Innovative Health has earned its 50th U.S. Food and Drug Administration (FDA) clearance to reprocess single-use medical devices used in electrophysiology and cardiology labs. The latest clearance authorizes the company to reprocess the Agilis NxT Steerable Introducer, originally manufactured by Abbott, for two additional uses in the laboratory. Innovative Health is the only reprocessing company that is cleared to reprocess this introducer two times.

An FDA clearance to reprocess a single-use device requires extensive reverse engineering, coding, cleaning research, and validation, as well as development of testing and inspection procedures. A narrow focus on cardiology and electrophysiology device technology has been the key to Innovative Health’s speed in getting FDA clearances: This focus has allowed the company to develop competencies in the technological, clinical, and regulatory aspects of device reuse within these clinical areas.

An increase in the number of times a device, such as the Agilis NxT Steerable Introducer, can be reused has a direct, positive financial impact in hospitals that use Innovative Health’s reprocessing program. FDA-cleared reprocessed devices are safe to use, and Innovative Health provides only functional, high-quality reprocessed devices to its partner hospitals.

“Fifty clearances in 10 years is something to be proud of,” Innovative Health CEO Rick Ferreira said. “A strong commitment to helping healthcare facilities drive down procedure costs, a positive, collaborative partnership with FDA, and our staff of experienced reprocessing professionals have made this possible. This is also what will make more clearances in the future possible.”

This 50th FDA clearance occurs as Innovative Health expands its customer base and implements sustainable reprocessing technologies in its Scottsdale, Ariz., reprocessing plant.

Innovative Health is an advanced medical device reprocessing company that offers smarter utilization of medical devices in hospitals’ cardiology and electrophysiology programs.