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Latex Surgical Gloves Routinely Fail, Risk of Infection Greater than Believed

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 Thursday.

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 studies.

"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 puncture.

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 failure."

"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 surgical gloves.

"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 penetration."

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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