Medtronic device recalled after Lifespan hospital reports infection cluster

Providence-based Rhode Island Hospital saw an increase in external ventricular drain infections after switching to a Medtronic device that has since been recalled, the CDC said April 11.

The hospital, part of Lifespan, started using the Medtronic Duet EVD system in its emergency department and neurocritical care unit last September due to limited availability of the Integra Life Sciences EVD system.

External ventricular drains are inserted into a patient's brain to drain excess fluid, monitor pressure and administer medications. While the devices are commonly used among patients with neurological conditions, any disconnections or breaks in the drain can increase the risk of infection.

Rhode Island Hospital's rate of EVD-related infections jumped from 0.7 per 1,000 EVD days before using Medtronic's system to 6.5 per 1,000 after. Positive cultures of cerebrospinal fluid also increased threefold. 

The hospital's infection control team conducted an investigation and found frequent reports of disconnects and breaks involving the EVD system. The hospital filed a Medical Product Safety Network with the FDA, and Medtronic recalled the device Jan. 22 due to the risk for disconnections. 

"Given the widespread use of EVD systems by neurosurgery centers and the risk for EVD-associated infections, a strategy for future consideration by hospital infection prevention and control programs might be inclusion of EVD-associated infections in hospital surveillance programs to rapidly identify increases in these events and determine factors related to such infections to prevent additional infections," the CDC said.

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