Latex Labeling Required for Medical Devices
Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
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T97-50 Sharon Snider: 301-827-6242 September 30, 1997 Consumer Media: 800-532-4440 LATEX LABELING REQUIRED FOR MEDICAL DEVICES In response to reports of allergic reactions to some medical devices, the Food and Drug Administration is requiring all medical devices containing latex to be labeled as such and to carry a caution that latex can cause allergic reactions. Devices that contain natural rubber latex will be required to carry a statement on the label which says, "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions." Medical device packaging that contains latex will be required to carry a similar statement on the label. Products and packaging that contain dry natural rubber will have to be identified as containing dry natural rubber. The new requirements, published today in the Federal Register as a final regulation, will help protect people who are allergic to latex by enabling them to easily identify medical devices that contain latex and avoid contact with them. Over the past decade, FDA has received more than 1,700 reports of severe allergic reactions, including 16 deaths, related to medical devices containing latex. The deaths all occurred in 1989 among children with spina bifida. They were caused by a reaction to latex cuffs used on the tip of barium enema catheters. The manufacturer voluntarily recalled all the enema tips on the market and started using tips with silicone cuffs instead. Allergic reactions have been reported to a wide range of medical devices that contain latex, including latex surgical gloves, adhesive bandages, intravenous catheters, and anesthesia equipment. FDA sponsored an international conference on latex sensitivity in 1992 to determine the cause and extent of the problem and explore ways to address it. For the general public, the risk of an allergic reaction to latex is estimated to be less than 1 percent. But because of constant exposure to latex, two groups are at greater risk--health-care workers and children with spina bifida and other conditions involving multiple surgical procedures. FDA is also requiring that all "hypoallergenic" claims on medical devices be removed because they incorrectly imply that the devices may be safely used by people sensitive to latex. Such claims are currently found on many medical devices that contain reduced levels of latex protein. However, these products may still cause allergic reactions in people who are latex sensitive. Manufacturers have one year -- until Sept. 30, 1998 --, to comply with the new law. The regulation does not apply to latex containing medical devices that do not come in contact with people. ####