Washington, DCA heartbreaking story involving the mix-up of feeding tubes with other intravenous tubes points to a problem that has existed for decades, according to a recent New York Times report—but also reveals a serious deficiency with the US Food and Drug Administration's (FDA) existing approval process for medical devices.
Medical tubing is used for to bring oxygen to the lungs, liquid nourishment to the stomach, and drugs and/or saline solution to the veins. The tubing, say critics, is remarkably similar under current requirements. While this may not pose a problem in isolation, it becomes an issue when numerous tubes are used on a patient for different functions at the same time. In the often stress-filled hospital environment, mix-ups can and do occur, often with devastating results.
The 8/20/10 edition of the New York Times told the sad story of Robin Rodgers, a Kansas woman who was losing weight and vomiting in the 35th week of her pregnancy. Her doctor ordered the 24-year-old mother of a three-year-old boy hospitalized and fed through a feeding tube until her baby was born. The patient was outfitted with a feeding tube and an intravenous (IV) tube that would deliver drugs and/or saline solution directly to Rodger's bloodstream.
The tubes—required for completely different functions—reportedly appear remarkably similar. And so it was that in this case, the bag of the tube feeding formula was mistakenly connected to the existing IV line. Nourishment meant for delivery directly to the stomach was instead fed directly to the vein.
Such mistakes, according to the report, are not uncommon. In 2006 a nurse mistakenly connected a bag of breast milk to an IV line hooked up to a premature infant. The error nearly claimed the life of Chloe Back. Another time, a nurse assigned to assist a 16-year-old girl giving birth mistakenly connected spinal anesthetic to an IV line inserted into a vein, killing the mother. There was no indication in the report as to whether or not the child survived.
A 2006 survey of hospitals revealed that 16 percent of respondents had experienced a feeding tube mix-up. However, such a statistic may not adequately reflect the real gravity of the errors, given that such errors are rarely reported.
It's far from a new problem. However, manufacturers are reluctant to change the designs of their tubing in order to differentiate their appearance for diverse functions without a regulatory mandate to do so, or in the absence of an international set of standards that will see everybody adhering to the same protocols.
Such discussions to arrive at a consensus have been underway for years, and recommendations are still years away.
It doesn't help that the FDA currently employs a fast-track approval process that requires that manufacturers of new devices only establish that new products work essentially in similar fashion to existing devices already on the market, regardless of whether those devices are actually safe.
On occasion, according to the Times report, the FDA has approved a new device only to urge its recall—and then later approve a similar device because of the rules already established for approvals.
The FDA has issued alerts to hospitals and manufacturers with regard to tube mix-ups. However, there appears to be a chicken-and-egg dynamic going on, according to Nancy Pratt, a senior vice president at Sharp HealthCare in San Diego and an advocate for change. "The regulators have been waiting for the manufacturers to come up with a solution," Ms. Pratt told the Times, "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."
For his part, Dr. Robert Smith, a former device reviewer with the FDA who left the agency at the end of July, told the Times that the "FDA could fix this tubing problem tomorrow, but because the agency is so worried about making industry happy, people continue to die."
Smith was among nine FDA employees who last year called the FDA approval process for medical devices illegal and dangerous, noting that the tubing problem was another example of how the FDA failed in its mandate to protect the public.
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