FDA Consumer

Final rule adds warning on devices containing latex

Final rule adds warning on devices containing latex – Brief Article

Surgical gloves, adhesive bandages,

intravenous catheters, and other medical

devices containing latex will have to

start carrying a warning for people

allergic to the rubber substance, according to

an FDA final rule.

Beginning Sept. 30, 1998, labels of

latex-containing medical devices will

have to state, “Caution: This Product

Contains Natural Rubber Latex Which

May Cause Allergic Reactions.” Similar

labeling will be required on medical

devices containing dry natural rubber and

medical device packaging that contains


Also, the rule will prohibit use of the

claim “hypoallergenic” on labels of

latex-containing medical devices. As now

used on devices with reduced latex levels,

the claim implies that such products

are safe for latex-sensitive people. But

even reduced amounts of latex can cause

allergic reactions in susceptible people.

During the past decade, FDA received

more than 1,700 reports of severe

allergic reactions, including 16 deaths in

children with spina bifida, related to

medical devices containing latex.

Health-care workers and children with

spina bifida and other conditions requiring

multiple surgeries are at greatest risk

of allergic reaction because of their

constant exposure to latex-containing

devices. For the general public, the risk of

allergic reaction is less than 1 percent.

FDA published the rule in the Sept.

30, 1997, Federal Register.

COPYRIGHT 1998 U.S. Government Printing Office

COPYRIGHT 2004 Gale Group