Post-Market Clinical Follow-up – Long-Term Hemodialysis Catheters

This observational post-market clinical follow-up (PMCF) collected real-world evidence on the safety and performance of a long-term haemodialysis catheter system. The study was designed to align with MDR requirements and to monitor device use in routine clinical practice.

From the coordinator

“Despite the limited operational outcome, the project clarified what is critical for PMCF success - feasible site engagement models and clear retrospective data pathways that preserve clinical and commercial confidentiality.”

PROJECT COORDINATOR Izabela
Chodara Director of Strategy and Operations

Challenges

Conducting a multi-site PMCF relying on retrospective clinical records while protecting patient privacy and ensuring consistent data quality.

Evaluating two device variants under real-world conditions without exposing commercial identifiers.

Securing site engagement and prioritisation to achieve planned data capture for routine clinical endpoints.

Description of the study

An open-label, retrospective observational PMCF was prepared to assess insertion success and device-related adverse events in patients undergoing long-term haemodialysis. Two device variants were to be compared using routinely collected clinical records; primary outcomes included insertion success rate and incidence of device-related infections expressed per catheter-days. The study emphasised MDR-aligned documentation and governance, alongside rigorous data handling to preserve confidentiality. Although enrolment did not progress as intended, the project yielded practical recommendations to improve the feasibility and robustness of future post-market evidence generation.

Results

The study protocol and retrospective data model were implemented.

Key feasibility lessons were identified to strengthen future PMCF activities (site selection, data access pathways, and stakeholder coordination).

No device-specific performance claims are presented.

Key findings

Successful PMCF depends on feasible site engagement and consistent clinical data.

Izabela Chodara

Project Manager

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