Reprocessor receives FDA clearance for 4 catheters
- Innovative Health said it received FDA clearance to reprocess four catheter brands, two from Medtronic and one each from Johnson & Johnson’s Biosense Webster division and Abbott’s St. Jude Medical.
- The Arizona-based company, which specializes in reprocessing catheters for the cardiology sector, said it has earned 23 FDA clearances in the past two years.
- Innovative Health collects used catheters from hospitals and then cleans, tests and sterilizes them for re-use in a proprietary process under FDA oversight.
The growing medical device reprocessing industry has emerged from hospitals’ drive to manage costs. Some hospitals save more than $1 million a year through FDA-cleared reprocessing of medical devices, and millions of pounds of medical waste are diverted from landfills, according to the Association of Medical Device Reprocessors.
FDA requires reprocessors to demonstrate that reprocessed devices are substantially equivalent to original equipment devices. In 2008, the U.S. Government Accountability Office reviewed FDA’s procedures for monitoring adverse event data related to reprocessed devices and said it found no reason to question FDA’s finding of no patterns that would point to such devices presenting an elevated health risk.
However, the practice of reprocessing medical devices has drawn new scrutiny more recently after infectious bacteria lingering in reprocessed duodenoscopes were linked to at least 35 deaths.
FDA earlier this year issued warning letters to three manufacturers of duodenoscopes — Olympus, Fujifilm and Pentax — for failing to conduct postmarket studies ordered in 2015 on the effectiveness of the devices, as part of an effort to prevent patient infections linked to reprocessing of the instruments.
Innovative Health focuses on catheters used in cardiology procedures and not duodenoscopes.
The four catheters that Innovative Health recently gained FDA clearance for are Abbott’s Advisor FL Circular Mapping Catheter, Medtronic’s Torqr and Marinr, and J&J’s Decanav. The devices are used to map cardiac tissues during ablation procedures.
“Now that we’ve received the clearance to begin reprocessing Decanav, Advisor, Torqr and Marinr, Innovative Health is clearly poised to dominate the reprocessing industry across all types of catheters,” Rick Ferreira, CEO of Innovative Health, said in a press release.
The company also reprocesses Abbott’s ViewFlex Xtra and all models of J&J’s Soundstar and Acunav catheters.
- Innovative Health Innovative Health Receives FDA Clearances to Reprocess St. Jude Medical’s Advisor™ FL, Two Medtronic Diagnostic Catheters and Biosense Webster’s DECANAV
- Healthcare Dive Seattle hospital wins $6.6M in Olympus medical scopes trial
- FDA FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance studies to assess contamination risk
- GAO FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk