Text of FDA latex allergy regulation------
T97-50 Sharon Snider: 301-827-6242
September 30, 1997 Broadcast Media: 301-827-3434
Consumer Media: 800-532-4440
LATEX LABELING REQUIRED FOR MEDICAL DEVICES
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, 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 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--health-care 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 Sept. 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. #### |
