Look-alike Medical Tubes Kill Patients

Posted by Todd Borghesani

With regard to preventable medical errors, medical tube mix-ups are a reality the can be solved with training and improved product design. While improved product design is hampered by federal approvals and international standards adoption, online and simulation training in [virtual] environments using 3D devices and mannequins remains a cost-effective and time sensitive solution.

“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.

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.

But in a mistake that stemmed from years of lax federal oversight of medical devices, the hospital mixed up the tubes. A bag of the tube feeding formula was mistakenly connected to an existing intravenous line. 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.

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.

The catalyst for those questions, according to internal documents provided to The New York Times, was an application filed in August 2009 from Alan Reid, president of Multi-Med in West Swanzey, N.H., to produce feeding tubes for newborns that go into the stomach using the same connectors as those that go into veins. The F.D.A. was so concerned about the application that it inspected the Multi-Med plant in September and issued a warning letter for Multi-Med’s failure to test or design its pediatric feeding tubes adequately.

The similarity of feeding and intravenous tubes caused the near death of Johannah Back’s premature infant, Chloe Back, in 2006. A nurse mistakenly connected a bag of breast milk to an intravenous tube, leading Chloe to form tiny blood clots throughout her body, bleed profusely and suffer seizures for months.

“These problems have been going on since at least the 1970s. Why?” asked Ms. Back, of Las Vegas.

CALLS FOR SAFETY

Dr. Robert Smith, an F.D.A. device reviewer who left the agency on July 31 and was among nine agency employees who in 2009 decried the agency’s device approval process as illegal and dangerous, said that the tubing problem, which has gone on for decades, was another example of how the agency failed to protect the public. “F.D.A. could fix this tubing problem tomorrow, but because the agency is so worried about making industry happy, people continue to die,” Dr. Smith said.

In the meantime, the F.D.A. has issued three alerts to hospitals and manufacturers warning about tube mix-ups, the most recent of which was sent out last month after The Times began asking about the issue. Ms. Pratt said she persuaded one manufacturer, Viasys, to produce neonatal feeding tubes that are incompatible with other tubing. Viasys’s tubing is now used in Sharp’s neonatal intensive-care units, but they are expensive — $13 compared with $1.50 for regular tubes.

“The regulators have been waiting for the manufacturers to come up with a solution,” Ms. Pratt said, “and the manufacturers won’t spend the money to design and produce something different until the regulators force them to. And now the international standards organization is taking forever to get the whole world onto the same page.”

Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association, agreed, “These things are hard to change when you have to get so many different organizations to act in concert.”

First published in the New York Times by Gardiner Harris

Rate this blog post: