Federal Officials Weigh In on Infant Tubing Saga

December 9, 2021

More than four years after concerns were raised about certain hospital tubing devices, the Food and Drug Administration finally acknowledged their potential danger to infants.

The Potential for Overdose

The “ENFit” tubing connector was developed to minimize dangerous tubing misconnections. But in the years since the device was released, it’s become clear ENFit connectors introduce a different danger.

The ENFit design features a moat around the tip. If the moat area is not cleared before medication is administered, there is a potential for tiny babies to get an incorrect amount of medication. In fact, ENFit adaptors “significantly increase” the possibility of inaccurate dosing, according to one study.

Recommendations for Safe Use

In its safety message, the FDA provided recommendations for optimizing dose accuracy using the ENFit device. Among its guidance, the FDA suggests users should:

  • Tap the tip of the syringe to ensure it is free of air bubbles and that the moat is free from fluids
  • Use a filling adapter to prevent fluid and medications from entering the moat area of the syringe tip
  • Flush the medication or fluid after administration to prevent overdose.

The FDA also requested manufacturers update relevant labeling and training materials to include information about how to accurately dose medication and reduce the risk of overdose.

Alerting Providers

Health care providers need this information so they can safely use ENFit tubing devices. And individual hospitals should have the autonomy to decide what is in the best interest of their tiniest patients – whether that’s using ENFit or another safe, FDA-approved tubing option.

There is no margin of error when dosing medication for babies. Safety and precision must be priority – even federal officials agree.

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