A narrative review of the technical standards for extracorporeal life support devices (pumps and oxygenators) in Europe

Matteo Di Nardo, Leen Vercaemst, Justyna Swol, Nicholas Barret, Fabio S. Taccone, Maximilian V. Malfertheiner, Lars M. Broman, Federico Pappalardo, Jan Belohlavek, Thomas Mueller, Roberto Lorusso, Margherita Lonero, Mirko Belliato

Research output: Contribution to journalArticle

Abstract

This review summarizes the European rules to control the market when introducing new products. In particular, it shows all the steps to achieve the European Conformity (CE Mark), a certification that all new medical products must achieve before being used in Europe. Extracorporeal membrane oxygenation (ECMO) devices are exposed to the same procedures. Hereby, we present some regulatory issues regarding pumps and oxygenators, providing technical details as released by the manufacturers on their websites and information charts.

Original languageEnglish
JournalPerfusion (United Kingdom)
DOIs
Publication statusAccepted/In press - Apr 1 2018

Keywords

  • centrifugal pumps
  • ECLS
  • ECMO
  • ISO
  • oxygenators

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Safety Research
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialised Nursing

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  • Cite this

    Di Nardo, M., Vercaemst, L., Swol, J., Barret, N., Taccone, F. S., Malfertheiner, M. V., Broman, L. M., Pappalardo, F., Belohlavek, J., Mueller, T., Lorusso, R., Lonero, M., & Belliato, M. (Accepted/In press). A narrative review of the technical standards for extracorporeal life support devices (pumps and oxygenators) in Europe. Perfusion (United Kingdom). https://doi.org/10.1177/0267659118772452