Doctors to push tubing changes

Dr. Ron Kline, the state association president, said Thursday the four-member Nevada delegation to a November meeting of the policymaking AMA House of Delegates will offer a resolution asking "that the AMA support federal regulations that would prevent medical tubing used to carry different types of fluid and gases from being mistakenly connected."

"The implementation of this common sense safety measure has been hindered by industry resistance and delays at the Food and Drug Administration," the resolution from the Nevada delegation reads. "This problem could easily be remedied by the creation of tubing with incompatible connectors that would prevent inappropriate medical tubing connections."

Kline cited a July 15 article in the Review-Journal, in which national safety experts speculated that tubing misconnections could have played a role in injuries to infants in the neonatal intensive care unit at Sunrise Children’s Hospital. He said the article prompted him to draft the resolution that has been endorsed by Nevada AMA delegates, Marietta Nelson, Ralph Coppola and Wayne Hardwick.

In the July 15 article, Debora Simmons, head of the Houston-based National Center for Cognitive Informatics and Decision Making in Healthcare, said medical device manufacturers have placed profits above patient safety.

"You can’t put diesel fuel in your gas tank, but you can inadvertently mix medication and nutrition for a baby through a tubing misconnection," Simmons said. "The medical industry is probably the only industry that designs things where anything can connect to anything."

She went on to say, "It’s craziness. We don’t recognize in the way our medical equipment is manufactured that people can make mistakes. When it comes to public safety, when it is at all possible, you have to engineer things so they are incompatible. Don’t you think a lot of people might be ruining their engines by mistake with diesel fuel if engineering hadn’t made it impossible to do?"

Often working quickly and in low light to connect IVs for medication and fluids as well as feeding tubes, nurses may sometimes forget to look at where the tubes originate, Simmons said.

"The best solution is to design tubes so that the ones that shouldn’t fit together don’t," Simmons said, arguing that the cost of re-engineering equipment is largely the reason it hasn’t been done.

"There is no good reason that (the re-engineering) hasn’t been done," said Kline, who said the Review-Journal article reminded him of a death at an East Coast hospital early in his career. "Fortunately, the mix-ups don’t happen that often."

Kline said he believes the resolution of the Nevada delegation "will easily pass" in the AMA House of Delegations "because it is the right thing to do."

He hopes that pressure from the nation’s most influential physicians’ organization will force the necessary changes in the engineering of tubing.

"We can’t drag our feet when it comes to patient safety," he said. "It’s what we’re supposed to be about."

Mike Cohen, head of the Pennsylvania based Institute for Safe Medication Practices, said a number of children die each year when tubing used to deliver breast milk to a baby is mistakenly connected to an IV delivering medications.

A 2006 survey of medical centers determined that 16 percent had experienced a feeding tube mix-up.

Not only children suffer because of tubing misconnections, Cohen stresses.

Several people have died after tubing from a blood pressure machine or an oxygen mask was mistakenly connected to an IV tube supplying food and medicine into a vein. The wrong connection allowed air to enter the vein, causing a fatal embolism.

How many people die or are injured because of tubing misconnections is unknown because such errors are rarely reported. The national Institute of Medicine estimates that as many as 98,000 people die each year because of preventable medical errors.

An FDA spokesman said the agency has worked with manufacturers to get them to re-engineer tubing, pointing to a July 9 letter to manufacturers.

The letter suggests manufacturers make design changes that include color coding and adopt the principle "of designed incompatibility, to ensure that devices that should not be connected cannot, in fact, be connected."

The ease of connection, the letter states, has "led to misconnections that have inadvertently linked unrelated systems, and at times have resulted in serious adverse events."

There is no penalty, however, if manufacturers refuse to comply.

Simmons said it is past time to have regulations with sanctions in place for those who don’t comply, noting that safety experts have been working with the FDA since the 1990s to put new regulations forward.

A spokeswoman for AdvaMed, the trade organization for manufacturers, said it takes time to come up with universal standards that work well and she denied that manufacturers were placing profits above safety.

Wanda Moebius said AdvaMed wanted to make sure the standards are fair and work well for everyone.

"It’s not easy to do," she said.

In 2008 California legislators pushed through legislation that would have mandated that in 2011 feeding tubes could no longer be compatible with tubing that goes into veins or skin. But a year later AdvaMed lobbied successfully to have the law delayed until 2013 or 2014 or until an international standards group reaches a consensus on what standards should be.

"The medical technology industry is committed to providing safe and effective medical devices and diagnostics to patients and their physicians, and we are working with multiple stakeholders to develop an international standard that will help prevent misconnections of intravenous, epidural, or enteral feeding tubes used in health care facilities," Janet Trunzo, AdvaMed’s executive vice president, technology and regulatory affairs, said Friday in a statement that called for an international standard.

"We believe any changes to existing connector designs need to be done carefully, so that there is coordination across manufacturers and users which will facilitate the optimal introduction of the new connectors. The issue of preventing medical errors like misconnections is systemic and calls for a systemic response. All of us in health care — manufacturers, providers, hospitals, regulators and others — have roles to play.

"The adoption of an international standard, such as the one our industry has long supported, will provide clear design requirements to manufacturers to help eliminate tubing connection errors. Together with the Food and Drug Administration, foreign regulators, clinicians and others, our industry is working to expeditiously finalize this standard."

Mary Logan, president of the Association for the Advancement of Medical Instrumentation that has been trying to come up with international standards for three years, said she believes an "umbrella" standard will be reached by 2011. Complete standards could take years longer, she said, adding that it also would take time for the medical industry to adapt to new regulations and re-engineer products.

Logan said she is hopeful that the FDA will support what her organization comes up with because representatives from the federal agency have had input.

It will be incumbent on the FDA to come up with a compliance and approval process, she said.

Whether tubing misconnections played a role in what Sunrise Children’s Hospital officials announced in July were 14 cases of "disrupted catheters" is unknown.

What is known is that 2-month-old Miowne Obote, who died after several days on the critical list, succumbed as a result of a severed umbilical catheter. Her July 22 death was ruled a homicide by the Clark County coroner.

An infant who had emergency surgery to survive a catheter disruption at Sunrise is now at home, as are the other 12 infants, according to hospital officials.

The officials have never said whether the injured infant, or the 12 others, were victims of tubing misconnections.

Safety experts said they have never heard of a severed catheter resulting from a tubing misconnection.

Two nurses have been fired and their licenses to practice suspended as a result of what Sunrise officials said first occurred at the hospital in February. No charges have been filed by police.

It is not uncommon for nurses to be charged with felony neglect in tubing misconnection cases.

In 2006, a Wisconsin nurse who mistakenly put a spinal anesthetic into a vein was charged with felony neglect, but ultimately pleaded no contest to two misdemeanors as part of a plea bargain.

Cohen said the Institute for Safe Medication Practices believes it is time to recognize that nurses should not be charged with crimes for tragic accidents.

"We spend too much time blaming nurses rather than recognizing they shouldn’t have been placed in such a situation," he said. "We are now recognizing that the system was a real problem."

Contact reporter Paul Harasim at pharasim@reviewjournal.com or 702-387-2908.