2018
DOI: 10.1177/0267659118772452
|View full text |Cite
|
Sign up to set email alerts
|

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

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 inf… Show more

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...
3
1
1

Citation Types

0
13
0

Year Published

2018
2018
2024
2024

Publication Types

Select...
9

Relationship

4
5

Authors

Journals

citations
Cited by 12 publications
(13 citation statements)
references
References 3 publications
0
13
0
Order By: Relevance
“…We sought to determine how different flow rates in an ECMO circuit would affect haemolysis and coagulation parameters. Recommended flow rates for ECMO support are well-recognized [5]. On the other hand, lower flow rates and how they alter coagulation have not been thoroughly explored.…”
Section: Discussionmentioning
confidence: 99%
See 1 more Smart Citation
“…We sought to determine how different flow rates in an ECMO circuit would affect haemolysis and coagulation parameters. Recommended flow rates for ECMO support are well-recognized [5]. On the other hand, lower flow rates and how they alter coagulation have not been thoroughly explored.…”
Section: Discussionmentioning
confidence: 99%
“…Recommended flow rates for ECMO support have been well-documented [5]; however, less is known about how minimum blood flow rates affect haemolysis and coagulation. This is especially relevant during ECMO weaning.…”
Section: Introductionmentioning
confidence: 99%
“…[39][40][41][42] As soon as ECMO blood flow commences, plasmatic proteins (in particular, coagulation factors), fibrinogen, and von Willebrand factor (vWF) are consumed by the cleavage by the ADAMTS-13 protein. 37,43 Fibrinogen may contribute to thrombus formation, while loss of high-molecular vWF may contribute to a bleeding tendency. 44 Platelets can be activated by multiple mechanisms: contact with biomaterial interface causes exposure of surface integrins and adhesion to the circuit; high shear stress, due to blood flow through the pump and oxygenator, induces activation of surface proteins, spreading the process, and exposing the phospholipids.…”
Section: Pathophysiology Of Coagulation Activation During Ecmomentioning
confidence: 99%
“…Bleeding is one of the most significant complications of extracorporeal membrane oxygenation (ECMO), and even today, with more biocompatible and easierto-use devices, hemorrhage is still one of the main causes of mortality during ECMO, above all for intracranial hemorrhage. [1][2][3][4][5] Causes of bleeding in ECMO are multifactorial and include heparin administration, coagulopathy, thrombocytopenia, platelet dysfunction, acquired von Willebrand syndrome, and hyperfibrinolysis. 6,7 The main sites of bleeding during ECMO according to the extracorporeal life support organization (ELSO) registry are cannulation site, chest, nose, central nervous system, and gastrointestinal (GI) system.…”
Section: Introductionmentioning
confidence: 99%