Hospitals and third-party companies have long been cleaning, retesting, and reusing medical devices, including those labeled as single-use, an approach known as “reprocessing.”
Often, this can help cut down medical waste and save money, and it doesn’t appear to compromise safety: As of 2000, the FDA requires reprocessed devices to meet the same formal regulatory standards of the original products, including premarket testing.
In 2008, the Government Accountability Office found that “the available data, while limited, do not indicate that reprocessed [single-use devices] present an elevated health risk.”
However, the use of these refurbished devices still faces resistance from original manufacturers, who profit more from the devices being disposed of after one use or reprocessing devices themselves, according to a 2020 review in Health Affairs.
The medical reprocessing industry hopes a recent court ruling may change that.
The ruling. On May 16, a California jury unanimously found Biosense Webster—now Johnson & Johnson Medtech—violated antitrust laws by not providing the same clinical support for one third-party company’s reprocessed version of catheters that it does for new versions.
Then on June 5, the damages were automatically tripled, increasing J&J Medtech’s penalty for this violation from $147 million to $442 million in damages. The pharma giant must pay this out to the company that brought the suit, Innovative Health.
“Going forward, given this is such a big verdict, my hope is that the larger medtech industry will work with us instead of against us,” Dan Vukelich, president of trade group the Association of Medical Device Reprocessors, told Healthcare Brew.
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J&J Medtech rejected these claims. “We strongly disagree with the jury’s verdict and believe it will not withstand appellate review. In the meantime, we will comply with the ruling and any court-ordered relief pending the outcome of the appellate process,” J&J spokesperson Madeline Nafus told Healthcare Brew.
Tell me more. The lawsuit was brought by Innovative Health, a company based in Arizona that reprocesses J&J Medtech catheters for electrophysiology studies, which measure heart activity in order to diagnose abnormal heart rhythms.
J&J Medtech sells its catheters as single-use devices to hospitals. The FDA had also approved Innovative Health to reprocess and sell used catheters back to hospitals for one to three more uses in 2009, according to Innovative’s complaint.
But the suit alleges J&J Medtech policies have penalized hospitals that use Innovative Health’s reprocessed versions.
For instance, the catheters can only be used with a specific J&J brand cardiac mapping system that requires clinical support to operate. J&J Medtech offers free clinical support to providers, but about 10 years ago, it started withholding that clinical support when providers used reprocessed catheters from Innovative Health, the suit alleges.
It’s important to make reprocessing easier in order to cut down on medical waste and patch medical device supply chain vulnerabilities, Vukelich added.
“This case is an opportunity for us to highlight with our healthcare provider partners or hospitals and surgical centers that they don’t need to tolerate this anymore. They should forcefully push back—and now more than ever,” he said.