Extracorporeal membrane oxygenation ECMO system: Overview, Uses and Top Manufacturer Company

Introduction

Extracorporeal membrane oxygenation (ECMO) is a form of extracorporeal life support (ECLS) in which blood is circulated outside the body through a membrane oxygenator that adds oxygen and removes carbon dioxide, then returned to the patient. An Extracorporeal membrane oxygenation ECMO system is the integrated medical device (console, pump, oxygenator interface, sensors, alarms, and accessories) used to deliver that support safely in critical care environments.

This clinical device matters because it can provide temporary, high-intensity support when conventional therapies (mechanical ventilation, vasoactive medications, or standard cardiopulmonary support) are not sufficient, and time is needed for recovery, definitive therapy, or decision-making. ECMO programs also affect hospital operations: they require specialized staffing, consumables, strict safety practices, coordinated logistics, and strong biomedical engineering support.

This article is designed for two groups at once:

• Learners (medical students, residents, trainees): to understand what ECMO is, how it works in plain language, how it is used in common ICU scenarios, and how to interpret typical readings and alarms.
• Hospital decision-makers (administrators, clinicians, biomedical engineers, procurement teams): to understand operational prerequisites, safety systems, training needs, maintenance planning, infection prevention considerations, and how the global market environment influences access and service capacity.

The focus is educational and operational. Clinical decisions must always follow local protocols, manufacturer Instructions for Use (IFU), and oversight by trained ECMO teams.

What is Extracorporeal membrane oxygenation ECMO system and why do we use it?

An Extracorporeal membrane oxygenation ECMO system is hospital equipment that provides temporary extracorporeal circulation and gas exchange. In simple terms, it functions like an external, controllable “artificial lung” (and sometimes partial heart support), moving blood through a circuit where oxygen is added and carbon dioxide is removed, then returning blood to the patient.

Clear definition and purpose

ECMO is used to support patients with severe but potentially reversible respiratory and/or cardiac failure, or as a bridge to a more definitive therapy. The purpose is not to “treat” the underlying disease directly, but to buy time while the underlying condition improves or while a next step is arranged (for example, surgery, transplant evaluation, or recovery after a major insult).

Common clinical settings

You most commonly encounter ECMO as an ICU-based therapy, but it can be initiated and managed in multiple hospital locations depending on local capability:

• Intensive care unit (ICU): for severe respiratory failure (e.g., severe acute respiratory distress syndrome) or cardiogenic shock.
• Operating room (OR) / cardiothoracic surgery: for failure to wean from cardiopulmonary bypass, or post-cardiotomy shock.
• Emergency department (ED) / cath lab: in select centers for extracorporeal cardiopulmonary resuscitation (ECPR) or profound shock.
• Interfacility transport: in some systems, for moving high-acuity patients to ECMO-capable centers (requires mature teams and strict protocols).

Key benefits in patient care and workflow (general)

When used appropriately by trained teams, an Extracorporeal membrane oxygenation ECMO system can:

• Provide high-level oxygenation and carbon dioxide removal when mechanical ventilation alone is inadequate.
• Provide circulatory support in configurations that return blood to the arterial system.
• Enable clinicians to adjust ventilator and hemodynamic strategies while maintaining oxygen delivery targets (always protocol-driven).
• Create time for diagnostics, stabilization, referral, and definitive interventions.
• Support structured decision-making (“bridge to recovery,” “bridge to decision,” “bridge to transplant/assist device”), depending on local practice and patient factors.

Operationally, ECMO can standardize care pathways in high-acuity shock/respiratory failure by triggering predefined checklists, staffing escalation, and laboratory/imaging workflows. It also introduces complexity: more devices at the bedside, more alarms, more line management, and higher demands on nursing and perfusion coverage.

Plain-language mechanism of action (non-brand-specific)

At a high level, ECMO works through these elements:

• Cannulas: Large-bore catheters placed in major vessels to drain blood from the patient and return it after processing. Cannulation approach varies (peripheral vs central; single-site dual-lumen vs two cannulas), and is highly protocol-dependent.
• Pump: Usually a centrifugal pump that generates flow through the circuit. The pump speed is typically set in revolutions per minute (RPM) and results in a measured blood flow (e.g., L/min), depending on resistance, cannula size, and patient factors.
• Membrane oxygenator: A device with a semi-permeable membrane where gas exchange occurs. “Sweep gas” passes on one side of the membrane while blood passes on the other, allowing oxygen to diffuse into blood and carbon dioxide to diffuse out.
• Gas blender and sweep gas control: Adjusts the oxygen concentration delivered to the oxygenator and the sweep gas flow rate. In general terms, blood flow strongly influences oxygen delivery, while sweep gas flow strongly influences carbon dioxide removal (with important caveats).
• Heat exchanger (in many circuits): Helps maintain target temperature by transferring heat to/from circulating water or an integrated temperature control module.
• Sensors and alarms: May include flow sensors, pressure transducers (pre- and post-oxygenator), bubble detectors, venous saturation monitoring, temperature monitoring, and system integrity checks. Features vary by manufacturer and model.

Core ECMO configurations (conceptual)

• Veno-venous (VV) ECMO: Venous drainage and venous return. Primarily supports the lungs (oxygenation and CO₂ removal). Hemodynamic support is indirect and variable.
• Veno-arterial (VA) ECMO: Venous drainage and arterial return. Provides both oxygenation support and circulatory support.
• Hybrid configurations: Used in select cases when standard VV or VA does not meet goals. Naming and approach vary by center.

