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Standardization of In-Vitro Evaluation of Extracorporeal Life Support (ECLS) Devices for Research and Development
Univ Twente, Fac Engn Technol, Dept Biomech Engn, Engn Organ Support Technol, Drienerlolaan 5, NL-7522 NB Enschede, Netherlands.
Fdn IRCCS Policlin San Matteo, SC AR2 Anestesia & Terapia Intensiva Cardiotorac, , Pavia, Italy.
Karolinska Univ Hosp, ECMO Ctr Karolinska, Dept Pediat Perioperat Med & Intens Care, Stockholm, Sweden; Karolinska Inst, Dept Physiol & Pharmacol, Stockholm, Sweden.
Rhein Westfal TH Aachen, Univ Hosp Aachen, Inst Appl Med Engn, Dept Cardiovasc Engn, Aachen, Germany.
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2026 (English)In: ASAIO journal (1992), ISSN 1058-2916, E-ISSN 1538-943X, Vol. 72, no 7, p. 525-538Article in journal (Refereed) Published
Abstract [en]

Extracorporeal life support (ECLS) technology has witnessed remarkable advancements during the last decades. However, further research and development of devices are required to increase, for example, performance-efficiency, hemocompatibility, and long-term stability. All novel devices, even in early research stages, must undergo rigorous testing and evaluation. Yet, these early evaluations are often conducted under nonstandardized conditions, resulting in data difficult to compare, interpret, or translate into clinical practice. Establishing well-defined, standardized in-vitro testing protocols for all ECLS components and devices would represent a major step forward. Such protocols would improve methodological consistency and ensure reproducibility across research groups. This document, developed by an international group of ECLS experts from all disciplines in which such components are designed, developed, and applied, provides clear recommendations and standardized criteria for device testing according to international norms. Adoption of these criteria including the ways of reporting results will foster a unified approach among scientists, engineers, clinicians, and the medical device industry. Ultimately, this common framework will facilitate data interpretation, improve comparability of study results between different groups, making the review of studies more straightforward, as not every aspect of testing requires additional review and discussion, certainly favoring decision-making in the development and application of ECLS technologies.

Place, publisher, year, edition, pages
Ovid Technologies (Wolters Kluwer Health) , 2026. Vol. 72, no 7, p. 525-538
Keywords [en]
standardization, in-vitro testing, extracorporeal membrane oxygenation, ECMO, extracorporeal life support, ECLS, oxygenator, pump, cannula, tubing, blood cell damage
National Category
Anesthesiology and Intensive Care
Identifiers
URN: urn:nbn:se:kth:diva-386715DOI: 10.1097/MAT.0000000000002623ISI: 001801126700015PubMedID: 41931830Scopus ID: 2-s2.0-105036392687OAI: oai:DiVA.org:kth-386715DiVA, id: diva2:2090409
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QC 20260806

Available from: 2026-08-06 Created: 2026-08-06 Last updated: 2026-08-25Bibliographically approved

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Prahl Wittberg, Lisa

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