Can catheter design impact patient safety? That’s the question of a new peer-reviewed study from Medical Components, Inc. (Medcomp), based on a retrospective analysis of 3,546 catheter insertions captured in Truveta Data. Used to deliver life-sustaining dialysis treatment, short-term hemodialysis (STHD) catheters provide temporary vascular access for patients with acute kidney injury or other urgent conditions. This new analysis points to a notable safety signal: triple-lumen hemodialysis catheters were associated with a significantly higher risk of infection-related events compared to dual-lumen devices, despite their growing adoption in critical care.
Published in The Journal of Vascular Access, the study—Design features, associated risks, and usage trends of non-tunneled hemodialysis catheters: A retrospective evaluation of dual and triple lumen devices—is one of the first to evaluate non-tunneled STHD catheter designs using a large, real-world dataset spanning 2011 to 2023. It underscores how medical device companies can use regulatory-grade electronic health record (EHR)-based insights to examine adverse events, benchmark device configurations, and assess trends in clinical practice across health systems.
Study insights: Safety tradeoffs and shifting preferences
Key findings:
- Triple-lumen catheters had 54% higher adjusted odds of infection-related events compared to dual-lumen catheters.
- Despite this elevated risk, usage of triple-lumen catheters rose sharply—from 29% in 2018 to 68% in 2022.
- Infection rates among triple-lumen catheters fell over time, dropping from 18% in 2018 to 7% in 2022, suggesting potential improvements in clinical practice or changes in patient populations.
- Female patients experienced lower infection risk, while Black patients had higher risk, raising important questions about demographic disparities.
Additional findings showed potential influence of lumen shape (oval vs circular) and extension configuration (straight vs curved), though some associations were not statistically significant in all models. Notably, 91% of catheters in the study were made of polyurethane, with silicone use declining over the five-year trending period.
Why it matters for device innovators
Medical device manufacturers need robust evidence to guide 510(k) submissions, design enhancements, and market positioning. This study offers a window into how real-world data can:
- Surface safety signals at scale across diverse hospitals and care settings.
- Track adoption trends in response to practice changes and clinical need.
- Validate assumptions or challenge legacy design rationales—like the long-held belief that triple-lumen catheters carry no additional infection risk.
The authors also point out that many triple-lumen catheters were approved based on equivalence to dual-lumen designs without prospective safety data. In contrast, this real-world study found a clear difference in risk, especially relevant given the now-widespread use of TLCs.
Truveta’s role: Enabling post-market surveillance and device safety research
This study leveraged de-identified electronic health record data from Truveta, the most representative, complete, and timely patient journey data. All analyses were retrospective and observational, capturing device brand, configuration, lumen number, material, insertion site, and infection outcomes within 14 days of placement.
For medical device teams, Truveta offers a scalable way to:
- Analyze adverse events linked to specific device attributes
- Monitor real-world usage trends over time
- Compare multiple products or generations across manufacturers
- Evaluate demographic and practice-based disparities in outcomes
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