How medical students typically encounter or learn this device in training

Most learners first meet ECMO in one of four ways:

• ICU rounds: observing ECMO flows, sweep, alarms, anticoagulation monitoring, and daily goals of care.
• Simulation training: learning circuit safety (clamp discipline, air management), emergency drills, and team communication.
• Perioperative/cardiac surgery exposure: understanding differences between ECMO and cardiopulmonary bypass, and post-operative support pathways.
• Case-based teaching: reviewing indications, complications, and ethical/resource considerations, especially when the “exit strategy” is unclear.

For learners, the biggest conceptual leap is recognizing that ECMO is support, not cure—and that safe operation depends as much on human factors and teamwork as it does on the pump and oxygenator.

When should I use Extracorporeal membrane oxygenation ECMO system (and when should I not)?

Decisions about ECMO are high-stakes, time-sensitive, and heavily dependent on local capability. The information below is general and meant to frame clinical reasoning and operational readiness, not to replace institutional criteria.

Appropriate use cases (general categories)

An Extracorporeal membrane oxygenation ECMO system may be considered in selected patients with refractory respiratory and/or cardiac failure despite optimized conventional management, when:

• The underlying condition is potentially reversible, or a definitive therapy is available.
• A trained ECMO team and appropriate environment are available.
• There is a clear plan for monitoring, escalation, and potential weaning/transition.

Common scenario categories include:

• Severe hypoxemic respiratory failure that remains inadequate despite advanced ventilatory strategies.
• Severe hypercapnic respiratory failure with inadequate ventilation despite optimization.
• Cardiogenic shock where perfusion is insufficient despite pharmacologic and mechanical support options.
• Post-cardiotomy or peri-procedural support in selected cases.
• Extracorporeal CPR (ECPR) in systems with established protocols, rapid cannulation capability, and post-arrest care pathways.
• Bridge strategies (to recovery, decision, transplant, or durable mechanical support) when appropriate programs exist.

Neonatal and pediatric ECMO has additional use patterns and equipment considerations (cannula size ranges, congenital heart disease pathways, and specialized ICU staffing), and varies significantly by region.

Situations where it may not be suitable

ECMO is resource-intensive and carries substantial risk. In general, it may be unsuitable when:

• The underlying disease process is irreversible without an available definitive therapy (“no exit strategy”).
• Severe comorbidities or multi-system failure make meaningful recovery unlikely (judgment varies by team and context).
• The patient cannot be managed safely due to logistical constraints (no trained staff, no ICU capability, limited blood products, lack of imaging/lab support, or inability to provide continuous monitoring).
• There is an inability to obtain required vascular access or manage complications in the available setting.

Safety cautions and contraindications (general, non-prescriptive)

Contraindications are highly protocol- and patient-specific. Commonly discussed caution categories include:

• High bleeding risk or active uncontrolled bleeding (given that many ECMO pathways require anticoagulation).
• Severe neurologic injury or conditions where systemic anticoagulation may be particularly hazardous.
• Inability to achieve safe cannulation (anatomic constraints, vascular disease, or access limitations).
• Severe, uncontrolled infection or profound immunosuppression may be considered in the risk-benefit balance (context-specific).
• Prolonged, severe hypoperfusion prior to initiation may reduce benefit in some scenarios (not absolute; depends on case).

Emphasize clinical judgment, supervision, and local protocols

For trainees, a safe mental model is:

• ECMO is not “just another ventilator setting.” It is a program-level therapy.
• If your hospital has ECMO capability, there will be inclusion/exclusion criteria, consultation triggers, and escalation pathways—use them.
• If your hospital does not have ECMO capability, the key action is usually early recognition, stabilization, and timely referral according to regional systems of care.

For administrators and operations leaders, “appropriate use” also includes ensuring 24/7 coverage, supply chain resilience, defined leadership, training pathways, and clear transfer agreements when ECMO is not available onsite.

What do I need before starting?

Starting ECMO safely requires more than a console. It requires an environment, a team, supplies, and governance.

Required setup, environment, and accessories

A typical ECMO-capable environment includes:

• Space and layout: Enough room for the Extracorporeal membrane oxygenation ECMO system, infusion pumps, ventilator, ultrasound, and staff to work on both sides of the bed.
• Reliable power: Dedicated outlets, appropriate power conditioning per facility policy, and clear plans for power loss (battery duration varies by manufacturer).
• Gas supply: Oxygen/air availability for the gas blender and sweep gas; backup cylinders for transport or emergencies.
• Suction and airway equipment: For routine ICU care and bleeding/airway emergencies.
• Thermal management capability: If using an external heater-cooler or integrated temperature module (varies by manufacturer).
• Point-of-care and lab support: Blood gases, hemoglobin/hematocrit, coagulation testing (method varies), chemistry panels, lactate, and hemolysis markers per protocol.
• Imaging access: Ultrasound for cannulation guidance and cannula position checks; radiography as needed.

Common accessories and disposables (varies by model and clinical strategy):

• Single-use ECMO circuit (tubing set), oxygenator, and pump head
• Cannulas (venous and/or arterial), connectors, clamps, securement devices
• Pressure monitoring lines/transducers (pre-/post-oxygenator, access/return pressures)
• Flow probe(s) and calibration accessories (if applicable)
• Bubble detector (if used), temperature probes, venous saturation module (if used)
• Emergency equipment: spare circuit/oxygenator, connector kits, and a plan for rapid exchange

Training and competency expectations

Because ECMO is high risk, most programs require:

• Initial training (didactic + hands-on) for all ECMO bedside roles.
• Simulation-based drills (air in circuit, pump failure, oxygenator failure, massive bleeding, transport events).
• Competency validation at onboarding and at regular intervals (frequency varies by center).
• Role clarity: Who is allowed to change settings, clamp lines, administer sweep gas changes, or respond to alarms.

