FDA acknowledges powdered latex gloves risky
* Thousands said to be at risk
* We recognize the severity of the problem
* Latex allergy has become an epidemic
* Manufacturer dismisses powder risk
January 7, 1998
It seemed innocuous: Put powder on latex gloves
and hurried hospital workers could pull them on
more easily. But scientists now say the powder's
dust spreads life-threatening latex allergens,
strong enough that a few whiffs have sent nurses
into shock.
A consumer group urged the government Wednesday to
ban powdered latex gloves. The Food and Drug
Administration acknowledged a serious problem and
pledged to write rules quickly to minimize the
danger, but stopped short of agreeing to a ban.
"Powdered latex gloves are a serious, unnecessary
menace in hospitals and other health care
facilities all over the country," said Dr. Sidney
Wolfe of Public Citizen Health Research Group.
"Safer alternatives such as powder-free gloves are
easily and currently available."
Thousands said to be at risk
An estimated 8 percent of the nation's 7 million
health care workers have latex allergies that can
cause reactions ranging from itching and hives to
difficulty breathing and life-threatening shock.
Experts say thousands of patients are at risk,
too. Most are patients who undergo multiple
surgeries, particularly as children. Between 40
percent and 65 percent of spina bifida patients,
for example, have latex allergies.
In the last year, the FDA has received 305 reports
of serious reactions to latex gloves -- powdered
and powder-free -- and Oregon tried to ban
powdered gloves after a nurse there died.
Glove makers successfully fought the ban but are
facing lawsuits in other states by allergic health
care workers who lost their jobs.
The FDA has studied the problem for two years and
encouraged glove makers to go powder-free, said
medical device chief Dr. Bruce Burlington. But he
said the FDA would not ban powdered gloves because
so few alternatives are sold that hospitals would
face serious shortages.
We recognize the severity of the problem
Powdered latex gloves make up the vast majority of
the U.S. surgical glove market. Powder-free latex
gloves make up about 26 percent of the market and
vinyl gloves, a relatively new product, a small
portion of it.
"We recognize the severity of the problem,"
Burlington said. "We need to move on it, but in a
way that doesn't leave the vast majority of health
care workers without the protection they need."
When pressed about the two-year delay, FDA
Associate Commissioner William Hubbard said the
agency will soon start writing regulations to
minimize the risk -- but he would not provide
specifics.
Latex gloves are worn mostly by health care
workers to protect against the AIDS virus and
other diseases but are also worn by restaurant
workers, janitors, police and firefighters.
Latex allergy has become an epidemic
Scientists say the latex risk is exacerbated by
gloves coated in cornstarch powder -- because the
powder absorbs latex proteins and emits them in
dust as people pull the gloves on and off.
"Among health care workers who are highly exposed
to powdered latex gloves, latex allergy has become
an epidemic disease," said Dr. Lauren Charous of
the Milwaukee Medical Center. He is a member of
the American College of Allergy, Asthma and
Immunology, which recently urged an end to
powdered glove use.
The powder itself also can cause complications,
including infections and scar tissue, when it gets
inside surgical wounds, said Dr. Richard Edlich of
the University of Virginia, who sparked the FDA's
initial probe two years ago.
The FDA in 1971 warned surgeons to wash their
hands after donning the gloves to remove some
powder. Last September, it also ordered every
latex-containing medical product to carry an
allergy warning label.
Manufacturers are trying out gloves made from
other materials.
Manufacturer dismisses powder risk
But a spokesman for leading manufacturer Johnson &
Johnson, which makes both powdered and powder-free
latex gloves, dismissed the powder risk. "We've
never seen any documentation ... indicating the
additional risk of powder," said spokesman John
McKeegan.
Powder-free gloves can be more expensive, and some
surgeons particularly resist changing, say three
hospitals that banned powdered gloves: Brigham &
Women's in Boston, Jackson Memorial in Miami and
Methodist Hospital of Indiana.
"It has not been easy going powder-free," wrote
Jackson Memorial administrator Alma Breeden. But
seeing allergic employees consequently return to
work "has been a rewarding experience."
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