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