Staffing models vary globally. Some programs are perfusionist-led, others use nurse/respiratory therapist ECMO specialists with perfusionist oversight, and some use hybrid models.

Pre-use checks and documentation

A practical pre-initiation checklist often includes:

• Verify the correct device model and required modules are present and functional.
• Confirm the circuit and oxygenator are within expiry and stored per manufacturer requirements.
• Inspect packaging integrity and lot traceability (important for recall management).
• Perform console self-tests, confirm alarm function, verify sensor calibration status (if applicable).
• Confirm availability of a backup plan: spare oxygenator/circuit, backup console (if available), and escalation contacts.

Documentation typically includes:

• Indication for ECMO and agreed clinical goals (support target, bridge plan)
• Time-out completion and team roles
• Cannulation details and device identifiers (serial/lot numbers)
• Baseline parameters and first blood gas set after initiation (per protocol)
• Ongoing ECMO flow sheet and event log (including alarms and interventions)

Operational prerequisites: commissioning, maintenance readiness, consumables, and policies

From a hospital operations perspective, readiness usually includes:

• Commissioning/acceptance testing: Electrical safety checks, functional verification, and documentation before first clinical use (biomedical engineering responsibility in many facilities).
• Preventive maintenance (PM): A schedule aligned to manufacturer guidance, usage intensity, and local risk management.
• Software/firmware governance: Version control, update testing, cybersecurity review if network-connected (varies by manufacturer and local IT policy).
• Consumables management: Par levels for circuits, oxygenators, cannulas, sensors; shelf-life tracking; substitution rules when preferred items are out of stock.
• Policies and protocols: Anticoagulation management, transfusion thresholds (if used), transport, emergency drills, device cleaning, and adverse event reporting.
• Quality program: Case review, complication tracking, and a mechanism for learning from near-misses.

Roles and responsibilities (clinician vs. biomedical engineering vs. procurement)

Clear accountability reduces risk:

• Clinical leadership (ICU/cardiac surgery/anesthesia): Patient selection, cannulation decisions, clinical targets, and bedside management strategy.
• ECMO specialists/perfusionists: Circuit setup, parameter changes per scope, alarm response, emergency management, and staff coaching.
• Nursing/RT teams: Patient monitoring, line management, ventilation coordination, medication administration, and documentation.
• Biomedical engineering: Device commissioning, PM, repairs coordination, failure investigation, loaner management, and user safety notices handling.
• Procurement/supply chain: Contracting, pricing structure transparency (console vs disposables), inventory strategy, distributor management, and continuity planning.

How do I use it correctly (basic operation)?

Workflows vary by model, local protocol, and patient population. The steps below describe a commonly universal sequence for safe initiation and early stabilization using an Extracorporeal membrane oxygenation ECMO system.

1) Confirm the clinical plan and assemble the team

• Confirm indication, intended configuration (e.g., VV vs VA), and “exit strategy” conceptually.
• Assign roles explicitly: cannulator, airway lead, ECMO circuit lead, medication nurse, documentation, and runner.
• Perform a time-out that includes blood product readiness (if needed), imaging plan, and emergency contingencies.

2) Prepare the console and circuit

Common steps (details vary by manufacturer):

• Position the console for visibility of alarms and screen access.
• Connect to reliable power; confirm battery status for backup.
• Install the pump head and oxygenator module as designed.
• Assemble the circuit tubing and connectors using aseptic technique as required by policy.
• Prime the circuit and de-air thoroughly per protocol; document prime type (varies by center).
• Connect sweep gas line(s) to the oxygenator and verify gas blender function.
• Confirm pressure monitoring lines and flow sensors are connected and reading appropriately (if used).

Universal safety principles:

• Keep clamps organized and applied deliberately.
• Keep all connections visible and secured.
• Ensure there is a clear plan to prevent air entrainment during all steps.

3) Set baseline alarm limits and monitoring

Alarm philosophies differ, but typical categories include:

• Low/high blood flow
• Low/high inlet (drainage) pressure
• High return pressure
• High pressure gradient across the oxygenator (delta pressure)
• Air/bubble detection (if present)
• Temperature out of range
• Power or gas supply failure

Set alarm limits according to local protocol and patient goals. Avoid leaving “factory defaults” unreviewed.

4) Cannulation and connection (high-level overview)

Cannulation technique is outside the scope of this operational overview and must follow trained practice. In general:

• Use sterile technique and imaging guidance as appropriate.
• Choose cannulas based on patient size, desired flow, and access site strategy.
• Secure cannulas robustly; protect the skin and reduce tension on insertion sites.
• Connect cannulas to the circuit with clamps applied, confirming correct orientation (drainage vs return).

5) Initiate flow gradually and stabilize

Common universal steps:

• Start the pump at a low setting and confirm flow direction and stable circuit pressures.
• Increase toward the intended support level gradually while watching:
• Patient hemodynamics and oxygenation
• Circuit pressures and signs of access insufficiency (“chatter” may indicate drainage limitation)
• Evidence of air, leaks, or abnormal noise/vibration
• Start sweep gas and adjust as needed per protocol; confirm oxygenator function via blood gases and clinical response.

6) Verify performance with clinical correlation

ECMO management requires continuous correlation:

• Bedside monitors: saturation, blood pressure, temperature, end-tidal CO₂ (if applicable)
• Laboratory: arterial blood gas trends, hemoglobin, coagulation markers, markers of hemolysis (per protocol)
• Imaging: cannula position checks as indicated

Be cautious about overreacting to a single number. Look for trends and confirm sensor validity.

