New York Times Slams FDA for Failure to Act on Look-Alike Tubes Used in Hospitals

An article in the New York Times illustrates the dangerous consequences of mistakes involving look-alike tubing in medical applications and faults the U.S. Food and Drug Administration’s lax oversight of these medical devices.

Much of the clear plastic tubing used in hospitals for intravenous IV lines, feeding tubes, oxygen delivery and a wide range of other uses looks the same and is often interchangeable because of its small connector called a luer fitting. While the luer connection is cheap and universal, it contributes to misconnection mistakes that can cause serious or fatal results.

The article entitled U.S. Inaction Lets Look-Alike Tubes Kill Patients appeared online August 20, 2010 and printed in the August 21, 2010 New York edition.

The New York Times tells of a fatal mistake in which hospital staff connected a liquid food bag meant for a stomach tube to the IV line of a 24-year-old pregnant woman, introducing the food to directly to her bloodstream and comparing it to pouring concrete into a drain. Another pregnant woman died after a nurse accidentally put an epidural spinal anesthetic directly into a vein.

Incidences of tubing misconnections are not a new problem, reports of misconnections go back as far as the 1970’s and health professionals and advocacy groups have been trying to get manufacturers and government to differentiate the tubing or connections since 1996.

Yet millions of people in hospitals each year are at risk of injury from tubing misconnections.

“More than 1200 times in the past 10 years, U.S. hospital workers have inadvertently connected tubes meant to link one device or system—an IV, a feeding tube, a catheter—into another device, frequently causing harm and sometimes death,” says a March 2009 article by the Medical Device and Diagnostic Industry (MDDI). “But these figures may represent just a fraction of the total incidents. That’s because they are based on voluntary, anonymous reports from only 15% of the country’s 5800 hospitals—the 875 facilities that participate in an error-sharing program created by U.S. Pharmacopeia, a pharmacy standards agency.”

The FDA regulates these tubes as a medical device. Although the agency has sent out notifications warning hospitals of the potential for tubing mix-ups, it has failed to define standards requiring different types of medical tubing to have different connectors.

“The regulators have been waiting for the manufacturers to come up with a solution, and the manufacturers won’t spend the money to design and produce something different until the regulators force them to,” Nancy Pratt, a senior vice president at Sharp HealthCare in San Diego told the New York Times. “And now the international standards organization is taking forever to get the whole world onto the same page.”

In November 2008, the FDA sponsored a webcast entitled Luer Connector Misconnections: Under-Recognized but Potentially Dangerous Events to identify and educate about the potential of misconnections with the medical tubes.

Reported instances of tubing misconnections prompted the FDA release its 2009 Medical Device Safety Calendar depicting twelve different misconnection cases, one for each month, including:

• An infant in the pediatric intensive care unit died after medical personnel inadvertently placed the feeding tube into the trach tube and delivered milk into the infant’s lungs.
• An anesthetist and a midwife mistakenly connected an epidural set to the maternity patient’s IV tubing, causing the delivery of epidural medication into the IV and the death of the patient.
• Medical personnel inadvertently connected the IV tubing to the trach cuff port of a child in the pediatric intensive care unit, the IV fluid over-expanded the trach cuff to the point of breaking and continuous IV fluids entered the child’s lungs, killing the child.
• A patient’s oxygen tubing disconnected from his nebulizer and a staff member accidentally reattached it to his IV tubing Y-site, causing the patient to die from an air embolism even though the connection was broken within seconds.

To find out more about tubing misconnections, see these FDA resources or this issue of Safe Practices in Patient Care.