Invited Commentary: Another Healthcare Catch-22

The lack of heater-cooler unit (HCU) for extracorporeal membrane oxygenation (ECMO) therapy is a concerning issue that can have serious implications for patients in need of this lifesaving treatment. ECMO therapy is a complex procedure that requires precise temperature control to ensure the safety and well-being of patients. Without an adequate supply of HCU, healthcare providers may and do face significant challenges in delivering ECMO therapy effectively. The authors of the article, “Safety and Efficacy of Extracorporeal Membrane Oxygenation Heating Units”, in this issue, ¹ have clearly stated that the lack of FDA-approved HCU is the main reason for testing other options such as the Micro-temp (CSZ Medical) and the HTP-1500 (Adroit Medical), outside of manufactures instructions for use.

Temperature control is a critical aspect of ECMO therapy, as deviations from the optimal temperature range can lead to complications and compromise patient outcomes. Hypothermia or hyperthermia can have detrimental effects on the body, affecting organ function, blood coagulation, and overall patient stability. The HCU plays a vital role in maintaining the patient's blood at a consistent and appropriate temperature throughout the ECMO procedure. The authors showed that both systems tested provided adequate temperature control with the HTP-1500 achieving at a faster rate.

The shortage of heater-coolers for ECMO therapy puts healthcare providers in a difficult position, as they may have to resort to alternative measures or make do with suboptimal equipment. These workarounds can introduce additional risks and uncertainties into the treatment process. In some cases, providers may have to use makeshift heating or cooling methods that lack the precision and reliability of dedicated heater-coolers. This improvisation increases the likelihood of temperature fluctuations and compromises the quality of care provided to patients.

Moreover, the lack of heater-coolers can lead to delays or limitations in providing ECMO therapy to patients who urgently need it. ECMO is often used as a last resort for individuals with severe respiratory or cardiac failure, and timely access to appropriate equipment is crucial for their survival. Without sufficient heater-coolers, healthcare facilities may struggle to accommodate the demand for ECMO therapy, resulting in potential delays or even the inability to provide this life-sustaining treatment to critically ill patients.

The shortage of heater-coolers for ECMO therapy highlights the importance of addressing equipment availability and supply chain issues in healthcare systems. It underscores the need for proactive planning, adequate resource allocation, and effective communication among stakeholders involved in the delivery of ECMO therapy. Manufacturers, healthcare facilities, and regulatory bodies must collaborate to ensure an adequate supply of heater-coolers, along with rigorous maintenance and quality control processes. In addition, it will be necessary to verify the direction of any exhaust from the device to ensure microdroplets from the water tank are not directed toward the patient.

In conclusion, the lack of heater-coolers for ECMO therapy poses significant challenges for healthcare providers and compromises the quality of care for critically ill patients. Timely access to reliable and properly functioning heater-coolers is essential for maintaining optimal blood temperature during ECMO therapy. Addressing the shortage requires a comprehensive approach involving manufacturers, healthcare institutions, and regulatory bodies to ensure an adequate supply of these FDA-approved critical devices. There is a known fear by manufacturers of developing these units, due to the nontuberculous mycobacteria infections caused by any device that uses water. However, by developing small, inexpensive, easily replaceable units, we can enhance patient safety, improve outcomes, and optimize the delivery of ECMO therapy to those in need. Of note, there are heater-cooler units in development that do not use water as the temperature control liquid, electing to use polyethylene glycol. This eliminates the worry of infection from water-based pathogens. More institutions need to study and publish on the off-label use of heater units for ECMO, especially larger hospital systems. This will entice manufacturers to consider developing or updating their instructions for use to include ECMO.