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Infection Prevention Measures Challenged: An Insight into the Medtronic Duet EVD System Recall

External ventricular drain (EVD) insertion, commonly employed in neurosurgical procedures, plays a crucial role in managing intracranial hypertension, monitoring intracranial pressure, and administering medications, while managing excess cerebrospinal fluid (CSF). Any unintentional disconnections or breaks in the EVD systems can result in infections linked with EVD because of CSF leakage, increasing the contamination odds.

In 2023, following the replacement of the Integra Life Sciences EVD systems with Medtronic Duet EVD systems at Rhode Island Hospital, there was an unsettling increase in the prevalence of positive CSF cultures and infections. This subsequent investigation states that the Medtronic Duet system often faced frequent disconnections and breaks, attributing to the surge in EVD-associated infections.

This alarming increase in the prevalence of EVD-associated infections post-introduction of the Medtronic Duet system necessitated immediate investigation from the hospital’s Infection Control team. As per their findings, there were 326 reports nationwide stating disconnection issues and breaks in the components of the Duet EVD system.

The Rhode Island Hospital, proactively putting the emphasis on infection prevention, ceased the use of Medtronic Duet EVD systems, transitioning to an alternative. Following an official recall of the product by Medtronic in January 2024, the hospital also filed individual FDA Medical Product Safety Network reports to record the surge in incidents post-transition to the new EVD system.

Although EVD insertion is among the most common neurosurgical procedures performed annually in the U.S., the recall of Medtronic Duet EVD systems has heightened the need for constant surveillance of EVD-associated infections in hospitals. The incident underscores the importance of national reporting databases and hospital infection surveillance programs in quickly identifying and responding to infectious outbreaks.

While the limitation of this report pertains to it being a single-center investigation spanning a short follow-up period, the drastic increase in infection rates and positive CSF cultures post-transition of EVD systems provides comprehensive insight into the challenges in infection prevention measures and their magnitude in affecting public health.


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