The U.S. Food and Drug Administration (FDA) issued a safety alert regarding a possible link between pneumothorax events and deaths associated with enteral access systems (EAS) feeding tube placements, Thursday.
The FDA has currently approved three EAS devices -- Corpak Medsystems’ Cortrak 2 EAS, Covidien’s Kangaroo Feeding Tube and ART Healthcare’s smARTrack’s Feeding Tube – that have all different techniques to track the position of the feeding tube during the insertion procedure for marketing in the U.S.
According to the FDA, it received 51 medical device reports (MDRs), including 11 fatalities, for the Corpak Medsystems’ device, while receiving 28 MDRs, including five fatalities, for the Covidien’s device, from January 2012 to July 2017.
"The smARTrack device is not currently being sold within the U.S. and no MDRs have been received for this device," the FDA said in a statement.
MDRs are reports of a suspected medical device associated deaths, serious injuries and malfunctions submitted to the FDA by a medical professional.
Most of the records indicated that the pulmonary events required urgent intervention, including needle decompression or chest tube placement. Several of these incidents caused a cardiopulmonary arrest that led to the patient’s death.
“For both devices, the relationship between the pulmonary events and the death cannot be concluded definitively in all cases,” the FDA said. “Although most pneumothorax is a known rare complication of ‘blind insertion’ of feeding tubes, the agency is alerting clinicians that the use of EAS devices does not eliminate this risk.”
However, since the MDR system is based on passive surveillance, FDA cannot determine how the rate of these complications compares to that estimated for blind insertion, the FDA added.
Currently, Covidien’s Kangaroo Feeding Tube is the only product marketed in Korea.
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