Latex Surgical Gloves Routinely Fail, Risk of Infection Greater
SAN DIEGO--March 20, 1997-- More than 77,000 patients die
annually from infections at U.S. hospitals and statistics point to
needed improvements in infection control monitoring.
Doctors say that if they were left with only one piece of
protection in the operating room -- it would be their surgical
latex gloves. Yet, that protection fails them more often than they
and their patients realize, according to studies released
Using newly developed testing procedures that simulate actual
conditions in surgery, latex gloves that had passed the
manufacturers' standard leak test actually allowed viruses to pass
through. The findings are significant considering that 1.2 billion
surgical latex gloves are sold in the United States annually.
"Latex gloves are the thin line of defense against infection.
What these studies show is that the primary barrier against
infection from such diseases as HIV/AIDS and Hepatitis B and C is
being breached more often than previously realized," said M. Lee
Hulsebus, chief executive officer, president and chairman of the
Board of Medical Device Technologies Inc., which commissioned the
"What these studies tell us is that both patient and physician
need to demand better monitoring systems of their latex gloves for
effective infection control."
"The findings come at a time when infection control has become a
dominant issue for most U.S. hospitals," said Dr. Mark S. Davis of
the DeKalb Medical Center in Atlanta. The U.S. Centers for Disease
Control and Prevention report that approximately 2 million patients
acquire infections each year while hospitalized and more than
77,000 of these patients die as a result of such infections.
Medical Device Technologies, a San Diego-based company engaged
in licensing, developing and manufacturing specialty medical
devices, commissioned the glove studies as part of their effort to
increase safety in the operating room and other medical settings
where surgical latex gloves are used.
Previous studies published in scientific and medical journals
showed that more than 400 million out of 1.2 billion surgical
gloves used annually in the United States lose their ability to
protect against infection during a surgical procedure. These
breaches could be caused by a tear, hole or small needle
According to studies released Thursday -- which involved gloves
tested in simulated clinical use -- an even greater number of
gloves may be failing due to the fluid saturation of gloves.
"The fact is that latex gloves fail -- some of them right out of
the box, some within the first hour of surgery. When gloves fail,
it allows bacteria and viruses to pass through," said Dr. Lawrance
C. Pollak, an orthopedic surgeon at Sharp Rees-Steely Medical Group
in San Diego.
"The problem is that physicians, nurses, dentists and others do
not know exactly when their surgical gloves begin to leak, or
worse, when the gloves have been punctured. That's why we need
continuous monitoring systems that can instantaneously detect glove
"Most Americans believe the operating room is a sterile
environment. The fact is there is room for improvement," Hulsebus
said. "It's time to let technology reduce the potential for
infection in perhaps the most important area of the surgical
setting -- and that is through a constant monitoring system for
"Without a better alternative to latex gloves at the present
time, hospitals and federal regulatory agencies such as the
Occupational Safety and Health Administration (OSHA) should now
insist on better methods to monitor glove safety."
The lead investigation into latex glove failure was performed by
DPR Biomedical at San Diego State University. Similar results were
achieved during parallel studies performed at the University of
Texas Health Science Center, San Antonio and by a private testing
laboratory registered by the FDA.
Less extensive studies published earlier in peer-reviewed
scientific and medical journals also have shown that viruses
penetrate a significant%age of gloves tested.
The test presently mandated by the U.S. Food and Drug
Administration (FDA) -- ASTM method D-151-92 -- involves filling a
glove with water and hanging it upside down. If the glove leaks
within two minutes, it is deemed to have failed "the test." This
test procedure is performed on less than 2% of all latex gloves
that enter the market.
Unlike the test presently mandated by the FDA, the Medical
Device Technologies-commissioned studies put gloves through a test
simulating actual-use conditions in surgery. In these tests, 11
brands of latex gloves were exposed to mechanical stress while
simultaneously in contact with fluids containing viruses.
On average, 21% of the "intact" gloves tested -- i.e., gloves
that passed the FDA's test for leak detection -- allowed small
numbers of viruses to pass through the glove.
The results from each of the three testing sites in the Medical
Device Technologies' studies detected virus penetration through
"intact" gloves. Another result involved a test that pierced the
gloves with a 26-gauge needle, one of the smallest used in
surgeries. The FDA's test detected a leak in less than half of the
pierced gloves. However, more than 90% of these pierced gloves
allowed substantial amounts of virus to pass through within five
minutes of exposure.
"Viruses are very small, and obviously, tiny enough to pass
through a microscopic pore in a latex glove," Pollak said. "Tests
clearly show that viruses pass through gloves much easier than we
previously thought. At the very least, these results show that the
stand-by leak test does not come close to detecting virus
OSHA regulations presently require gloves to be "replaced as
soon as practical when contaminated or as soon as feasible if they
are torn, punctured or when their ability to function as a barrier
is compromised." However, glove changes are usually done without
the health care professional's knowledge of when and whether the
glove has actually failed.
The U.S. Food and Drug Administration cleared electronic
monitoring devices for latex gloves that are available today,
including the Fluid Alarm System produced by Medical Device
Technologies. Electronic monitoring devices have been shown to warn
health care professionals with an effectiveness of 96% or greater
upon fluid contact with a patient. As neither surgeons nor patients
know when a glove fails, continuous electronic monitoring alerts
them of these failures.
[Dr's Guide to Medical News, March 20, 1997]
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