The US Food and Drug Administration (FDA) has received numerous reports of pneumothorax events associated with feeding tube placement procedures performed by using two of the three FDA-approved enteral access systems (EASs).
“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,” the FDA said in a safety communication issued January 11.
Pneumothorax is a known rare complication of “blind insertion” of feeding tubes (typically < 0.5%) but the use of EAS devices does not eliminate this risk, the FDA said.
From January 2012 to July 2017, the agency received 51 medical device reports (MDRs) of pneumothorax events related to use of the Corpak MedSystems Cortrak 2 device, including 11 deaths. The FDA also received 28 MDRs about pneumothorax events involving the Covidien Kangaroo device, including 5 deaths.
The third EAS device cleared by the FDA — the smARTrack Feeding Tube by ART Healthcare — is not being sold in the United States, and no MDRs have been received for this device, the FDA said.
For both the Cortrak 2 and the Kangaroo devices, “the relationship between the pulmonary events and the death cannot be concluded definitively in all cases,” the FDA said. And, because the MDR system is based on passive surveillance, the agency said it can’t determine how the rate of these complications compares to that estimated for blind insertion.
The EASs use different technology to track the position of the feeding tube during the insertion procedure. The Covidien device uses a camera embedded in the distal end of the tube and provides a video stream of the gastrointestinal tract during placement. The Cortrak 2 device uses electromagnetic sensors in a stylet to provide a visual representation of the tip of the tube relative to an external receiving unit placed over the patient’s xiphoid process.
When EAS devices are used, the FDA recommends the following:
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The device should be used only by clinical staff who have received the required training developed by the manufacturer and who are credentialed within their institution to place an enteral feeding tube.
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The device should not be used in patients who have contraindications for nasoenteric feeding tubes in general.
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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 reassessed.
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The final tube position should be confirmed per institution protocol, in particular if any difficulty occurred during insertion, the patient showed 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 2 device, the FDA also recommends the following:
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The user should ensure 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 xiphoid-sternal junction, level, and parallel with spine and midline.
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The user should observe and assess 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.
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The device should be used with caution when in close proximity to other electrical equipment (especially those emitting in the 20 to 300 kHz frequency band) because readings may be affected.
In a letter to healthcare providers, the FDA said it is working with manufacturers of EAS devices to better understand the risks associated with their use and contributing factors. The agency is also actively monitoring the situation and will alert providers of any new developments.
Healthcare professionals are encouraged to report adverse events or side effects related to these devices to MedWatch, the FDA’s safety information and adverse event reporting program.
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