Notes

Avanos Medical faces Class I recalls for its the feeding tube system that has been associated with 23 deaths since 2015.

After seven years of shaky results with the Avanos Medical insertal feeding tube placement system for children The FDA has issued its most serious warning regarding the recall of this device.

Cortrak*2 Enteral Access System contains an electromagnetic stylet as well as an external receiver. The system provides a live feed of medical tubes being placed into patients' stomachs or small bowels. Cortrak 2 eternal access system https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/ This facilitates the improvement of tip placement precision and reduction of complications.

Despite this task it has been implicated in dozens of patient injuries, leading Avanos to launch a recall earlier this year of all Cortrak*2 devices used between January 2021 and January 2022--totaling around 630 devices initially released between April 2016 and the start of the year.

https://www.ormanager.com/briefs/fda-updates-safety-alert-for-cortrak-2-enteral-access-system/ The incident that caused the safety issue does not constitute an recall. Avanos has asked healthcare providers to not return the devices to their manufacturers. Avanos only wants to make sure that the devices are being utilized correctly.

The incorrect placement of a feeding tube could result in damage to the vocal cords, lungs or the trachea. This could result in serious injury, or even death. Avanos Mediacal Cortrak 2 Avanos was alerted of the deaths of 23 people and injuries to 60 in the year 2015 by the FDA. These events were all connected to the Cortrak*2 system that controls the installation of the feeding tube.

There are a variety of injuries that have been documented such as respiratory failure, lung infections and collapsed lung.

The FDA advised users of the need to verify the placement of a nasogastric or nasoente tube in accordance with their institution guidelines in its March 21 field correction notification. Avanos has also asked users to attach the safety statement to the operating manual for the system and confirm that they have received the update.

Avanos Medical Avanos announced that they'll soon release an updated labeling for the device. Avanos Medical feeding tube feeding tube placement It will include the directions to put tubes according to their guidelines.

This is the FDA’s second warning on tube feeding into the gastrointestinal tract this year. The FDA released a safety announcement in February warning parents, healthcare providers and children about the dangers of strangulation from tubes for feeding.

The announcement came in the wake of two deaths reported in 2021. In each instance, a tubing system was discovered be wrapped around the neck of patients under the age of two even though they were not being monitored by caregivers or hospital workers.

"While the FDA believes that serious injury or death due to strangulation caused by tubing for enteral feeding in children is rare Healthcare providers and their caregivers need to be aware that these events are possible and can happen," the agency said in the announcement and suggested that similar incidents may not had been reported to the FDA.


Read More: https://www.medscape.com/viewarticle/891200