FDA panel: 30-year-old ECMO therapy should be reclassified to lower-risk Class II

September 13, 2013 by Ingrid Mezo

An FDA advisory panel recommends reclassifying extracorporeal membrane oxygenator therapy from the highest-risk category to the less-risky Class II designation.

FDA panel: 30-year-old ECMO therapy should be reclassified to lower-risk Class II

An FDA panel yesterday recommended that the FDA reclassify membrane lung for long-term pulmonary support systems, or so-called extracorporeal membrane oxygenator circuits and accessories, from the highest-risk Class III category to the less burdensome Class II, with special controls.

ECMO systems, which have been available for around 30 years, provide assisted extracorporeal circulation and physiologic gas exchange of a patient's blood when an acute reversible respiratory or cardiac condition prevents the patient's own body from providing the physiologic gas exchange needed to sustain life, according to the FDA.

Doctors use ECMO systems as a last resort for patients who are unresponsive to optimal ventilation or pharmacologic management. As pre-amendments Class III devices, they currently require a 510(k) to get to market rather than the more burdensome pre-market approval required of Class III devices.

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In effect, ECMO systems already are Class II devices, because they are currently regulated as such, the panel pointed out.

"I want to address 2 comments. One is, how poorly individuals do who receive ECMO therapy," said Dr. Richard Lange of the University of Texas in San Antonio. "These are devices that are usually put in as a very last choice of treatment for individuals who fail medical therapy, and there really is no other therapy thought to be available to sustain their life, either for a reversible condition that they can get over, or a definitive therapy. So, it's sobering that patients do not do very well, but absent this, the thought is, as my colleagues mentioned, they would die.