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The U.S. Food and Drug Administration (FDA) warned health care teams about the risk of pneumothorax caused by certain enteral feeding tubes that use technology to guide their insertion, also called enteral access systems (EAS). It issued a safety communication stating,
Most reports indicate these pulmonary events required urgent intervention, including needle decompression or chest tube placement. Several of these events were associated with cardiopulmonary arrest and patient death."
FDA issued the alert after receiving 51 adverse event reports about one system (the Corpak MedSystems Cortrak 2 device) over a five year period, associated with 11 deaths. There were 28 pneumothorax events and 5 deaths reported involving the Covidien Kangaroo device. These events were associations, and FDA emphasized "the relationship between the pulmonary events and the death cannot be concluded definitively in all cases." There could be no accurate assessment of the actual event rate, or how it compared to standard enteral tube placement.
Most enteral feeding tubes are inserted blindly by a nurse, using standardized technique followed by chest/abdominal radiographs to confirm enteral placement before use. The rate of pneumothorax following blind insertion of enteral feeding tubes is unknown, but estimated at less than 1 in 200 (0.5%).
So-called enteral access systems can employ thin polyurethane feeding tubes with Dobhoff tips, but use technology (a video-scope tip for Covidien's product; electromagnetic sensors in a stylet for Corpak's) to display feeding tube position to the user during placement.
FDA advised the following:
RECOMMENDATION: For Enteral Access Systems, the FDA recommends:
- The device only be used by clinical staff who have received the prerequisite training developed by the manufacturer and who are credentialed within their institution to place an enteral feeding tube.
- The device not be used in patients who have contraindications for naso-enteric feeding tubes in general.
- If any resistance is met during placement or the patient demonstrates any signs of respiratory distress, including cough or shortness of breath, the tube should be withdrawn and the patient re-assessed.
- Confirmation of the final tube position should be done per institution protocol, in particular if:
- Any difficulty occurred during insertion;
- The patient displayed any signs of respiratory distress during or after the procedure;
- The tube’s path during placement appeared to deviate from expected or the final location is uncertain;
- The patient has a variation in normal gastrointestinal anatomy; or
- The patient is intubated or has an altered level of consciousness.
For the Cortrak device, the FDA also recommends:
- The user ensures that the receiver is aligned properly throughout the procedure and does not move. The manufacturer instructions call for the top of the receiver to be positioned at the xipho-sternal junction, level, and parallel with spine and midline.
- The user observes and assesses the real-time tracing to ensure the proper path of the tube. The final location, including which quadrant the tip is located in, and the centimeter marking, should not be solely relied upon for assessment of whether the device is correctly placed or not.
- The device be used with caution in proximity to other electrical equipment (especially those emitting in the 20-300 kHz frequency band) as readings may be impacted.
FDA asks health care professionals to report adverse events to its reporting program, MedWatch.