FDA flags lingering patient safety concerns over feeding tubes

The FDA issued new guidance on Sept. 7 raising concerns with continued reports of misconnections with enteral devices. (Getty/Kaipungyai)

The Food and Drug Administration issued new guidance on Friday to hospital purchasing departments and healthcare providers warning them to use enteral devices with connectors to avoid misconnections—a known risk for patient injury. 

The guidance, which was also directed to manufacturers of enteral feeding tubes, said the FDA is "concerned" by continued reports of misconnections. The FDA pointed to enteral connectors that meet the proper standard under the trade name ENFit as a solution.

Misconnections may occur when one type of medical device is mistakenly attached to another device that performs a different function.

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"Misconnections between enteral devices and other medical devices, such as tracheostomy tubes, have been associated with patient death and serious injuries," the FDA said in the warning (PDF).

Since 2011, the FDA has received reports of two deaths, 24 serious injuries and 32 device malfunctions related to enteral misconnections, but officials said they are also concerned many misconnections are not reported or are reported as medication errors.

This is far from the first time this sort of warning has been issued. 

In 2015, the FDA published a guidance document recommending manufacturers design and test enteral connectors based on the ISO 80369 standard, which was developed to prevent deadly medical mistakes. The standard would make the tubes incompatible with other tubing systems that deliver medicines, gases or fluids.

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The FDA also issued a letter to manufacturers and health providers about the danger of misconnections in 2010. 

Citing the Global Enteral Device Supplier Association, PlasticsNews reported in February that adoption has been slow at U.S. hospitals due to concern over the limited supply of ENFit components. Manufacturers have also raised patient safety concerns, they said.

The ECRI Institute named "slow adoption of safer enteral feeding connectors" among its top 10 list of technology hazards for hospitals to prepare against in 2018.

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