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U.S. Inaction Lets Look-Alike Tubes Kill Patients

Posted by on Aug. 24, 2010 at 1:10 AM
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Thirty-five weeks pregnant, Robin Rodgers was vomiting and losing weight, so her doctor hospitalized her and ordered that she be fed through a tube until the birth of her daughter.

Robin Rodgers and her unborn child died after a feeding tube was inserted into a vein instead of through her nose and into her stomach.

But in a mistake that stemmed from years of lax federal oversight of medical devices, the hospital mixed up the tubes. Instead of snaking a tube through Ms. Rodgers’s nose and into her stomach, the nurse instead coupled the liquid-food bag to a tube that entered a vein.

Putting such food directly into the bloodstream is like pouring concrete down a drain. Ms. Rodgers was soon in agony.

“When I walked into her hospital room, she said, ‘Mom, I’m so scared,’ ” her mother, Glenda Rodgers, recalled. They soon learned that the baby had died.

“And she said, ‘Oh, Mom, she’s dead.’ And I said, ‘I know, but now we have to take care of you,’ ” the mother recalled. And then Robin Rodgers — 24 years old and already the mother of a 3-year-old boy — died on July 18, 2006, as well. (She lived in a small Kansas town, but because of a legal settlement with the hospital, her mother would not identify it.)

Their deaths were among hundreds of deaths or serious injuries that researchers have traced to tube mix-ups. But no one knows the real toll, because this kind of mistake, like medication errors in general, is rarely reported. A 2006 survey of hospitals found that 16 percent had experienced a feeding tube mix-up.

Experts and standards groups have advocated since 1996 that tubes for different functions be made incompatible — just as different nozzles at gas stations prevent drivers from using the wrong fuel.

But action has been delayed by resistance from the medical-device industry and an approval process at the Food and Drug Administration that can discourage safety-related changes.

Hospitals, tube manufacturers, regulators and standards groups all point fingers at one another to explain the delay.

Hospitalized patients often have an array of clear plastic tubing sticking out of their bodies to deliver or extract medicine, nutrition, fluids, gases or blood to veins, arteries, stomachs, skin, lungs or bladders.

Much of the tubing is interchangeable, and with nurses connecting and disconnecting dozens each day, mix-ups happen — sometimes with deadly consequences.

“Nurses should not have to work in an environment where it is even possible to make that kind of mistake,” said Nancy Pratt, a senior vice president at Sharp HealthCare in San Diego who is a vocal advocate for changing the system. “The nuclear power and airline industries would never tolerate a situation where a simple misconnection could lead to a death.”

Tubes intended to inflate blood-pressure cuffs have been connected to intravenous lines, leading to deadly air embolisms. Intravenous fluids have been connected to tubes intended to deliver oxygen, leading to suffocation. And in 2006 Julie Thao, a nurse at St. Mary’s Hospital in Madison, Wis., mistakenly put a spinal anesthetic into a vein, killing 16-year-old Jasmine Gant, who was giving birth.

Ms. Thao, who had worked two eight-hour shifts the day before, was charged with felony neglect. She pleaded no contest to two misdemeanor charges. But experts say such mistakes are possible only because epidural bags are compatible with tubes that deliver medicine intravenously.

“This is a deadly design failure in health care,” said Debora Simmons, a registered nurse at the University of Texas Health Science Center who studies medical errors. “Everybody has put out alerts about this, but nothing has happened from a regulatory standpoint.”

An international standards group is seeking consensus on specific designs on how tubes for different bodily functions should differ, but the group has been laboring for years and its complete recommendations will take years more. Some manufacturers have used color-coding to distinguish tubes for different functions, but with each manufacturer using a different color scheme, the colors have in some cases added to the confusion.

An Alarm Is Raised

Advocates in California got legislation passed in 2008 that would have mandated that feeding tubes no longer be compatible with tubes that go into the skin or veins by 2011. But in 2009, AdvaMed, the manufacturers’ trade association, successfully pushed legislation to delay the bill’s effects until 2013 and 2014 or until the international standards group reaches a decision.

In the meantime, F.D.A. reviewers have begun to question whether feeding tubes that could mistakenly be connected to intravenous tubes should be declared fundamentally unsafe.

Continued here : http://www.nytimes.com/2010/08/21/health/policy/21tubes.html?_r=1

by on Aug. 24, 2010 at 1:10 AM
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