Top 5 Takeaways

1. Significant Increase in Infections: After switching to Medtronic Duet EVD systems, Rhode Island Hospital observed a threefold increase in positive cerebrospinal fluid (CSF) cultures and an eightfold increase in confirmed infections from October 2023 to January 2024.
2. Product Recall: Due to frequent disconnections and breaks leading to CSF leakage and infections, the Medtronic Duet EVD system was recalled in January 2024.
3. Surveillance and Investigation: Hospital surveillance and a thorough investigation were crucial in linking the increased infection rates to the new EVD system and initiating a recall.
4. Data from FDA Database: The FDA’s Manufacturer and User Facility Device Experience database revealed 326 reports of malfunction, including disconnections and breaks specifically related to the Medtronic Duet EVD system.
5. Implications for Public Health: This case underscores the importance of robust hospital infection control programs and the inclusion of EVD-associated infections in hospital surveillance protocols.

Original Article Author and Citation

Corresponding Author

Kevin M. Gibas, kgibas@lifespan.org

Suggested Citation

Gibas KM, Auld D, Parente S, Horoho J, Mermel LA. Infections Associated with Medtronic Duet External Ventricular Drains — Rhode Island Hospital, Providence, Rhode Island, January 2023–January 2024. MMWR Morb Mortal Wkly Rep 2024;73(14):312–316. DOI: http://dx.doi.org/10.15585/mmwr.mm7314a4.

Summary

The transition from Integra Life Sciences EVD systems to Medtronic Duet EVD systems at Rhode Island Hospital led to a significant increase in both CSF culture positivity and actual infections, prompting extensive investigation and subsequent product recall.

Methods

This study utilized comprehensive data analysis from hospital records, FDA reports, and direct hospital investigations to assess the impact of the EVD system change on infection rates.

Discussion

The findings from the Rhode Island Hospital case study highlight the critical role of surveillance and rapid response in healthcare settings to prevent and control infections associated with medical device malfunctions.

Conclusion

The investigation into the Medtronic Duet EVD systems at Rhode Island Hospital led to important changes in practice and policy, including the recall of the problematic EVD system and recommendations for enhanced surveillance of similar devices.

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