Innovative Health, Inc. announced that it has received its 31st FDA clearance for reprocessing Electrophysiology (EP) devices since the company’s inception in 2016. Single-use device (SUD) reprocessing is an FDA regulated and sanctioned activity restricted to registered medical device reprocessors that can demonstrate that their reprocessed devices are substantially equivalent to predicate (new) devices and pose no added safety risk to patients.
Innovative Health specializes in reprocessing SUDs for use in cardiac procedures. Reprocessed SUDs typically cost the hospital and the EP lab 50% less than new devices, and usage of reprocessed cardiology devices can aggregate to hundreds of thousands of dollars in savings every year.
Since the company’s foundation, Innovative Health has pursued more advanced reprocessing technologies in order to reprocess complex cardiology devices. As a result, the company has received eight new clearances to reprocess single-use cardiology devices in 2019 alone. Out of these, three clearances are for devices that no other company is cleared to reprocess.
Innovative Health CEO Rick Ferreira says: “Each of these devices represents a new savings opportunity that the EP labs cannot achieve unless they work with us. A single reprocessing round of these three devices together adds savings of more than $1,500 to the EP lab and presents a compelling proposition.”
