Infections Associated with Medtronic Duet External Ventricular Drains - Rhode Island Hospital, Providence, Rhode Island, January 2023-January 2024.

External ventricular drains (EVDs) are medical devices that are inserted into the ventricles of the brain to drain excess fluid, manage intracranial hypertension, monitor intracranial pressure, and administer medications. Unintentional disconnections and breaks or fractures (breaks) of EVDs or associated drainage system components can result in cerebrospinal fluid (CSF) leakage and increased risk for EVD-associated infections. After replacement of Integra Life Sciences EVD systems with Medtronic Duet EVD systems at Rhode Island Hospital in mid-September 2023, a threefold increase was observed in the prevalence of positive CSF cultures, from 2.8 per 1,000 days with an EVD in place (EVD days) during January-September 2023 to 11.4 per 1,000 EVD days during October 2023-January 2024 (rate ratio [RR] = 5.7; 95% CI = 1.5-22.0; p = 0.01) and an eightfold increase in the prevalence of infections, from 0.7 to 6.5 per 1,000 EVD days (RR = 9.8; 95% CI = 1.1-87.3; p = 0.04). An investigation by Rhode Island Hospital Infection Control during December 2023-January 2024 identified frequent reports of disconnections and breaks of the Medtronic Duet EVD system. A search of the Food and Drug Administration Manufacturer and User Facility Device Experience database identified 326 reports nationwide of disconnection and breaks of components of the Duet EVD system, including 175 during 2023. A Medical Product Safety Network report was filed. The Duet EVD product was ultimately recalled in January 2024, citing disconnections of the EVD system and reports of CSF leakage and infection. 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.

Risk factors and outcomes associated with external ventricular drain infections.

BACKGROUND: Insertion of an external ventricular drain (EVD) is a common neurosurgical procedure which may lead to serious complications including infection. Some risk factors associated with EVD infection are well established. Others remain less certain, including specific indications for placement, prior neurosurgery, and prior EVD placement. OBJECTIVE: To identify risk factors for EVD infections. METHODS: We reviewed all EVD insertions at our institution from March 2015 through May 2019 following implementation of a standardized infection control protocol for EVD insertion and maintenance. Cox regression was used to identify risk factors for EVD infections. RESULTS: 479 EVDs placed in 409 patients met inclusion criteria, and 9 culture-positive infections were observed during the study period. The risk of infection within 30 days of EVD placement was 2.2% (2.3 infections/1,000 EVD days). Coagulase-negative staphylococci were identified in 6 of the 9 EVD infections). EVD infection led to prolonged length of stay post-EVD-placement (23 days vs 16 days; P = .045). Cox regression demonstrated increased infection risk in patients with prior brain surgery associated with cerebrospinal fluid (CSF) diversion (HR, 8.08; 95% CI, 1.7-39.4; P = .010), CSF leak around the catheter (HR, 21.0; 95% CI, 7.0-145.1; P = .0007), and insertion site dehiscence (HR, 7.53; 95% CI, 1.04-37.1; P = .0407). Duration of EVD use >7 days was not associated with infection risk (HR, 0.62; 95% CI, 0.07-5.45; P = .669). CONCLUSION: Risk factors associated with EVD infection include prior brain surgery, CSF leak, and insertion site dehiscence. We found no significant association between infection risk and duration of EVD placement.