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Standardization of In Vitro Evaluation of Extracorporeal Life Support (ECLS) Devices for Research and Development
Jutta Arens1, Mirko Belliato2, Lars Mikael Broman3,4
1Engineering Organ Support Technologies, Department of Biomechanical Engineering, Faculty of Engineering Technology, University of Twente, Enschede, the Netherlands.
Artificial Organs
|April 3, 2026
Summary
Standardized in vitro testing protocols are crucial for advancing Extracorporeal Life Support (ECLS) technology. Implementing these guidelines ensures consistent, reproducible data for better device development and clinical application.
Area of Science:
- Biomedical Engineering
- Medical Device Development
- Cardiovascular Research
Background:
- Extracorporeal life support (ECLS) technology has advanced significantly.
- Further improvements in device performance, hemocompatibility, and long-term stability are needed.
- Current early-stage device evaluations lack standardization, hindering data comparability and clinical translation.
Purpose of the Study:
- To establish standardized in vitro testing protocols for ECLS components and devices.
- To improve methodological consistency and reproducibility in ECLS research.
- To provide clear recommendations and criteria for device testing aligned with international norms.
Main Methods:
- Development of recommendations by an international group of ECLS experts.
- Focus on standardized criteria for device testing and reporting results.
- Adherence to international norms for rigorous evaluation.
Main Results:
- A common framework for ECLS device testing has been proposed.
- Standardized protocols will foster a unified approach among researchers, engineers, and clinicians.
- Improved data interpretation and comparability across studies are expected.
Conclusions:
- Adoption of standardized testing protocols is essential for ECLS technological advancement.
- A unified framework facilitates decision-making in the development and application of ECLS technologies.
- Enhanced data comparability and review processes will accelerate clinical translation.