Typical “settings” you will see and what they generally mean

Terminology can differ, but these are common parameters:

• Pump speed (RPM): The rotational speed of the pump. Higher RPM often increases flow, but flow also depends on resistance, cannula position/size, and volume status.
• Blood flow (L/min): The measured circuit flow. This is a key determinant of oxygen delivery support capacity.
• Sweep gas flow (L/min): The gas flow through the oxygenator. This is often adjusted to influence CO₂ removal.
• Gas FiO₂ (fraction of inspired oxygen) to the oxygenator: The oxygen concentration in sweep gas. This affects oxygen transfer in the oxygenator.
• Circuit pressures: Access (drainage) pressure, return pressure, and oxygenator delta pressure. These help detect obstruction, clot formation, cannula issues, and inappropriate flow targets.
• Temperature: Patient or circuit temperature management via heat exchanger (if used).

7) Ongoing bedside operation (common universal practices)

• Reassess cannula securement and dressing integrity every shift (or more often per policy).
• Confirm alarms are audible and actionable.
• Keep emergency clamps and backup supplies at the bedside.
• Document parameter changes with reasons, not just numbers (important for handover and review).
• Standardize communication: “flow, sweep, FiO₂, pressures, alarms, patient status” during handoffs.

8) Weaning and decannulation (conceptual)

Weaning is a structured process that varies by configuration and patient condition:

• Evaluate whether native lung/heart function is recovering.
• Reduce support in a controlled way (e.g., sweep reduction trials for VV; flow reduction trials for VA), while monitoring labs and clinical stability.
• Plan decannulation with appropriate staffing, sterility, and post-removal monitoring.

How do I keep the patient safe?

An Extracorporeal membrane oxygenation ECMO system adds powerful support—and introduces powerful risks. Safety is achieved by combining device features (alarms, sensors, connectors) with disciplined human performance (training, checklists, communication, and escalation).

Core patient safety practices and monitoring (general)

• Continuous observation: ECMO is not “set and forget.” Continuous patient and circuit monitoring is essential.
• Cannula and limb monitoring: Assess insertion sites for bleeding, hematoma, migration, and infection risk. For arterial cannulation, monitor distal perfusion per protocol (methods vary).
• Neurologic vigilance: Many ECMO patients are at risk for neurologic complications. Monitoring approach varies by ICU resources and patient condition.
• Bleeding and thrombosis balance: ECMO circuits can promote clot formation, while anticoagulation increases bleeding risk. Anticoagulation strategy, lab targets, and monitoring assays vary by center and manufacturer guidance.
• Hemolysis surveillance: Watch for signs of red blood cell damage (labs and circuit clues). Causes can include high shear, cannula issues, clot burden, or pump problems.
• Oxygenator performance trends: Monitor gas exchange effectiveness and pressure gradients to anticipate oxygenator failure rather than reacting to an emergency.

Alarm handling and human factors

Alarms are safety tools—but only if handled well:

• Treat alarms as “clinical questions”: What changed? Is the patient stable? Is the circuit intact?
• Avoid silencing alarms without identifying cause and documenting the response.
• Use a two-person check for high-risk actions (clamp changes, circuit access, component swaps), when feasible.

Human factors that reduce error:

• Line labeling and standard routing: Clearly identify drainage and return lines; route tubing consistently to reduce misconnections.
• Connection discipline: Ensure secure fittings, avoid excessive torque on connectors, and keep access ports capped.
• Workspace organization: Avoid clutter at the bedside. Secure tubing to reduce tension and accidental dislodgement.
• Fatigue management: ECMO is cognitively demanding. Staffing plans should account for breaks and handover quality.

Risk controls beyond the bedside

Strong ECMO programs build systems that prevent predictable failures:

• Standardized checklists for initiation, transport, and emergencies
• Mandatory simulation for rare but catastrophic events (air entrainment, pump failure)
• Clear criteria for calling for help (ECMO lead, perfusion, surgeon, biomedical engineering)
• Robust incident reporting culture (near-misses included), with feedback loops for training and process improvement

Labeling checks and configuration control

Device safety also depends on logistics:

• Verify consumables (oxygenator, tubing, cannulas) are the intended type and size.
• Check expiry dates and packaging integrity before opening.
• Maintain traceability for lots/serials for recall management and post-event investigation.
• Avoid “mix and match” component substitutions unless specifically validated by local policy and manufacturer guidance (compatibility varies by manufacturer).

Transport safety (brief operational emphasis)

Transporting a patient on ECMO increases risk:

• Confirm power and gas supply plan for the entire route, including contingencies.
• Secure the Extracorporeal membrane oxygenation ECMO system and circuit to prevent tipping or traction.
• Perform a pre-transport time-out with roles, route, and emergency stop points.
• Ensure receiving teams are ready before departure to reduce time in transit corridors.

How do I interpret the output?

ECMO outputs are meaningful only in context. A number on the console reflects circuit mechanics and sensor assumptions—not the whole patient.

Types of outputs/readings you may see

Depending on model and installed modules, the Extracorporeal membrane oxygenation ECMO system may display:

• Blood flow (L/min) and pump speed (RPM)
• Access (drainage) pressure and return pressure
• Oxygenator pressure gradient (delta pressure)
• Temperature (patient/circuit)
• Venous saturation (circuit-based, if available) and/or other optical monitoring
• Bubble/air detection status (if available)
• System status indicators: battery, gas supply, module connectivity, self-test results

Clinicians interpret these alongside:

• Patient vital signs and perfusion indicators
• Arterial blood gases and lactate trends
• Hemoglobin/hematocrit and coagulation labs per protocol
• Imaging and bedside exam

How clinicians typically interpret them (general patterns)

• Low flow with high RPM may suggest high resistance, poor venous drainage, cannula malposition, hypovolemia, or circuit obstruction (interpretation is case-specific).
• Worsening oxygenation despite stable flow may reflect lung pathology progression, oxygenator performance decline, recirculation (in VV), or mixing phenomena (in VA).
• Rising delta pressure across the oxygenator can be a warning sign for clot burden or oxygenator dysfunction, prompting closer surveillance and contingency planning.
• Saturation readings (pulse oximetry or circuit sensors) must be interpreted based on cannulation configuration; in VA ECMO, upper-body saturation may differ from lower-body saturation depending on native cardiac output and return site.

