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,
the 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 to a
wide range of medical devices that contain latex have
been reported, including latex surgical gloves,
adhesive bandages, intravenous catheters, and
anesthesia equipment. The 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 --
healthcare workers and children with spina bifida and
other conditions involving multiple surgical
procedures.
The 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 health
sensitive. |
