제  목 : FDA requires labeling for latex medical devices
  일  자 : 1997년 12월
  제공처 : INTERNET

    FDA requires labeling for latex medical devices
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In response to reports of allergic reactions to some medical devices, the Food
and Drug Administration (FDA) is requiring all medical devices containing latex
to be labeled as such and to carry a caution that latex can cause allergic re-
actions.

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 con-
taining dry natural rubber.

The new requirements, published September 30 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 allerg-
ic 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   healthcare 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 September 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.