Common pitfalls and limitations

• Sensor drift and calibration issues: Some sensors require calibration or have known limitations; follow local biomed and manufacturer guidance.
• Recirculation (VV ECMO): Oxygenated return blood can be drawn back into the drainage cannula, reducing effective support. Console numbers may look “fine” while patient oxygenation is suboptimal.
• Cannula position changes: Patient movement, turning, or transport can shift cannulas. A small migration can cause large changes in pressures/flow.
• Artifacts: Electrical interference, poor probe positioning, vibration, or fluid contamination can distort readings.
• False reassurance: A stable console does not guarantee patient stability; hemorrhage, neurologic events, and infection can evolve without immediate circuit changes.

Clinical correlation is non-negotiable

A safe practice is to treat ECMO console data as one layer in a multi-layer assessment:

• Patient exam and bedside monitors
• Circuit inspection (connections, tubing color, vibration, condensation, clots)
• Laboratory and imaging trends
• Team discussion and documented goals for the next shift

What if something goes wrong?

ECMO troubleshooting should be structured, calm, and team-based. The first step is usually to assess the patient, then the circuit, then the console.

A practical troubleshooting checklist (general)

• Confirm the patient status: airway/ventilation, blood pressure, rhythm, level of consciousness/sedation plan, bleeding.
• Call for help early: ECMO specialist/perfusion, ICU attending, cannulating service, and additional nursing support as needed.
• Check the circuit mechanically:
• Are any lines kinked, compressed, or clamped?
• Are connections secure and dry (no leaks)?
• Is there visible air, foam, or unusual color change?
• Are cannulas under tension or displaced?
• Check alarms and trends:
• Low flow, high negative access pressure, high return pressure
• Rising oxygenator delta pressure
• Gas supply failure or sweep interruption
• Temperature control faults
• Power/battery warnings
• Verify gas delivery:
• Sweep gas connected and flowing
• Gas blender settings appropriate to the plan
• Adequate supply source (wall vs cylinder)

When to stop use (general principles)

Stopping ECMO abruptly can be dangerous. Decisions are case-specific and require trained oversight. In general, urgent escalation is needed when there is:

• Suspected air entrainment with risk of embolization
• Catastrophic circuit rupture or uncontrolled leak
• Pump/console failure without immediate backup
• Severe patient instability where the circuit is suspected to be contributing

Follow facility emergency protocols, and ensure roles are clear (who clamps, who manages hemodynamics, who prepares backup equipment).

When to escalate to biomedical engineering or the manufacturer

Escalate to biomedical engineering when:

• The console fails self-tests, has persistent hardware faults, or exhibits abnormal behavior.
• Alarms suggest sensor/module malfunction rather than physiologic change.
• There is suspected damage to cables, connectors, battery performance, or electrical safety concerns.

Escalate to the manufacturer (often via local representative) when:

• There is repeated unexplained device malfunction.
• You need model-specific guidance for error codes, module replacement, or service bulletins.
• There is a potential reportable device problem (requirements vary by country).

Documentation and safety reporting expectations

After any significant event:

• Document the timeline, alarms, interventions, and patient response.
• Preserve traceability: record serial numbers, lot numbers, and software versions when relevant.
• Submit internal incident reports (including near-misses) to support system learning.
• Quarantine suspected faulty components per policy for investigation (do not discard without guidance).

Infection control and cleaning of Extracorporeal membrane oxygenation ECMO system

Infection prevention for ECMO is both a patient-care issue (cannula sites, bloodstream infection risk) and a device reprocessing issue (console surfaces, accessories, and transport contamination).

Cleaning principles (non-brand-specific)

• Treat the bedside Extracorporeal membrane oxygenation ECMO system as high-touch hospital equipment.
• Clean and disinfect external surfaces between patients and when visibly soiled.
• Use only disinfectants that are compatible with the device materials; chemical compatibility varies by manufacturer.

Disinfection vs. sterilization (general)

• Disinfection reduces microbial burden on surfaces (typical for consoles, screens, poles).
• Sterilization is used for items intended to be sterile at point of use.
• ECMO circuits and oxygenators are typically single-use and not reprocessed (follow local regulations and IFU).

High-touch points to prioritize

Commonly missed surfaces include:

• Touchscreen, buttons/knobs, and alarm silence controls
• Handles, cable junctions, and module latches
• IV pole clamps or mounting points used with the console
• Gas connection points and flowmeter surfaces
• Transport cart rails and accessory baskets

Example cleaning workflow (adapt to policy)

• Perform hand hygiene and don facility-required PPE.
• Place the device in a safe state (standby/off as appropriate), disconnect from the patient area, and unplug if required by policy.
• Remove disposable accessories and discard per biomedical waste policy.
• Wipe surfaces with approved disinfectant, ensuring required contact time.
• Avoid fluid ingress into vents, ports, and electrical connectors.
• Allow surfaces to dry fully before reconnecting power.
• Document cleaning completion and report any damage noticed (cracks, screen delamination, loose connectors).

Follow the manufacturer IFU and facility infection prevention policy

Do not improvise reprocessing steps. If a disinfectant damages plastics or seals, it can create long-term safety risk. When in doubt, confirm compatibility with infection prevention and biomedical engineering, and document any policy exceptions.

Medical Device Companies & OEMs

In ECMO and other extracorporeal therapies, the supply chain can involve multiple entities.

Manufacturer vs. OEM (Original Equipment Manufacturer)

• A manufacturer markets the final medical device under its name and is responsible for regulatory compliance, quality systems, labeling, IFU, and post-market surveillance for that product.
• An OEM (Original Equipment Manufacturer) may produce a component or subsystem (for example, pumps, sensors, controllers, or disposables) that is integrated into another company’s branded system, or may manufacture the complete product under contract.

How OEM relationships impact quality, support, and service

OEM relationships can affect:

• Traceability: Clear lot/serial traceability supports recalls and adverse event investigation.
• Serviceability: Parts availability, repair workflows, and the speed of field service can depend on how components are sourced.
• Consistency: Component changes over time may require revalidation; transparency varies by manufacturer.
• Support boundaries: When failures occur, responsibility may be split across entities; hospitals should ensure escalation pathways are explicit in contracts.

For procurement and biomedical engineering, practical questions include:

• Who provides field service locally?
• What is the expected turnaround time for repairs?
• Are loaners available?
• What consumables are proprietary vs cross-compatible (varies by manufacturer)?
• What training is included, and for which roles?

Top 5 World Best Medical Device Companies / Manufacturers

Example industry leaders (not a ranking). Specific ECMO portfolios, availability, and regulatory status vary by country and product line.

1. Getinge
   Getinge is widely recognized in acute care and cardiopulmonary support categories, with a global footprint across many hospital systems. Its portfolio commonly intersects with ICU, OR, and perfusion workflows, which can matter for integrated service planning. Support models and distribution structures vary by region. For ECMO programs, procurement teams often evaluate how well service coverage aligns with 24/7 clinical needs.

2. Medtronic
   Medtronic is a large global medical device manufacturer with broad offerings across cardiovascular, surgical, and critical care domains. In many markets, the company is present in cath lab, OR, and ICU supply chains, which can influence contracting and logistics. ECMO-related components and availability vary by manufacturer portfolio and geography. Hospitals often assess training resources and consumable continuity when considering system-level adoption.

3. Terumo
   Terumo operates internationally with strong presence in cardiovascular and perfusion-adjacent device categories in many regions. For extracorporeal support programs, centers may consider how disposables supply, clinical education, and service workflows are structured locally. Product configurations and compatibility are manufacturer-specific. Procurement commonly evaluates total cost of ownership, including consumables and education.

4. LivaNova
   LivaNova is known for products in cardiothoracic and extracorporeal circulation-related spaces in many healthcare systems. Its relevance to ECMO programs often relates to how perfusion teams interface with device platforms and disposables. Availability and service support depend on local distribution and agreements. Hospitals typically look closely at training pathways and long-term consumable supply.

5. Fresenius Medical Care (including extracorporeal therapy subsidiaries in some regions)
   Fresenius Medical Care is widely associated with dialysis and extracorporeal therapies globally, and in some regions its corporate family includes extracorporeal oxygenation-focused businesses. For hospitals, corporate scale can influence service networks and logistics capabilities, though specific ECMO offerings and support vary by country. Due diligence should focus on local technical support, training, and consumables availability.

Vendors, Suppliers, and Distributors

Hospitals often use multiple commercial pathways to acquire and support ECMO-related hospital equipment and consumables.

Role differences: vendor vs. supplier vs. distributor

• A vendor is a broad term for any company selling goods or services to a hospital (may include manufacturers, distributors, or service providers).
• A supplier provides products (and sometimes services) to the hospital; this can include single-use consumables, accessories, or capital medical equipment.
• A distributor specializes in logistics and fulfillment—holding inventory, managing shipping/importation, and sometimes providing local customer support on behalf of manufacturers.

In ECMO, many hospitals buy the console through direct manufacturer channels while sourcing some accessories via distributors. The exact model depends on country regulations, tender structures, and service coverage.

Top 5 World Best Vendors / Suppliers / Distributors

Example global distributors (not a ranking). Actual ECMO procurement routes vary by country, and many ECMO systems are supplied via authorized manufacturer channels.

1. McKesson
   McKesson is a large healthcare distribution organization in markets where it operates, supporting logistics, contracting, and supply continuity for hospitals and health systems. Its relevance to ECMO programs is often indirect—supporting associated ICU and procedural supply needs. Service offerings and product availability vary by region and business unit. Buyers typically engage for supply chain reliability and inventory management capabilities.

2. Cardinal Health
   Cardinal Health is known for broad hospital supply distribution and logistics services in regions where it has a footprint. For ECMO-adjacent procurement, distributors can support standardized ICU supply flow, documentation, and contract structures. ECMO-specific devices may still be manufacturer-direct depending on local authorization. Hospitals evaluate distributor performance on fill rates, traceability, and responsiveness.

3. Medline
   Medline supplies a wide range of medical-surgical products and offers logistics services in multiple countries. For ECMO programs, the value may be in consistent access to ICU consumables, dressing supplies, and standardized product sets that support cannula site care workflows. Regional availability and service scope vary. Health systems may use such suppliers to reduce SKU complexity and improve readiness.

4. Henry Schein
   Henry Schein is a global healthcare distribution company with a strong presence in selected segments and geographies. Its role in hospital critical care supply can vary, and in many places it functions as a channel partner for multiple manufacturers. For specialized therapies like ECMO, hospitals should confirm whether the distributor is authorized, trained, and able to support urgent needs. Service level agreements are important for high-acuity programs.

5. Owens & Minor
   Owens & Minor provides supply chain and logistics services in markets where it operates, often supporting hospital inventory and distribution operations. For ECMO programs, the key operational question is whether distribution services can meet time-critical demands and maintain traceability for high-risk items. Availability varies by region. Hospitals typically assess warehouse capability, backorder management, and recall handling processes.

Global Market Snapshot by Country

The market for the Extracorporeal membrane oxygenation ECMO system is shaped by ICU capacity, perfusion/critical care workforce availability, funding models, import pathways, and the maturity of referral networks. Below is a qualitative snapshot focused on operational realities rather than market sizing.

India

Demand is concentrated in large private and academic hospitals where advanced cardiac surgery, transplant evaluation, and tertiary ICUs are available. Access remains uneven, with urban centers far more likely to have trained ECMO teams and reliable consumables supply. Many components are imported, so procurement planning often emphasizes distributor reliability, service coverage, and buffer stock for disposables. Training programs and standardized protocols are expanding, but staffing models vary widely between institutions.

China

High-capacity tertiary hospitals in major cities have driven growth in ECMO capability, supported by expanding critical care infrastructure and specialized training. Domestic manufacturing capability in medical equipment is substantial, but the ECMO ecosystem still commonly includes imported disposables or components depending on the system and region. Service and training quality can differ between provinces, with stronger support in urban referral centers. Procurement decisions often consider integration with hospital information systems and local after-sales service responsiveness.

United States

ECMO use is relatively established in many large academic medical centers and some community hospitals with mature critical care programs. The service ecosystem includes strong perfusion and critical care staffing pipelines in many regions, though staffing shortages can still limit capacity. Procurement often focuses on total cost of ownership, device standardization across hospital networks, and robust service contracts. Referral patterns and transport capabilities shape access, with rural regions relying on transfer systems to high-volume centers.

Indonesia

Access is largely concentrated in major urban hospitals, with limited availability across smaller islands and rural settings due to workforce and logistics constraints. Import dependence and complex distribution pathways can make disposables availability a key operational risk. Hospitals building ECMO programs often prioritize training partnerships, clear maintenance plans, and reliable oxygen/gas supply infrastructure. Referral networks and inter-island transport limitations influence patient selection and timing.

Pakistan

ECMO capability is present in selected tertiary centers, often in major cities, where cardiac surgery and advanced ICU services are available. Growth is influenced by funding constraints, import logistics, and the availability of trained perfusion and ICU staff. Hospitals commonly face challenges maintaining consistent consumables supply and 24/7 coverage. Program development tends to focus on clear criteria, strong governance, and careful budgeting for disposables.

Nigeria

ECMO access is limited and typically concentrated in a small number of high-resource facilities, often in urban areas. Key barriers include high capital and consumable costs, limited specialized workforce, and dependence on imported equipment with variable service support. Where programs exist or are developing, sustainability depends on training, reliable power/gas infrastructure, and secure supply chains. Broader access is constrained by critical care capacity and referral/transport systems.

Brazil

Brazil has advanced tertiary centers and established cardiac surgery capability in major cities, supporting ECMO program development in those settings. Public-private differences can influence availability, with high-complexity care more accessible in certain networks. Import pathways, regulatory processes, and distributor support affect device selection and long-term serviceability. Regional disparities remain significant, with rural and remote areas relying on referral systems.

Bangladesh

ECMO availability is generally limited to a small number of tertiary hospitals, primarily in major urban areas. Import dependence can create delays or variability in consumables availability, making inventory planning and vendor reliability central operational considerations. Workforce development—ECMO specialists, perfusionists, and ICU nursing capacity—often determines sustainable program size more than the number of consoles purchased. Financing models and patient affordability can strongly influence utilization.

Russia

ECMO capability exists in larger regional and academic centers, with utilization influenced by critical care infrastructure and specialty availability. Supply chain complexity and import restrictions or administrative barriers (which can change over time) may affect access to certain brands, components, or disposables. Hospitals may prioritize devices with strong local service presence and predictable consumables supply. Urban centers generally have stronger staffing and maintenance support than remote regions.

Mexico

ECMO programs are typically concentrated in major urban tertiary hospitals, with access shaped by public versus private system resources and referral capacity. Import dependence and distributor service coverage can influence device uptime and consumables continuity. Training and standardized protocols are key growth enablers, especially where staff rotate across units or institutions. Interfacility transport capability is an important determinant of equitable access beyond major cities.

Ethiopia

ECMO access is very limited, largely due to constrained critical care infrastructure, specialized workforce shortages, and high dependence on imported high-complexity hospital equipment. Where advanced services are being developed, sustainability hinges on stable power, oxygen supply, biomedical engineering capacity, and long-term consumables procurement. Concentration in the capital or major referral hospitals is typical. Partnerships for training and service support are often essential.

Japan

Japan has a mature critical care and cardiovascular care environment in many tertiary centers, supporting advanced extracorporeal therapies. Device selection may emphasize reliability, integration into established ICU workflows, and comprehensive service support. Training standards and protocol-driven practice are commonly strong in high-volume centers, though regional differences exist. Procurement often considers long-term lifecycle management and the availability of certified service personnel.

Philippines

ECMO access is concentrated in major metropolitan tertiary hospitals, with limited availability in rural areas due to staffing and infrastructure constraints. Import dependence can affect lead times for disposables, making planning and vendor reliability important. Programs often grow through structured training and collaboration between ICUs, perfusion services, and cardiac surgery teams. Transport logistics across islands adds complexity for referrals and interfacility transfers.

Egypt

ECMO programs are more likely to be found in large tertiary hospitals and specialized centers, particularly in major cities. Import pathways and service coverage are key determinants of device choice, especially where rapid replacement of disposables is needed. Training and maintaining 24/7 ECMO expertise can be challenging, influencing program scale. Public and private sector differences affect access and adoption speed.

