Summary: Despite Extracorporeal Membrane Oxygenation (“ECMO”) gaining significance as part of critical care treatment in India, especially post-COVID-19, the regulations for ECMO treatment continue to be restricted to the Medical Devices Rules, 2017, and the device risk classification guidelines of the Central Drugs Standard Control Organization. This blog discusses the evolving regulatory regime in relation to ECMO in India, the lack of specific clinical governance protocols for ECMO treatment, and the need for such a protocol.
The Science behind ECMO
Extracorporeal Membrane Oxygenation (“ECMO”) provides advanced form of life support to patients experiencing severe but reversible cardiac or respiratory failure, when standard treatment measures prove insufficient. Initially conceived as part of a series of early experiments on artificial blood oxygenation in the 1940s, ECMO evolved into a legitimate technique in the 1970s and achieved wide recognition after COVID-19. ECMO operates as an external circulatory loop that extracts blood from the patient, adds oxygen to it, removes carbon dioxide, and then transfers it back into the bloodstream. It involves cannulation and uses an external pump and oxygenator to maintain temporary cardiac and/ or respiratory support until full recovery. ECMO is typically required for conditions like acute respiratory distress syndrome, respiratory failure, pulmonary embolism, cardiogenic shock, myocarditis, among others.
Even with its life-saving capacity, ECMO is a technically challenging procedure with numerous risks, including bleeding, infection, blood clots, stroke, circuit malfunction, kidney dysfunction, and limb ischemia. Hence, it is usually thought of as a last resort procedure. However, ECMO has increasingly become an important component of modern critical care practice, particularly in the aftermath of the COVID-19 pandemic.
From Niche Therapy to Critical Care Mainstay
While initially developed for serious cardiac or respiratory failures, ECMO has greatly outgrown its initial scope in the last 20 years. Currently, it is being applied in various critical care circumstances, such as acute respiratory distress syndrome, pulmonary embolism, cardiogenic shock, serious cardiac damage, as well as a bridging modality in cases requiring transplantation of hearts or lungs. The COVID-19 pandemic was a watershed moment for ECMO utilisation. Its popularity grew as it was administered to over 10,500 COVID-19 patients by November 2021. Scientific evidence showed positive results in select coronavirus-related respiratory insufficiency cases, leading to the establishment of various ECMO programmes and training opportunities globally. By August 2024, the number of global ECMO cases registered by Extracorporeal Life Support Organization (“ELSO”) exceeded 2,29,000. This rapid expansion of ECMO utilisation has highlighted the need for regulatory frameworks capable of addressing not only device safety and quality standards, but also broader issues relating to clinical governance, training, and service delivery.
ECMO in India: Between Medical Device Regulation and Clinical Governance
There is no established legal or clinical governance system in India, which deals with ECMO procedures as a whole. ECMO equipment is governed under the Medical Devices Rules, 2017 (“MDR 2017”), but ECMO clinical practice remains unregulated. The regulatory stance on ECMO use was clarified by the Central Drugs Standard Control Organization vide draft notification dated April 1, 2025, regarding “Revised Risk-Based Classification of Medical Devices under Cardiovascular and Neurological Categories”, wherein the CDSCO updated the classification of 351 cardiovascular medical devices, including ECMO systems as ‘Class C’ medical devices, placing them within the moderate to high-risk category under MDR 2017. Consequently, ECMO systems’ manufacturers/ importers fall under the MDR 2017 regulations for conformity assessment, quality management, licensing, and post-market surveillance that are relevant to class C medical devices.
ECMO is becoming a significant part of critical-care management facilities in India, especially since COVID. As reported by the ECMO Society of India, there are around 33 ECMO centers across the country, primarily located in metro cities like Delhi, Mumbai, Chennai, Bengaluru, Hyderabad, and Kolkata. Recently published industry reports also suggest that the National Pharmaceutical Pricing Authority (“NPPA”) has proposed that ECMO equipment be included in a national emergency medical equipment reserve, and even considered more stringent procurement criteria for suppliers, which could include quality certification, technical service infrastructures, and after sales support. They further note that the NPPA has temporarily allowed certain ECMO equipment manufacturers, listed in the national emergency medical equipment reserve, to provide after-sales support without setting up a local service hub. Instead, these manufacturers can use alternative solutions such as remote diagnostics and authorised service technicians.
Besides the regulation of medical devices, there is no overall national guidance on how ECMO services are to be provided in India. There are no national standards for accreditation, patient selection, staffing, transportation, emergencies, reporting outcomes, or registry inclusion. The regulatory position in India is nascent when compared to other jurisdictions with extended clinical governance and standard of care guidelines.
Beyond Device Regulation: ECMO Governance in the UK and the US
Unlike India’s technology-driven regulatory system, there are other countries that have adopted mechanisms for clinical management of ECMO. For instance, in the UK, the 2025 “British Societies Guideline on the Management of Emergencies in Patients on Extracorporeal Membrane Oxygenation” became the first nationally adopted, multi-societal guideline for ECMO emergencies. All 14 UK ECMO centers were involved in the drawing up of the guidelines. It standardises protocols for cardiac arrest recognition, ECMO circuit emergencies, team management, and advanced life support.
Similarly, in the US, although the use of ECMO devices is governed by the US Food and Drug Administration, clinical practices are governed by ELSO. ELSO has published comprehensive guidelines for ECMO centers, patient selection criteria, anticoagulation protocol, transport protocols, circuit management, and training. Although such guidelines are non-binding in nature, they serve as accepted standards, alongside ELSO registry that helps update the practice through data collection and analysis.
Conclusion
The growing reliance on ECMO in India raises the need for governing mechanisms beyond mere regulation of medical devices. ECMO is a complex procedure that requires specialised patient selection, emergency planning and management, patient transport, and outcome assessment. Hence, there is a need to formulate a governance framework specific to ECMO in India. Such a framework would not be unprecedented as the CDSCO has previously published the “Draft Guidance Document on Medical Device Software” to provide regulatory clarity for a specialised category of medical devices (namely, software as medical device). Similarly, dedicated guidance notes or circulars may be considered for ECMO, addressing minimum standards for ECMO centers, training and competency requirements, patient-selection criteria, emergency response protocols, outcome reporting, and quality-assurance mechanisms.