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FDA will require
warning labels on medical latex products posted 10-14-97 The Food and Drug Administration recently released regulations to make it easier for health professionals and patients who are allergic to latex to avoid latex products. Beginning next September, manufacturers must include warning labels on all medical devices containing natural rubber latex if the products directly or indirectly contact living human tissue. The FDA guidelines also prohibit companies from claiming latex products are "hypoallergenic," since the term erroneously implies that people allergic or sensitive to latex can use the product safely. Patients who require a lot of surgeries and health professionals who are frequently exposed to latex are most vulnerable to allergies. The FDA filed more than 2,300 reports of latex reactions as of June 1996, including 28 deaths, according to ELASTIC (Education Latex Allergy/Support Team & Information Coalition). The fatalities include 16 children with spina bifida who died in 1989 from allergic reactions to latex cuffs used on the top of barium enema catheters. The cuffs have since been replaced with silicone. As many as 25 percent of healthcare workers may be allergic to latex, while less than 1 percent of the general population is. Latex can be found in adhesive tape, disposable syringes, elastic bandages, protective sheets, wound drains, stethoscope tubing, electrode pads, and other devices. One of the most common latex products, gloves, can be even more hazardous when used with powder since the airborne particles absorb latex proteins and are inadvertently inhaled. Related Site |