Democratic Republic of the Congo

ECMO availability is extremely limited, largely due to constrained ICU capacity, specialized workforce scarcity, and the complexity of maintaining high-risk extracorporeal medical equipment. Import dependence, variable infrastructure reliability, and limited biomedical engineering resources make sustained programs difficult. Where high-acuity services exist, they are usually concentrated in major urban centers. Broader access is constrained by referral and transport limitations.

Vietnam

Vietnam’s ECMO capability has expanded in selected tertiary and academic centers, particularly in major cities with developing critical care systems. Import dependence remains relevant for many systems and disposables, so distributor support and procurement planning are important. Training programs and protocol standardization are key drivers of safe scale-up. Rural access remains limited, making referral pathways and transport readiness central operational concerns.

Iran

ECMO availability is present in certain tertiary hospitals, with utilization influenced by local manufacturing capacity in medical equipment, import limitations, and the availability of specialized consumables. Service support and parts availability can be significant determinants of device uptime. Training and staffing stability are crucial for safe operation, particularly where turnover is high. Access is typically concentrated in major urban referral centers.

Turkey

Turkey has a strong network of tertiary hospitals in major cities, supporting ECMO program development in advanced critical care and cardiac surgery settings. Device procurement may involve a mix of direct manufacturer relationships and authorized distributors, with service coverage being a key differentiator. Training capacity and standardized protocols support program maturity in established centers. Regional disparities persist, with more limited access outside large urban hubs.

Germany

Germany has a well-developed ICU and cardiothoracic care infrastructure, and ECMO is established in many tertiary centers. Procurement decisions often emphasize adherence to rigorous standards, comprehensive service contracts, and integration with existing clinical engineering workflows. Workforce availability (perfusion, ICU nursing) supports sustained use, though staffing pressures can still affect capacity. Referral networks and inter-hospital coordination influence case distribution and outcomes tracking practices.

Thailand

Thailand’s ECMO capability is concentrated in large tertiary and academic hospitals, particularly in Bangkok and other major cities. Growth depends on training pipelines for ECMO specialists and perfusion services, as well as reliable access to imported disposables and maintenance support. Public and private sector differences can influence availability and affordability. Referral and transport systems play a major role in extending access beyond urban centers.

Key Takeaways and Practical Checklist for Extracorporeal membrane oxygenation ECMO system

• Treat the Extracorporeal membrane oxygenation ECMO system as a program, not just a machine.
• Ensure 24/7 staffing coverage is realistic before expanding ECMO capacity.
• Define VV versus VA ECMO goals clearly at initiation and during every handover.
• Use standardized initiation and emergency checklists to reduce variability.
• Assign roles explicitly before cannulation and before any circuit intervention.
• Confirm reliable power access and know the console’s battery behavior (varies by manufacturer).
• Verify gas supply reliability and have a backup source for transport and outages.
• Maintain strict clamp discipline and connection visibility to reduce air and leak risk.
• Document device serial numbers and consumable lot numbers for traceability.
• Stock critical disposables with safety buffer levels based on local lead times.
• Avoid component substitutions unless validated by policy and manufacturer guidance.
• Train for rare events with simulation (air entrainment, pump failure, oxygenator failure).
• Keep emergency clamps and a planned circuit-exchange pathway immediately available.
• Treat alarms as actionable safety signals; avoid silencing without investigation.
• Correlate console readings with patient exam, labs, imaging, and trends.
• Monitor cannula sites every shift for bleeding, migration, and infection risk.
• Secure cannulas to prevent traction during turns, procedures, and transport.
• Plan transport as a separate high-risk workflow with a time-out and contingencies.
• Track oxygenator performance trends, not just single blood gas values.
• Watch for rising oxygenator delta pressure as a potential early warning sign.
• Use structured handovers: flow, sweep, gas FiO₂, pressures, alarms, and patient status.
• Build a culture of near-miss reporting and learning, not blame.
• Engage biomedical engineering early for commissioning, PM schedules, and service planning.
• Maintain software/firmware version control if the device is updateable.
• Confirm cleaning and disinfection products are IFU-compatible (varies by manufacturer).
• Prioritize cleaning of touchscreens, knobs, handles, and cable junctions.
• Quarantine suspect components after events for investigation per policy.
• Clarify escalation pathways: ECMO lead, perfusion, surgeon, biomed, and vendor contacts.
• Audit staff competency regularly and retrain when exposure is infrequent.
• Consider total cost of ownership: console, disposables, service, training, and downtime risk.
• Ensure supply chain plans account for import delays and distributor limitations.
• Align procurement decisions with your hospital’s case mix and referral network role.
• Use protocol-driven criteria to avoid ad hoc initiation under pressure.
• Plan for ethical review and goals-of-care discussions in complex “bridge to decision” cases.
• Build ICU workflows to reduce clutter and minimize accidental line dislodgement.
• Standardize line labeling and tubing routing to reduce misconnections.
• Validate alarm limits for your patient population rather than relying on defaults.
• Ensure oxygenator and circuit storage meets environmental requirements in your facility.
• Keep a maintenance log that includes failures, repairs, and user feedback trends.
• Verify vendor service response times match the clinical reality of ECMO emergencies.
• Include infection prevention leadership in ECMO workflow and cleaning policy design.
• Integrate ECMO data documentation into ICU charting to reduce transcription errors.
• Review every ECMO case in multidisciplinary quality meetings for system improvement.
• Confirm training includes human factors: communication, fatigue, and situational awareness.
• Do not expand ECMO volume faster than staffing, training, and consumables allow.
• Treat every parameter change as a documented clinical intervention with rationale.
• Maintain clear criteria for escalation, weaning trials, and decannulation planning.

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