Lax regulation of tube design harms patients

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Weak federal oversight of tube design makes it all too easy for tubes with different functions to get mixed up in hospitals, harming patients, the New York Times reports.

When the wrong connections are made, what goes down the tubes can end up in the wrong place. For instance, fluid intended for a feeding tube is channeled into a vein, or a substance intended for IV administration goes into feeding tube and into the digestive tract. The Times specifically tells the story of a woman who had to be fed through a tube. After the nurse connected the liquid food bag to a tube that entered a vein, the patient was in agony and later died.

Putting such food directly into the bloodstream to pouring concrete down a drain, the Times notes.

Sixteen percent of hospitals in a 2006 survey had experienced a feeding tube mix-up. Although experts and standards groups have called for tubes with different functions to be made with incompatible connectors so that it is impossible to use a tube incorrectly, they have encountered resistance from the medical device industry and the Food and Drug Administration's approval process, which does little to advance safety-related improvements.

"This is a deadly design failure in healthcare," Debora Simmons, a registered nurse with the University of Texas Health Science Center, told the Times. "Everybody has put out alerts about this, but nothing has happened from a regulatory standpoint.

The FDA approval process poses problems, because currently, all a manufacturer has to do is prove that a new product works like an old one, regardless of whether the earlier one is safe. As a result, the FDA sometimes OKs devices although officials believe they might harm patients.

An international taskforce that includes manufacturers, clinicians, and the FDA has been trying for three years to develop new connectors so that incompatible systems can't be accidentally connected, Peggi Guenter, Director of Clinical Practice for the American Society for Parenteral and Enteral Nutrition, told FierceHealthcare. She noted that the six systems that should not overlap are enteral tube feeding, respiratory gases, urinary devices, neuraxial, blood pressure cuffs, and IV sets.

Within one year, she said that the first distinct systems will be designed. Manufacturers would then get a three-year window to make the transition. "Everyone is going to have to retool," Guenter said.



To learn more:
- read the New York Times article

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