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ISO/NP 25735 Cardiovascular implants and artificial organs — Device output-parameter nomenclature and data format used in extracorporeal life support

Source:
ISO
Committee:
CH/150/2 - Cardiovascular implants
Categories:
Information management | Standardization. General rules
Comment period start date:
Comment period end date:

Comment by:

Scope

This standard lists a series of parameters of Extracorporeal Life Support (ECLS) devices and their respective abbreviations for displaying during procedures. Additionally, it lists the order in which these parameters shall be organized for exporting for later analysis. Although this standard is intended for ECLS, it may be used in other applications such as cardiopulmonary bypass (CPB).

Purpose

Extracorporeal life support (ECLS) systems are a keystone in today’s critical care medicine and have
been constantly refined after their first introduction to modern medicine in the 1970s. They usually
consist of a drainage cannula, draining blood from the patient, a blood pump, pumping it through a
membrane lung that removes carbon dioxide and optionally oxygenates the blood and a return cannula that readministers the blood to either the venous or arterial side depending on the configuration of the extracorporeal life support system circuit.
Over the last decades, efforts were made to unify clinical nomenclature after more complex circuit
configurations and technological advances yielded more heterogeneous semantics in ECLS-related
publications. Two landmark papers on the topic are the “Extracorporeal Life Support Maastricht Treaty”
(Conrad et al., 2018) and a subsequent publication on cannula configuration naming conventions
(Broman et al., 2019).
Unfortunately, to this day, a naming convention for output parameters measured by ECLS devices is
lacking.
Typical parameters measured by ECLS consoles and dedicated measurement devices attached to the
circuit (e.g., flow sensors) are:
- the negative pressure before the blood pump
- the positive pressure after the blood pump, i.e., the pressure before the membrane lung
- the positive pressure after the membrane lung
- the positive pressure gradient as the difference between pre-membrane lung and post-membrane
lung pressure measurements
- (total) blood flow
- the rotational speed of the blood pump
Depending on the design, some consoles can also draw blood for blood gas analysis, measure
oxygenation parameters directly via dedicated probes, control the oxygen mix administered to the
membrane lung, measure arterial pressures, or provide cooling solutions for post-cardiac arrestinduced hypothermia.
A typical example of different naming schemes can be found in Table 1.
Parameter ELSO Red Book, 6th version, 2022 “ELSO Maastricht Treaty, 2018” Getinge AB, Cardiohelp
Fresenius Medical Care, Xenios
pre-blood pump pressure p1 Pump inlet pressure (PINLET) Pven p1
pre-membrane lung pressure p2 Pre-membrane pressure (PPRE) Pint p2
post-membrane lung pressure p3 Post-membrane pressure (PPOST) Part p3
Table 1: Different naming schemes depending on the manufacturer compared to the official ELSO Red

Book and naming proposals of the “ELSO Maastricht Treaty” 

Therefore,a new standard for output parameters of ECMO monitoring devices is for both the parameters shown on the monitor for direct use by the caregivers and for saving patient data in the device for later analysis. 

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Please email further comments to: debbie.stead@bsigroup.com

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