins responsible for NRL allergy.
People most at risk for NRL sensitization include those who frequently use NRL gloves such as physicians, nurses, dentists, medical technicians, hairdressers, housekeepers, and food service workers. Employees in facilities that manufacture products containing NRL are also at risk.
Consumers concerned about NRL allergies should check the medical product label, if readily available, or ask their health care provider if the product of interest contains NRL.
Today’s draft recommendations would apply only to FDA-regulated medical products, such as drugs, medical devices, biologics and veterinary products. The law does not require medical product manufacturers to state on the product labeling when NRL has not been used in the manufacture of the product or product packaging. However, medical device manufacturers are required to include a caution statement on the labeling of devices that are made with NRL.
For more information:

FDA Draft Guidance for Industry and FDA Staff: Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex

FDA Consumer Update: There’s No Guarantee of ‘Latex Free’

CDC: Latex Allergy: A Prevention Guide

CDC: Home Healthcare Workers: How to Prevent Latex Allergies

Latex Allergy A Prevention Guide

Latex gloves have proved effective in preventing transmission of many infectious diseases to health care workers. But for some workers, exposures to latex may result in allergic reactionsa.html. Reports of such reactions have increased in recent years--especially among health care workers.

What is latex?

In this pamphlet, the term "latex" refers to natural rubber latex, the product manufactured from a milky fluid derived from the rubber tree, Hevea brasiliensis. Several types of synthetic rubber are also referred to as "latex," but these do not release the proteins that cause allergic reactions.

What is latex allergy?

Latex allergy is a reaction to certain proteins in latex rubber. The amount of latex exposure needed to produce sensitization or an allergic reaction is unknown. Increasing the exposure to latex proteins increases the risk of developing allergic symptoms. In sensitized persons, symptoms usually begin within minutes of exposure; but they can occur hours later and can be quite varied. Mild reactions to latex involve skin redness, rash, hives, or itching. More severe reactions may involve respiratory symptoms such as runny nose, sneezing, itchy eyes, scratchy throat, and asthma (difficult breathing, coughing spells, and wheezing). Rarely, shock may occur; however, a life-threatening reaction is seldom the first sign of latex allergy.

Who is at risk of developing latex allergy?

Health care workers are at risk of developing latex allergy because they use latex gloves frequently. Workers with less glove use (such as housekeepers, hairdressers, and workers in industries that manufacture latex products) are also at risk.

Is skin contact the only type of latex exposure?

No. Latex proteins become fastened to the lubricant powder used in some gloves. When workers change gloves, the protein/powder particles become airborne and can be inhaled.

How is latex allergy treated?

Detecting symptoms early, reducing exposure to latex, and obtaining medical advice are important to prevent long-term health effects. Once a worker becomes allergic to latex, special precautions are needed to prevent exposures. Certain medications may reduce the allergy symptoms; but complete latex avoidance, though quite difficult, is the most effective approach.

Are there other types of reactions to latex besides latex allergy?

Yes. The most common reaction to latex products is irritant contact dermatitis- the development of dry, itchy, irritated areas on the skin, usually the hands. This reaction is caused by irritation from wearing gloves and by exposure to the powders added to them. Irritant contact dermatitis is not a true allergy. Allergic contact dermatitis (sometimes called chemical sensitivity dermatitis) results from the chemicals added to latex during harvesting, processing, or manufacturing. These chemicals can cause a skin rash similar to that of poison ivy.

How can I protect myself from latex allergy?

Take the following steps to protect yourself from latex exposure and allergy in the workplace:

Use nonlatex gloves for activities that are not likely to involve contact with infectious materials (food preparation, routine housekeeping, general maintenance, etc.).

Appropriate barrier protection is necessary when handling infectious materials. If you choose latex gloves, use powder-free gloves with reduced protein content.

Such gloves reduce exposures to latex protein and thus reduce the risk of latex allergy.

So-called hypoallergenic latex gloves do not reduce the risk of latex allergy. However, they may reduce reactions to chemical additives in the latex (allergic contact dermatitis).

Use appropriate work practices to reduce the chance of reactions to latex.

When wearing latex gloves, do not use oil-based hand creams or lotions (which can cause glove deterioration).

After removing latex gloves, wash hands with a mild soap and dry thoroughly.

Practice good housekeeping: frequently clean areas and equipment contaminated with latex-containing dust.

Take advantage of all latex allergy education and training provided by your employer and become familiar with procedures for preventing latex allergy.

Learn to recognize the symptoms of latex allergy: skin rash; hives; flushing; itching; nasal, eye, or sinus symptoms; asthma; and (rarely) shock.

What if I think I have latex allergy?

If you develop symptoms of latex allergy, avoid direct contact with latex gloves and other latex-containing products until you can see a physician experienced in treating latex allergy.
If you have latex allergy, consult your physician regarding the following precautions:

Avoid contact with latex gloves and products.

Avoid areas where you might inhale the powder from latex gloves worn by other workers.

Tell your employer and health care providers (physicians, nurses, dentists, etc.) that you have latex allergy.

Wear a medical alert bracelet.

Additional Information

For additional information about latex allergy, or to request a copy of NIOSH Alert No. 97-135, Preventing Allergic Reactions to Natural Rubber Latex in the Workplace, call 1-800-35-NIOSH (1-800-356-4674)
You may also visit the NIOSH Homepage
To access latex allergy websites, select Latex Allergy through the NIOSH Homepage, or access the websites directly at the following locations: