FDA polices latex labeling
The U.S. Food and Drug Administration is requiring that within one year, medical devices containing latex carry warning labels. The prescribed warning will read, "Caution: This product contains natural rubber latex which may cause allergic reactions." In addition, manufacturers must remove claims that products are hypoallergenic or carry little likelihood of causing allergic reactions. Devices that don’t come into contact with a person are exempt from the policy.
Over the last 10 years, the FDA has received more than 1,700 reports of latex reactions, including 16 deaths involving children with spina bifida who had reactions to latex used in catheters. Those catheters have subsequently been replaced with silicone.
Though less than 1% of the population is known to harbor latex allergy, health care workers and patients undergoing frequent procedures develop increased sensitivity due to recurring exposure. (See the articles in Hospital Peer Review’s special July 1997 issue on latex sensitivity for further details on this growing problem.)
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